Cheryl Iglesia, MD

In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management: Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

• iatrogenic injury and tissue seeding of both benign and malignant tissue
• exacerbation of any occult malignancy and possible worsening of prognosis
• missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.¹ And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.^1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management: If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management: Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted. Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management: Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

• iatrogenic injury and tissue seeding of both benign and malignant tissue
• exacerbation of any occult malignancy and possible worsening of prognosis
• missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.¹ And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.^1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management: If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management: Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted. Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the absence of a definitive FDA decision on the future of power morcellation in minimally invasive gynecologic surgery, many surgeons have stopped offering the option, often in response to constraints placed by their institutions, or have greatly expanded the informed consent discussion.

In Part 1 of this two-part roundtable discussion, which appeared in the September 2014 issue of OBG Management, our expert panelists discussed their current approach to tissue extraction during hysterectomy and myomectomy, as well as their preferred approach to both procedures amid this changing surgical environment. Here, in Part 2, they discuss patient counseling and the likely effects of FDA action.

How has your counseling changed?
OBG Management: Given recent concerns about the use of power morcellation, how has your counseling of the patient changed?

Kimberly Kho, MD, MPH: Though I look forward to the development of instruments and techniques that will make contained power morcellation safer, I am not using it currently and have been able to find minimally invasive alternatives such as minilaparotomy and vaginal removal of masses for the cases I would have considered for power morcellation.

Certainly, with power morcellation or any type of morcellation, it’s important to discuss the risks and benefits, as well as alternatives. Discussion should include the potential for:

• iatrogenic injury and tissue seeding of both benign and malignant tissue
• exacerbation of any occult malignancy and possible worsening of prognosis
• missing or mischaracterizing an occult malignancy.

Although there is no surefire way to avoid cellular dissemination with any type of surgery, I think it’s equally important to explain that, often, the only way to completely avoid fragmenting a large mass is to remove it en bloc, which would mean a large laparotomy for many patients. Women should understand the risks of laparotomy as well, including more frequent wound complications, longer hospitalization, and slower recovery.

Arnold P. Advincula, MD: If a clinician anticipates or plans the use of power morcellation, he or she certainly needs to go through an informed consent process with the patient. This process may include a separate form specific to power morcellation as well as detailed documentation during the preoperative visit.

OBG Management: What elements of the preoperative visit do you believe are important to document?

Dr. Advincula: It is important to clearly document the indications and alternatives for the surgery, as well as the decision-making process that led to the selection of a particular procedure and route of access. If any type of morcellation (power-driven or not) is anticipated, then the risks associated with it must be thoroughly discussed and documented in addition to the standard risks associated with any type of abdominal-pelvic surgery. No surgical procedure is without risks. Therefore, the process of informed consent cannot be taken lightly and is a critical part of the process that allows a patient to decide upon a particular intervention.

Jason D. Wright, MD: I believe the current role of power morcellation is limited. Patients considering the procedure should be counseled about the risks of cancer as well as other adverse pathologic abnormalities, including smooth muscle tumors of uncertain malignant potential, disseminated leiomyomatosis, and endometrial hyperplasia that may be associated with an occult cancer.

OBG Management: Do you recommend a separate consent form for power morcellation, as Dr. Advincula suggested?

Dr. Wright: Given the risk of adverse pathology, I think the role of electric power morcellation is limited. Patients should be carefully counseled about alternative surgical approaches that avoid tissue disruption and understand that the sensitivity of preoperative testing and intraoperative evaluation of smooth muscle neoplasms is limited. Further, patients considering contained morcellation also should be informed that the data examining the efficacy of these techniques are sparse.

Linda D. Bradley, MD: As I mentioned in Part 1 of our discussion, I’m giving patients new information about our concerns regarding occult malignancy, quoting the risk estimates given by the FDA this year.¹ And the fact that we no longer use power morcellation at the Cleveland Clinic means that I no longer discuss it as an option, although one or two patients have asked for it in recent months.

I think many patients have read about it in the news or, once hysterectomy or myomectomy was planned, found discussion of the controversy surrounding it during their research. I’ve even had patients who underwent hysteroscopic myomectomy 2 or more years ago contacting me to find out whether power morcellation was used, and I have had to explain that hysteroscopic morcellation is different from the laparoscopic variant.

Patients are critical readers and are much more knowledgeable as a result of social media, so I do find myself spending more time discussing their procedure with them.

For myomectomy in particular, we send for a frozen section intraoperatively. Although that approach still is not 100% sensitive, it does guide what we do during surgery. If a sarcoma is found, for example, we call in the oncologists. I discuss that possibility with the patient as well. So I am spending more time with patients, but I don’t go into power morcellation because that is no longer an option for me.

OBG Management: Dr. Iglesia, has your counseling of patients changed in any way?

Cheryl Iglesia, MD: I do not routinely use power morcellation. However, the findings from the FDA and Dr. Wright about the higher risk of occult malignancy in fibroids is information I share with patients preoperatively.^1,2

For women with fibroids who want uterine conservation procedures or who desire medical management, such as focused ultrasound or uterine fibroid embolization, MRI is routine. However, we make patients aware that this imaging modality is not 100% sensitive in detecting occult cancer—and neither are random biopsies of fibroids. Patients also need to be made aware that treatment with fibroid embolization or other medical options also could delay the detection of cancer and sarcoma. Any morcellation technique (power, hand, vaginal) does have the risk of potential cancer spread and upstaging, so morcellation should not be used in any women with suspected or known malignancy.

Effects of likely FDA actions
OBG Management: If the FDA decides to ban power morcellation outright, in some ways the approach to patient counseling will be simpler, as one option will have been permanently eliminated. But if the FDA allows power morcellation to continue, with stricter labeling, would that affect how you counsel patients? And would you reconsider power morcellation in that light?

Dr. Kho: I think the current discussion has highlighted again how important the informed consent process is as an opportunity for information sharing. It’s an ongoing discussion of risks, benefits, and alternatives. It also offers us an opportunity to understand the patient’s values and perspectives throughout the process of surgical planning. So, no, I don’t think the FDA’s actions will change how I counsel patients. Regardless of the FDA’s decisions, I think open power morcellation as we currently know it may be obviated as new instruments for contained morcellation—as well as other techniques we’ve discussed—become more popular. But it’s critical that we meaningfully monitor these techniques for long-term safety. In order to make evidence-based decisions, we will need good data.

Dr. Iglesia: I cannot comment on a final FDA decision. However, my feeling is that any information that patients can use to become educated about treatment alternatives—including the risks and benefits of each option—will help inform and improve the shared decision-making process.

Dr. Advincula: Regardless of the verdict rendered by the FDA, the way we approach tissue extraction in minimally invasive surgery has been changed forever. It is always important to take a critical look at the way things are done, but not at the expense of throwing the proverbial baby out with the bath water. If power morcellation were to remain a viable option, my counseling would remain as is, as it already has been modified and quite detailed in the wake of this whole controversy. I still believe there is a role for power morcellation, albeit modified from its current iteration, when applied by the right physician in a properly evaluated patient with the right indication.

Summing up
OBG Management: Do you have any additional comments about this issue?

Dr. Advincula: The ability to accurately and reliably detect an occult uterine malignancy—specifically, leiomyosarcoma—is lacking at present. Whether or not power morcellation remains a viable option in the future, the bottom line is that patients will still present with occult uterine malignancy. Minimizing the mishandling of this unfortunate diagnosis will depend on sound clinical judgment as well as improvements in diagnosis. It always will be important to avoid blaming the lack of sound clinical practice on surgical devices that, when used appropriately, have the potential to benefit the majority of women.

