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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 the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.
Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.
If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.
The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.
While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.
The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.
The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.
In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.
"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.
Dr. Jaspan said he had no disclosures.
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 the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.
Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.
If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.
The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.
While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.
The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.
The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.
In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.
"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.
Dr. Jaspan said he had no disclosures.
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 the estimated 1 in 350 women with an unsuspected sarcoma, the Food and Drug Administration announced on April 17.
Based on an analysis of currently available data, the FDA has determined that the practice "poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcoma, beyond the uterus," Dr. William Maisel said during a press briefing. Physicians should discuss alternative treatment options with women who have symptomatic uterine fibroids, including the risks and benefits of those options, according to the FDA recommendations. The agency did not ban the use of the devices.
If, after "careful consideration of the benefits and risks," power morcellation is considered the best option, health care providers should inform the patient that "their fibroid may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis," said Dr. Maisel, deputy director for science and chief scientist at the FDA Center for Devices and Radiological Health.
The recommendationis based on the FDA’s analysis of currently available literature, conducted in response to approximately 12 reports to the FDA of women whose cancer had spread as a result of morcellation for fibroids, and a high profile case in the media. The analysis came up with the estimate that 1 in every 350 women who undergo a hysterectomy or myomectomy for uterine fibroids have a uterine sarcoma, which Dr. Maisel noted is higher than previous estimates in the medical literature and community, which have ranged from 1 in 500 to 1 in 10,000 cases.
While specimen bags may contain tissue during morcellation, Dr. Maisel said this approach is not "a panacea," and does not completely mitigate the risk. Bags can tear or obstruct the view of the operative field and have been associated with rare reports of uterine damage, he added.
The FDA is asking morcellator manufacturers to review the product labeling to ensure that these warnings are included and will hold a public meeting this summer of the agency’s Obstetrics and Gynecology Devices advisory committee to review the evidence on risks and whether it is possible to reduce those risks. The panel will not be asked to recommend whether the devices should be taken off the market, Dr. Maisel said.
The first power morcellator was cleared for marketing in 1995; approximately 24 devices are currently marketed for laparoscopic power morcellations for gynecologic indications, according to the FDA. They are considered class II "moderate risk" devices and were cleared for use based on older devices that were already on the market, such as electrosurgical cutting devices, Dr. Maisel said.
In an interview, Dr. David Jaspan, chairman of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, said that prior to the focus on this risk, resulting from the media attention, a patient who was going to have a supracervical laparoscopic hysterectomy may not have been informed about the need to morcellate. But the increased focus on the issue and the FDA announcement has opened up the line of communication about morcellation between physicians and their patients "and enables physicians to enhance their discussions with their patients about risk," he said.
"Then it becomes a decision between the physician and patient about what risk is warranted, which is no different than any other surgical procedure." Another positive outcome of this announcement is that it may lead to more collaboration between leaders in the field of minimally invasive surgery and device manufacturers to developing innovations that improve the safety of minimally invasive procedures, he added.
Dr. Jaspan said he had no disclosures.
