In the aftermath of an April 17th warning by the U.S. Food and Drug Administration, Johnson & Johnson has announced that it is suspending worldwide sales of its laparoscopic power morcellators. Although several companies manufacture and market power morcellators, Johnson & Johnson is the largest manufacturer of the medical devices.
Laparoscopic power morcellators are used in hysterectomies and myomectomies to treat uterine fibroids. The FDA is now discouraging use of these medical devices due to the increased risk of spreading cancerous tissue beyond the uterus. It is estimated that 1 of every 350 women who are surgically treated for uterine fibroids has an undiagnosed, unsuspected uterine sarcoma. Laparoscopic surgery using a power morcellator involves fragmenting tissue into small pieces that can be easily removed through small incisions. It is this aspect of the procedure that can disperse cancerous cells, spreading them throughout the pelvis and significantly decreasing the woman’s changes of long-term survival.
In the FDA warning, doctors were discouraged from using laparoscopic power morcellators during hysterectomies and myomectomies for treatment of uterine fibroids. Although the medical devices have not been recalled, some hospitals have stopped using the devices. In announcing suspension of sales, J&J stated that it was suspending global sales, distribution and promotion of morcellation medical devices “while the role of morcellation for patients with symptomatic fibroid disease is redefined by the FDA and the medical community.” Johnson & Johnson also noted that its morcellation devices have always included warnings about the potential for spreading malignant tissue.
The Johnson & Johnson products that are being suspended include the Gynecare Morcellex Tissue Morcellator, the Morcellus Sigma Tissue Morcellator System and the Gynecare X-Tract Tissue Morcellator, all sold by the company’s Ethicon division. Laparoscopic power morcellators are also manufactured by FemRx, Hologic, Lemenis, Inc, Interlace Medical, Smith & Nephew, Olympus, Nouvag, Blue Endo, LNM Medical, Karl Storz, and Richard Wolf
Clark, Perdue & List are investigating claims of uterine cancer following laparoscopic power morcellator surgery. If you or a loved one has been diagnosed with cancer and had this procedure, call the Ohio Medical Device Attorneys at Clark, Perdue & List.