Dr. Kho: The current attention on power morcellators presents an opportunity to improve upon our current practices and find solutions to the issues we are encountering. I think this is an exciting time for examining preoperative risk stratification, the innovation of new techniques, repopularization and improvement of older ones such as vaginal tissue extraction, and, overall, to improve our system of safety monitoring and surgical device surveillance.

Dr. Iglesia: Intraperitoneal power morcellation should not be used in cases of malignancy or suspected malignancy or in postmenopausal patients with bleeding or growing fibroids. The availability of power morcellators may be limited as manufacturers
 cease distribution, hospitals ban use, or insurers refuse payment for use.

Alternative minimally invasive approaches—especially the transvaginal approach—should be considered, since there are fewer complications associated with vaginal surgery, especially compared with open and laparoscopic surgery.

Dr. Wright: Although electric power morcellation may allow some women to undergo a minimally invasive procedure, the data currently available clearly suggest that adverse pathology is more common in women who undergo morcellation than was previously thought.

Although the debate around morcellation has focused on leiomyosarcoma, epithelial endometrial tumors and other preinvasive abnormalities are also common. These unexpected pathologic findings in women who underwent electric power morcellation highlight the importance of performing more rigorous evaluation of new methods of tissue extraction.

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page, and then see how your peers have voted. Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

As a member of the Obstetrics & Gynecology Devices Panel FDA Advisory Committee, Dr. Iglesia digested the information presented at the hearing on July 10 and 11 and made her recommendations, along with her fellow panel members, for the fate of laparoscopic power morcellators to the FDA. Tune in to this special audiocast to hear Dr. Iglesia discuss the specific issues the panel weighed when making their final recommendations.

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Associate Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She also serves on the OBG Management Board of Editors.

TRANSCRIPT

Janelle Yates:   OBG Management Editorial Board Member Dr. Cheryl Iglesia attended the July 10th and 11th FDA hearing on microscopic power morcellation as a member of the Obstetrics and Gynecology Devices Panel Advisory Committee. In this audiocast, she describes the hearing and the panel’s recommendations as well as many of the fine points considered in weighing the risks and benefits of power morcellation. Dr. Iglesia is Director of the Section of Female Pelvic Medicine and Reconstructive Surgery at MedStar Washington Hospital Center, and Associate Professor in the Departments of Ob/Gyn and Neurology at Georgetown University’s School of Medicine in Washington, DC.

Dr. Iglesia, could you describe your role on the FDA’s Obstetrics and Gynecology Device Panel Advisory Committee?

Cheryl B. Iglesia, MD:         I’m considered a special government employee and I have a 5-year term on the ObGyn Devices Panel. I was a member of the panel that reviewed vaginal mesh, and this is my second ObGyn devices panel as a consultant on power morcellation for laparoscopy. After the hearing, which was July 10th and 11th, we make recommendations as a panel but no final decisions are made until everything has been reviewed by officials at the FDA, and the FDA will come up with final decisions based in part on some of the recommendations that the panel has made. Therefore I can’t give you an official view, and what I’ll be talking about right now mostly represents my own opinion.

Ms. Yates:     Just to review: What was the goal of the 2-day hearing, and whose points of view were represented to the panel?

Dr. Iglesia:    The goal was to discuss the risk of disseminating unsuspected uterine malignancy with power morcellation. We talked on the panel about what the risk is of occult leiomyosarcoma in women with uterine fibroids. We talked about the preoperative screening evaluation process, talked about options for interoperative strategies to minimize or mitigate intraperitoneal fragmentation or dissemination of the tissue. They talked about various types of morcellators and, moving forward, if leiomyosarcoma was diagnosed, whether or not power morcellation upgraded an occult malignancy. And what the benchmarks should be for future devices, and whether or not future devices— not just for the power morcellators with containment, like containment bags—how they should be evaluated and tested moving forward. There was also some discussion about the role of registries.

Ms. Yates:     What final recommendations did the panel make to the FDA?

Dr. Iglesia:    Overall, there was a very long discussion about the risk of having an unsuspected sarcoma and the rates ranged from one in 350 to one in 7,450. What we as a panel realized is that while there are some indicators that could be suspicious for leiomyosarcoma, particularly on an MRI, that one cannot be 100% certain, particularly when you have a fibroid that’s degenerating, that it’s not just leiomyosarcoma but other occult malignancies.

The bottom line is the patients must be adequately worked up, particularly if there is abnormal bleeding. An evaluation would include normal cervical cytology, normal endometrial sampling, either sonograms or MRIs if indicated, and we talked about patient selection. In particular of being very worried about using morcellation in the postmenopausal woman who’s bleeding. We talked a lot about other options for morcellation. In general, if you can remove a uterus through the vagina or intact, that’s ideal because there’s a lot of data about the pros and cons from the vaginal approach to hysterectomy. But we’re not 100% certain that containment bags are going to be the “be-all and end-all.” In that, particularly if you’re doing subtotal hysterectomies, you still might be cutting through cancers and occult malignancies and the containment bags are very thin so that there’s a possibility that there could be leakage and/or breakage or unintended injury to other interperitoneal organs like bowels and vessels, etc. So we can’t be complacent about being 100% certain that things will go right even with the use of a bag.

Ms. Yates:     Were there any final recommendations about informed consent?

Dr. Iglesia:    A lot of discussion, particularly on the second day, was in the area of labeling special controls and it would be labeling for a patient and practitioners or physician surgeons who are using the morcellator. To the extent that—and there have been some precedents I think in silicon breast and other devices—where both the patient and the physician have to sign off that they’re aware that morcellators may be used, that there’s a potential for dissemination of an occult malignancy or even dissemination of benign disease like leiomyomatosis and incomplete removal. There are risks of using the morcellator in terms of injury, just a whole checklist. But it’s interesting for the labeling, both the patient and the physician in this: One of the recommendations for special controls would be included.

Ms. Yates:     And would that involve a black box warning?

Dr. Iglesia:    I think there were several discussions about the black box warning; I’m not sure what the final discussion is. Some people believe that with the black box on an administrative level, it sends a signal and a reminder to everyone about the labeling. But labeling can be done without a black box and it can be done with a black box. I’m not 100% certain how that will ultimately be decided upon by the FDA.

Ms. Yates:     What were your reactions to the hearing, apart from your role on the panel? Did you feel that adequate testimony was heard from all the parties that have a stake in the immediate and long-term fate of laparoscopic power morcellation?

Dr. Iglesia:    I think that the FDA did an excellent job in convening all the players, anybody who has interests in the stake I feel was represented--from industry and companies that make morcellators, companies that make containment bags, medical societies, ACOG, and AAGL gave testimony. AAGL’s testimony was very powerful, particularly by Dr. Jubilee Brown in mentioning that without the morcellator more women may be subjected to abdominal procedure, which in and of itself has some morbidity and mortality associated with that type of operation, and it was a nice study analysis. In terms of a decision tree what the potential harms would be without available morcellators to use, and I thought the MRI imaging that was done by the radiologist was also very interesting and discussed the limits of our ability to detect.

I also found some of the testimony to be extremely powerful from the patients, including that of Dr. Amy Reed and her family and the other women who presented. In some of the cases, we and several people on the panel, including myself, did wonder about the selection or the choice to use the morcellator in the first place in some cases, particularly in women who had uterine fibroids and they were postmenopausal. I think that that would be a particular case where you know go ahead and make an incision because there’s a potential higher index of suspicion for cancer in those kinds of cases.

Ms. Yates:     Do you care to predict whether gynecologic surgeons will continue to use power morcellators after this controversy?

Dr. Iglesia:    You know, and this was also discussed by Dr. Fisher and some of the officials from the FDA, that if anything this would be a call for innovation and improving products that could morcellate and contain at the same time. I know that we have some hysteroscopic morcellators that you can insert and there’s a vacuum and so things get kind of vacuumed up and whether or not we can develop something that has very little spill—obviously none at all would be key—and I do believe that at some point there will be some ingenuity and some improvements made to the current devices that will allow us to continue this is in our armamentarium.

