October 2, 2015
The United States Government Accountability Office (GAO) reportedly has decided to conduct a probe into the power morcellator surgical device. Medical device makers have been marketing and selling the dangerous devices to hospitals and gynecologists for twenty years. Recently, the Food and Drug Administration (FDA) warned that the morcellator device can spread undetected uterine cancer.
A power morcellator looks like a power drill. With a rotating blade instead of a drill bit, the device is used by gynecologists during surgery to dice up fibroid tumors and remove the bits of tumor through small slits in a woman’s abdomen. Unfortunately, the device also chops up any undetected cancer in the uterus and propels the cancerous cells to other areas in the body.
In August, a bipartisan group of twelve federal legislators wrote to the GAO asking it to investigate the dangerous medical devices. The lawmakers were particularly alarmed to learn that women undergoing laparoscopic surgery with a power morcellator have a 1-in-350 chance of having an undetected uterine cancer that could be spread during the procedure.
Legislators want to know whether morcellator manufacturers reported problems with the device to the FDA as they are required to do. Another issue concerns the training that manufacturers provided to doctors who use the morcellator devices. In addition, law makers have asked what the FDA can do to decide whether it’s safe for morcellators to be used at all.
Although the GAO will conduct its own investigation into these matters, the morcellator probe likely will not begin for another five months due to staffing issues.
We understand that injuries caused by power morcellators are personal and they’re sensitive. That’s why we’ve assembled a legal team, most of whom are women, to provide our morcellator clients with compassionate and aggressive representation throughout the litigation. To learn more about Waters Kraus Paul & Siegel, or to have one of our attorneys review your potential morcellator case, contact us by email or call our medical device lawyers, like Kyla Cole in our Texas office, at 800.226.9880.
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