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Originally published Wednesday, April 30, 2014 at 4:27 PM

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Sale halted of J&J uterine growth-removal devices

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


The Associated Press

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WASHINGTON — Johnson & Johnson is halting sales of devices used to remove growths in the uterus after a government warning that the electronic surgical tools can inadvertently spread cancer to other parts of the body.

The announcement came one week after the Food and Drug Administration (FDA) discouraged doctors from using the devices, laparoscopic power morcellators. Surgeons use the devices to treat fibroids, either by removing the growths 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 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.

Doctors have long recognized the risk of accidentally spreading cancer from undetected tumors, but FDA officials said last Thursday that the problem appears far more common than previously thought. An FDA analysis estimated 1 in 350 U.S. women who undergo fibroid procedures each year have a form of cancer called uterine sarcoma.

Fibroids are noncancerous growths in the uterus that can cause severe pain, heavy bleeding, and bladder and bowel dysfunction, mostly among women in their late 30s and 40s. It’s unclear what causes the tumorlike growths — which can grow as large as cantaloupes — but they account for 240,000 of the 600,000 annual hysterectomies in the U.S. At least 50,000 U.S. women undergo hysterectomy using the power-morcellation technique.

Hysterectomy, or surgically removing the uterus, is a key treatment because it is the only way to ensure that fibroids do not return. Myomectomy, surgery that removes fibroids while leaving the uterus intact, is recommended for women who still want to become pregnant.



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