U.S. Representative Michael Fitzpatrick has asked the Food and Drug Administration’s Office of Criminal Investigations to investigate allegations that hundreds of women have died as a result of surgical procedures done with a power morcellator.
Despite initial guidance that the cancer risk associated with the power morcellator was relatively low, the FDA now believes that the device could spread cancer in as many as 1 in 352 cases, Qmed reports. These numbers led the agency to issue a warning in 2014, recommending that the morcellator not be used in most patients.
The power morcellator is used in laparoscopic uterine fibroid surgeries and hysterectomies. The device is inserted into the lower abdomen via a small incision. The morcellator’s rapidly spinning blades cut tissue into tiny pieces that can be removed through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and sharply reduces the woman’s long-term survival chances.
Congressman Fitzpatrick is asking for an investigation of Ethicon, a subsidiary of Johnson & Johnson that was the major maker of morcellators. (Ethicon halted sale of morcellators in 2014.) Fitzpatrick also asked the FDA to investigate hospitals that used the devices extensively, including Brigham and Women’s in Boston and the University of Rochester Medical Center. Fitzpatrick’s letter specifically mentions three women who likely died from cancer spread by the morcellator. He questions whether those deaths were properly reported to the FDA, according to Qmed. In a letter to Fitzpatrick in November 2015, the FDA told the congressman that prior to late 2013, it did not “receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissues.” The first report of a cancer being spread via a morcellator came from a physician whose wife had undergone a procedure with the device.
Although the FDA did not issue any warning about power morcellators until 2014, in 2006, Ethicon amended the label for its Gynecare Morcellex device to warn that the device “may lead to dissemination of malignant tissue,” according to Qmed. In November 2014, the FDA amended its morcellator advisory to add a black box warning for the device. (The black box is the agency’s strongest warning.) Although the morcellator has not been banned, many hospitals have restricted its use to carefully screened patients and a number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.
In August 2015, Rep. Fitzpatrick, along with Rep. Louise Slaughter, and a bipartisan group of lawmakers, asked the U.S. Government Accountability Office to examine the criteria the FDA used to clear morcellators for sale and whether medical device reporting regulations are being followed appropriately, according to Qmed. In May 2016, the Wall Street Journal reported that the FBI was investigating Johnson & Johnson to determine what company officials they knew about the morcellator’s potential to spread cancer.