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F.B.I. Investigates What J&J Knew About Morcellator Risks

F.B.I. Investigates What J&J Knew About Morcellator Risks

May 27, 2015 — F.B.I. agents are trying to find out when Johnson & Johnson’s Ethicon unit learned about the cancer-spreading risks associated with morcellators.

The Wall Street Journal reports that the F.B.I. interviewed Dr. Robert Lamparter, a former pathologist at a small hospital in Pennsylvania.

Dr. Lamparter warned Ethicon about the problem back in February 2006, eight years before the company pulled all of their power morcellators off the market.

At the time, power morcellators were used in thousands of hysterectomies and fibroid surgeries per year. Experts believed the risk of disseminating undiagnosed cancer was low. However, about once a year, Dr. Lamparter found cancer in morcellated tissues from women who had undergone gynecological surgery.

He contacted Ethicon and said the devices were jeopardizing patient safety because there was a “1/150 to 1/300 chance that a uterus will have an unexpected malignancy.” Ethicon responded by updating the label on morcellators to warn that it could “lead to dissemination of malignant tissue.”

Unfortunately, cancer concerns about morcellators did not go mainstream until December 2013, when the WSJ picked up the story of Dr. Amy Reed, a 41 year-old anesthesiologist with six children. She was diagnosed with stage-4 leiomyosarcoma after a morcellators was used in her hysterectomy and has aggressively campaigned to ban the surgical tools.

The F.B.I. interviewed Dr. Amy Reed and another woman who blamed morcellators for upstaging her cancer, Sarah Robinson, who has a list of 386 women with similar complaints.

Last year, the FDA issued a Safety Communication to warn against the use of power morcellators in the “vast majority” of women. According to the FDA, one in 350 women who undergoes the procedure actually has undiagnosed uterine cancer.

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