A Houston attorney says a controversial medical device no longer in use may have played a role in spreading cancer in some women.
“Using the power morcellator comes with the risk of what’s called upstaging cancer,” said Sean Tracey of Tracey & Fox. “When used in women with uterine cancer, it could make their condition much worse.”
Power morcellators are medical devices used to remove uterine fibroids from 1994 to 2013. The devices have high-speed blades that cut the fibroids into small pieces so that they could be removed during minimally invasive surgery instead of a more open procedure. But it was later discovered that the procedure could have dangerous consequences in women with undiagnosed uterine cancer.
“Doctors using this device unknowingly spread cancer inside women and killed them,” said Tracey.
The issue came to light in 2013 after Amy Reed underwent a morcellation procedure at Brigham and Women’s Hospital in Boston. Reed and her husband, both physicians, led a fight to ban the device, and the FDA added a “black box” warning to power morcellator labels the following year.
Because power morcellators were similar to a previously approved device, they did not have to undergo rigorous safety testing or clinical trials before being put on the market.
“There was no testing,” Tracey said. “Many doctors weren’t even aware that these devices only went through the very abbreviated 510(k) process, not the full testing and approval process.”
Tracey said he hopes an awareness campaign will encourage women to learn more.
“We get calls from people wondering if this is what happened to them or their mother or their wife,” he said. Tracey urges women who may be affected to review their medical records to see if a power morcellator was used during a hysterectomy or myomectomy.