Johnson & Johnson Pulls Hysterectomy Device from Hospitals Due to Belief of Spreading Cancer in Women

Johnson & Johnson has pulled hysterectomy devices from hospitals after being blamed from spreading cancer to women. The move amounts to an effective recall for the device called a laparoscopic power morcellator. J&J immediately stopped the sales of the devices in April 2014 after the U.S. FDA advised doctors not to use the tool, which slices up uterine masses called fibroids, and uteruses themselves, into fragments so they can be removed in minimally invasive surgery.

J&J defended the safety of the tool back in April. They said they were waiting for a definitive decision from the FDA.

The FDA has not issued a permanent decision on the device but J&J’s Ethicon subsidiary plans to inform customers in a letter that it is initiating a voluntary market recall of the product because it is not clear that the benefits of the device outweigh the risks. This is not an official recall because the action is not related to how the product performs.

Uterine cancers, called sarcomas, can masquerade as benign fibroids and can’t be reliably detected before surgery. Using a morcellator can inadvertently spread malignancies and other diseased tissues inside the body.

It is believed that J&J is officially withdrawing from the morcellation business.

 

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