Leading Gynecological Specialists Contend FDA Warning is Ill-Conceived

A group of leading practitioners in gynecology and related specialties have joined in requesting the FDA to revise or rescind a recently issued warning about a device used in minimally invasive procedures to treat uterine fibroids. In an open letter to the FDA on December 7, the group of 48 stated their belief that the agency’s action, aimed at protecting women against a very rare form of uterine cancer, was based on faulty data. “Our research finds that morcellation can be a safe, effective, minimally invasive treatment option for fibroids,” said Daniel Clarke-Pearson, MD, chair of the Department of Obstetrics and Gynecology at University of North Carolina School of Medicine. “We believe the FDA failed to identify important information that has led to inaccurate conclusions that would negatively impact the health of many women across the country.”

Benign fibroids, also called leiomyomas, can be found in about 75 percent of all women at some point in their lives. Surgical removal is often performed laparoscopically, using a small device called a power morcellator to break down the fibroids so that they can be removed through small incisions. The FDA’s concern is that if a presumed benign fibroid is later found to be a highly aggressive malignancy called a leiomyosarcoma, fragments of the cancer will be scattered by the power morcellator, increasing the risk of spread. However, the letter signatories contend that the FDA conclusions are based on a flawed review of the medical literature, and that instead of abandoning a minimally invasive procedure that provides clear benefits to most patients, future research should focus on better preoperative identification of extremely rare leiomyosarcoma. Read a news story about the FDA recommendations and the opposing position here.


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