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Amid continuing concerns about the increased risk of spreading undiagnosed cancer with morcellation used during laparoscopic hysterectomy and myomectomy procedures, new research suggests that individuals who are only having uterine fibroids removed, keeping the uterus mostly intact, may face less of a risk during the minimally invasive procedure.
Morcellators are medical devices used during laparoscopic surgery to allow the doctors to cut up the uterus or fibroids through a small incision in the abdomen, avoiding the risks associated with traditional or open procedures. The devices have become increasingly popular in recent years during complete hysterectomies and myomectomies, where only the uterine fibroids are removed.
Over the past year, the devices have been largely abandoned within the medical community after it was discovered that many women undergoing a laparoscopic hysterctomy or myomectomy for symptomatic uterine fibroids have undiagnosed cancers hidden within the uterus. For these women, morcellation may rapidly upstage aggressive cancers like leiomyoscarcoma, endometrial stromal sarcoma or other uterine sarcoma.
In a study published this month in the American Journal of Obstetrics and Gynecology (PDF), Italian researchers indicate that the rate of unsuspected cancers found within women who undergo a myomectomy is much less than that found among women who underwent a hysterectomy.
Researchers suggest the different morcellation risks may be because women who have a myomectomy, which often allows a woman to still bear children, are typically younger than those having a hysterectomy
Prior estimates released by the FDA suggest that as many as one out of every 350 women undergoing surgery may have unsuspected sarcoma, leading most experts to avoid using morcellators during any myomectomies or hysterectomies.
In this latest study, researchers suggest that those estimates are more accurate for women undergoing a hysterectomy than those who receive a myomectomy.
Researchers from Milan looked at a database of laparoscopic myomectomies from January 1999 to December 2013, involving 2,356 women. All of the cases involved fibroids removed with power morcellators. They found one case that resulted in advanced stage leiomyosarcoma, and another involving a smooth muscle tumor of uncertain malignant potential (STUMP). The woman with leiomyosarcoma died four months after her procedure. The STUMP case never developed into cancer and was cancer-free two years after her surgery.
“In our large myomectomy series, the risk of unexpected leiomyosarcoma was less than 1/2000,” the researchers noted. “Including the STUMP case, the proportion of unexpected tumors was below 1/1000, substantially lower than that indicated by the FDA. However, the FDA estimate was based mainly on hysterectomy series, in which the risk of occult leiomyosarcoma should be higher because women are generally older than those undergoing myomectomy.”
The study suggests that the risk of undiagnosed leiomyosarcoma in younger women, who opt for a myomectomy because they can often still have children later in life, is “exceedingly” low.
Morcellation Cancer Lawsuits
There are currently several dozen power morcellator cancer lawsuits pending throughout the federal court system against manufacturers of the devices, alleging that inadequate warnings were provided about the cancer risks for women undergoing a laparoscopic myomectomy or hysterectomy.
As lawyers continue to review and file morcellator cases for women diagnosed with the spread of uterine cancer following a hysterectomy or uterine fibroid removal, it is ultimately expected that several hundred lawsuits will be filed nationwide.
In June, a group of plaintiffs filed a motion to centralize the power morcellator litigation before one judge in the federal court system, which is designed to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different courts and the serve the convenience of the witnesses, parties and the judicial system.
Johnson & Johnson’s Ethicon subsidiary, Karl Storz, Richard Wolf Medical and other manufacturers of the controversial devices have opposed the creation of a morcellator MDL, arguing that there are too many different manufacturers and types of devices involved in the cases to justify centralization, and that the lawsuits will be dominated by the individual facts of each case.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments last week on whether to consolidate the cases. A ruling is expected soon.