FDAnews Device Daily Bulletin

Ethicon Suspends Sales of Laparoscopic Power Morcellators

May 19, 2014

Ethicon has suspended the sales of its medical devices used during hysterectomies and other procedures to treat uterine fibroids because of an April 17 FDA advisory that the equipment could spread cancer, the Blue Ash, Ohio-based devicemaker said.

The devices, called laparoscopic power morcellators, are used to remove the uterus during a hysterectomy or to remove noncancerous growths during a myomectomy. The morcellators cut tissue into small pieces that can be removed through an incision in the abdomen.

If a woman has an unsuspected uterine sarcoma — a cancer seen in about one in 350 women who are treated for fibroids, there is real cause for concern.

“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” the FDA said.

However, the FDA maintained that power morcellation may still be the best option for some patients after evaluating risk.

Ethicon said the company would no longer sell, distribute or promote its morcellation devices until questions about their use is resolved by the FDA and the medical community.

Ethicon’s decision comes on the heels of a similar decision made by Johnson & Johnson last month. — Kellen Owings

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