What was interesting was that one of the questions that was addressed to the panel was, “When do you see that the benefits may outweigh the risks, in what population?” And leiomyosarcoma, which is just one of the occult malignancies—and there’s different types of sarcomas including endometrial stromal sarcomas and other endometrial cancer and malignancies. What’s interesting is that when you look at fibroids and even when you do a myomectomy it’s not necessarily just the power of morcellation, it’s just cutting through cancer or morcellating either vaginally or open. You’re doing an open myomectomy, just removal of the fibroid, and it turns out that that’s cancer. You know that is not a good prognosis to start with, but to spread it clearly is not good for the patient and makes a bad condition even worse.

But it really means that we need to do a better job in pretty accurately identifying patients. And while we’re there, we did mention on the panel that maybe we can develop risk calculators or ways to stratify based on the MRI imaging, patient age, patient race, and whether or not something has a higher index of suspicion for being cancerous. What I meant to say is the two benefits outweigh the risk.

One other case was the young 20-something-year-old fertility patient with the fibroids that clearly have an impact. I mean you don’t want to do a hysterectomy and you still want to remove the fibroid in as noninvasive a way as possible and morcellation may be the best in terms of creating less adhesions. The other case was something that I had mentioned in patients who have prolapse who you’re thinking about placing mesh. Some people do subtotal hysterectomies and then attach the mesh to the cervix as opposed to the vaginal cuff to decrease the risk of cuff erosion and that’s another technique where benefits might outweigh the risk, particularly in older postmenopausal women with not particularly enlarged uteri. So, more to come. 

The authors would like to acknowledge Lauren Melcher, MD, an ObGyn resident at Washington Hospital Center, who contributed to this article.

CASE: New-onset dyspareunia in a menopausal patient

J. B., 53 years old, has been menopausal for 2 years. Several months after her annual examination, she schedules another appointment to discuss a worsening complaint: dyspareunia. She says she never had the problem until she reached menopause, and reports that it has become so severe that she has started avoiding sexual intercourse altogether. Even when she avoids intercourse, however, she is bothered by vaginal itching and burning.

What can you offer to her?

Various hormonal and nonhormonal products are available to relieve the frequent complaint, in menopausal women, of symptoms of vaginal atrophy: vaginal dryness, itching, burning, and dyspareunia.^1-3 The array of products isn’t really surprising: As women advance through menopause, their complaints of vaginal dryness increase fivefold.⁴

Systemic and local estrogen therapies reverse some atrophic changes and alleviate symptoms.⁵ After menopause, local vaginal estrogen formulations are recommended as first-line treatment for women who experience moderate or severe symptoms of vaginal atrophy.³ Formulations such as the vaginal ring, vaginal tablet, and transdermal gels and sprays are increasingly popular.

In this article, we describe these and other products, including nonhormonal lubricants and moisturizers, to relieve:

• the range of symptoms of vaginal atrophy in menopausal women
  
• isolated vaginal dryness in premenopausal women.
  

Is hormonal therapy always necessary?

When a postmenopausal woman complains of chronic vaginal dryness, and the exam is consistent with vaginal atrophy, the recommended treatment is local vaginal estrogen. If she complains of vaginal dryness during sexual intercourse only, a vaginal lubricant is a suitable option.

When a premenopausal woman complains of vaginal dryness, a vaginal moisturizer is the best long-term treatment option. However, a vaginal lubricant is recommended for intermittent dryness during intercourse or dyspareunia.

Local estrogens avoid many risks of systemic therapy

Topical estrogen preparations are available as vaginal creams, tablets, and rings, and as transdermal lotions, gels, and patches (TABLE 1). Local preparations are preferred to systemic therapy for the treatment of atrophy because they bypass the gastrointestinal tract, undergo less conversion in the liver, and improve local tissue with minimal elevation of the serum estradiol level.^1,3

The vaginal ring (Estring) delivers the lowest systemic estradiol level—approximately 5 to 10 μg of estradiol daily. Femring delivers more estradiol daily and requires the addition of progesterone in women who have an intact uterus.

Studies suggest that patients favor the estradiol-releasing vaginal ring because of its ease of use, comfort, and effectiveness, compared with vaginal estrogen cream.^2,5

Local estrogen formulations were compared and reviewed in a systematic Cochrane meta-analysis of 19 trials that included 4,162 women.⁵ Vaginal cream, tablets, and rings were all equally effective in treating symptoms of atrophy. One trial found that cream (conjugated equine estrogen) increased the risk of uterine bleeding, breast pain, and perineal pain, compared with vaginal tablets.

Newer estrogen formulations include topical and transdermal patches, gels, lotions, and sprays (TABLE 1), all of which are systemic. They are effective in the treatment of vasomotor symptoms and vaginal atrophy.

TABLE 1

Topical estrogen formulations—a rundown of local and systemic options

When to add a progestin

A progestin is recommended in addition to a systemic estrogen formulation in women who have a uterus. For low-dose, local vaginal estrogen formulations, a progestin is usually not needed.³ However, when the treatment is vaginal cream, consider progestin supplementation when the dosage exceeds 0.5 g twice weekly for an extended time (>1 year).

The serum estrogen level with local vaginal treatment is dose-dependent, and the long-term endometrial effects of vaginal estrogens are unknown. If vaginal bleeding develops, a workup is indicated and may necessitate imaging of the endometrial echo or endometrial sampling to rule out hyperplasia, neoplasia, and cancer.

Counsel the patient about any risks

If you prescribe transdermal or oral estrogen for a patient, be sure to counsel her about the risks of systemic therapy described in the Women’s Health Initiative.⁶

Consider the patient’s preference

Local estrogen treatment is recommended over systemic therapy for vaginal atrophy, but patient preference should also be considered. Some women may prefer the ring or tablet to minimize excess vaginal discharge, while others may prefer a cream because of its soothing effects. Always individualize management!

Lubricants and moisturizers

Insufficient lubrication during intercourse is a common complaint among both premenopausal and postmenopausal women: As many as 60% of women report intermittent episodes of insufficient lubrication.⁷

Many women and their partners use a vaginal lubricant to assist with sexual relations and to self-treat for pain. A wide variety of nonhormonal products are available—many of them advertised at pharmacies and in the media—despite little published scientific evaluation. Because gynecologists routinely counsel patients on sensitive matters, including sexual practices, you may find it valuable—with appropriate candidates—to open a line of questioning about difficulties with intercourse and resulting attempts to self-medicate using over-the-counter products.

What are the indications?

A vaginal lubricant is a solution used locally, and as a temporary measure, to moisten the vaginal epithelium to facilitate a medical examination or sexual intercourse.² Because it has a short duration, it must be applied at the time of intercourse. Lubricants can be categorized as water-, silicone-, and oil-based. Each formulation may affect the local inflammatory response, viability of sperm, and condom integrity.

A vaginal moisturizer is a gel or cream used regularly to maintain hydration of the vaginal epithelium for long-term relief of vaginal dryness.²

Both lubricants and moisturizers have many indications for both medical and personal use. Personal lubricants can be used for assistance during sexual activity, such as intercourse, masturbation, or use of sex toys. These products reduce friction and are thought to enhance pleasure in women who suffer from vaginal dryness. However, we lack sufficient data to confirm that lubricants can improve sexual dysfunction and vaginal atrophy. In general, these products are affordable, readily available, and may be helpful in the treatment of sexual dysfunction and vaginal dryness.

See TABLE 2 for a list of personal lubricants and vaginal moisturizers.

