By Jof Enriquez,
Follow me on Twitter @jofenriq
Johnson & Johnson (J&J) has temporarily halted the worldwide sale, distribution and promotion of its surgical morcellators used to remove fibroids, following an FDA warning against the use of such devices. The decision affects all of J&J’s morcellators, which are marketed as Gynecare X-Tract, Gynecare Morcellex, and Morcellex Sigma.
J&J says it wants the FDA and the medical community to clarify the effectiveness and safety of morcellators before resuming the commercialization of the products.
"Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant tissue," according to a report by Reuters, quoting a J&J letter addressed to customers.
The decision comes on the heels of a safety communication notice by the FDA saying that morcellators may inadvertently spread cancer during surgery, citing latest clinical data.
According to the notice, the use of laparoscopic power morcellation tools for the removal of the uterus or uterine fibroids “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the press release.
Power morcellators are tube-shaped blades inserted through a small hole in the abdomen to cut fibroids and other bits of suspicious uterine tissue. Morcellators are used about 50,000 times annually in fibroid removal procedures, according to the Wall Street Journal.
Most fibroids are benign, but a small percentage of women with fibroids may also have a malignant cancer called uterine sarcoma. Cutting fibroids apart may inadvertently spread cancer cells and worsen survival rates.
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals,” said Maisel.
J&J says that the FDA notice is not a product recall or removal, and that patients can still consult with healthcare professionals and give consent to using morcellation for hysterectomies and myomectomies.