A bipartisan group of twelve lawmakers have called on the U.S. Government Accountability Office (GAO) to look into the FDA’s approval and monitoring of morcellators.
The FDA has approved at least 10 of the devices in the last 24 years, but did not warn about cancer-spreading risks until “decades after some studies were already pointing to a serious problem,” according to a letter reviewed by the WSJ.
The letter also states:
“The FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000. … How did they get it wrong for so long?”
Laparoscopic power morcellators use spinning blades to shred tissues, making them easier to suck out of a patient’s body. Unfortunately, they can also leave behind tiny pieces of tissue. If that tissue contains cancerous cells, the morcellator can spread uterine cancer and significantly worsen a patient’s chances of long-term survival.
The FDA apparently knew early on that morcellators could spread cancerous cells, but they thought the risk was low. In the general population, only about 1 in 10,000 women has undiagnosed uterine cancer.
However, women who have pain or bleeding from fibroids are actually much more likely to have undiagnosed uterine cancer. They are also more likely to get a hysterectomy and be treated with a morcellator.
Last year, the FDA warned that 1 in 350 women who undergoes a hysterectomy or fibroid surgery actually has undiagnosed uterine cancer. The recommended against using power morcellators in the “vast majority” of women, but never recalled the devices.
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