Popular uterine fibroid device pulled amid cancer fears


Health company Johnson & Johnson this week announced it has suspended world-wide sales, distribution and promotion of a popular medical device used to remove fibroids after concerns emerged about the device’s potential to spread a deadly cancer.

New Jersey-based Johnson & Johnson’s suspension will affect all of its power morcellator products, which go by the names "Gynecare Morcellex," "Morcellex Sigma" and "Gynecare X-Tract."

Uterine fibroids are the most common benign tumors in women of childbearing age, according to the National Institutes of Health.

The Wall Street Journal reports  the company is not permanently pulling the devices from the market.

Johnson & Johnson took action to temporarily halt sales after a Food and Drug Administration advisory April 17 discouraging doctors from using the devices to remove fibroids.

"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."

Most women will develop uterine fibroids at some point in their lives, the NIH says. Fibroids are most often benign.

But the FDA says there is a 1 in 350 risk that women undergoing surgery to remove these growths will have an undetected cancer known as a uterine sarcoma.

The case of a 41-year old Boston woman who developed advanced uterine cancer shortly after a hysterectomy recently called attention to the risks, The Wall Street Journal reports.

Johnson & Johnson is the world’s largest maker of the device. The company announced sales will remain suspended until there is more clarity on the dangers of the procedure.

"We are also reaching out to regulatory agencies around the globe as this is a global notification," J&J spokeswoman Sheri Woodruff told Reuters.

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