Urogynecologists Respond to FDA on Mesh for POP

PROVIDENCE, R.I. – After the Food and Drug Administration issued an updated safety communication concerning the surgical placement of transvaginal mesh to repair pelvic organ prolapse on July 13, 2011, leaders of the American Urogynecologic Society sprang into action.

The American Urogynecologic Society (AUGS) leadership alerted its members, participated in a stakeholders’ conference call the following day with the FDA, polled its members, created a blog on its website, released its own recommendations, and testified before an FDA investigatory panel Sept. 8-9 regarding the safe and effective use of transvaginal mesh for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The FDA’s Safety Communication of 7/13/2011

The FDA’s safety communication concerning transvaginal placement of surgical mesh for POP was actually the second one issued by the agency regarding transvaginal placement of surgical mesh. The first one was issued in 2008 after more than 1,000 adverse events were reported to the FDA for surgical mesh used in the repair of POP and SUI. From Jan. 1, 2008, through Dec. 31, 2010, the FDA received 2,874 additional reports of adverse events, with 1,503 linked to POP repairs and 1,371 linked to surgery for SUI.

After a systematic review of the literature from 1996 to 2011, the FDA concluded that transvaginal POP repair with mesh may have an anatomic benefit that may not necessarily improve symptoms or quality of life over traditional nonmesh repair. They stated that in most cases, POP can be treated successfully without mesh, and mesh surgery should be chosen only after weighing associated risks and benefits.

The FDA Panel Hearing

It was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP.

On Sept. 8-9, 2011, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider the use of transvaginal mesh for POP and SUI. The 19-person panel, chaired by Dr. Tommaso Falcone of the Cleveland Clinic, included 12 physicians, 2 statisticians, and representatives of patients, consumers, and industry. Five were members of AUGS, including Dr. Cheryl B. Iglesia, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at Washington (D.C.) Hospital Center, who spoke about her experiences at the AUGS annual meeting.

The AUGS’ Stand and the Panel’s Recommendations

On Sept. 15, 2011, at the AUGS annual meeting, an update was held to inform members about new developments regarding vaginal placement of mesh. President Deborah Myers presented the AUGS leadership stance, which was also outlined in an executive summary (available on the organization’s website, www.augs.org). Dr. Iglesia presented a summary of the recommendations made by the panel to the FDA.

The AUGS statement described some of the complexities regarding the use of transvaginal mesh for pelvic reconstruction. The society indicated that it supports the FDA Safety Communication Update recommendations: that often POP can be treated successfully without mesh. However, while AUGS does not support the routine use of vaginal mesh for POP repair, it recognizes "that there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

After discussion of a number of serious adverse events associated with the use of vaginal mesh for POP repair, the panel’s consensus was that the safety of such mesh is not well established. Depending on the compartment, vaginal placement of mesh for POP repair may not be more effective than traditional "native-tissue" repair without mesh, and the consensus was that the risk/benefit of vaginal placement of mesh for POP repair is not well established.

The AUGS statement indicated that there is insufficient data available to guide treatment decisions for individual patients, noting that such decisions should be made collaboratively by physicians and patients. Although outcomes reflect both surgical training and skill, many members of AUGS report excellent outcomes and low complication rates with transvaginal mesh.

With this in mind, "AUGS does not support a 'blanket' withdrawal of currently available transvaginal mesh products from the market." Instead, AUGS supports the judicious use of transvaginal mesh for POP repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.

AUGS’ stance on informed consent is "in sync" with the FDA. It supports a consent process that informs patients of nonsurgical options, alternative native tissue surgical repairs, and abdominal repairs, as well as possible adverse outcomes associated with mesh. The organization is planning to offer an online informed consent checklist.

Strategies for Mesh in POP Surgery

Within the next 12 months, AUGS plans to develop educational and training recommendations to guide hospitals in privileging those who may conduct POP surgery using transvaginal mesh. Until those recommendations are issued, AUGS suggests "that continued placement of transvaginal mesh for POP be performed only by providers who have extensive training in pelvic surgery, maintain a high volume of surgical procedures for prolapse, have specific training in the device and method used, and are able to track both objective and subjective short-term and long-term outcomes."

Currently, postmarketing surveillance is voluntary and not inclusive of all vaginal meshes. AUGS recommends that the FDA invoke its power under section 522 of the Food and Drug Administration Modernization Act of 1997 to require postmarketing surveillance by means of a postmarket registry and/or national database of all users of vaginally placed mesh, to track both positive and negative anatomic and subjective outcomes. Until the registry is created, AUGS recommends all surgeons track their own outcomes.

