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In response to concerns about the risk of uterine cancer being spread by morcellators used during laparoscopic hysterectomies and fibroid surgery, an FDA advisory committee is scheduled to meet next month to evaluate how the agency should address the issue, and whether the medical community should continue to use the devices.
The FDA posted a notice in the Federal Register today, indicating that a meeting of its Obstetrics and Gynecology Devices advisory panel will be held on July 10 and 11 at the agency’s White Oak Campus in Silver Spring, Maryland.
The meeting comes following an FDA safety communication issued on April 17, at which time the agency urged doctors not to use power morcellators for uterine fibroid removal during minimally invasive hysterectomy and myomectomy procedures.
Power morcellators are medical devices that have become increasingly popular in recent years, allowing surgeons to perform minimally invasive procedures where the uterus or uterine fibroids are removed through a small incision in the abdomen.
The FDA indicated that the devices appear to carry an unreasonable risk of spreading cancerous cells that may be undetected within the uterus, leading to the rapid spread of cancer throughout the body. However, a morcellator recall was not required at that time.
In the statement issued in April, the FDA indicated that it would convene this public meeting to discuss: (a) what clinical role power morcellators should play in the treatment of uterine fibroids; (b) whether certain surgical techniques or accessories, such as tissue collection bags, may make power morcellators safer; and (c) whether a “boxed warning” about the risk of cancer being spread should be required for the devices.
Power Morcellation Spreading Uterine Cancer
The FDA has 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.
Morcellation involves the cutting up of the uterus or uterine fibroids into small pieces through a port incision, reducing recovery time and the risk of complications. However, for women who have unsuspected sarcoma contained within the uterus, they may have cancerous tissue spread throughout the peritoneal cavity, quickly upstaging the cancer within a matter of days or weeks.
Following the FDA warnings, many hospitals have already announced that they will not use power morcellators until a medical consensus on the safest way to use the devices is reached. In addition, Johnson & Johnson’s Ethicon division, the largest manufacturer of the devices, has stopped power morcellator sales.
Next month’s meeting may have a large influence on the role power morcellators play in minimally invasive uterine fibroid surgeries. FDA advisory committees have a strong influence over future agency decisions, though they have no direct power to make the FDA do anything.
“FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data,” the notice states. “The committee will make recommendations regarding the appropriate use, premarket testing, labeling and other risk mitigations (including the use of containment bags) for these devices.”
The bags have been identified as a possible means for collecting the tissue debris left behind by the power morcellators. However, some doctors have said that the bags are too unwieldy and have not used them.
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 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.