April 30, 2014 — Johnson & Johnson, the largest manufacturer of power morcellators, will stop worldwide sales, distribution, and promotion of the tools but will not permanently pull them off the market. The FDA recommends against using power morcellators in hysterectomies and/or uterine fibroid surgery due to the risk of cancer.
Morcellators affected by sales halt include:
- Gynecare Morcellex
- Morcellex Sigma
- Gynecare X-Tract
The Wall Street Journal reports that J&J owned about 72% of the laparoscopic power morcellator market in 2011. They purchased FemRx, manufacturer of the “Diva” morcellator, in 1998.
Power morcellators are used in laparoscopic surgery to remove uterine fibroids, painful but benign growths on the uterus. They are one of the most common reasons why women have hysterectomies. During the procedure, morcellators grind up the uterus and fibroids into smaller pieces that are easier to remove from the body.
However, when surgeons use morcellators without a protective surgical bag, tiny pieces of tissue are often left behind. If these tissues contain cancerous cells, morcellators can help aggressive cancers spread throughout a woman’s pelvis and abdomen. Earlier this month, the FDA warned that about 1 in 350 women with fibroids actually has cancer (uterine sarcoma).
In March, Ethicon was hit with a lawsuit filed on behalf of Donna Burkhart, a 53 year-old woman who died of metastatic leiomyosarcoma after undergoing a hysterectomy using a power morcellator.
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