Johnson & Johnson is pulling from the global market a device used during hysterectomies and other uterine procedures after reports it may spread and accelerate the growth of undetected cancer inside women.
The move builds on J&J’s decision in April to suspend use of the devices after the U.S. Food and Drug Administration warned doctors that the widely employed surgical tool may disperse malignant cells. The equipment, known as a power morcellator, shaves tissue or growths into tiny pieces they can be extracted without open surgery.
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,” he said.
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.
It’s not known how many women undergo such procedures each year in the U.S., though more than 20,000 minimally invasive or robotic hysterectomies are done annually, according to an article published in the Journal of the American Medical Association in March.
J&J, based in New Brunswick, New Jersey, is the world’s largest seller of health-care products.