Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery is voluntarily asking for the return of laparoscopic power morcellators used in fibroid surgeries, on the risk that the devices may unintentionally spread cancer cells during the procedures, according to news reports.
Ethicon had already suspended sales of the devices last April, following FDA warnings that the devices may might spread undetected cancers.
At the time the company stopped short of a full recall, telling customers that federal healthcare regulators continue to view morcellation as an important option for some patients. Ethicon noted that the devices have always carried a label warning of the "potential spread of malignant tissue," but said yesterday that the uncertainty of the cancer risk prompted a recall, according to Reuters.
"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,"a spokesman told the news service via email.
An FDA advisory panel convened earlier this month failed to reach a consensus on the devices’ safety, despite outraged testimony from physicians and attendees at the hearing. The FDA’s Obstetrics and Gynecology Devices panel met July 10-11 to review the use of LPMs in removing uterine fibroids thought to be benign. The practice has been implicated in the spread of undetected uterine cancers, the "upstaging" of a cancerous growth to a fatal stage IV cancer.
In April, the FDA in April issued a Safety Communication discouraging the use of LPMs, estimating that around 1 in 350 women who undergo hysterectomy or myomectomy for presumed fibroids have an unsuspected and difficult-to-diagnose type of uterine cancer called uterine sarcoma. The watchdog agency also requested that manufacturers of LPMs indicated for gynecologic procedures review the products’ labeling to ensure that it contains accurate safety information.
The 15-member panel offered several suggestions for mitigating the risk of spreading uterine sarcomas in using the morcellators, including an outright ban, stricter product labeling and limiting use in some patient populations.
The advisory panel urged surgeons to take precautions including MRI, radiologic imaging and biopsy and to take patient age and exam findings into account to ensure a fibroid is not cancerous prior to removal. Peri-menopausal and post-menopausal women should definitely not have morcellation, they said. The committee also called for enhanced warnings to surgeons and increased communication to ensure that patients know there is a small but grave risk associated with the use of laparoscopic surgery and the use of LPMs and that other options, such as more invasive abdominal surgery, are available.