Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.
The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.
Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.
Source: FDA warning on uterine device draws opposition from doctors | Newsday
The Wall Street Journal (5/22, A1, Levitz, Kamp, Subscription Publication, 5.51M) reported that the FDA has discouraged Doctors from using power morcellators to remove uterus and uterine fibroids. The agency had warned against using the procedure because of concerns it could accidentally spread cancer to other parts of the body.
A morcellator is a surgical instrument used for division (“morcellation“) and removal of large masses of tissues during laparoscopic surgery.
This comes in the wake of Johnson & Johnson suspending worldwide sales its power morcellators on April 30, 2014.
If you have to to undergo laparoscopic surgery for removal of uterus and uterine fibroids, make sure you confirm with your doctor that he/she is not planning on using a power morcellator.
Nathan T. Williams