Gynecologists use power morcellators to remove uterine growths called fibroids, often during hysterectomy surgeries. The device slices tissue into tiny fragments that are removed through small incisions, but the procedure may leave tissue behind that can grow and spread, whether benign or malignant.
The vast majority of fibroid masses are benign. However, the FDA estimates that about 1 in 350 women who undergo hysterectomy or myomectomy surgery have undiagnosed uterine sarcoma. If surgeons use power morcellators on these patients, there is a risk the devices may spread cancerous tissue to other areas of the body.
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
Healthcare Insurance Companies Dropping Morcellator Coverage
May 5, 2015 – Aetna Inc., the nation’s third-largest health plan with about 23 million medical members, has announced that it will stop covering routine procedures that involve use of a power morcellator later this month, according to the Wall Street Journal. “The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis,” said Aetna spokeswoman Cynthia Michener. Click here to learn more.
Feds to Investigate J&J Over Morcellator Cancer Risk
The FBI is investigating whether Johnson & Johnson knew that its laparoscopic power morcellator could spread undetected cancer in patients before bringing the device to market, according to the Wall Street Journal. J&J says it has not been contacted about the investigation; However, the bureau has conducted a number of interviews with doctors, patients and others who may have been harmed by morcellators. Click here to learn more.
Uterine Sarcoma (Leiomyosarcoma)
Uterine leiomyosarcoma (ULMS) is an aggressive form of cancer that develops in the muscular part of the uterus, typically occurring in women between the ages of 40 and 60. ULMS tumors are highly metastatic, with nearly 70% of patients who have had their tumors removed seeing a recurrence within 8 to 16 months.
In most women who have a recurrence, the disease has migrated to other parts of the body such as the ovaries, lungs or liver. When this occurs, it is called “metastatic leiomyosarcoma” and classified as either stage III or IV. Patients with non-metastatic leiomyosarcoma have a 5 year survival rate of approximately 50%, while the 5 year survival rate for patients with metastatic leiomyosarcoma is between 4 and 16%.
List of Morcellators & Manufacturers
- FemRx – Diva Morcellator
- Hologic – MyoSure
- Lumenis Inc. – VersaCut Morcellator
- Ethicon Gynecare – X-Tract
- Ethicon Gynecare – Morcellex Tissue Morcellator
- Ethicon – Morcellex Sigma
- Interlace Medical – Hysteroscopic Morcellator
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- Olympus – PlasmaSORD
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
Are Morcellator Lawsuits Being Filed?
In March 2014, a man filed a lawsuit in U.S. District Court, Eastern District of Pennsylvania, after his 53-year-old wife died from uterine cancer less than a year after undergoing hysterectomy surgery with a power morcellator. While the manufacturer of the device has not been identified, the lawsuit names Blue Endo, Ethicon, LiNA Medical and others as defendants. Another case was recently filed in New York by a woman who developed cancer after having robot-assisted hysterectomy that involved the use of power morcellation.
The lawsuits are not part of a class action – rather, they are individual claims filed by women who have their own attorney. If the litigation continues to grow (and all indications are that it will), these cases may be formed into a multidistrict litigation (MDL).
Do I Have a Morcellator Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Morcellator Lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was diagnosed with cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and we can help.