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Johnson & Johnson Withdraws Power Morcellators from Market

July 30, 2014 — Johnson & Johnson announced plans to ask doctors to return all power morcellators, calling the move a “worldwide market withdrawal” but stopping short of issuing an official recall.

Johnson & Johnson’s Ethicon unit is the largest manufacturer of laparoscopic power morcellators in the world. Three months ago, they suspended sales of the devices pending a safety review by the U.S. Food and Drug Administration (FDA).

In a statement e-mailed to Reuters, Johnson & Johnson explained:

“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”

In April, the FDA warned that morcellators should not be used in hysterectomies due to the risk of spreading uterine cancer. One of the most common reasons for a hysterectomy is removing fibroids, which can cause pain and bleeding. About one-in-350 women with fibroids actually has undiagnosed uterine cancer, and one-in-500 has leiomyosarcoma (LMS), a highly-aggressive cancer.

Earlier this month, a panel of experts met to discuss whether to recommend further regulator action. Major gynecological groups have defended the devices, saying they reduce operating time, require smaller incisions, and reduce bleeding. Whether these benefits outweigh the risk of uterine cancer is still unclear.

Some have suggested the use of protective surgical bags to prevent spreading cancerous cells in a woman’s abdomen. Unfortunately, leaving behind even tiny pieces of malignant tissue could greatly reduce a woman’s chances of long-term survival.

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