On Wednesday, July 30th, Johnson & Johnson announced it was withdrawing a surgical tool that can spread cancer in women. This voluntary recall removed the devices made by the largest manufacturer of those devices from the market amid a contentious debate over its use.
The company planned to tell customers world-wide in a letter to return the devices known as laparoscopic power morcellators. J&J already suspended sales of new morcellators in April after the U.S. Food and Drug Administration advised doctors not to use the tool, which slices up common uterine masses called fibroids, and uteruses themselves, into fragments so they can be removed in minimally invasive surgery. In April, J&J defended the safety of the tool but said it was waiting for more guidance from the medical community.
J&J’s Ethicon unit, the largest maker of the devices, is withdrawing them from the market because the risks and benefits for women undergoing hysterectomies or surgery to remove fibroids remain uncertain, Matthew Johnson, a company spokesman, said yesterday in an e-mail. The decision was reinforced by an FDA meeting earlier this month that highlighted the difficulty in diagnosing cancer before a procedure is performed and the risk of disseminating tumors, he said.
“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” Johnson said.
Uterine cancers called sarcomas can masquerade as benign fibroids and can’t be reliably detected before surgery. Using a morcellator can inadvertently spread malignancies and other diseased tissues inside the body, possible worsening outcomes. The FDA found that 1 in 350 women who undergo surgery with the devices may have a type of cancer that the procedure can spread beyond the uterus. The seeding of malignant cells in the abdomen and pelvis can significantly worsen a woman’s chance of survival, the agency said. Last month, a study done by Columbia University researchers underscored the risk.
The problems associated with the morcellator go well beyond typical surgical complications. If you were diagnosed with cancer after uterine surgery, a power morcellator may be to blame. You need to speak with an attorney experienced with medical device cases about your options. If you or a loved one has suffered complications as a result of the use of a power morcellator during surgery for uterine fibroids, please contact the attorneys at the Locks Law Firm.
