Morcellator Recall

The Johnson & Johnson morcellator recall comes on the heels of studies, FDA involvement, and a rising number of lawsuits concerning the role that these surgical devices play in spreading cancer.

The power morcellator is a small tool with blades that rotate in order to break up tissue from the uterus or uterine fibroids during hysterectomy or myomectomy (surgery for the removal of fibroids) surgery. The tool was introduced as a means to facilitate less invasive surgeries; it is inserted into a small opening during the procedure and helps eliminate the need for a larger and potentially more risky incision. Unfortunately, recent evidence suggests that the tool may spread previously undetected uterine cancers, some of them quite aggressive.

Following the release of studies and an FDA recommendation against the use of the devices, Johnson & Johnson’s subsidiary corporation, Ethicon, pulled three models of power morcellator from the market in a “voluntary recall,” designed to prevent further illness or loss of life.

For some women, Ethicon’s actions have come too late. As debates in the FDA about appropriate action continue, some public officials would like to see additional manufacturers respond to the risks that morcellators appear to pose.

Events leading to the Ethicon power morcellator recall

Ethicon took action regarding their power morcellator devices this summer after a chain of events convinced the company that this was the best course of action.

The following is a time-line of the events leading up to Ethicon’s decision to pull its power morcellator unit off the market:

• 1993: the power morcellator is first introduced into the U.S. market for use during hysterectomies
• 2012: Study published in the journal PlosOne indicates that rates of undetected uterine cancer that could potentially be spread by morcellators were 9 times higher than previously thought. The researchers involved in the study were doctors from Brigham & Women’s Hospital in Boston, where morcellators are no longer used in gynecological surgery. (A study published later in the September 2014 issue of JAMA also found high rates of such cancer.)
• 2013: Dr. Hooman Noorchashm and his wife Dr. Amy Reed spearhead a high-profile campaign to ban the morcellation procedure after Dr. Reed contracts cancer following the use of morcellation during a hysterectomy.
• 2014, March: The first lawsuit over power morcellator-related cancer is filed in Philadelphia. Scott Burkhart alleges that his wife Donna’s cancer death was directly related to the use of a power morcellator during hysterectomy surgery.
• 2014, April 17: FDA issues a safety communication regarding the risks of power morcellators and discourages their use. Noting that recent data suggests that 1 in 350 women who undergo uterine surgery have an unsuspected uterine sarcoma, the agency expressed concern about the safety of the procedure and announced plans to convene a meeting to discuss risks associated with power morcellation and reasonable responses (see 2014, July 10-11, below, for the outcome of the meeting.)
• 2014, April: Following the FDA safety announcement, Johnson & Johnson’s subsidiary company Ethicon suspended sales and production of their power morcellators. They did not issue a recall at this time, however. The suspension was to be followed by more concrete action pursued in light of the decision that the company awaited from the upcoming FDA panel discussion. The devices in question are the Gynecare Morcellex, the Morcellex Sigma, and the Gynecare X-Tract.
• 2014, July 10-11: Medical Devices Advisory Committee Meeting, Obstetrics and Gynecology Devices Panel of the FDA meets to discuss risks associated with power morcellation. A number of options are considered, including: classifying power morcellators as Class III devices (which requires strict testing); requiring patient consent forms before morcellation is carried out during surgery; and adding a black-box warning label (the strictest available) to the device. No agreement was reached on these issues, however.
• 2014, July 30: Ethicon power morcellator recall announced. The company contacted doctors and hospitals directly to request the return of the devices. However, this action stopped short of a full or official recall, according to the company, whose spokesman referred to it as a “market withdrawal.” The distinction hinges on the company’s insistence that the devices do function as designed and are not, of themselves, defective.

FDA and uterine fibroid morcellation recalls

Although Ethicon’s “market withdrawal” was prompted, in part, by actions that the FDA took in connection to their products, the recall was not orchestrated directly by the FDA. Ethicon’s actions have been praised as responding proactively to the morcellator cancer risks; they may also comprise an attempt to control damage on a legal front as plaintiffs begin to file lawsuits regarding morcellation-linked cancer.

Because the morcellators are currently considered “class II” devices by the FDA, the manufacturer only needs to demonstrate that they are “substantially similar” to devices used previously, without having to undergo rigorous testing. Under the FDA’s 510 (k) clearance process, only those devices that are designated Class III require such rigorous testing. The FDA is considering reclassifying the morcellators as “Class III” devices; however, because they have not made such a final determination, the devices are subject to substantially less regulation than they appear to require.

Although Ethicon, the manufacturer with the largest market share in the morcellator industry, has issued a voluntary “market withdrawal,” approximately 20 other models produced by companies other than Ethicon remain in the field. Senators Chuck Schumer and Kirsten Gillibrand sent a letter to the FDA dated August 19 in which they request that all such devices be removed from the market pending additional investigation.

Meanwhile, a small but growing number of women or there families have filed power morcellator lawsuits regarding the relationship between morcellation and cancer.

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