Johnson & Johnson subsidiary Ethicon Inc. is moving to settle a number of lawsuits over its power morcellator devices that are alleged to spread cancer in women. The Wall Street Journal has reported that the company has settled nearly 70 cases over the past few months involving its laparoscopic power morcellator device, which plaintiffs say spreads undetected tumors.
Power morcellators are used in hysterectomies and uterine fibroid removal surgery. The morcellator cuts fibroids into fragments that are then removed through a small incision in the abdomen. If there are undetected cancer cells in the fibroid fragments, they may be spread in the removal process to the abdomen and pelvis, and then grow throughout the body.
In 2013, Dr. Amy Reed raised the alarm about power morcellators in a Wall Street Journal story after undergoing an operation to remove uterine fibroid tumors. Her surgeons used a power morcellator to shred the tumors, which then spread previously undetected cancer throughout her body.
In 2014, the FDA issued a warning about the use of power morcellators. The agency noted that approximately one in 350 women with fibroids also have uterine sarcoma, and that using the power morcellators on those patients could spread the cancer to the pelvis and abdomen.
Later that year, the FDA placed a “black box warning” — its most stringent — on power morcellators, recommending that their use be discontinued for most women undergoing a hysterectomy. Ethicon withdrew its morcellation devices from the market just prior to the FDA’s issuance of its black box warning.
In May 2015, the Newark, NY, office of the FBI said it was investigating whether or not Johnson & Johnson knew of the cancer risks associated with its power morcellators. A Congressional committee also called for an investigation into the FDA’s slow response to complaints about the device.
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