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As debate continues about the risk of morcellation spreading cancer, a major health insurer has announced that it will no longer pay for laparoscopic hysterectomy or uterine fibroid removal procedures that involve the use of a power morcellator to cut up tissue during the minimally invasive surgery.
Highmark, Inc. indicated this week that it will cease coverage for laparoscopic morcellation surgery on September 1, due to the risk that the medical device may cause the spread of cancerous tissue for some women, quickly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers that may be hidden within the uterus.
The company is the first major health insurance company to stop covering the procedure, announcing the move in tandem with an announcement by the University of Pittsburg Medical Center, a major network of hospitals in western Pennsylvania, which indicated that it is suspending use of power morcellation.
Highmark also owns the West Penn Allegheny Health System, which means that the procedure will no longer be performed throughout much of Pennsylvania after the first of next month. The company also provides coverage in Delaware and West Virginia, and the insurer indicates that it hopes other hospital systems and health insurance companies will follow suit.
Power morcellators are medical devices used during robotic or laparoscopic hysterectomy and myomectomy procedures, allowing doctors to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen.
The procedures have become increasingly popular over the past ten years, providing a minimally invasive surgery that reduces the risk of infection, minimizes scarring and shortens recovery time.
Over the past year, concerns began to surface within the medical community about the risk that power morcellation may cause the spread of aggressive cancers throughout the body if women have unsuspected sarcoma, which doctors are unable to detect prior to surgery.
In response to the mounting evidence linking laparoscopic hysterectomy morcellation and cancer, the FDA issued a statement earlier this year urging doctors avoid using the device and scheduled an advisory committee meeting to review the available data.
The FDA indicated that about one in 350 women undergoing laparoscopic surgery for uterine fibroids may have the contained cancer hidden within their uterus. Power morcellation may cause these cancer cells to be quickly spread throughout the body, substantially reducing a woman’s chances for long-term survival.
Following the FDA advisory panel meetings last month, the outside experts were unable to reach a consensus on whether to recommend that power morcellators be banned or whether they should remain available with stronger warnings provided to women about the potential risks. However, the committee agreed that there was no known way to make morcellation for uterine fibroid removal safe.
While a number of hospitals and surgeons have already announced they will no longer perform laparoscopic hysterectomy morcellation due to the cancer risks, many proponents of the minimally invasive surgery have indicated that the devices should not be completely abandoned.
Highmark’s announcement came just days after Johnson & Johnson’s Ethicon unit announced a power morcellator recall, indicating that it was getting out of the morcellation business until and unless new technology can make the procedure safer. Prior to the decision, Ethicon manufactured more than 70% of all power morcellators used.
Laparoscopic Hysterectomy Morcellation 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 laparoscopic hysterectomy 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.