FDA Issues New Guidelines, Safety Communication On Use Of Power Morcellators
Amid scientific evidence that power morcellator use during laparoscopic hysterectomies and other gynecologic surgeries may cause the spread of undiagnosed cancer cells, federal health officials have taken new steps to increase awareness and require specific product labeling.
The U.S. Food and Drug Administration (FDA) issued a new draft Laparoscopic Power Morcellators (LPMs) Guidance on February 26, focusing on labeling specifications recommending that an LPM only be used in certain gynecologic surgeries with a compatible containment system to prevent the unintentional and unknown spread of cancerous tissue.
Morcellators are medical devices which allow doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. The minimally invasive procedures were recommended as a way to limit the risk of surgical complications and reduce recovery time.
However, use of the devices has largely been abandoned over the last several years, since the medical community discovered morcellators may spread undiagnosed cancer cells contained within the uterus, leading to the rapid upstaging of leiomyosarcoma, endometrial stromal sarcoma and other difficult to treat cancers.
In conjunction with the new draft guidance, FDA officials issued a Power Morcellator Safety Communication providing marketing authorization for the PneumoLiner containment systems, with the requirement of updated labeling to define the appropriate patient population.
According to the safety communication, since the likelihood of unsuspected cancer among women undergoing hysterectomy or myomectomy increases with age, the devices will be required to contain a warning indicating they should only be used in women who have fibroids if they are pre-menopausal and under 50 years old.
Recent scientific research identified that the benefit-risk profile of using LPMs is worse in older women when compared to younger women, and decreases their long-term survival rate.
The FDA indicates the device should be used by healthcare providers only if they discuss the risks and benefits with patients before use. Healthcare providers are encouraged to discuss all possible alternative treatments with patients, especially those close to the high-risk age range.
The agency is encouraging the public comments and suggestions on the draft before a final guidance is submitted. Comments can be submitted either online or written to the FDA Dockets Management division before April 27, 2020.
Power Morcellator Cancer Risks
The risks of cancer has been linked to power morcellators since 2014, when the FDA issued a black box warning and safety communication, warning doctors to stop using power morcellation during hysterectomy and myomectomy procedures to prevent the spread of undiagnosed uterine sarcoma and leiomyosarcoma.
The warning came after the FDA estimated that about 1 in 352 of the roughly 50,000 women who had undergone uterine fibroid surgery each year where a morcellator was used, had an undiagnosed case of uterine sarcoma, and 1 out of every 498 had undiagnosed leiomyosarcoma.
The FDA’s notices were issued shortly after Johnson & Johnson subsidiary, Ethicon, announced their power morcellator recall in July 2014, indicating the company had determined there was no way to use the medical devices safely without the risk of spreading undiagnosed cancer. Ethicon, which controlled more than 70% of the market, urged doctors to return all of its power morcellator products and to stop using them.
In the aftermath, Johnson & Johnson faced a number of morcellation cancer lawsuits brought on behalf of women who suffered problems after a laparoscopic procedure, and wrongful death claims by family members of women who had died of such cancers.
The lawsuits claimed the devices were not adequately tested or studied before being introduced, and inadequate warnings were provided to patients or the medical community about the risk of morcellation spreading cancer. Most of those cases have been resolved through morcellator settlement agreements.