J&J had originally defended the safety of the tool but said it was waiting for more guidance from the medical community. However, in recent weeks, concerns about the tool’s risks have grown.
In April J&J suspended the use of the devices after the FDA warned doctors that the vastly utilized surgical tool, known as a laparoscopic power morcellation, may disperse malignant cells when it shaves tissue or growths into small pieces that are extracted without open surgery. The FDA found that 1 in 350 who undergo surgery with the device may have a type of cancer in the uterus that could spread to other parts of the body. This “seeding” of malignant cells to other areas, including the abdomen and pelvis, can significantly worsen a woman’s chance of surviving cancer, according to the FDA.
Matthew Johnson, a company spokesman, stated that J&J’s Ethicon unit is withdrawing from the market because the risks and benefits for women undergoing hysterectomies or surgery to remove fibroids remain uncertain. He also stated that the decision was reinforced by an FDA meeting held earlier in July focusing on the difficulty in diagnosing cancer before women undergo these procedures and the risk of spreading cancerous tumors from the original growth to a secondary site. Johnson stated that, “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.”.
Currently, it is unknown how many women undergo these procedures each year in the U.S., but more than 20,000 minimally invasive or robotic hysterectomies are performed annually, according to an article published in the Journal of the American Medical Association in March.