TABLE 2

Vaginal moisturizers and lubricants are plentiful and diverse

What to offer when estrogen is not an option

Some women may want to avoid hormonal treatment, or have a contraindication to it, such as estrogen-receptor–positive breast cancer.⁸ In premenopausal women, vaginal atrophy can occur with lactation or postpartum hormonal changes, or may result from the use of anti-estrogenic agents for breast cancer. Other candidates for nonhormonal therapy are women who have chronic vulvar pain syndromes. In these women, vaginal lubricants can be especially useful.

Although they are less effective than estrogen, vaginal moisturizers, such as Replens, have been shown to reverse symptoms of vaginal atrophy and decrease discomfort during intercourse.⁹

Specialty lubricants are unproven

In contrast to products designed to treat vaginal dryness and atrophy, some lubricants are marketed specifically for sexual enhancement. Warming lubricants cause a heating sensation on the skin and usually contain menthol, L-arginine, or capsaicin. Natural and artificial flavors are used to manufacture flavored lubricants.

None of these products have been scientifically proven to enhance sexual function.

Oil-based lubricants may impede condom integrity

It is estimated that 40% of couples who use condoms also use a lubricant to assist with intercourse.¹⁰ The integrity of latex condoms has been shown to deteriorate with the use of an oil-based lubricant or petrolatum. One study, in which the mean burst time of condoms was assessed during pressurized air inflation, showed a significant reduction in that time when vaginal lubricants that contained mineral or vegetable oil were used.¹¹

Oil-based lubricants also have been shown to increase the slippage rate, with a trend toward increased breakage.¹⁰

Water-based lubricants may slightly increase slippage, but they reduce breakage.

Women should avoid oil-based lubricants when their partner uses a condom.

Some lubricants affect sperm quality

Choosing a vaginal lubricant can be of particular concern to a woman who is being treated for infertility. Lubricants may affect the integrity and function of sperm, even if they do not contain spermicide. Noncommercial products, such as glycerin, olive oil, vegetable oil, and, even, saliva have been associated with a loss of sperm function.¹²

A recent study found that Replens and Astroglide cause a dramatic decrease in sperm motility. FemGlide causes less of a decrease—but still a significant one.¹² The nonphysiologic osmolality and pH of these products may be the cause of such sperm damage. Pre-Seed, which has a more physiologic pH level and isotonic quality, was found to cause minimal harm to sperm motility and chromatin quality.¹²

Avoid propylene glycol in women who have vulvodynia

Vaginal lubricants and moisturizers are also used in the treatment of vulvodynia or chronic vulvar pain syndromes. According to an ACOG Committee Opinion, topical application of preservative-free solutions, such as vegetable oil or plain petrolatum, is recommended to hold moisture within the tissues and provide a protective barrier.¹³ Adequate lubrication is also recommended during intercourse.

Products that contain propylene glycol, or alcohol, may act as an irritant in women who experience local pain and heightened vaginal sensitivity. For that reason, such products should be avoided in this population.

CASE RESOLVED

Careful examination reveals urogenital atrophy with absence of any fungal or bacterial infection of the vulva or vagina. The patient chooses to use a water-based lubricant during sexual relations and begins using intravaginal estradiol tablets (other options include the vaginal ring or cream). Symptoms of dyspareunia disappear almost immediately, and vaginal burning improves after 6 weeks.

The authors would like to acknowledge Lauren Melcher, MD, an ObGyn resident at Washington Hospital Center, who contributed to this article.

CASE: New-onset dyspareunia in a menopausal patient

J. B., 53 years old, has been menopausal for 2 years. Several months after her annual examination, she schedules another appointment to discuss a worsening complaint: dyspareunia. She says she never had the problem until she reached menopause, and reports that it has become so severe that she has started avoiding sexual intercourse altogether. Even when she avoids intercourse, however, she is bothered by vaginal itching and burning.

What can you offer to her?

Various hormonal and nonhormonal products are available to relieve the frequent complaint, in menopausal women, of symptoms of vaginal atrophy: vaginal dryness, itching, burning, and dyspareunia.^1-3 The array of products isn’t really surprising: As women advance through menopause, their complaints of vaginal dryness increase fivefold.⁴

Systemic and local estrogen therapies reverse some atrophic changes and alleviate symptoms.⁵ After menopause, local vaginal estrogen formulations are recommended as first-line treatment for women who experience moderate or severe symptoms of vaginal atrophy.³ Formulations such as the vaginal ring, vaginal tablet, and transdermal gels and sprays are increasingly popular.

In this article, we describe these and other products, including nonhormonal lubricants and moisturizers, to relieve:

• the range of symptoms of vaginal atrophy in menopausal women
  
• isolated vaginal dryness in premenopausal women.
  

Is hormonal therapy always necessary?

When a postmenopausal woman complains of chronic vaginal dryness, and the exam is consistent with vaginal atrophy, the recommended treatment is local vaginal estrogen. If she complains of vaginal dryness during sexual intercourse only, a vaginal lubricant is a suitable option.

When a premenopausal woman complains of vaginal dryness, a vaginal moisturizer is the best long-term treatment option. However, a vaginal lubricant is recommended for intermittent dryness during intercourse or dyspareunia.

Local estrogens avoid many risks of systemic therapy

Topical estrogen preparations are available as vaginal creams, tablets, and rings, and as transdermal lotions, gels, and patches (TABLE 1). Local preparations are preferred to systemic therapy for the treatment of atrophy because they bypass the gastrointestinal tract, undergo less conversion in the liver, and improve local tissue with minimal elevation of the serum estradiol level.^1,3

The vaginal ring (Estring) delivers the lowest systemic estradiol level—approximately 5 to 10 μg of estradiol daily. Femring delivers more estradiol daily and requires the addition of progesterone in women who have an intact uterus.

Studies suggest that patients favor the estradiol-releasing vaginal ring because of its ease of use, comfort, and effectiveness, compared with vaginal estrogen cream.^2,5

Local estrogen formulations were compared and reviewed in a systematic Cochrane meta-analysis of 19 trials that included 4,162 women.⁵ Vaginal cream, tablets, and rings were all equally effective in treating symptoms of atrophy. One trial found that cream (conjugated equine estrogen) increased the risk of uterine bleeding, breast pain, and perineal pain, compared with vaginal tablets.

Newer estrogen formulations include topical and transdermal patches, gels, lotions, and sprays (TABLE 1), all of which are systemic. They are effective in the treatment of vasomotor symptoms and vaginal atrophy.

TABLE 1

Topical estrogen formulations—a rundown of local and systemic options

When to add a progestin

A progestin is recommended in addition to a systemic estrogen formulation in women who have a uterus. For low-dose, local vaginal estrogen formulations, a progestin is usually not needed.³ However, when the treatment is vaginal cream, consider progestin supplementation when the dosage exceeds 0.5 g twice weekly for an extended time (>1 year).

The serum estrogen level with local vaginal treatment is dose-dependent, and the long-term endometrial effects of vaginal estrogens are unknown. If vaginal bleeding develops, a workup is indicated and may necessitate imaging of the endometrial echo or endometrial sampling to rule out hyperplasia, neoplasia, and cancer.

Counsel the patient about any risks

If you prescribe transdermal or oral estrogen for a patient, be sure to counsel her about the risks of systemic therapy described in the Women’s Health Initiative.⁶

Consider the patient’s preference

Local estrogen treatment is recommended over systemic therapy for vaginal atrophy, but patient preference should also be considered. Some women may prefer the ring or tablet to minimize excess vaginal discharge, while others may prefer a cream because of its soothing effects. Always individualize management!

