The U.S. Food and Drug Administration (FDA) currently estimates that 1 in 350 women are at potential risk for uterine cancer due to the use of power morcellators.
The power morcellator is a medical device used to remove uterine fibroid tumors and in hysterectomies. The device cuts the fibroids into small pieces that are then removed via a small abdominal incision. Some fibroids may have undetected cancer cells, which can be spread throughout the body when the morcellator cuts them into fragments.
The FDA issued a warning about power morcellators in 2014, saying that because approximately one in 350 women with fibroids also have uterine sarcoma, the use of power morcellators could pose a dangerous risk of spreading the cancer. Ethicon, a division of Johnson & Johnson, removed its power morcellators from the market following that warning.
A few months after that announcement, the FDA added a “black box warning” -- it most severe -- on power morcellators, with the recommendation that they no longer be used for hysterectomies. Johnston & Johnson has already settled almost 70 lawsuits that allege the company’s power morcellator spread cancer in plaintiffs.
A new study published in the August 2016 issue of the Journal of the American Medical Association (JAMA) shows that following the FDA’s warnings, the use of power morcellators declined significantly. The study also found that the complication rates from traditional hysterectomies did not increase as supporters of the device had warned if the use of morcellators decreased. Morcellator use has decreased from 14% in 2014 to 3% in 2015.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.