July 11, 2014 — An advisory panel to the U.S. Food and Drug Administration (FDA) is considering requests to ban morcellators in hysterectomies and fibroid surgery due to the risk of spreading cancer, according to the Associated Press.
More than a dozen people, including women with cancer, surviving family members, and physicians argued that the risk of deadly cancer outweighs benefits like saving time in the operating room.
One woman, Colleen Daley, lost her sister to leiomyosarcoma after a morcellator procedure. She asked:
“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?”
Concerns About 510(k) Approval
The FDA has approved dozens of laparoscopic power morcellators through the 510(k) process, which allows manufacturers to introduce new devices without conducting new safety studies so long as the device is “substantially equivalent” to a device that is already on the market.
Manufacturers convinced the FDA that electrically-powered morcellators were equivalent to hand-operated morcellators, which have been on the market since the early 1970s. The popularity of electrical morcellators boomed in the 1990s. Unfortunately, it became commonplace for gynecologists to use the devices without protective surgical bags to contain tissues.
Scrutiny over the 510(k) system is a déjà vu moment for the FDA, which has already faced criticism in the wake of several public health disasters. In the last five years, over 100,000 lawsuits have been filed by people who were injured by vaginal mesh, metal-on-metal hip implants, and other defective devices that were cleared through the 510(k) process.
Do I have a Fibroid Surgery Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting power morcellator induced injury cases in all 50 states. If you or somebody you know has been injured by cancer after fibroid surgery or a hysterectomy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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