The U.S. Food & Drug Administration (FDA) has warned surgeons to avoid using laparoscopic power morcellators for removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) because they may spread undetected cancerous tissue, notably uterine sarcomas, beyond the uterus.
Free Morcellator Uterine Sarcoma Lawsuit Evaluation: If you or a loved one was diagnosed with uterine sarcoma after undergoing power morcellation, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and we 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 the 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.
What is a Power Morcellator?
According to the FDA, about 500,000 women undergo hysterectomy surgery each year in the U.S. Approximately 10% of these surgeries include a myomectomy, or removal of uterine fibroids. Surgeons have been increasingly using laparoscopic power morcellators during these procedures in order to avoid complex abdominal surgeries that require longer recovery time, more complications and larger scars. Morcellators, which have spinning blades, are used to dice the uterus or uterine fibroids into tiny pieces that can be removed through small incisions in the abdomen.
FDA Warning: Morcellators May Spread Cancerous Tissue
A recent study conducted at Columbia University found that about 1 in 350 women undergoing hysterectomies have undiagnosed sarcomas that may be spread by a morcellator. Sarcomas are difficult to detect before surgery and are often only diagnosed when the tissues are biopsied later. There is no reliable way to determine whether a uterine fibroid is cancerous before it is removed.
As a result of these problems, in April 2014, the FDA issued a safety communication advising surgeons against using power morcellators for the removal of uterine fibroids after it concluded that the devices could spread cancerous tissue throughout the body and significantly reduce a patient’s chances of survival.
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.
HCA Hospitals Ban Laparoscopic Morcellation
HCA Holdings Inc., the largest for-profit hospital operator in the U.S., said power morcellation for uterine fibroid removal will no longer be performed at its facilities, after the procedure was linked to the spread of cancer. The company’s decision to ban power morcellators marks one of the first major shifts concerning the controversial medical devices since the FDA’s Nov. 24 warning. Click here to learn more.
Uterine Sarcoma Symptoms
- Bleeding that is not part of menstrual periods
- Bleeding after menopause
- A mass in the vagina
- Pain or a feeling of fullness in the abdomen
- Frequent urination
In response to growing concerns about the risks associated with power morcellators, Johnson & Johnson’s Ethicon division announced in April 2014 that it was suspending all sales of these products until additional studies could be completed. Three months later, Ethicon declared that it was voluntarily exiting the morcellator market, and that surgeons should return all Gynecare X-Tract, Morcellex Sigma and Gynecare Morcellex devices to the company immediately. Ethicon officials stated that the risk of morcellators spreading cancer was greater than initially believed and simply too great to ignore.
Morcellator Lawsuit Pennsylvania
A wrongful death lawsuit has been filed in Pennsylvania by the widower of a woman who allegedly died after undergoing uterine fibroid removal surgery with a power morcellator made by LiNA Medical. The alleged victim in the case, a 53-year-old mother of two, underwent the procedure in 2012 as part of a hysterectomy, and was diagnosed with an aggressive form of uterine sarcoma just 9 days later. Click here to learn more.
Recommendations for Woman
For women considering whether to undergo surgery with a laparoscopic power morcellator, FDA recommends that you:
- Ask your health care provider to discuss all the options available to treat your condition and discuss the risks and benefits of each.
- If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes 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 provider.
Can I File a Morcellator Uterine Sarcoma Lawsuit?
Only a qualified attorney can determine whether you are eligible to file a lawsuit against the maker of a power morcellator, which is why we are currently offering free case evaluations. Simply fill out the confidential evaluation form below to contact our law firm now.
Most cases involving medical devices allege that a product was sold with design, manufacturing, and/or marketing defects, which typically refers to a company’s failure to warn of a certain complication. In the case of morcellators, our attorneys suspect that patients may be able to take legal action in light of claims that manufacturers failed to adequately warn doctors and patients about the risk of uterine sarcoma.
How Can Filing a Lawsuit Help Me?
By filing a lawsuit against the maker of a power morcellator, you may be entitled to collect compensation for all current and future medical expenses related to the treatment of your uterine cancer, as well as for damages for pain and suffering. Additionally, filing a lawsuit can help hold the morcellator’s manufacturer accountable for releasing an allegedly defective medical device into the marketplace, and to discourage other companies from engaging in similar conduct.
Do I Have a Morcellator Uterine Sarcoma 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 uterine sarcoma cases in all 50 states.
Free Morcellator Uterine Sarcoma Lawsuit Evaluation: Again, if you or a loved one developed uterine sarcoma after undergoing morcellation surgery, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Suit and we can help.