Lubricants and moisturizers

Insufficient lubrication during intercourse is a common complaint among both premenopausal and postmenopausal women: As many as 60% of women report intermittent episodes of insufficient lubrication.⁷

Many women and their partners use a vaginal lubricant to assist with sexual relations and to self-treat for pain. A wide variety of nonhormonal products are available—many of them advertised at pharmacies and in the media—despite little published scientific evaluation. Because gynecologists routinely counsel patients on sensitive matters, including sexual practices, you may find it valuable—with appropriate candidates—to open a line of questioning about difficulties with intercourse and resulting attempts to self-medicate using over-the-counter products.

What are the indications?

A vaginal lubricant is a solution used locally, and as a temporary measure, to moisten the vaginal epithelium to facilitate a medical examination or sexual intercourse.² Because it has a short duration, it must be applied at the time of intercourse. Lubricants can be categorized as water-, silicone-, and oil-based. Each formulation may affect the local inflammatory response, viability of sperm, and condom integrity.

A vaginal moisturizer is a gel or cream used regularly to maintain hydration of the vaginal epithelium for long-term relief of vaginal dryness.²

Both lubricants and moisturizers have many indications for both medical and personal use. Personal lubricants can be used for assistance during sexual activity, such as intercourse, masturbation, or use of sex toys. These products reduce friction and are thought to enhance pleasure in women who suffer from vaginal dryness. However, we lack sufficient data to confirm that lubricants can improve sexual dysfunction and vaginal atrophy. In general, these products are affordable, readily available, and may be helpful in the treatment of sexual dysfunction and vaginal dryness.

See TABLE 2 for a list of personal lubricants and vaginal moisturizers.

TABLE 2

Vaginal moisturizers and lubricants are plentiful and diverse

What to offer when estrogen is not an option

Some women may want to avoid hormonal treatment, or have a contraindication to it, such as estrogen-receptor–positive breast cancer.⁸ In premenopausal women, vaginal atrophy can occur with lactation or postpartum hormonal changes, or may result from the use of anti-estrogenic agents for breast cancer. Other candidates for nonhormonal therapy are women who have chronic vulvar pain syndromes. In these women, vaginal lubricants can be especially useful.

Although they are less effective than estrogen, vaginal moisturizers, such as Replens, have been shown to reverse symptoms of vaginal atrophy and decrease discomfort during intercourse.⁹

Specialty lubricants are unproven

In contrast to products designed to treat vaginal dryness and atrophy, some lubricants are marketed specifically for sexual enhancement. Warming lubricants cause a heating sensation on the skin and usually contain menthol, L-arginine, or capsaicin. Natural and artificial flavors are used to manufacture flavored lubricants.

None of these products have been scientifically proven to enhance sexual function.

Oil-based lubricants may impede condom integrity

It is estimated that 40% of couples who use condoms also use a lubricant to assist with intercourse.¹⁰ The integrity of latex condoms has been shown to deteriorate with the use of an oil-based lubricant or petrolatum. One study, in which the mean burst time of condoms was assessed during pressurized air inflation, showed a significant reduction in that time when vaginal lubricants that contained mineral or vegetable oil were used.¹¹

Oil-based lubricants also have been shown to increase the slippage rate, with a trend toward increased breakage.¹⁰

Water-based lubricants may slightly increase slippage, but they reduce breakage.

Women should avoid oil-based lubricants when their partner uses a condom.

Some lubricants affect sperm quality

Choosing a vaginal lubricant can be of particular concern to a woman who is being treated for infertility. Lubricants may affect the integrity and function of sperm, even if they do not contain spermicide. Noncommercial products, such as glycerin, olive oil, vegetable oil, and, even, saliva have been associated with a loss of sperm function.¹²

A recent study found that Replens and Astroglide cause a dramatic decrease in sperm motility. FemGlide causes less of a decrease—but still a significant one.¹² The nonphysiologic osmolality and pH of these products may be the cause of such sperm damage. Pre-Seed, which has a more physiologic pH level and isotonic quality, was found to cause minimal harm to sperm motility and chromatin quality.¹²

Avoid propylene glycol in women who have vulvodynia

Vaginal lubricants and moisturizers are also used in the treatment of vulvodynia or chronic vulvar pain syndromes. According to an ACOG Committee Opinion, topical application of preservative-free solutions, such as vegetable oil or plain petrolatum, is recommended to hold moisture within the tissues and provide a protective barrier.¹³ Adequate lubrication is also recommended during intercourse.

Products that contain propylene glycol, or alcohol, may act as an irritant in women who experience local pain and heightened vaginal sensitivity. For that reason, such products should be avoided in this population.

CASE RESOLVED

Careful examination reveals urogenital atrophy with absence of any fungal or bacterial infection of the vulva or vagina. The patient chooses to use a water-based lubricant during sexual relations and begins using intravaginal estradiol tablets (other options include the vaginal ring or cream). Symptoms of dyspareunia disappear almost immediately, and vaginal burning improves after 6 weeks.

The authors would like to acknowledge Lauren Melcher, MD, an ObGyn resident at Washington Hospital Center, who contributed to this article.

CASE: New-onset dyspareunia in a menopausal patient

J. B., 53 years old, has been menopausal for 2 years. Several months after her annual examination, she schedules another appointment to discuss a worsening complaint: dyspareunia. She says she never had the problem until she reached menopause, and reports that it has become so severe that she has started avoiding sexual intercourse altogether. Even when she avoids intercourse, however, she is bothered by vaginal itching and burning.

What can you offer to her?

Various hormonal and nonhormonal products are available to relieve the frequent complaint, in menopausal women, of symptoms of vaginal atrophy: vaginal dryness, itching, burning, and dyspareunia.^1-3 The array of products isn’t really surprising: As women advance through menopause, their complaints of vaginal dryness increase fivefold.⁴

Systemic and local estrogen therapies reverse some atrophic changes and alleviate symptoms.⁵ After menopause, local vaginal estrogen formulations are recommended as first-line treatment for women who experience moderate or severe symptoms of vaginal atrophy.³ Formulations such as the vaginal ring, vaginal tablet, and transdermal gels and sprays are increasingly popular.

In this article, we describe these and other products, including nonhormonal lubricants and moisturizers, to relieve:

• the range of symptoms of vaginal atrophy in menopausal women
  
• isolated vaginal dryness in premenopausal women.
  

Is hormonal therapy always necessary?

When a postmenopausal woman complains of chronic vaginal dryness, and the exam is consistent with vaginal atrophy, the recommended treatment is local vaginal estrogen. If she complains of vaginal dryness during sexual intercourse only, a vaginal lubricant is a suitable option.

When a premenopausal woman complains of vaginal dryness, a vaginal moisturizer is the best long-term treatment option. However, a vaginal lubricant is recommended for intermittent dryness during intercourse or dyspareunia.

Local estrogens avoid many risks of systemic therapy

Topical estrogen preparations are available as vaginal creams, tablets, and rings, and as transdermal lotions, gels, and patches (TABLE 1). Local preparations are preferred to systemic therapy for the treatment of atrophy because they bypass the gastrointestinal tract, undergo less conversion in the liver, and improve local tissue with minimal elevation of the serum estradiol level.^1,3

The vaginal ring (Estring) delivers the lowest systemic estradiol level—approximately 5 to 10 μg of estradiol daily. Femring delivers more estradiol daily and requires the addition of progesterone in women who have an intact uterus.

Studies suggest that patients favor the estradiol-releasing vaginal ring because of its ease of use, comfort, and effectiveness, compared with vaginal estrogen cream.^2,5

Local estrogen formulations were compared and reviewed in a systematic Cochrane meta-analysis of 19 trials that included 4,162 women.⁵ Vaginal cream, tablets, and rings were all equally effective in treating symptoms of atrophy. One trial found that cream (conjugated equine estrogen) increased the risk of uterine bleeding, breast pain, and perineal pain, compared with vaginal tablets.

