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Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.
The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.
In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."
However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."
The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.
Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.
The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.
But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.
Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."
At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.
As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.
But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.
Dr. Jaspan had no disclosures.
Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.
Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.
The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.
In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."
However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."
The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.
Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.
The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.
But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.
Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."
At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.
As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.
But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.
Dr. Jaspan had no disclosures.
Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.
Ethicon has initiated a worldwide withdrawal of the company’s morcellation devices because of the uncertainty over the risk-benefit profile of these devices when used in hysterectomies and myomectomies for women with fibroids, the company announced in a letter on July 30.
The withdrawal – which is voluntary – is an expansion of the company’s suspension of worldwide sales of these devices in April, following the Food and Drug Administration (FDA) announcement recommending that the use of power morcellation during laparoscopic hysterectomy or myomectomy to remove uterine fibroids should be "discouraged," because the procedure could spread cancerous tissue in women with an unsuspected sarcoma.
In its letter, Ethicon stated that the company believes that its morcellation devices "perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators."
However, the letter adds that "the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures remains uncertain," and the company believes that market withdrawal "is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk."
The Ethicon withdrawal was announced less than 3 weeks after the FDA held a 2-day meeting of its Obstetrics and Gynecology Devices Advisory Panel to discuss the benefits, risks, and clinical role of laparoscopic power morcellators (LPMs) in the treatment of women with uterine fibroids.
Panelists also discussed strategies that might reduce the risks of morcellation disseminating cancerous tissue into the pelvis and abdomen of women with an unsuspected uterine sarcoma or leiomyosarcoma (LMS). Two panelists said that LPMs should not be used for gynecologic indications until better data are available, and during the open public hearing, Dr. Hooman Nourchashm, a cardiothoracic surgeon, reiterated his call for a worldwide moratorium on all gynecological tissue morcellation devices and on the practice of intracorporeal uterine morcellation during minimally invasive hysterectomy. He and his wife, anesthesiologist Dr. Amy Reed, who was diagnosed in 2013 with stage IV LMS after undergoing a hysterectomy with morcellation at the age of 40 for what was thought to be benign fibroids, are leading a campaign calling for the ban.
The Ethicon letter states that the discussion during the meeting "demonstrated the complexity of this issue, particularly with respect to the difficulty for medical professionals to preoperatively diagnose some malignancies, such as leiomyosarcoma ... [and] the risk of disseminating unsuspected malignant tissue while using power morcellation devices," as well as methods to mitigate this risk.
But to date, Ethicon, a Johnson & Johnson company, is the only manufacturer of morcellation devices used in gynecology to suspend and withdraw its products. There are five other manufacturers or distributors of LPMs with gynecologic indications that have been marketed in the past year, according to the FDA.
Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said in an interview that he views the Ethicon move to withdraw all morcellation devices as a business decision. This "may be the first domino to fall," and whether competing manufacturers of morcellation devices also decide to withdraw their products or choose an alternative path "remains to be seen."
At the Einstein health care network in Philadelphia, there is currently a moratorium prohibiting the use of power morcellation in gynecologic surgery, while a standard acceptable counseling form is being developed. Dr. Jaspan is working with robotic and minimally invasive surgeons "to create a document that we feel will provide patients with transparency, alternatives, and choice," he noted.
As a result of the FDA’s safety announcement, there has been an increase in open procedures for fibroids in patients who would have been "excellent candidates" for a robotic procedure; did not have a sarcoma; and would have avoided a prolonged length of stay, time away from work, delay in activities of daily living, more blood loss, and pain, he said.
But the FDA estimates that among women who undergo a hysterectomy or myomectomy for a presumed fibroid, about 1 in 350 has a uterine sarcoma, and about 1 in 500 has an LMS. Dr. Jaspan is among those who believe this is an overestimate.
Dr. Jaspan had no disclosures.
Ethicon can be contacted at 877-384-4266 for more information. Adverse events related to LPMs or other medical devices should be reported to the FDA at 800-332-1088 or here.
