J&J halts sale of electric fibroid removal devices

Published on NewsOK Modified: April 30, 2014 at 1:04 pm •  Published: April 30, 2014
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WASHINGTON (AP) — Johnson & Johnson is halting sales of devices used to remove growths in the uterus following a government warning that the electronic surgical tools can inadvertently spread cancer to other parts of the body.

The announcement comes one week after the Food and Drug Administration discouraged doctors from using the devices, known as laparoscopic power morcellators. Surgeons use the devices to treat painful fibroids, either by removing the growths themselves or the entire uterus. Power morcellators shred the tissue so it can be removed through a small incision in the abdomen, instead of a larger opening required for traditional surgery.

The FDA said there is a significant risk that the devices can grind up undetected uterine tumors, spreading the cancer to the pelvis, abdomen and other regions.

J&J said in a statement that its three power morcellators have always included language cautioning doctors about this risk. The company said the sales suspension applies to its Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract devices.

"We believe that suspending the commercialization of these products until their role is better understood and redefined by the medical community is the appropriate course of action at this time," a spokeswoman said in an emailed statement.

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