Manufacturer Yanks Cancer-Spreading Device from the Market
As lawsuits mount over the incidence of cancer associated with the use of a medical device in the surgical removal of uterine fibroids, Johnson & Johnson announced last week that it’s recalling all of the power morcellators it has manufactured in recent years.
And early this week, a major East Coast health insurer said it no longer would cover the gynecological procedure involving power morcellation.
Power morcellation surgery has become quite popular because it’s performed laparoscopically. That’s a minimally invasive procedure whose small incision prompts faster recovery, less pain, less bleeding and less opportunity for site infection. The morcellator, whose market is dominated by J&J, cuts up the fibroids into tiny bits that can be removed through the incision.
But the machine has been associated with the risk of spreading aggressive forms of uterine cancer in patients in whom cancer was never even suspected. Earlier this year, we wrote about the shock of women finding out they had advanced cancer only after undergoing what is generally a fairly benign procedure. We followed up a couple months later with a report about the FDA issuing morcellation warnings.
Now, as reported on AboutLawsuits.com, J&J contacted doctors known to use the devices with the admission that the risk of spreading cancer is too high with morcellators, and that it has no future plans to manufacture or sell them. With about 72% of the market, J&J has asked hospitals to voluntarily return all of the laparoscopic surgery power morcellators.
According to Reuters, health insurer Highmark Inc., with 5.2 million customers in Pennsylvania, Delaware and West Virginia, will stop covering the procedure as of Sept. 1.
At an FDA meeting, it was determined that as many as 1 in 350 women who undergo laparoscopic surgery for uterine fibroid removal might have unsuspected sarcoma, and cancer cells within the uterus that could be spread throughout the body by power morcellation.
Although in April the FDA urged doctors to stop using the procedure, last month an FDA advisory committee split on whether to recommend severe safety warnings on power morcellator or a total power morcellator recall. We wonder why there was any doubt, given that the panel acknowledged that there was no known way to make morcellation for uterine fibroid removal safe.
It’s unknown when the FDA will make a final recall decision, but J&J didn’t wait for it to pull their devices. In the face of the lawsuits, everyone’s wondering why adequate warnings weren’t issued long ago, and whether manufacturers made devices as safe as they could have.
Luckily, for women in need of uterine fibroid removal, there are options beyond power morcellation — traditional surgical hysterectomy performed vaginally or abdominally; catheter-based blocking of the uterine artery; high-intensity focused ultrasound; drug therapy and laparoscopic hysterectomy or fibroidectomy without use of morcellation.
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