The most contentious issue concerns the type of clinical evidence needed to support continued use of mesh already in the marketplace and future technology. Currently available mesh were generally approved as class II devices under the 510(k) process, often with another legally marketed, predicate device as control.

"Many things we deal with are class II, requiring general or special controls," said Dr. Matthew Barber of the Cleveland Clinic, president-elect of AUGS. Class III devices require a premarket approval application (PMA), and such devices are often considered high risk, life sustaining, life supporting or of substantial health importance, or present unreasonable risk or injury. Like drugs, class III devices require independent assessment of safety and effectiveness prior to marketing.

"There may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

AUGS stated that it supports mandatory clinical trials for transvaginal mesh for POP and is in favor of a requirement that premarket notifications or PMAs include clinical trials that use patient-centered outcomes and long-term patient follow-up. The studies should be prospective, and can be cohort studies, registries or randomized, controlled trials, but randomized controlled trials are not required. Clinical trials should have a minimum of 1-year of follow-up with an additional 2-4 years of patient follow-up, and FDA reporting for new prolapse mesh devices or for significant modifications of existing devices. AUGS supports keeping transvaginal mesh devices as class II devices, and would assist the FDA in developing special controls if required by the FDA.

"The bottom line is, we want them to leave slings alone and place them into a registry," remarked Dr. Myers of Brown Medical School, Providence, R.I..

Setting Standards and Evaluating Vaginal Mesh

The panel called for stricter standards than currently exist or requested by AUGS, recommending that premarket evaluation of vaginal mesh for POP was needed, and that the control arm for such studies be women undergoing surgical repair of POP without the use of mesh. Therefore, class II special controls would not be sufficient, and the panel’s consensus was that vaginal mesh for POP repair be reclassified from class II to class III. The panel felt that there were enough data available to support the use of mesh for abdominal sacral colpopexy. There was no need for clinical performance data for new mesh products similar to products already on the market, and postmarketing surveillance was not needed.

AUGS also clearly makes the distinction between the use of mesh for prolapse and use for SUI. It "strongly opposes withdrawal of synthetic mesh devices for surgical treatment of SUI and does not feel any change in the current regulatory status of synthetic mesh for this use is warranted." Noting the considerable evidence supporting its use, AUGS asserts that midurethral slings, placed either by a retropubic or transobturator approach, is the current standard of care for the surgical treatment of SUI. AUGS supports establishing a postmarket registry for mesh used for SUI, and appropriate premarket clinical trials for devices significantly different from those that are currently available.

The situation is still in flux. Recommendations made by the advisory panel are not mandatory, noted Dr. Iglesia. "If the recommendations are adopted by the FDA, it will take several years to take effect, and existing products will stay on the market."

During the question-and-answer session following the AUGS update, it was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP, with some extolling their use and others overwhelmed by the need to repair mesh-related complications, especially mesh implanted by inadequately trained practitioners.

No financial disclosures were listed for Dr. Myers, Dr. Barber, or Dr. Iglesia.

PROVIDENCE, R.I. – After the Food and Drug Administration issued an updated safety communication concerning the surgical placement of transvaginal mesh to repair pelvic organ prolapse on July 13, 2011, leaders of the American Urogynecologic Society sprang into action.

The American Urogynecologic Society (AUGS) leadership alerted its members, participated in a stakeholders’ conference call the following day with the FDA, polled its members, created a blog on its website, released its own recommendations, and testified before an FDA investigatory panel Sept. 8-9 regarding the safe and effective use of transvaginal mesh for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The FDA’s Safety Communication of 7/13/2011

The FDA’s safety communication concerning transvaginal placement of surgical mesh for POP was actually the second one issued by the agency regarding transvaginal placement of surgical mesh. The first one was issued in 2008 after more than 1,000 adverse events were reported to the FDA for surgical mesh used in the repair of POP and SUI. From Jan. 1, 2008, through Dec. 31, 2010, the FDA received 2,874 additional reports of adverse events, with 1,503 linked to POP repairs and 1,371 linked to surgery for SUI.

After a systematic review of the literature from 1996 to 2011, the FDA concluded that transvaginal POP repair with mesh may have an anatomic benefit that may not necessarily improve symptoms or quality of life over traditional nonmesh repair. They stated that in most cases, POP can be treated successfully without mesh, and mesh surgery should be chosen only after weighing associated risks and benefits.

The FDA Panel Hearing

It was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP.