Newer estrogen formulations include topical and transdermal patches, gels, lotions, and sprays (TABLE 1), all of which are systemic. They are effective in the treatment of vasomotor symptoms and vaginal atrophy.

TABLE 1

Topical estrogen formulations—a rundown of local and systemic options

When to add a progestin

A progestin is recommended in addition to a systemic estrogen formulation in women who have a uterus. For low-dose, local vaginal estrogen formulations, a progestin is usually not needed.³ However, when the treatment is vaginal cream, consider progestin supplementation when the dosage exceeds 0.5 g twice weekly for an extended time (>1 year).

The serum estrogen level with local vaginal treatment is dose-dependent, and the long-term endometrial effects of vaginal estrogens are unknown. If vaginal bleeding develops, a workup is indicated and may necessitate imaging of the endometrial echo or endometrial sampling to rule out hyperplasia, neoplasia, and cancer.

Counsel the patient about any risks

If you prescribe transdermal or oral estrogen for a patient, be sure to counsel her about the risks of systemic therapy described in the Women’s Health Initiative.⁶

Consider the patient’s preference

Local estrogen treatment is recommended over systemic therapy for vaginal atrophy, but patient preference should also be considered. Some women may prefer the ring or tablet to minimize excess vaginal discharge, while others may prefer a cream because of its soothing effects. Always individualize management!

Lubricants and moisturizers

Insufficient lubrication during intercourse is a common complaint among both premenopausal and postmenopausal women: As many as 60% of women report intermittent episodes of insufficient lubrication.⁷

Many women and their partners use a vaginal lubricant to assist with sexual relations and to self-treat for pain. A wide variety of nonhormonal products are available—many of them advertised at pharmacies and in the media—despite little published scientific evaluation. Because gynecologists routinely counsel patients on sensitive matters, including sexual practices, you may find it valuable—with appropriate candidates—to open a line of questioning about difficulties with intercourse and resulting attempts to self-medicate using over-the-counter products.

What are the indications?

A vaginal lubricant is a solution used locally, and as a temporary measure, to moisten the vaginal epithelium to facilitate a medical examination or sexual intercourse.² Because it has a short duration, it must be applied at the time of intercourse. Lubricants can be categorized as water-, silicone-, and oil-based. Each formulation may affect the local inflammatory response, viability of sperm, and condom integrity.

A vaginal moisturizer is a gel or cream used regularly to maintain hydration of the vaginal epithelium for long-term relief of vaginal dryness.²

Both lubricants and moisturizers have many indications for both medical and personal use. Personal lubricants can be used for assistance during sexual activity, such as intercourse, masturbation, or use of sex toys. These products reduce friction and are thought to enhance pleasure in women who suffer from vaginal dryness. However, we lack sufficient data to confirm that lubricants can improve sexual dysfunction and vaginal atrophy. In general, these products are affordable, readily available, and may be helpful in the treatment of sexual dysfunction and vaginal dryness.

See TABLE 2 for a list of personal lubricants and vaginal moisturizers.

TABLE 2

Vaginal moisturizers and lubricants are plentiful and diverse

What to offer when estrogen is not an option

Some women may want to avoid hormonal treatment, or have a contraindication to it, such as estrogen-receptor–positive breast cancer.⁸ In premenopausal women, vaginal atrophy can occur with lactation or postpartum hormonal changes, or may result from the use of anti-estrogenic agents for breast cancer. Other candidates for nonhormonal therapy are women who have chronic vulvar pain syndromes. In these women, vaginal lubricants can be especially useful.

Although they are less effective than estrogen, vaginal moisturizers, such as Replens, have been shown to reverse symptoms of vaginal atrophy and decrease discomfort during intercourse.⁹

Specialty lubricants are unproven

In contrast to products designed to treat vaginal dryness and atrophy, some lubricants are marketed specifically for sexual enhancement. Warming lubricants cause a heating sensation on the skin and usually contain menthol, L-arginine, or capsaicin. Natural and artificial flavors are used to manufacture flavored lubricants.

None of these products have been scientifically proven to enhance sexual function.

Oil-based lubricants may impede condom integrity

It is estimated that 40% of couples who use condoms also use a lubricant to assist with intercourse.¹⁰ The integrity of latex condoms has been shown to deteriorate with the use of an oil-based lubricant or petrolatum. One study, in which the mean burst time of condoms was assessed during pressurized air inflation, showed a significant reduction in that time when vaginal lubricants that contained mineral or vegetable oil were used.¹¹

Oil-based lubricants also have been shown to increase the slippage rate, with a trend toward increased breakage.¹⁰

Water-based lubricants may slightly increase slippage, but they reduce breakage.

Women should avoid oil-based lubricants when their partner uses a condom.

Some lubricants affect sperm quality

Choosing a vaginal lubricant can be of particular concern to a woman who is being treated for infertility. Lubricants may affect the integrity and function of sperm, even if they do not contain spermicide. Noncommercial products, such as glycerin, olive oil, vegetable oil, and, even, saliva have been associated with a loss of sperm function.¹²

A recent study found that Replens and Astroglide cause a dramatic decrease in sperm motility. FemGlide causes less of a decrease—but still a significant one.¹² The nonphysiologic osmolality and pH of these products may be the cause of such sperm damage. Pre-Seed, which has a more physiologic pH level and isotonic quality, was found to cause minimal harm to sperm motility and chromatin quality.¹²

Avoid propylene glycol in women who have vulvodynia

Vaginal lubricants and moisturizers are also used in the treatment of vulvodynia or chronic vulvar pain syndromes. According to an ACOG Committee Opinion, topical application of preservative-free solutions, such as vegetable oil or plain petrolatum, is recommended to hold moisture within the tissues and provide a protective barrier.¹³ Adequate lubrication is also recommended during intercourse.

Products that contain propylene glycol, or alcohol, may act as an irritant in women who experience local pain and heightened vaginal sensitivity. For that reason, such products should be avoided in this population.

CASE RESOLVED

Careful examination reveals urogenital atrophy with absence of any fungal or bacterial infection of the vulva or vagina. The patient chooses to use a water-based lubricant during sexual relations and begins using intravaginal estradiol tablets (other options include the vaginal ring or cream). Symptoms of dyspareunia disappear almost immediately, and vaginal burning improves after 6 weeks.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

The overall rate of ureteral injury at the time of hysterectomy and other gynecologic procedures for benign disease has been estimated at 8.8 injuries for every 1,000 procedures, with the highest rate (17.3/1,000) occurring during laparoscopic hysterectomy with bilateral salpingo-oophorectomy (BSO). The rate of bladder injury is estimated at 16.3 for every 1,000 gynecologic procedures and 29.2 for every 1,000 laparoscopic hysterectomies with BSO.¹

Cystoscopy is a low-risk procedure that may be beneficial in surgeries associated with a high rate (1% to 2%) of lower urinary tract injury.² Early detection of bladder or ureteral injury is preferable to avoid postoperative complications such as fistula formation, loss of renal function, and other complications requiring additional surgery and prolonged hospitalization. Early detection also reduces medicolegal risk.

Ibeanu and associates point out that many gynecologic surgeons do not perform cystoscopy routinely, because of either a lack of training or difficulty obtaining privileges to perform this urologic procedure. They also note that the benefits of cystoscopy clearly outweigh the risks.

Only 25.6% of injuries were detected by visual inspection

Roughly one in four injuries to the bladder and ureter were detected without the aid of cystoscopy; the rest were identified using cystoscopy.

Twenty-four cases of bladder injury (2.9%) and 15 cases of ureteral injury (1.8%) were identified at the time of rigid diagnostic cystoscopy after hysterectomy. The majority (544) of the hysterectomies were abdominal, followed by vaginal hysterectomy (227) and laparoscopically assisted vaginal hysterectomy (61) ( TABLE ).

