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Johnson & Johnson is pulling power morcellators used for performing hysterectomies, responding to concerns that the devices risk spreading cancer to healthy tissues.
Doctors had been warned against using the device by the U.S. Food and Drug Administration in April, but J&J is now asking surgeons not to use its power morcellating line of products. The Associated Press reports that the company is "conducting a worldwide withdrawal of all of its morcellators still on the market."
Noting that this is a withdrawal and not a recall, what future legal implications do these morcellators hold for J&J?
J&J's power morcellators have been the subject of several lawsuits from women who either fear or have confirmed the spread of uterine cancer following procedures performed with these medical devices. The morcellators had been largely used by surgeons to remove uterine fibroids, cysts, or even perform hysterectomies in a minimally invasive procedure.
One small problem: The FDA in April alerted the general public to the danger of these devices potentially spreading uterine cancer to other healthy tissues. There was no official recall issued by the federal agency, simply a statement advising medical professionals of the potential dangers of power morcellators.
Perhaps in an attempt to stem the flow of potential lawsuits from power morcellators on the market, J&J has voluntarily announced it will be pulling the Ethicon Inc. line of power morcellators. It had already halted the marketing and sales of these morcellators after the FDA's April announcement.
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FDA Weighs Future Action
The AP reports that the FDA is "weighing regulatory actions to reduce the risk of cancer spread," but until more is learned, it is unclear what actions will be taken. The FDA has the power to require companies to recall products based on a spectrum of risk to consumers, but in J&J's case, the products will have already been pulled.
The FDA's findings on the danger posed by these devices may go a long way toward ensuring the success of any pending or future power morcellation lawsuits -- especially any link between the device's use and the likelihood of spreading uterine cancer.
If you have had a laparoscopic hysterectomy or other uterine surgery and worry that power morcellators may have been used, you may wish to contact an experienced products liability attorney in your area to discuss your legal options.