FDA Program Fails to Monitor High-Risk Devices Like Power Morcellator, Study Suggests

Published on October 3, 2014 by Sandy Liebhard

A new study finds problems with the U.S. Food and Drug Administration (FDA)’s system for regulating high-risk medical devices, which may raise questions about the agency’s handling of dangers that have been alleged in power morcellator lawsuit filings.

According to research that appears in the current issue of JAMA: Internal Medicine, the FDA may not be adequately monitoring problems with high-risk devices. Findings presented by Pew Charitable Trusts indicate that the FDA only required 223 post-approval studies of 158 high-risk devices between 2005 and 2011. Most of the companies appeared to not have been reprimanded for study delays, which may have been too small to fully assess safety. Only one device was taken off the market during that time, researchers found, and labeling changes were made for 31 products.

FDA Fails to Properly Monitor Power Morcellator Risks, Campaigner Suggests

Dr. Hooman Noorchashm, a pioneer of the fast-growing crusade against uterine morcellation surgeries, waved this action off as being unsufficient in properly warning the public about device problems. “Label changes aren’t going to do anything to protect anybody,” he said. “It’s just another layer of informed consent.”

Noorchashm is hardly someone who waits for the government to take action on an issue that deserves public awareness. The online petition he launched via Change.org to ban power morcellator procedures in the U.S. included 85,443 virtual signatures on October 3rd, and the FDA has begun to take action. On April 14, the agency issued a public health alert that warned of a possible association between power morcellators and the spread of uterine cancer, which could affect the thousands of women who undergo fibroid removal surgeries and undergo hysterectomies each year. 1 in 350 women may have undiagnosed cancer cells prior to their uterine morcellation procedure, the FDA noted, which be spread outside the peritoneal cavity during surgery. The bladed surgical tool is used in minimally-invasive gynecologic surgeries to more easily cut up uterine tissue so it can be extracted through a tiny incision.

Noorchashm points out that these efforts have not translated to a widespread ban on power morcellator surgery. “The FDA does not have patient safety as its primary directive,” he said. “It wants to get innovative products to market quickly.”