|Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson|
Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.
The agency on Monday recommended against using laparoscopic power morcellator tools in the "majority" of women undergoing a hysterectomy or the removal of uterine fibroids, and advised that manufacturers add boxed warnings and two contraindications for the devices in their product labels, the FDA said in a statement. The boxed warning informs patients and providers about morcellator risks, including that uterine tissue may contain unsuspected cancer and that use of power morcellators during fibroid surgery may spread cancer and decrease patients' long-term survival.
Two contraindications recommend that power morcellators should not be used to remove uterine tissue containing suspected fibroids in women who are peri- or post-menopausal, or in patients who could have tissue removed intact through the vagina or a mini-laparotomy incision. Regulators also advised against using the devices in gynecological surgeries where tissue is known or suspected of being cancerous.
|CDRH's William Maisel|
The guidance is set to take effect immediately, allowing the agency to "issue its recommendations expeditiously to help address a significant public health issue," the FDA said in a statement.
"The FDA's primary concern is the safety and well-being of patients and taking these steps will help the agency's safety recommendations to be implemented as quickly as possible," William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement. "Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed."
This is not the first time the FDA has weighed in on power morcellator safety. In April, the agency issued a warning against using the devices in minimally invasive surgeries to remove uterine fibroids, saying that women undergoing the procedures carried a 1 in 350 risk of having uterine sarcoma and that the tools could worsen the spread of cancerous tissue. Before the advisory was issued, power morcellators were used in an estimated 50,000 U.S. uterine surgeries each year, The Wall Street Journal reported.
In July, the FDA convened for a two-day advisory panel meeting to discuss the risks and potential benefits of using power morcellation in gynecological procedures. The agency's Obstetrics and Gynecology Devices panel recommended upgrading the labeling for power morcellator devices and advising patients about risks prior to surgery, although its suggestions were nonbinding.
The FDA's new recommendations come a critical moment, as the industry faces mounting criticism from patients and providers regarding power morcellator devices. In July, Johnson & Johnson's ($JNJ) Ethicon unit pulled its related product from the global market, months after the company decided to suspend sales of the devices due to growing safety concerns. The move also followed on the heels of troubling data, as a study by Columbia University physicians published in a July issue of the Journal of the American Medical Association found that one in 370 women who underwent a hysterectomy with the device have hidden uterine cancer, and that morcellator tools could spread a wider range of cancers than previously expected.
- read the FDA release
- here's the FDA guidance (PDF)