Most ureteral injuries (80%) occurred at the level of the uterine artery. The ureter is difficult to visualize or palpate once it goes under the uterine artery and courses along the anterior vagina before entry into the urinary bladder.

Ureteral injury also was common at the level of the infundibulopelvic ligament. One patient developed vesicovaginal fistula postoperatively that was missed on initial cystoscopy.

TABLE

Injury rate, by hysterectomy procedure

Cystoscopy is imperfect, but effective, and its cost is justifiable

Cystoscopy should be performed routinely after any gynecologic procedure associated with a high risk of injury, such as difficult bladder or ureteral dissection. Findings that justify cystoscopy include de novo hematuria and air in the Foley bag during laparoscopy.

Although cystoscopy may not identify all injuries, its benefits likely outweigh any additional cost associated with the procedure when a high rate of injury is likely (greater than, say, 1.5%).³

This study was conducted over 8 years at three academic practices, so it may not be possible to generalize its findings broadly across practitioners.

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.

When the suburethral sling was first described in 1907 by von Giordano, it entailed placing autologous tissue underneath the bladder neck and suspending it superiorly. Complications including urethral erosion, infection, bleeding, and fistula formation led many surgeons to use it sparingly.

Fast forward to the 21st century: Synthetic materials and new techniques were introduced, simplifying the sling procedures and raising the long-term success rates to 84%.¹ As a result, slings now stand at the forefront of stress urinary incontinence (SUI) treatment. Among advances are the tension-free vaginal tape (TVT) sling (Gynecare, a division of Ethicon Inc., Somerville, NJ) and the SPARC sling (American Medical Systems, Inc., Minnetonka, Minn). The former, approved in the U.S. in 1998, calls for another look due to of the recent publication of a Cochrane review of outcomes studies, while the latter, approved by the FDA in August 2001, is the newest technique deserving examination. Clearly, with 83,010 incontinence procedures performed in the U.S. in 1999,² a detailed look at the suburethral sling is warranted. Here, we review materials, indications, techniques, complications, and outcomes.

Materials

The choice of material—either organic or synthetic—depends on several factors: availability, cost, patient and surgeon preference, and clinical variables. (TABLE 1) outlines the advantages and disadvantages of each material type. Organic slings include autologous tissues (rectus fascia and fascia lata graft), and allografts or xenografts (cadaveric fascia lata graft, human dermal graft, or porcine small intestine and dermal graft). Synthetic slings are made of polyethylene terephthalate, expanded polytetrafluoroethylene, and polypropylene.

While sling procedures utilizing organic materials do have their benefits, synthetic slings, particularly the polypropylene mesh used in TVT and SPARC, have proven to be a stable material unlikely to deteriorate with time. Further, increased collagen metabolism around this synthetic sling promotes an ingrowth of tissue through the mesh.

TABLE 1

Slings: advantages and disadvantages of various materials

Indications

Suburethral sling procedures are typically used for the treatment of genuine stress urinary incontinence (GSUI), in which the urethra becomes either hypermobile and unstable or its intrinsic sphincter becomes incompetent. In fact, slings are technically easier to place in patients with anatomic urethrovesical junction hypermobility compared to those with fixed urethras. Several authors also have suggested the sling’s advantage in patients with low-pressure urethras.³

Use urodynamic criteria to diagnose intrinsic sphincter deficiency (ISD), which is defined as a Valsalva leak point pressure of less than 60 cm water or maximal urethral closure pressure of less than 20 cm water. (Bear in mind, however, that these cut-off criteria are controversial.^4,5)

Also, consider slings in patients with recurrent GSUI, inherited collagen deficiency, and increased abdominal pressure (e.g., women with chronic obstructive pulmonary disease, obesity, or high-impact physical activity). The sling also can be used as an adjunct to other transvaginal surgeries (e.g., hysterectomy or prolapse repair).

Autologous slings may be a better choice than synthetic slings in cases of severe urogenital atrophy, previous radiation, or extensive scarring from previous repairs. In these instances, the patient may be at-risk for postoperative vaginal necrosis or erosion.⁶ Due to their biocompatibility, autologous slings are more likely to heal over a vaginal erosion and less likely to infect or erode into the urethra. In any event, urogenital atrophy should be treated with local estrogen preoperatively to prevent some of these complications.

Technique

Conventionally, suburethral slings were placed via a combined vaginal and abdominal approach into the retropubic space of Retzius. Alternatively, the procedure could be performed abdominally by creating a suburethral tunnel via pelvic incisions, but this is the most difficult route.

Most recently, technological advances have simplified the vaginal approach, which utilizes minimal suburethral dissection and small suprapubic incisions. This technique is subdivided into “bottom-up” and “top-down” approaches. In the bottom-up TVT, the sling is inserted into a vaginal incision and threaded up through the patient’s pelvis, exiting from a small suprapubic incision. The topdown SPARC entails a reverse approach, starting from a suprapubic incision and exiting from a vaginal incision. New modifications allow for an abdominal TVT approach, as well, which we describe in detail in a later section.

Surgeons who are familiar with traditional needle suspensions may be more comfortable with the top-down approach. The need for concomitant surgery (e.g., hysterectomy or prolapse repair) not only determines the type of incontinence procedure, but also dictates the approach.

Preparing the patient. Place the patient under regional or local anesthesia with sedation so that an intraoperative cough stress test can be performed. Then administer an intravenous dose of a broad-spectrum antibiotic. Insert a 16 to 18 French Foley catheter into the urethra. Mark the suprapubic region 1 cm above and 1 cm lateral to the pubic symphsis on the left and right sides of the patient. Inject approximately 20 cc of a 1:1 mixture of local anesthetic and normal saline into the marked areas. We typically use 60 cc of 0.25% bupivicaine with epinephrine, diluted 1:1 with 60 cc of normal saline. After administering the local anesthetic suprapubically, inject a similar solution into the anterior vaginal wall suburethrally in the midline and laterally toward the retropubic tunnels.

Making the incisions. Both the TVT and SPARC techniques utilize the same type and location of incisions. As such, make a 0.5-cm incision into the abdominal skin on each side of the midline, approximately 1 cm lateral to midline and 1 cm above the pubic symphsis. Next, make a 1.5- to 2-cm vertical incision in the vaginal mucosa, starting 1.5 cm from the urethral meatus (FIGURE 1). Use Metzenbaum scissors to dissect the vaginal mucosa from the pubocervical fascia sub- and para-urethrally on both sides (FIGURE 2). Insert a Foley catheter guide (similar to the Lowsley retractor) into the catheter and deviate it to the ipsilateral side, thereby retracting the bladder neck to the contralateral side. Proceed with the placement of either the TVT or SPARC sling.

Placing the TVT sling. Attach the TVT introducer to the curved needle trocar on 1 end of the polypropylene sling. Insert the trocar with the tape attached into the vaginal incision and push through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone (FIGURES 3 and 4). Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side (FIGURE 5). It is important to not deviate too laterally, medially, or cephalad during trocar insertion to prevent vessel, bladder, or bowel injury. Perform a cystoscopy to rule out cystotomy. Place the second trocar in a similar manner on the opposite side. After both trocars have been pulled through their respective incisions, perform a tension test.

Placing the SPARC/abdominal TVT sling. Guide the abdominal needles through the previously marked suprapubic incision and the patient’s retropubic cavity (keeping the needle behind the pubic bone), to a finger placed in the vaginal incision (FIGURE 6). Snap the abdominal needle guides with the attached polypropylene mesh to the sling connectors (FIGURE 7). Bring the abdominal needles through the suprapubic incisions. Perform a tension test. As with the TVT sling, perform a cystoscopy after each needle placement to rule out cystotomy. Then pass the sling through the tunnel.

