FDA Panel Split On Power Morcellator Recall, Black Box Warnings

An FDA panel of independent advisors convened last week to evaluate the risk of power morcellators spreading cancer was unable to agree on whether the medical devices used to remove uterine fibroids need to be banned or whether stronger warnings should be required. However, the experts did all agree that they are not currently safe. 

The FDA’s 15-member Obstetrics and Gynecology Device advisory panel met for two days last week, reviewing the link between the spread of aggressive cancer and power morcellation used during laparoscopic hysterectomy and myomectomy procedures for uterine fibroid removal.

Power morcellators are medical devices used during the minimally invasive surgery, allowing the uterus or uterine fibroids to be cut up and removed through a small incision in the abdomen.

More than 500,000 procedures have been performed annually in recent years, due to the benefits provided of reducing recovery time, minimizing scarring and the risk of infection. However, use of power morcellators has largely stopped in recent months, following FDA warnings in April that indicated the devices may cause the spread of cancerous tissue for women with unsuspected sarcoma.

Estimates have suggested that about one out of every 350 women who under go uterine fibroid surgery have unsuspected sarcoma contained within the uterus, with about one out of every 400 women having the even deadlier leiomyosarcoma. These uterine cancer cells are hidden inside some fibroids, and there is no effective way for doctors to diagnose the cancer prior to a hysterectomy or removal of the uterine fibroids.

For these women with unsuspected sarcoma contained within the uterus, power morcellators have been known to spread cancerous tissue throughout the peritoneal cavity, quickly upstaging the cancer within a matter of days or weeks. This may greatly reduce long-term survival chances and greatly diminish the overall quality of life.

In response to the risk, the FDA issued a statement urging doctors to stop using power morcellators for uterine fibroid removal in April 2014, and indicated that it would convene an advisory panel to determine what additional regulatory steps need to be taken.

While the FDA did not issue a power morcellator recall at that time, many hospitals and doctors have announced that they will no longer use the devices until further guidance is provided. In addition, Johnson & Johnson’s Ethicon unit, which is the largest manufacturer of the devices, stopped morcellator sales and production until additional recommendations are issued by the FDA.

Power Morcellation Cancer Risks

During two days of presentations and testimony on the topic, the FDA advisory panel did not come to a clear consensus on whether the FDA should recall power morcellators from the market until design changes can be made or allow the devices to remain available with stronger “black box” warnings designed to alert women and the medical community to the potentially serious risk of spreading cancer during the hysterectomy and uterine fibroid removal procedures.

The FDA panel did agree that there is currently no safe way to perform laparoscopic power morcellation as part of any minimally invasive surgery without posing a risk of spreading cancer. However, the panel was split among those who called for a ban on the device and those who felt the option should remain available with informed consent.

Some manufacturers have suggested that the use of surgical bags as an accessory may eliminate the risk of spreading cancer during a hysterectomy or myomectomy, allegedly containing tissue and debris caused by morcellation. However, the advisory panel shot that option down, finding that it does not make power morcellation safer.

It is unclear when the FDA will make a final decision on power morcellation. The advisory panel’s recommendations are not binding, and the agency has made no announcements that a rulemaking or new regulations are pending. However, most in the medical community familiar with the issue expects the agency to make some kind of ruling in the near future.

The advisory panel’s recommendations, discussions and findings are expected to weigh heavily in that final determination.

Morcellator Lawsuits Filed By Women With Cancer Spread

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 fibroid morcellation lawsuits are now being pursued on behalf of individuals who had leiomyosarcoma, endometrial stromal sarcoma or other cancers spread during the procedures.

Plaintiffs allege that as they are currently designed, 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.