On Sept. 8-9, 2011, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider the use of transvaginal mesh for POP and SUI. The 19-person panel, chaired by Dr. Tommaso Falcone of the Cleveland Clinic, included 12 physicians, 2 statisticians, and representatives of patients, consumers, and industry. Five were members of AUGS, including Dr. Cheryl B. Iglesia, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at Washington (D.C.) Hospital Center, who spoke about her experiences at the AUGS annual meeting.

The AUGS’ Stand and the Panel’s Recommendations

On Sept. 15, 2011, at the AUGS annual meeting, an update was held to inform members about new developments regarding vaginal placement of mesh. President Deborah Myers presented the AUGS leadership stance, which was also outlined in an executive summary (available on the organization’s website, www.augs.org). Dr. Iglesia presented a summary of the recommendations made by the panel to the FDA.

The AUGS statement described some of the complexities regarding the use of transvaginal mesh for pelvic reconstruction. The society indicated that it supports the FDA Safety Communication Update recommendations: that often POP can be treated successfully without mesh. However, while AUGS does not support the routine use of vaginal mesh for POP repair, it recognizes "that there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

After discussion of a number of serious adverse events associated with the use of vaginal mesh for POP repair, the panel’s consensus was that the safety of such mesh is not well established. Depending on the compartment, vaginal placement of mesh for POP repair may not be more effective than traditional "native-tissue" repair without mesh, and the consensus was that the risk/benefit of vaginal placement of mesh for POP repair is not well established.

The AUGS statement indicated that there is insufficient data available to guide treatment decisions for individual patients, noting that such decisions should be made collaboratively by physicians and patients. Although outcomes reflect both surgical training and skill, many members of AUGS report excellent outcomes and low complication rates with transvaginal mesh.

With this in mind, "AUGS does not support a 'blanket' withdrawal of currently available transvaginal mesh products from the market." Instead, AUGS supports the judicious use of transvaginal mesh for POP repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.

AUGS’ stance on informed consent is "in sync" with the FDA. It supports a consent process that informs patients of nonsurgical options, alternative native tissue surgical repairs, and abdominal repairs, as well as possible adverse outcomes associated with mesh. The organization is planning to offer an online informed consent checklist.

Strategies for Mesh in POP Surgery

Within the next 12 months, AUGS plans to develop educational and training recommendations to guide hospitals in privileging those who may conduct POP surgery using transvaginal mesh. Until those recommendations are issued, AUGS suggests "that continued placement of transvaginal mesh for POP be performed only by providers who have extensive training in pelvic surgery, maintain a high volume of surgical procedures for prolapse, have specific training in the device and method used, and are able to track both objective and subjective short-term and long-term outcomes."

Currently, postmarketing surveillance is voluntary and not inclusive of all vaginal meshes. AUGS recommends that the FDA invoke its power under section 522 of the Food and Drug Administration Modernization Act of 1997 to require postmarketing surveillance by means of a postmarket registry and/or national database of all users of vaginally placed mesh, to track both positive and negative anatomic and subjective outcomes. Until the registry is created, AUGS recommends all surgeons track their own outcomes.

The most contentious issue concerns the type of clinical evidence needed to support continued use of mesh already in the marketplace and future technology. Currently available mesh were generally approved as class II devices under the 510(k) process, often with another legally marketed, predicate device as control.

"Many things we deal with are class II, requiring general or special controls," said Dr. Matthew Barber of the Cleveland Clinic, president-elect of AUGS. Class III devices require a premarket approval application (PMA), and such devices are often considered high risk, life sustaining, life supporting or of substantial health importance, or present unreasonable risk or injury. Like drugs, class III devices require independent assessment of safety and effectiveness prior to marketing.

"There may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

AUGS stated that it supports mandatory clinical trials for transvaginal mesh for POP and is in favor of a requirement that premarket notifications or PMAs include clinical trials that use patient-centered outcomes and long-term patient follow-up. The studies should be prospective, and can be cohort studies, registries or randomized, controlled trials, but randomized controlled trials are not required. Clinical trials should have a minimum of 1-year of follow-up with an additional 2-4 years of patient follow-up, and FDA reporting for new prolapse mesh devices or for significant modifications of existing devices. AUGS supports keeping transvaginal mesh devices as class II devices, and would assist the FDA in developing special controls if required by the FDA.

"The bottom line is, we want them to leave slings alone and place them into a registry," remarked Dr. Myers of Brown Medical School, Providence, R.I..

Setting Standards and Evaluating Vaginal Mesh

The panel called for stricter standards than currently exist or requested by AUGS, recommending that premarket evaluation of vaginal mesh for POP was needed, and that the control arm for such studies be women undergoing surgical repair of POP without the use of mesh. Therefore, class II special controls would not be sufficient, and the panel’s consensus was that vaginal mesh for POP repair be reclassified from class II to class III. The panel felt that there were enough data available to support the use of mesh for abdominal sacral colpopexy. There was no need for clinical performance data for new mesh products similar to products already on the market, and postmarketing surveillance was not needed.

