Power morcellators are devices used in the tearing (morcellating) of tissue during arthroscopic procedures. Power morcellators were approved for use by the FDA in 1991. One common use of power morcellators was in laparoscopic surgical procedures to perform hysterectomies and myomectomies. Once a mainstay in gynecological care, power morcellators have been removed from the market due to the FDA Warning that their use leads to the spread of undetected cancer.
In April 2014, the FDA changed the labeling on power morcellators to reflect the newly discovered evidence that they can inadvertently disseminate cancer lying dormant in a woman's uterine fibroids. The majority of such fibroids are benign; however, there's currently no effective screening process to detect cancer in them. Three percent of women who underwent uterine surgery involving laparoscopic power morcellators contracted some form of cancer (predominantly leiomyosarcoma).
Other side effects of laparoscopic power morcellator use include the following:
- Spreading of fibroids to other pelvic or abdominal tissue
- Pain, swelling, and/or bruising around the surgical site
- Tissue damage or inflammation
If you have undergone laparoscopic surgery involving a power morcellator, watch for these symptoms of leiomyosarcoma:
- Vaginal discharge
- Irregular bleeding or spotting
- The development of a mass on your pelvis or abdomen
- Unaccounted-for weight loss
Recall and Litigation
Within weeks of the FDA's warning against power morcellator use for the removal of uterine fibroids, manufacturer Johnson and Johnson faced over 100 lawsuits for product liability and wrongful death. By July 2014, morcellator products were recalled entirely. The Wall Street Journal reported that Johnson and Johnson settled nearly 70 cases in the months leading up to the recall. Settlement amounts ranged from $100,000 to $1,000,000. A key component in what has made these cases so successful for plaintiffs is likely that manufacturers could have known about the significant risks presented but failed to disclose those risks to the FDA prior to 2014. Medical professionals have come forth for years expressing concerns about morcellators and their potential adverse effects on other organs within the body.