Testing for continence. Once the sling is in place, fill the bladder with 250 cc of water and perform a cough stress test. Adjust sling tension by pulling up on both sling arms until only a few drops of leakage are noted. It is important not to secure the sling too tightly as this may lead to urinary retention, detrusor instability, or urethral erosion. We prefer placing a hemostat between the sling tape and the urethra to avoid over tightening.

Suspending the sling arms. Remove the plastic sheaths after tension adjustment and cut the sling flush with the skin (FIGURE 8). Compared to the conventional bone-anchored slings, the newer tension-free sling devices are not anchored but instead suspended through the retropubic space. At first, the sling is held in place by friction from the opposing tissues. Over time, collagen formation fixes the mesh more strongly within the suburethral and paravaginal tissues.

Finally, close the suprapubic and vaginal incisions with absorbable sutures.

Placing autologous or allogenic slings. Fashion the graft, typically 2 cm wide and 10 to 12 cm long, with permanent sutures at the edges. Make a 1-cm incision into the suprapubic rectus fascia. Use either a Stamey-type needle trocar or uterine packing forceps and guide the instrument “top down” from the retropubic incision to the vaginal tunnel. The tunnel is made directly into the retropubic space from the vaginal incision. Bring the sling arms up on each side. Attach the arms to the rectus fascia and tie them down once cystoscopy and the tension test are complete.

The sling also can be performed with bone anchors placed through the vaginal incision into the pubic bone. Placement requires vaginal dissection into the retropubic space with no suprapubic incision. Once anchored, the sutures are then passed through the chosen graft materials and tied down. Bear in mind that anchoring into the periosteum of the pubic bone may cause severe osteomyelitis or osteitis pubis, though the actual incidence is unknown.⁷

FIGURE 1 Surgical steps for tension-free vaginal tape (TVT)

Place a Sims speculum into the vagina and make a vertical incision 1.5 cm from the external urethra meatus.

FIGURE 2

Use Metzenbaum scissors to dissect the vaginal mucosa from the underlying fascia bilaterally. Insert a Foley catheter with guide.

FIGURE 3

Place TVT trocars through the vaginal incision. Place abdominal guides suprapubically and attach them to the TVT trocar tip.

FIGURE 4

Push the tape through the retropubic space, keeping the trocar in close contact with the posterior surface of the pubic bone.

FIGURE 5

Continue pushing the trocar through the urogenital diaphragm until its tip comes through the suprapubic incision on the ipsilateral side.

FIGURE 6 Surgical steps for SPARC

Guide the needle down the posterior side of the pubic bone, keeping the needle tip in contact with the pubic bone.

FIGURE 7

Snap the needle guide and sling onto the sling connectors and pull through the suprapubic incision.

FIGURE 8

Perform a tension test. Remove the plastic sheaths and cut the sling flush with the skin.

Complications

Intraoperative and immediate postoperative complications include bladder perforation, vaginal or retropubic bleeding, wound or urinary tract infection (UTI), and short-term urinary retention. Possible long-term problems include urethral or vaginal erosion, mesh infection, prolonged voiding dysfunction, fistula formation, or de novo urge incontinence (TABLE 2).

Specifically, the TVT sling, which has been placed in more than 50,000 women in the U.S. and 200,000 worldwide, carries the potential for significant vascular injury and bowel perforation. In addition, the Food and Drug Administration (FDA) reported 4 deaths (2 from unrecognized bowel injuries, 1 from retropubic bleeding in a patient with a bleeding disorder, and 1 from a heart attack more than 1 week after an incontinence repair procedure complicated by a vascular injury); 168 device malfunctions (mostly tape or sheath detachment from the trocar); and 128 other injuries, including bowel perforations and major vascular injuries to the obturator, external iliac, femoral, or inferior epigastrics (TABLE 3).⁸ In a review of 1,455 TVT sling cases at 38 hospitals, Kuuva and Nilsson⁹ found bladder perforation in 3.8% of the patients and retropubic hematoma in 1.9%, along with 1 case of vesicovaginal fistula, 1 obturator nerve injury, and 1 epigastric vessel injury.

According to the FDA, there have been 2 complications reported with the SPARC sling system. Both involved vaginal erosion subsequently repaired by oversewing the vaginal mucosa. One of these complications occurred in a woman undergoing her fourth vaginal procedure who was therefore deemed to have “poor tissue.”⁸

TABLE 2

Suburethral sling complications¹

TABLE 3

TVT complications in 200,000 procedures worldwide

Outcomes studies

Unfortunately, most of the published clinical studies on the surgical management of stress urinary incontinence suffer from inadequate follow-up and sample size, unclear patient selection criteria, and poor postoperative documentation, especially with respect to quality of life. However, multiple studies to assess the effectiveness and safety of TVT slings have been published. The following is an outline of these preliminary yet important findings.

In 2002, the Cochrane Database evaluated 7 randomized and quasi-randomized trials of suburethral slings for the treatment of urinary incontinence.¹⁰ Of 682 women evaluated, 457 had some type of suburethral sling procedure. Four trials compared slings to retropubic urethropexies, 1 compared slings to Stamey needle suspensions, and 2 compared the use of different sling materials. The results indicated that the data were insufficient to suggest that slings were more effective than other incontinence procedures or that slings were associated with fewer postoperative complications. While TVT slings did provide similar cure rates as open retropubic urethropexy, research is still lacking with respect to other types of slings. More studies comparing TVT slings to traditional pubovaginal slings also are needed before the 2 can be deemed equivalent.

In Sweden and Finland, where the TVT procedure was developed,¹¹ 85 patients who had undergone the procedure were evaluated at 48 to 70 months. Of those, 84.7% were completely cured of stress incontinence, 10.6% had significantly improved symptoms, and 4.7% were regarded as failures.

A recent well-designed, multicenter, randomized, prospective trial in the U.K. and Ireland compared 146 open Burch colposuspensions to 170 TVTs. Similar cure rates (57% and 66%, respectively) were reported.¹² Although these rates are low compared to the Nordic nonrandomized TVT studies mentioned, the U.K./Ireland outcome criteria were particularly stringent and included a negative cystometrogram for stress incontinence and negative pad test. These differences in reported success rates highlight the importance of clearly defining objective outcomes criteria from randomized trials.

Nonetheless, the U.K./Ireland study showed that TVT is less invasive than the Burch procedure and is associated with shorter recovery periods and greater cost savings. Follow-up on complications (bladder perforation and hematoma in TVTs and incisional hernia formation in Burch colposuspensions) will be the most crucial aspect of this study.¹³

Clearly, the question of whether a Burch retropubic urethropexy or a suburethral sling procedure is better for SUI needs to be further investigated. Weber and Walters sought to answer this question by developing a decision analytical model (without the aid of randomized, controlled trials) and discovered similar cure rates.¹⁴ However, there were higher rates of urinary retention and detrusor instability associated with the traditional pubovaginal sling. But, most importantly, sensitivity analyses proved that if the rate of permanent urinary retention after a sling procedure was less than 9%—as in most sling series—the overall effectiveness of slings was higher than that of the Burch.

Conclusion

The suburethral sling procedure has undergone many modifications since its first description nearly a century ago. As such, Ob/Gyns need to familiarize themselves with the current options. Typically, we perform up to 6 suburethral sling procedures per month. Of those, 50% are referrals from failed incontinence procedures. Recently, we have made the switch from using autologous slings to tension-free type slings due to ease and good outcomes. While more data from randomized, prospective, multicenter trials are needed to determine the best approach for individual patients, surgeons should become comfortable with the technique that works best for them.

The authors report no financial relationship with any companies whose products are mentioned in this article.