As the conversation surrounding power morcellators and their risk of spreading undetected uterine cancer continues to escalate, two United States senators have called for the FDA to take a firmer stance on the devices.
The letter marks the first time political pressure has been put on the U.S. Food and Drug Administration to do more in regard to withdrawing the tools from the market.
A letter sent to the FDA from New York Democrats Chuck Schumer and Kirsten Gillibrand, according to a Wall Street Journal report, marks the first time political pressure has been put on the U.S. Food and Drug Administration to do more in regard to withdrawing the tools from the market. The senators’ letter, according to the Journal, urged the FDA “to request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinical education can be performed.”
Additionally, the senators pushed for the FDA to “seriously consider and not discount the testimony presented during the FDA’s July hearings” by those who had lost family members who had undergone surgery with a power morcellation device and were diagnosed with cancer. This testimony, according to reports, was presented with others at a two-day hearing held by the FDA in July to discuss the future of power morcellation devices.
In July, one of the makers of the surgical devices, Johnson & Johnson’s Ethicon unit, asked doctors to return the morcellators, a request viewed by industry and medical experts as the company’s de facto recall. A few months prior to this request, the FDA had advised surgeons to stop using the devices until the risks associated with power morcellation could be studied more thoroughly. To date, Johnson & Johnson is the only company to take any action in withdrawing morcellators, which are also manufactured by Karl Storz GmbH, Richard Wolf GmbH, Olympus Corp, LiNA Medical, and Blue Endo.
Lawsuits have alleged the morcellators, used to remove uterine fibroids in women through a small incision in the stomach, could spread undetected cancer cells in the body since it’s so difficult for doctors to distinguish benign fibroids from cancerous tumors. Recent numbers estimate that one in 350 women who have undergone uterine fibroid surgery with a power morcellator have an undetected form of cancer, a risk believed to be much higher than previously cited by doctors.
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