A growing number of product liability lawsuits are being filed over the use of power morcellators, medical devices used during hysterectomy and myomectomy surgeries. The U.S. Food & Drug Administration (FDA) has warned that morcellators can spread undetected cancer cells into other parts of women’s bodies.
Free Morcellator Cancer Lawsuit Evaluation: 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 suit against the manufacturer of the morcellator and our lawyers can help.
Hysterectomy and Myomectomy
A hysterectomy is an operation designed to address problems that occur in the female reproductive system. The procedure may involve removal of all of a woman’s reproductive organs (uterus, ovaries and cervix) or just one or two problematic areas. Hysterectomies are typically used to treat cancer, endometriosis, uterine fibroids, chronic pelvic pain and bleeding, polyps, uterine prolapse or adenomyosis (thickening of the uterus).
A myomectomy involves the surgical removal of uterine fibroids. The procedure allows the uterus to be left intact and may make pregnancy more likely to occur. Myomectomies are the preferred fibroid treatment for women who want to get pregnant at some point in the future.
Morcellators do the cutting in laparoscopic and robotic surgeries, breaking large tissue masses into small fragments with the help of tiny rotating blades. The broken down tissues are then vacuumed out of the patient’s body. Power morcellation requires incisions of less than 2 centimeters to remove fibroids and other tissue. These tiny incisions mean doctors do not have to make large cuts through the patient’s core stomach muscles. The technique has led to quicker patient recovery times, less pain and fewer complications.
What’s the Problem?
Unfortunately, power morcellators have recently been linked to the spread of an aggressive form of uterine cancer called leiomyosarcoma. Since 2013, numerous morcellator cancer lawsuits have been filed against Ethicon Inc., Blue Endo, Lina Medical and other companies that make the devices. Plaintiffs allege they were never warned that morcellators can “seed” undiagnosed leiomyosarcoma in uterine fibroids, leading to the spread of cancer.
FDA Warning on Power Morcellators
In April 2014, the U.S. Food & Drug Administration (FDA) issued a warning advising surgeons not to use laparoscopic power morcellators during hysterectomy or myomectomy surgeries due to the risk they may spread undiagnosed cancerous uterine tissue. FDA estimates that about 1 in 350 women who require hysterectomy or myomectomy surgery for uterine fibroids have undiagnosed uterine sarcoma. If morcellators are used on these patients, there is a risk they will spread cancerous tissue to other parts 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.”
In February 2015, a study published in Obstetrics & Gynecology found undetected uterine sarcomas in 2.7% (about 1 in 368) of 2,575 women who underwent fibroid removal surgery. Morcellators may spread the cancerous tissue, which is typically not diagnosed before surgery. Patients should be informed of “the possibility of a poorer prognosis should an unidentified malignancy be morcellated,” the researchers concluded.
Another study published the same month in JAMA Oncology found that the risk of spreading cancerous tissue via power morcellators increases with age. The researchers found that from 2006 to 2012, 7.7% of 41,777 myomectomies were performed with morcellators. “Electric power morcellation should be used with caution in older women undergoing myomectomy” the authors said.
Calling for Change in FDA Medical Device Approval: FOX News Report
FDA Strengthens Warning Against Use of Power Morcellator for Fibroid Removal
November 24, 2014: The FDA has strengthened its warning about the cancer-spreading risk associated with power morcellators, saying the devices should not be used for most women during fibroid removal surgery. The agency is recommending that manufacturers immediately update their products’ labeling to include a “boxed warning,” and to detail specific cases where morcellators should not be used.
“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” 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. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
Click here to learn more.
Hopkins Protocol Seeks to Minimize Power Morcellator Cancer Risk
To reduce the spread of cancerous tissue during fibroid removal and hysterectomy surgeries, Johns Hopkins University has announced it will no longer use power morcellators on women over the age of 50. Under the newly enacted “Hopkins Protocol,” morcellation will also be contraindicated in women who have risk factors for gynecologic cancer including tamoxifen use, pelvic radiation and hereditary cancer syndromes. Click here to learn more.
Senators Call For “Across-the-Board” Morcellator Recall
Senators Kirsten Gillibrand (D-NY) and Charles Schumer (D-NY) recently wrote a letter to the FDA urging the agency to order a comprehensive nationwide recall of all power morcellators. Specifically, the senators have asked that all remaining manufacturers initiate mandatory product recalls, including:
To date, none of these companies have made any effort to recall their power morcellators.
Insurance Companies Considering Limits on Uterine Morcellation
In response to the FDA’s warning that power morcellators may spread undetected uterine cancer, more health insurers are considering limits and even outright bans on coverage for uterine morcellation. According to a Wall Street Journal review of current and pending policies, Aetna, Health Care Service Corp., Cigna and America’s Health Insurance Plans are now preparing restrictions. Click here to learn more.
Aetna to Drop Morcellator Healthcare Coverage
Healthcare insurer Aetna Inc. has announced that it will stop covering routine use of power morcellators, according to the Wall Street Journal. The Hartford-based insurer is the largest managed-care firm to take direct action against morcellator use, although the move is part of a broader trend of insurer efforts that are steering doctors and patients to other surgical options. Click here to learn more.
Morcellator Cancer Death Lawsuit Filed in Boston
The widower of a woman who died in 2013 after undergoing a robotic hysterectomy with a power morcellator at Brigham and Women’s Hospital (BWH) has filed a lawsuit against the medical center, according to the Wall Street Journal. Plaintiff Rick Kaitz alleges BWH knew that morcellators could spread undetected cancer, but that the hospital failed to inform his wife about this risk. Erica Kaitz died in Dec. 2013 at the age of 52, about 18 months after undergoing the surgery. The wrongful death lawsuit also names the surgeon who performed the procedure and Karl Storz GmbH & Co. KG, the company that made the morcellator. Click here to learn more.
Uterine Sarcoma (Leiomyosarcoma)
Leiomyosarcoma is a rare but highly aggressive form of cancer that occurs in smooth muscle cells of the uterus or gastrointestinal tract. Uterine leiomyosarcoma (ULMS) develops in the muscular part of the uterus, and typically occurs 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 nearly 80% of patients who have a recurrence, the disease has spread to other parts of the body such as the ovaries, lungs or liver. When this occurs, it is referred to as 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
Philadelphia Women File Lawsuits Alleging Olympus Morcellator Spread Cancer
Two Philadelphia women have filed lawsuits against Olympus Corp. alleging that the company’s power morcellators spread cancer throughout their bodies. The lawsuits, which were filed separately in the Court of Common Pleas of Philadelphia County, accuse Olympus and its subsidiary Gyrus ACMI of misrepresenting their morcellators as being safe, and of failing to adequately warn doctors and patients about the cancer risk associated with the devices. Click here to learn more.
Do I Have a Morcellator Cancer 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 cancer cases in all 50 states.
Free Morcellator Cancer Lawsuit Evaluation: Again, if you or a loved one developed cancer after undergoing surgery with a power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellator Suit and we can help.