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In the face of mounting concerns about the risk of laparoscopic power morcellators spreading cancer concerns during uterine fibroid removal, Johnson & Johnson’s Ethicon division announced this week that it is recalling all of the devices they have manufactured in recent years, and will be getting out of the power morcellator business.
Power morcellators are medical devices used during minimally invasive laparoscopic hysterectomy and myomectomy procedures, allowing doctors to cut up uterine fibroids and remove the tissue through a small incision in the abdomen.
While the power morcellation surgery become increasingly popular in recent years, with Ethicon morcellators dominating the market, concerns have surfaced in recent months about the risk that the devices may quickly spread aggressive forms of uterine cancer, which doctors are not able to diagnose or detect before the procedure.
The Johnson & Johnson morcellator recall was announced yesterday, in emails and text messages sent by Ethicon to doctors known to use the devices. According to a report by the Wall Street Journal, the company has indicated that the risk of spreading cancer is too high and that the manufacturer has no plans to manufacture or sell power morcellators.
Ethicon was the largest provider of power morcellators in the world and controlled about 72% of the market. It has called for all hospitals to voluntarily return all of the laparoscopic surgery power morcellators.
Power Morcellator Cancer Concerns
The morcellator recall comes on the heals of recent FDA warnings and advisory panel meetings, where it was determined that as many as one out of every 350 women who undergo laparoscopic surgery for uterine fibroid removal may have unsuspected sarcoma, with cancer cells contained within the uterus that may be spread throughout the body by power morcellation.
This may rapidly upstage leiomyoscaroma, endometrial stromal sarcoma or other cancers, reducing life expectancy and quality of life.
On April 17, the FDA urged doctors to stop using power morcellators for uterine fibroid removal, and earlier this month an FDA advisory committee split on deciding whether to recommend severe power morcellator safety warnings or a total power morcellator recall. The committee agreed, however, that there was no known way to make morcellation for uterine fibroid removal safe.
After the April announcement, Ethicon halted sales of power morcellators to wait and see what the FDA would decide. However, Wednesday’s recall came without any indication that the agency has come to a decision.
It is unclear when the FDA will make a final decision on whether to recall morcellators manufactured by other companies. While the FDA advisory panel recommendations are not binding on the agency, they usually are factored heavily into any regulatory decisions.
Laparoscopic Morcellator Lawsuits By Women With Cancer Spread
As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.
A number of uterine fibroid morcellation lawsuits are now being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.
Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.