July 11, 2014 — The Associated Press reports that more than a dozen people have called on the U.S. Food and Drug Administration (FDA) to ban the use of morcellators in fibroid surgery and hysterectomies because they can spread cancer.
Women with cancer, family members of deceased patients, and doctors made implored an advisory panel to ban the devices. One woman, Colleen Daley, told the panel that her sister died in 2011 of leiomyosarcoma (LMS) after undergoing treatment with a morcellator. She said:
“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?”
Morcellators and 510(k) Approval
Dozens of laparoscopic power morcellators have been approved through 510(k) applications. This process allows new devices on the market without requiring new safety studies so long as they are “substantially equivalent” to a devices that is already on the market.
Manufacturers convinced the FDA that electrically-powered morcellators were equivalent to manual morcellators, which are hand-activated devices that were developed in the 1970s.
Electrical morcellators boomed in popularity during the 1990s because they saved time in the operating room. Although some manufacturers recommended using a protective surgical bag to prevent spillage of tissues during the procedure, it became commonplace for surgeons to morcellate without a bag.
It’s a déjà vu moment for the FDA, which has already faced criticism for putting public safety at risk by failing to adequately scrutinize 510(k) applications. In the last decade, over 100,000 lawsuits have been filed by people who were injured by vaginal mesh, metal-on-metal hip implants, and other devices that were cleared through this process.
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