August 10, 2015 — A bipartisan team of lawmakers is calling on the U.S. Government Accountability Office (GAO) to find out why it took the FDA decades to realize that power morcellators pose serious cancer-spreading risks for women undergoing hysterectomies.
The Wall Street Journal reports that twelve members of Congress sent a letter demanding an investigation of the FDA’s approval and monitoring of morcellators.
At least 10 power morcellators were approved in the last 24 years. However, it was not until “decades after some studies were already pointing to a serious problem” that the FDA realized the risk of spreading cancer was much higher than expected.
According to the letter reviewed by the WSJ:
“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?”
In the general population, about one in 10,000 women has undiagnosed uterine cancer. However, women who choose to have a hysterectomy are not the general population — they are usually choosing to have a hysterectomy to treat pain, bleeding, large fibroids, or other symptoms that could also be cancer.
For women being treated with a morcellator during a hysterectomy, about 1 in 350 has undiagnosed cancer. Unfortunately, there is no way of knowing whether a fibroid is actually cancer until after the hysterectomy.
In November 2014, the FDA issued a Safety Communication to warn that morcellators should not be used on the “vast majority” of women. However, no recalls were issued and many manufacturers continue to sell the controversial devices.
Do I have a Morcellator Lawsuit?
The Schmidt Firm, PLLC is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with uterine cancer, 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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