J&J Suspends Power Morcellator Sales Over Cancer Risk


April 30, 2014

Johnson & Johnson (J&J) is suspending worldwide sales of its laparoscopic power morcellators after a warning by the US Food and Drug Administration (FDA) earlier this month that the devices may spread occult cancer in the course of fibroid removal.

The FDA has approved some 2 dozen devices for laparoscopic power morcellation, which divides tissue into smaller pieces or fragments. The J&J products covered under its sales suspension are the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator, all sold by the company's Ethicon division.

In its warning, issued April 17, the FDA said that when used for hysterectomy or myomectomy for women with uterine fibroids, laparoscopic power morcellators can sometimes disperse occult cancerous tissues beyond the uterus. Accordingly, the agency is discouraging the use of these devices for the 2 procedures and encouraging clinicians and patients to discuss other options for fibroid removal.

The FDA is convening a meeting of its advisory committee on obstetric/gynecologic medical devices to discuss the clinical role of laparoscopic power morcellation in treating uterine fibroids, the efficacy of morcellation specimen bags designed to contain uterine tissue, and the advisability of a boxed warning on the cancer risks for these devices.

J&J notified its power morcellator customers about the sales suspension yesterday. In a statement released to Medscape Medical News, the company stated it is suspending global sales, distribution, and promotion of its morcellation devices "while the role of morcellation for patients with symptomatic fibroid disease is redefined by the FDA and the medical community."

J&J noted that instructions for its morcellation devices have always included precautions about the possible spread of malignant tissue.

Morcellation Critic Says Devices Should Be Recalled

A vocal critic of using laparoscopic power morcellators for fibroid removal told Medscape Medical News that J&J's decision to suspend sales of these devices does not go far enough. The company should recall its products from the market, said Hooman Noorchashm, MD, a cardiothoracic surgeon at Brigham and Women's Hospital, Boston, Massachusetts.

"Why are you leaving these devices on the shelves?" said Dr. Noorchashm.

He started a campaign against morcellation after his wife, anesthesiologist Amy Reed, MD, underwent a hysterectomy with power morcellation in October 2013 for fibroid removal only to discover afterward that she had a uterine leiomyosarcoma. Dr. Reed learned that the procedure might have spread the cancer through her abdomen, worsening her prognosis. A story in the Wall Street Journal last December about Dr. Reed's case kicked off a vigorous debate in medical circles about the benefits and risks of morcellation.

Dr. Noorchashm said J&J and other manufacturers of morcellators have known about these risks for years. "They're clearly irresponsible," he said.

He also said that the warning issued by the FDA is inadequate.

"We congratulate the FDA for acting, but they clearly could pull these devices off the market, and they haven't," said Dr. Noorchashm.

His wife, he added, is "recovering well" and undergoing her sixth round of chemotherapy, "hopefully her last."

"We intend to beat this cancer," said Dr. Noorchashm.


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