Product liability lawsuits are now being investigated for women who were severely injured after undergoing surgery with a laparoscopic power morcellator. When used for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy), morcellators can spread unsuspected cancerous tissue beyond the uterus.
Free Confidential Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Ethicon Morcellator Lawsuits Centralized in Multidistrict Litigation
October 21, 2015 – Lawsuits involving injuries allegedly caused by power morcellators made by Johnson & Johnson’s Ethicon unit have been consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the District of Kansas. The request for the MDL was made by plaintiffs in an effort to streamline the litigation and fastback the handling of claims affecting the lives of women all around the country. Click here to learn more.
FDA: Dangers of Laparoscopic Power Morcellation May Include Cancer
On April 17, 2014, the FDA issued a Safety Communication advising surgeons not to use laparoscopic power morcellators during hysterectomy or myomectomy procedures due to the risk that the devices may spread cancerous uterine tissue to other parts of the body. Based on current data, FDA estimates that of the approximately 600,000 hysterectomy surgeries performed in the U.S. each year:
- 30% are performed laparoscopically in women younger than 40
- 44% in women ages 40 to 49
- 16% in women ages 50 to 59
The agency has determined that about 1 in 350 women who undergo a hysterectomy or myomectomy surgery for uterine fibroids have an unsuspected form of cancer called uterine sarcoma. If laparoscopic power morcellators are used on these women, there is a significant risk that the device will spread cancerous tissue into the abdomen and/or pelvis.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” 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. “There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. 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.”
What is Power Morcellation?
Laparoscopic power morcellation is a form of fibroid treatment that uses a special device to divide uterine tissue into smaller pieces so it can be removed through a tiny incision in the abdomen, such as during a laparoscopic procedure. Before these devices became available, morcellation was performed using a machine that required the surgeon to manually ‘squeeze’ the handle, or use a scalpel to create small specimens that could be removed from the abdominal cavity. The first electronic power morcellator was introduced to the U.S. market in 1993. These devices are now made by a number of different U.S. manufacturers including:
- 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
What Are Uterine Fibroids?
Uterine fibroids are benign (non-cancerous) growths that develop in the smooth muscle tissue in the wall of the uterus. According to the National Institutes of Health (NIH), most women will develop these growths at some time in their lives. While most uterine fibroids are relatively harmless, they can cause symptoms that require medical or surgical therapy including:
- Heavy or prolonged menstrual bleeding
- Pelvic pressure or pain
- Frequent urination
Study Links Power Morcellators to Increased Risk of Death
In May 2011, a South Korean study demonstrated that women had far worse outcomes when a power morcellator was used to remove uterine tumors — 44% died after 39 months, compared to 19% after 63 months for women who had their uterus whole.
“Tumor morcellation and spillage during surgery may adversely affect treatment outcomes in patients with these highly malignant tumors,” said Jeong-Yeol Park, MD, Clinical Assistant Professor of Medicine at Asan Medical Center in Seoul.
The Federal Bureau of Investigation is looking into what J&J knew about the risks of power morcellation before the company pulled its devices off the market last year, according to the Wall Street Journal. The investigation equals more bad news for power morcellators, amid tightening restrictions on reusable medical devices by health insurers and U.S. regulators – particularly apt since the recent superbug outbreaks. Click here to learn more.
Senators Urge Nationwide Morcellator Recall
According to an August 2014 article published in the Wall Street Journal, NY Senators Chuck Schumer and Kirsten Gillibrand recently wrote a letter to the FDA requesting that the agency put more pressure on manufacturers to recall their power morcellators. Ethicon and J&J have already done so, announcing in July 2014 a global recall of their morcellators. They remain the only manufacturers to have done so, which means that many of the devices are still in use.
Despite Risks, Surgeons Continue to use Morcellators
Since the FDA issued its warning on the risks of power morcellators in April 2014, a number of hospitals put moratoriums on the tools and some insurers stopped covering their use. However, in spite of the dangers, many doctors are still using the devices. Robert Graebe MD, Department of Obstetrics and Gynecology chairman at Monmouth Medical Center, first thought the FDA had overreached but now agrees with the agency. He thinks power morcellators should be shelved until more studies can be conducted into their potential health risks.
He told Wall Street Journal, “People want to fight back, but it’s not putting patients’ safety first. It’s not worth playing Russian roulette with the patient.”
Ethicon Morcellator Wrongful Death Lawsuit
A wrongful death lawsuit has been filed on behalf of a Missouri woman who allegedly died after undergoing a laparoscopic hysterectomy and uterine fibroid removal surgery with an Ethicon Gynecare morcellator. Ms. Carl Cecilia Merrill had her uterus and fibroids removed in December 2012; she later learned that the device had spread previously undetected cancerous tissue throughout her peritoneal cavity, causing a rapid upstaging of the disease. Click here to learn more.
Calling for Change in FDA Medical Device Approval: FOX News Report
FDA Recommendation on Use of Morcellators
According to the FDA, A number of safer treatment options are available for women with uterine fibroids, including:
- Traditional surgical hysterectomy (performed either vaginally or abdominally)
- Laparoscopic hysterectomy and myomectomy without morcellation
- Other non-surgical options
Until more comprehensive data is available, FDA has instructed manufacturers of laparoscopic power morcellators to review their product labeling for adequate warnings risk information.
If you are considering surgery with a laparoscopic power morcellator, the FDA recommends that you:
- Discuss all the options available to treat your condition, including the risks and benefits of each with your health care professional.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your health care professional if power morcellation will be performed during your procedure and why it is the best treatment option for you.
- If you have already undergone a hysterectomy or myomectomy for fibroids, tissue removed during the procedure is typically tested for the presence of cancer. If you were informed these tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health care professional.
Do I Have a Morcellation 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 laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Confidential Case Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.