FDA Toughens Power Morcellation Warning

Disclosures

November 24, 2014

The US Food and Drug Administration (FDA) today issued a tougher warning against using laparoscopic power morcellators in hysterectomy and myomectomy to remove uterine fibroid tumors, saying surgeons should avoid them in the vast majority of women because of the risk of spreading occult cancerous tissue.

Updating a warning issued in April, the FDA today said the devices are contraindicated for removing uterine tissue with suspected fibroids in patients who are perimenopausal or postmenopausal or those who are candidates for removing tissue intact through the vagina or a minilaparotomy incision. These two categories "represent the majority of women with fibroids who undergo hysterectomy and myomectomy," the agency said in a news release today. The devices also should not be used in gynecological procedures to shred tissue either known or suspected to contain cancer.

In addition to these two changes, the label for power morcellators will receive a boxed warning that states the devices may spread unsuspected cancer during fibroid surgery and "decrease the long-term survival of patients." Surgeons must discuss this risk with patients considering this procedure, the boxed warning will state.

The FDA estimates that roughly one in every 350 women undergoing hysterectomy or myomectomy for fibroid removal has an unsuspected uterine sarcoma such as a leiomyosarcoma.

"Our hearts go out to the women who have suffered with metastatic cancer following these procedures, as well as their families and loved ones," said William Maisel, MD, MPH, deputy director for science and chief scientist at the agency's Center for Devices and Radiological Health, at a news conference. "We have certainly heard their voices and think of them every day in the work that we're doing."

The FDA stopped short of pulling power morcellators from the market, although one manufacturer, Johnson & Johnson, has already done that on a voluntary basis. Dr Maisel said power morcellation should remain an option for women with fibroids who are not yet perimenopausal and who wish to preserve their uterus, and especially younger women who want to remain fertile. However, choosing power morcellation in these situations should come only after informed consent about the risk of spreading occult cancer.

Today's decision drew a scathing response from a cardiothoracic surgeon who advocates recalling all power morcellators. Dr Hooman Noorchashm almost single-handledly ignited this year's intense debate about power morcellation after his wife, anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy in October 2013 for uterine fibroids and later discovered that the procedure had advanced an occult uterine cancer to stage IV. Dr Reed's cancer is in remission, and she intends to resume work in January 2015, Dr Noorchashm told Medscape Medical News, but other women whose occult cancer was spread by power morcellation continue to die.

"This is a massive regulatory failure on the FDA's part," said Dr Noorchashm, an assistant professor of surgery at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania. "The evidence of avoidable harm is overwhelming."

He accused the FDA of putting the interests of morcellator manufacturers above patient safety and said he would lobby for congressional hearings to investigate why the agency has gone off course.

Asked to comment on Dr Noorchashm's critique, Dr Maisel said at today's news briefing that the FDA based its decision "on what we believe is best for patients." He noted that for a very small population of women, the benefits of power morcellation may outweigh the risks. If power morcellation were banned, these women would have to resort to other fibroid treatment options, such as more invasive forms of surgery, which come with their own risks, according to Dr Maisel.

More information about today's announcement is available on the FDA's web site.

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