AUGS also clearly makes the distinction between the use of mesh for prolapse and use for SUI. It "strongly opposes withdrawal of synthetic mesh devices for surgical treatment of SUI and does not feel any change in the current regulatory status of synthetic mesh for this use is warranted." Noting the considerable evidence supporting its use, AUGS asserts that midurethral slings, placed either by a retropubic or transobturator approach, is the current standard of care for the surgical treatment of SUI. AUGS supports establishing a postmarket registry for mesh used for SUI, and appropriate premarket clinical trials for devices significantly different from those that are currently available.

The situation is still in flux. Recommendations made by the advisory panel are not mandatory, noted Dr. Iglesia. "If the recommendations are adopted by the FDA, it will take several years to take effect, and existing products will stay on the market."

During the question-and-answer session following the AUGS update, it was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP, with some extolling their use and others overwhelmed by the need to repair mesh-related complications, especially mesh implanted by inadequately trained practitioners.

No financial disclosures were listed for Dr. Myers, Dr. Barber, or Dr. Iglesia.

PROVIDENCE, R.I. – After the Food and Drug Administration issued an updated safety communication concerning the surgical placement of transvaginal mesh to repair pelvic organ prolapse on July 13, 2011, leaders of the American Urogynecologic Society sprang into action.

The American Urogynecologic Society (AUGS) leadership alerted its members, participated in a stakeholders’ conference call the following day with the FDA, polled its members, created a blog on its website, released its own recommendations, and testified before an FDA investigatory panel Sept. 8-9 regarding the safe and effective use of transvaginal mesh for both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The FDA’s Safety Communication of 7/13/2011

The FDA’s safety communication concerning transvaginal placement of surgical mesh for POP was actually the second one issued by the agency regarding transvaginal placement of surgical mesh. The first one was issued in 2008 after more than 1,000 adverse events were reported to the FDA for surgical mesh used in the repair of POP and SUI. From Jan. 1, 2008, through Dec. 31, 2010, the FDA received 2,874 additional reports of adverse events, with 1,503 linked to POP repairs and 1,371 linked to surgery for SUI.

After a systematic review of the literature from 1996 to 2011, the FDA concluded that transvaginal POP repair with mesh may have an anatomic benefit that may not necessarily improve symptoms or quality of life over traditional nonmesh repair. They stated that in most cases, POP can be treated successfully without mesh, and mesh surgery should be chosen only after weighing associated risks and benefits.

The FDA Panel Hearing

It was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP.

On Sept. 8-9, 2011, the FDA convened an Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to consider the use of transvaginal mesh for POP and SUI. The 19-person panel, chaired by Dr. Tommaso Falcone of the Cleveland Clinic, included 12 physicians, 2 statisticians, and representatives of patients, consumers, and industry. Five were members of AUGS, including Dr. Cheryl B. Iglesia, director of the Section of Female Pelvic Medicine and Reconstructive Surgery at Washington (D.C.) Hospital Center, who spoke about her experiences at the AUGS annual meeting.

The AUGS’ Stand and the Panel’s Recommendations

On Sept. 15, 2011, at the AUGS annual meeting, an update was held to inform members about new developments regarding vaginal placement of mesh. President Deborah Myers presented the AUGS leadership stance, which was also outlined in an executive summary (available on the organization’s website, www.augs.org). Dr. Iglesia presented a summary of the recommendations made by the panel to the FDA.

The AUGS statement described some of the complexities regarding the use of transvaginal mesh for pelvic reconstruction. The society indicated that it supports the FDA Safety Communication Update recommendations: that often POP can be treated successfully without mesh. However, while AUGS does not support the routine use of vaginal mesh for POP repair, it recognizes "that there may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

After discussion of a number of serious adverse events associated with the use of vaginal mesh for POP repair, the panel’s consensus was that the safety of such mesh is not well established. Depending on the compartment, vaginal placement of mesh for POP repair may not be more effective than traditional "native-tissue" repair without mesh, and the consensus was that the risk/benefit of vaginal placement of mesh for POP repair is not well established.

The AUGS statement indicated that there is insufficient data available to guide treatment decisions for individual patients, noting that such decisions should be made collaboratively by physicians and patients. Although outcomes reflect both surgical training and skill, many members of AUGS report excellent outcomes and low complication rates with transvaginal mesh.

