FDA officials issued a formal warning today asking doctors to avoid a certain method for removing uterine tissue out of concern that it may cause stealthy cancers to spread beyond the uterus.
U.S. healthcare regulators asked doctors to avoid laparoscopic power morcellation, a procedure in which the uterus or uterine fibroids are broken up into smaller pieces prior to removal. The increasingly popular procedure allows surgeons remove tissue through small incisions rather than through open surgery, but the FDA warned that it may also allow undetected cancers to spread.
"There is no reliable way to determine if a uterine fibroid is cancerous prior to removal," the FDA said in this week’s memo. "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."
Tissue morcellation has come under fire before, with prominent hospitals in Boston and Ohio speaking out late last year against the procedure. The Cleveland Clinic said in December that it would increase its informed consent requirements for patients undergoing the procedure.
"Right now I don’t think we’re heading to a moratorium, but it is to be discussed," OB/GYN staff physician Dr. Mary Jean Uy-Kroh told the Wall Street Journal at the time.
The FDA warned this week that as many as 1 in 350 patients undergoing hysterectomy may have a type of uterine cancer, called uterine sarcoma. Laparoscopic power morcellation may exacerbate an undetected cancer and cause it to spread to the abdomen, lowering a patient’s chances of survival.
The agency plans to host a public meeting of the Obstetrics and Gynecological Medical Devices Panel to further discuss the procedure and how to address concerns moving forward.
That’s bad news for the handful of medical device makers with morcellators on the market, including Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon and Denmark-based LiNA Medical.
