Doctors Dispute FDA Ruling On Device To Remove Uterine Fibroids

Leiomyoma of the Uterus

A team of gynecologists urge the U.S. Food and Drug Administration to revise its 2014 ban on the use of morcellator, a device designed to remove uterine fibroids. They argue that the regulatory agency relied on flawed analysis when it decided to ban the use of mechanical devices that chop fibroids into small pieces during surgery.

In April 2014, FDA issued a public warning against the use of laparoscopic uterine power morcellation on women with non-cancerous growths that develops from the muscular tissue of the uterus. Federal regulators claim that uterine fibroids may have potentially-fatal hidden cancer dubbed as leiomyosarcoma. This might be spread by the use of morcellators.

Seven months after the initial public warning, FDA issued an Immediately in Effect (IIE) guidance to order manufacturers to include warnings and contraindications in product labeling. FDA included that this method is contraindicated in patients with uterine fibroids to prevent cancer spread.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said.

FDA announced the ruling after the analysis of available data. According to the agency, an estimated one in 350 women who underwent either hysterectomy or myomectomy developed an unsuspected uterine sarcoma called leiomyosarcoma.

According to 48 gynecologists in their open letter, if morcellation will be banned, tens of thousands of women with fibroids may undergo major surgical operations with large incisions in the abdomen each year. They also cited that major surgeries will require longer hospital stays, longer recovery time and increased risk of adverse complications.

Aside from the open letter addressed to FDA, the group also published a study in the journal Obstetrics & Gynecology.

“Our research finds that morcellation can be a safe, effective, minimally invasive treatment option for fibroids,”said Dr. Daniel Clarke-Pearson, chair of UNC’s Department of Obstetrics and Gynecology at UNC’s 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,” he added.