With this in mind, "AUGS does not support a 'blanket' withdrawal of currently available transvaginal mesh products from the market." Instead, AUGS supports the judicious use of transvaginal mesh for POP repair performed only by surgeons with appropriate training on patients who have been fully informed of the risks and benefits of all available treatment options.

AUGS’ stance on informed consent is "in sync" with the FDA. It supports a consent process that informs patients of nonsurgical options, alternative native tissue surgical repairs, and abdominal repairs, as well as possible adverse outcomes associated with mesh. The organization is planning to offer an online informed consent checklist.

Strategies for Mesh in POP Surgery

Within the next 12 months, AUGS plans to develop educational and training recommendations to guide hospitals in privileging those who may conduct POP surgery using transvaginal mesh. Until those recommendations are issued, AUGS suggests "that continued placement of transvaginal mesh for POP be performed only by providers who have extensive training in pelvic surgery, maintain a high volume of surgical procedures for prolapse, have specific training in the device and method used, and are able to track both objective and subjective short-term and long-term outcomes."

Currently, postmarketing surveillance is voluntary and not inclusive of all vaginal meshes. AUGS recommends that the FDA invoke its power under section 522 of the Food and Drug Administration Modernization Act of 1997 to require postmarketing surveillance by means of a postmarket registry and/or national database of all users of vaginally placed mesh, to track both positive and negative anatomic and subjective outcomes. Until the registry is created, AUGS recommends all surgeons track their own outcomes.

The most contentious issue concerns the type of clinical evidence needed to support continued use of mesh already in the marketplace and future technology. Currently available mesh were generally approved as class II devices under the 510(k) process, often with another legally marketed, predicate device as control.

"Many things we deal with are class II, requiring general or special controls," said Dr. Matthew Barber of the Cleveland Clinic, president-elect of AUGS. Class III devices require a premarket approval application (PMA), and such devices are often considered high risk, life sustaining, life supporting or of substantial health importance, or present unreasonable risk or injury. Like drugs, class III devices require independent assessment of safety and effectiveness prior to marketing.

"There may be particular circumstances when the placement of transvaginal mesh is beneficial and appropriate."

AUGS stated that it supports mandatory clinical trials for transvaginal mesh for POP and is in favor of a requirement that premarket notifications or PMAs include clinical trials that use patient-centered outcomes and long-term patient follow-up. The studies should be prospective, and can be cohort studies, registries or randomized, controlled trials, but randomized controlled trials are not required. Clinical trials should have a minimum of 1-year of follow-up with an additional 2-4 years of patient follow-up, and FDA reporting for new prolapse mesh devices or for significant modifications of existing devices. AUGS supports keeping transvaginal mesh devices as class II devices, and would assist the FDA in developing special controls if required by the FDA.

"The bottom line is, we want them to leave slings alone and place them into a registry," remarked Dr. Myers of Brown Medical School, Providence, R.I..

Setting Standards and Evaluating Vaginal Mesh

The panel called for stricter standards than currently exist or requested by AUGS, recommending that premarket evaluation of vaginal mesh for POP was needed, and that the control arm for such studies be women undergoing surgical repair of POP without the use of mesh. Therefore, class II special controls would not be sufficient, and the panel’s consensus was that vaginal mesh for POP repair be reclassified from class II to class III. The panel felt that there were enough data available to support the use of mesh for abdominal sacral colpopexy. There was no need for clinical performance data for new mesh products similar to products already on the market, and postmarketing surveillance was not needed.

AUGS also clearly makes the distinction between the use of mesh for prolapse and use for SUI. It "strongly opposes withdrawal of synthetic mesh devices for surgical treatment of SUI and does not feel any change in the current regulatory status of synthetic mesh for this use is warranted." Noting the considerable evidence supporting its use, AUGS asserts that midurethral slings, placed either by a retropubic or transobturator approach, is the current standard of care for the surgical treatment of SUI. AUGS supports establishing a postmarket registry for mesh used for SUI, and appropriate premarket clinical trials for devices significantly different from those that are currently available.

The situation is still in flux. Recommendations made by the advisory panel are not mandatory, noted Dr. Iglesia. "If the recommendations are adopted by the FDA, it will take several years to take effect, and existing products will stay on the market."

During the question-and-answer session following the AUGS update, it was clear that AUGS members have a variety of opinions regarding intravaginal mesh for POP, with some extolling their use and others overwhelmed by the need to repair mesh-related complications, especially mesh implanted by inadequately trained practitioners.

No financial disclosures were listed for Dr. Myers, Dr. Barber, or Dr. Iglesia.