Johnson & Johnson’s Ethicon division, the manufacturer of laparoscopic power morcellators, announced that it is recalling all of the devices they have manufactured. According to news reports, J&J is getting out of the power morcellator business. Doctors and hospitals have expressed concerns about the risk of laparoscopic power morcellators spreading cancer during laparoscopic uterine fibroid removal.
What Are Power Morcellators?
Power morcellators are used during laparoscopic hysterectomy and fibroid removal procedures. The device is a fancy shredder that grinds up uterine fibroids and makes it easier to remove the uterine tissue during laparoscopic surgery.
Johnson & Johnson’s Ethicon morcellators has the largest market share, with almost 75% of the market. The Johnson & Johnson morcellator recall was sent by Ethicon to doctors known to use the devices. According to news reports, J&J knew that the risk of spreading cancer is too high and that the company has no plans to manufacture or sell power morcellators. Ethicon has called for all hospitals to voluntarily return all of the laparoscopic surgery power morcellators.
Power Morcellator Uterine Cancer Spread
Recently FDA has announced warnings and held advisory panel meetings, highlighting that one out of every 350 women who undergo laparoscopic surgery for uterine fibroid removal may have undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancers. The FDA is concerned that cancer cells may be spread throughout the body by power morcellation procedure, thereby converting a treatable stage 1 cancer disease into a stage 4 metastatic disease with very poor prognosis and early death.
FDA Warnings
On April 17, the FDA urged doctors to stop using power morcellators for uterine fibroid removal. In July, at an FDA advisory committee hearing, the experts could not decide whether to recommend increased power morcellator safety warnings or a complete power morcellator ban.
Laparoscopic Morcellator Lawsuits
As aggressive uterine cancers develop after laparoscopic hysterectomy from morcellator use, women are concerned why adequate warnings were not provided and whether manufacturers failed to make the devices safe.
Several uterine fibroid morcellation lawsuits have been filed for women diagnosed with metastatic leiomyosarcoma, and endometrial stromal sarcoma spread following a hysterectomy or myomectomy.
Women allege that power morcellators are unreasonably dangerous, and that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the doctors. There are several safer alternative treatment options available, including surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, and laparoscopic hysterectomy or myomectomy without use of morcellation.
