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Officials Ask How FDA Was So Wrong on Risks of Power Morcellation

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Washington, DCWith 34 power morcellator lawsuits filed against Ethicon consolidated for pretrial proceedings and the US government investigating allegations against the makers of power morcellators, 2016 could be a bad year for power morcellation device makers. The devices, used in laparoscopic hysterectomy or myomectomy, have come under scrutiny due to concerns that they could inadvertently spread cancerous tissue throughout a patient’s abdomen, increasing the risk of death.

Back in August 2015, 12 members of Congress sent a letter (8/7/15) to the US Government Accountability Office (GAO), requesting the GAO examine how power morcellators remained on the market despite evidence of a risk of undetected cancer being spread.

“It is unclear exactly how many women may be dead as a result of an unsuspected cancer having been spread by this device,” the letter notes.
“FDA’s warning came decades after some studies were already pointing to a serious problem. For example, a 1990 study found about one in 200 women had a hidden uterine sarcoma, a rare type of cancer.”

Despite that study and others suggesting the risk of hidden uterine sarcoma was greater than one in 500, the FDA and others reportedly maintained the risk of hidden cancer was as low as one in 10,000. “How did they get it so wrong for so long,” the letter’s writers ask.

The risk of hidden uterine sarcoma is an important one, because women undergoing power morcellation do so to break up uterine fibroids - benign masses in the uterus. In some cases, however, the uterine fibroids are actually uterine sarcomas, and blasting them with power morcellators can cause the sarcomas to break apart and spread through the patient’s abdomen, decreasing the chances of survival. A risk of one in 10,000 is vastly different from a risk of one in 500, especially when doctors cannot tell prior to the procedure if the fibroids are sarcomas.

In 2014, the FDA issued a black box warning about the use of power morcellators, but the members of Congress asked the GAO to investigate whether the agency was able to adequately identify the risk of adverse events before approving the devices, whether reporting regulations were adequately followed, whether clinicians were given training on use of the morcellators, and what steps the FDA is taking to ensure power morcellators are safe to remain on the market.

Meanwhile, patients have filed lawsuits of their own, alleging they were harmed by the use of the power morcellators. Thirty-four lawsuits have been consolidated for pretrial proceedings in MDL 2652, In Re: Ethicon, Inc, Power Morcellator Products Liability Litigation, before Judge Kathryn Vratil.


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