The U.S. Food and Drug Administration (FDA) admitted this month that they are unsure about whether to issue a power morcellator ban, but are continuing to discourage use of the devices in minimally-invasive surgeries for women.
The regulator sent a letter on October 8th to U.S. Senator Kirsten Gillibrand, who requested an end to uterine morcellation procedures two months earlier with fellow New York Senator, Charles E. Schumer. The FDA’s response relayed its plan to continue its “internal analysis and review of the available scientific data,” and “take into account all available information when considering any future regulatory action.”
Gillibrand’s original letter was issued on August 19th, and expressed concerns about the possibility of power morcellators spreading uterine sarcoma and other cancers throughout the peritoneal cavity. That April, the FDA issued a federal warning about the surgical tool, which was designed of more easily cut up uterine tissue in laparoscopic hysterectomy and fibroid removal surgeries so it can be more easily extracted via a tiny incision. The FDA estimated at this time that 1 in every 350 women having fibroids removed may have previously undiagnosed cancer cells that can only be detected until after they are removed. This situation has been alleged in a growing number of power morcellator lawsuit claims, according to court documents.
This past summer, an FDA advisory committee met this summer to discuss power morcellator surgery, and decided that there was no safe way to use the devices in fibroid removal surgery. Panelists could not conclusively decide after the July meeting whether they should be taken off the market, however. Johnson & Johnson took matters into its own hands later that month with a “complete market withdrawal” of morcellators marketed by its subsidiary, Ethicon Inc. Before that, reports indicate that the company was responsible for 70 percent of morcellator sales in the U.S. Senators Gillibrand and Schumer mentioned this decision in their August note, and encouraged the FDA to ask other companies to follow suit in removing their products from the market.
“We urge the FDA to request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinician education can be performed,” the note stated.