FDA warning on uterine device draws opposition from doctors | Newsday

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

Advertisements

Hysterectomy Device Tied to Spreading Cancer Recalled by Johnson & Johnson

Power Morcellators

Image Credit: Wall Street Journal

J&J just announced that it is voluntarily pulling its power morcellators globally. J&J’s decision comes in the wake of the FDA’s April 2014 warning to doctors that this device may spread, and consequently accelerate, the growth of undetected cancer cells in women. The FDA found that as many as 1 in 350 woman who undergo this procedure may have cancer that this machine could spread outside the uterus.

Power morcellators are robots that are used to preform minimally invasive robotic hysterectomies. The American Medical Association estimates that as many as 20,000 woman have these types of procedures preformed on an annual basis.

Our firm is currently reviewing cases where woman have had robotic hysterectomies and experienced injuries or the spread of cancer.

Bloomberg News published a good article on this: http://www.bloomberg.com/news/2014-07-31/j-j-withdraws-hysterectomy-device-tied-to-cancer-spread.html

Some Doctors Ignoring FDA Advice to Stop Using Power Morcellators

FDA Warning

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

TheWilliamsLitigationGroup.Com