Johnson & Johnson Voluntarily Withdraws Morcellators

Johnson & Johnson Voluntarily Withdraws MorcellatorsJuly 30, 2014 — Johnson & Johnson said it plans to ask doctors to return all laparoscopic power morcellators, effectively issuing a “worldwide market withdrawal” of the devices just three months after suspending sales.

Johnson & Johnson is by far the largest manufacturer of power morcellators. No manufacturers have issued formal recalls. High-profile consumer advocacy groups have petitioned the U.S. Food and Drug Administration (FDA) to ban the devices. Earlier this month, an advisory panel to the FDA met to decide whether regulatory action is necessary.

In an e-mailed statement to Reuters, the company said:

“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 because they can spread uterine cancer in women with fibroids. Since then, experts have debated whether benefits like smaller incisions and speedier operations are worth the potential risk of cancer.

The FDA estimates that one in 350 women who has surgery to remove fibroids actually has undiagnosed uterine cancer, and one in 500 has a highly-aggressive type known as leiomyosarcoma (LMS). When the morcellator grinds up tissues, it can leave behind malignant cells — essentially “seeding” cancer throughout a woman’s abdomen, greatly reducing her chances of long-term survival.

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