FDA Not Ready to Force A Uterine Fibroid Morcellator Recall, Agency Tells Senators

Although many lawmakers and consumer advocacy groups continue to call for an industry-wide power morcellator recall due to the uterine cancer risks, federal regulators indicate that they remain undecided about what actions to take for the medical devices used during laparoscopic hysterectomy or fibroid removal procedures.

Power morcellators are medical devices used during minimally invasive procedures to cut up the uterus or uterine fibroids, allowing doctors to remove the tissue through a small incision in the abdomen. However, concerns have emerged in recent months about the risks associated with using the devices, since some women may have undetectable cancer contained within the uterus, which may be spread throughout the body by uterine fibroid morcellation.

In an October 8 letter to U.S. Senator Kirsten Gillibrand (PDF), FDA officials said that while the agency continues to discourage the use of power morcellators during minimally invasive uterine fibroid surgery, they have not yet decided whether to take further action.

The response comes after an August 19 letter to FDA Commissioner Margaret Hamburg by Gillibrand and Senator Charles E. Schumer, both of whom represent New York, that called for the FDA to get the devices off the market.

The August 19 letter (PDF) expressed concern over the continued use of morcellators after the FDA issued a warning in April urging doctors to stop using the devices to remove uterine fibroids due to cancer risks.

The FDA’s warning came after the agency determined that about 1 in 350 women undergoing the procedure had undiagnosed uterine cancer cells in the fibroids, which could be ground up and distributed throughout the body cavity by the procedure. In such instances, the cancer can quickly be upstaged to its most deadly and untreatable levels.

Major Morcellator Recall Followed Hearings

The FDA held an advisory committee meeting this summer, and its advisors determined there was no safe way to use power morcellators for laparoscopic surgery to remove uterine fibroids, but could not decide on whether to call for a power morcellator recall or simply add warnings to the devices.

Johnson & Johnson’s Ethicon division, responsible for more than 70% of power morcellator sales, agreed and voluntarily issued a power morcellator recall for its own line of the devices, saying it would no longer manufacture the devices because they could not be used with a guarantee of safety. However, a number of manufacturers are trying to fill the void left behind instead of following in the company’s footsteps to protect women’s health.

“In light of this new evidence, we urge the FDA to request that other manufacturers of laparoscopic morcellation devices withdraw their equipment from the market until additional risk assessments and patient and clinician education can be performed,” Gillibrand and Schumer wrote. “Furthermore, as the FDA prepares to make a final determination on the use of these devices, we urge you to seriously consider and not discount the testimony presented during the FDA’s July hearings by our constituents who devastatingly lost family members to cancer after a power morcellation procedure.”

According to the FDA’s response, the agency just is not ready to make its next move.

“We plan to continue our internal analysis and review of the available scientific data and panel meeting information, as well as the public comments submitted to the docket we opened on this issue,” the office of FDA Associate Commissioner for Legislation, Thomas A. Kraus, responded. “FDA will take into account all available information when considering any future regulatory action.”

Uterine Fibroid Morcellator Cancer Lawsuits

As women and families learn that cases of aggressive uterine cancers diagnosed following a laparoscopic hysterectomy or myomectomy may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.

A number of uterine cancer morcellation lawsuits are now being pursued on behalf of individuals diagnosed with the spread of cancer following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.

Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.