Doctor Working on New Device As Alternative to Morcellation for Fibroids
A Pennsylvania doctor has just received grant funding to develop a new surgical tool designed to replace power morcellators during minimally invasive hysterectomy and uterine fibroid removal surgery, as the medical community has largely abandoned morcellation due to the risk that the device may spread aggressive cancer for some women.
Power morcellators are medical devices that have become increasingly popular in recent years, allowing surgeons to cut up the uterus or uterine fibroids during a laparoscopic hysterectomy or myomectomy, removing the tissue through a small incision in the abdomen. These minimally invasive procedures are designed to reduce the risk of complications, shorten recovery times and minimize scarring.
Over the past few months, many surgeons and hospitals nationwide have stopped using power morcellators during uterine fibroid surgery, following FDA warnings issued in April, which indicated that the devices may grind up and spread cancerous cells contained within the uterus. This can result in the rapid spread of aggressive cancers throughout the body, greatly shortening life expectancy.
Due to the fact that about one in 350 women undergoing the procedures have unsuspected sarcoma contained within the uterus, which doctors are unable to detect prior to surgery, many now consider the cancer risks with power morcellation too great to justify the benefits. This has left the medical community trying to figure out new, safer ways to perform minimally invasive surgery to remove tumors in the uterus.
Dr. Pamela Moalli is currently working on a device to do just that. Moalli, an associate professor of medicine at the University of Pittsburgh Medical Center (UPMC) in Pennsylvania, and several others at the university just received grant funding to develop the device, according to the Pittsburgh Business Times.
If successful, the proposed device would totally contain the fibroid to be removed and then break the tissue up in smaller pieces and remove all of the tissue without spreading debris or potentially cancerous cells. The proposed device includes no motorized blades like those in power morcellators. The group believes the device would eliminate the risk of cancer faced by women who would have otherwise undergone power morcellation.
Morcellator Cancer Lawsuits
Following the FDA warnings issued on April 17, serious questions have been raised about why the manufacturers of power morcellators failed to previously warn about the risk of spreading cancer.
A growing number of morcellation lawsuits are now being pursued on behalf of women nationwide who had leiomyosarcoma, endometrial stromal sarcoma or other uterine 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.
Johnson & Johnson’s Ethicon division, the largest manufacturer of the devices, has stopped power morcellator sales amid the cancer concerns, and an FDA advisory panel is scheduled to meet this week to review what further regulatory actions may be necessary to protect women from the risks.
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