Hospitals Abandon Morcellators for Laparoscopic Hysterectomy Surgeries
Following FDA warnings about the cancer risks associated with use of power morcellators, a growing number of hospitals and medical institutions are abandoning the devices during laparoscopic hysterectomy procedures and uterine fibroid removal surgeries, due to concerns that they spread undiagnosed sarcomas throughout the pelvis and abdomen.
On Wednesday, Cleveland Clinic and the University of Pennsylvania Health System were the latest leading institutions to announce that morcellators will no longer be used for uterine fibroid treatments during a hysterectomy or myomectomy. The hospitals follow Brigham and Women’s Hospital and Massachusetts General Hospital, who made similar decisions earlier this month.
The suspensions come after months of mounting concerns about the risk of morcellators spreading leiomyoscaroma cancer during uterine fibroid removals. The devices have become increasingly popular in recent years, allowing doctors to remove the tumors or the entire uterus through minimally invasive surgery.
Power morcellators cut tissue into smaller pieces that may be removed through the port incision during a laparoscopic surgery, providing shorter recovery times and reduced risk of infections or other complications. However, hospitals are just now learning that morcellation may spread aggressive cancer throughout the body for some women who have unsuspected sarcoma prior to surgery.
Earlier this month, the FDA issued a safety communication discouraging doctors from using power morcellators for laparoscopic hysterectomy surgery or uterine fibroid tumor surgery. The federal health regulators indicated that about 1 out of every 350 women who under the procedures may have sarcomas that are not diagnosed or detectable, which are contained within the uterus until the morcellator spreads the cancerous tissue throughout the abdomen or pelvis, shortening a woman’s chances for long-term survival.
Concerns Over Moratorium on Laparascopic Hyesterectomy Morcellation
Despite the risk of leiomyosarcoma cancer with morcellating during a laparoscopic hysterectomy or uterine fibroid removal surgery, the FDA did not outright ban use of power morcellators. However, a growing number of hospitals are now confirming that they will no longer use the controversial devices.
One organization, the AAGL, which is formerly known as the American Association of Gynecologic Laparoscopists, has expressed concern about the growing moratorium on use of morcellation. While the AAGL did not openly speak out against bans on power morcellators, it indicated that doctors and hospitals should exercise restraint and expressed concern that a potentially useful laparoscopic surgical option may be removed.
“[T]here has been much discussion lately within medical and public forums regarding the possible placement of a ban or moratorium on the clinical practice of power-driven mechanical morcellation,” the AAGL noted in a member update issued last month. “Such a decision would have obvious clinical impact to both patients and physicians as it pertains to the spectrum of minimally invasive gynecologic surgery.”
This week the AAGL issued another statement following the FDA’s announcement and growing concerns, saying that it “recognizes the role of the FDA in regulating the use of medical devices” but notes that the agency did not consult with the AAGL before making its decision to urge doctors away from using power morcellation for uterine fibroid removal.
The group announced that it recently convened a task force to look at uterine fibroid removal and the safety and efficacy of the treatment options available. The group announced it will release the task force’s findings in the coming weeks.
“While it is of paramount importance that our patients are counseled appropriately about the dissemination risks associated with intracorporeal morcellation, specifically, and tissue extraction in general, it is also important for our patients and the public to recognize the benefits provided to the vast majority undergoing minimally invasive surgery,” the member update states. “It is the shared responsibility of the physician and patient to weigh the risks and benefits of alternative approaches to surgery based on individual circumstances.”
Hysterectomy Morcellator Lawsuits
As women and families learn that cases of stage 4 leiomyosarcoma or other cancers diagnosed following a hysterectomy or myomectomy may have been caused by the use of morcellators, questions are being raised about why warnings were not provided and whether the manufacturers may have failed to make the devices as safe as they could have been.
A number of morcellation cancer lawsuits are likely to be filed in the coming months and years against the manufacturers of these devices.
The FDA has indicated that 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.
Some critics have suggested that morcellators could have been sold together with surgical bags, which would allow doctors to collect uterine tissue and prevent the spread of potentially cancerous tissue. While some manufacturers have provided warnings that surgical bags should be used when a malignancy is suspected, critics have pointed out it is impossible for doctors to detect sarcoma or leiomyosarcoma until after the morcellation procedure.
The moratoriums appear to indicate that a growing number of doctors and hospitals that the use of morcellators may be inherently unsafe without a method of containing tissue. The hospitals say the bans will remain in place and may become permanent depending on future FDA guidelines on whether they can be used safely.
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