Uterine Fibroid Morcellator Recalls Urged by Senators

Amid continuing concerns about the risk of uterine fibroid morcellators spreading cancer, two New York Senators intend to call on the FDA to push for all manufacturers of the controversial surgical devices to remove their products from the market.

Senators Chuck Schumer and Kirsten Gillibrand have drafted a letter to the FDA, which calls for a nationwide power morcellator recall, according to a report by the Wall Street Journal. The Senators indicate that the letter will be sent to FDA Commissioner Margaret Hamburg.

The request comes following an Ethicon morcellator recall issued last month, when the largest manufacturer of the devices decided to permanently stop selling the devices and urged doctors to return them.

Power morcellators are surgical tools commonly used in recent years during laparoscopic hysterectomy or myomectomy procedures to remove uterine fibroids. The devices cut up or morcellate the uterus or fibroids, allowing surgeons to remove the tissue through a small hole in the abdomen.

The minimally invasive uterine fibroid surgery is designed to reduce recovery time, minimize scarring and avoid complications associated with traditional procedures. However, concerns have emerged about the risk of spreading aggressive uterine cancers with the devices, since some women undergoing the procedures may have unsuspected sarcoma contained within their uterus, which doctors are unable to diagnose prior to the surgery.

Risk of Cancer Spreading from Uterine Fibroid Morcellation

Uterine fibroid morcellation may cause the spread of cancerous tissue throughout the abdomen for women with undiagnosed sarcoma, quickly upstaging the cancer and reducing the chances for long-term survival.

Late last year, two Boston doctors started to draw attention to the risk after one of them, Amy Reed, was diagnosed with the spread of leiomyoscarcoma, one of the deadliest forms of uterine cancer, following a power morcellation hysterectomy. Dr. Reed has indicated that she was not informed about the risk that the laparoscopic surgery tool may spread unsuspected sarcoma.

Reed and her husband started a petition on Change.org calling for a uterine fibroid morcellator ban, which now has more than 62,000 signatures.

In April, the FDA urged doctors to stop using power morcellators for uterine fibroid removal, and many hospitals and doctors have announced that they will no longer perform procedures with the devices. The agency estimated that one out of every 350 women undergoing uterine fibroid morcellation may have unsuspected sarcoma, and warned that the risk of spreading cancer may outweigh any benefits associated with the procedure.

Earlier this summer, two FDA advisory committees met to review the scientific data surrounding the cancer risk with power morcellators, but could not decide whether to recommend a recall or simply a black box label warning. However, the committees agreed that there appears to be no way to make morcellation safe for removing uterine fibroids.

Late last month, Johnson & Johnson’s Ethicon subsidiary issued a power morcellator recall, voluntarily announcing that it is getting out of the morcellation business. The company previously held more than 70% of the market for the surgical tool.

Senators Schumer and Gillibrand say they want the FDA to request that the remaining power morcellator manufacturers to follow suit. To date, neither Karl Storz, Richard Wolf, LiNA Medical, or Olympus Corp. have announced plans to recall morcellators they manufacture and sell.

Laparoscopic 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 fibroid morcellation lawsuits are now being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread 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.