Laparoscopic power morcellators are no longer uniformly recognized as safe for removing fibroids and other non-cancerous growths during a hysterectomy or myomectomy surgery. Recently, Johnson & Johnson recalled 3 of its morcellators following study results that found the devices could spread a cancerous tissue called leiomyosarcoma to other parts of a woman’s body.
Free Morcellator Leiomyosarcoma Lawsuit Evaluation: If you or a loved one was diagnosed with leiomyosarcoma 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.
The Link Between Power Morcellators and Cancer
Morcellators are used to remove certain non-cancerous growths during laparoscopic surgical procedures such as a hysterectomy or a myomectomy. The devices break 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. However, if a patient has undetected cancerous tumors or growths, morcellators can spread these tissues throughout the woman’s body. As such, the unintended consequences of morcellator use can include:
- Abnormal growth of tissue
- Harm to healthy tissue
- Cancer growth (particularly metastatic leiomyosarcoma)
What is Leiomyosarcoma?
Leiomyosarcoma (LMS) is a rare but highly aggressive cancer of smooth muscle cells. Smooth muscle cells make up involuntary muscles, which are found in the uterus, stomach, intestines, blood vessel walls and skin. These muscles are referred to as “involuntary” because you can’t make them move simply by thinking about them.
- Lump or swelling
- Abdominal discomfort / bloating
- Swelling or pain in any area of the body
- Bleeding from the vagina in women who have had the menopause, or a change in periods for women who have not yet had the menopause
FDA Warning on Laparoscopic Morcellation
On April 17, 2014, the FDA issued a Safety Communication urging surgeons to avoid using power morcellators for laparoscopic surgeries. According to the FDA:
“When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
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 Bans Use of Power Morcellators
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.
Morcellator Lawsuit Pennsylvania
A wrongful death lawsuit has been filed in U.S. District Court for the Eastern District of 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 leiomyosarcoma just 9 days later. Click here to learn more.
Can I File a Morcellator Leiomyosarcoma 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 leiomyosarcoma.
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 leiomyosarcoma, 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 Leiomyosarcoma 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 leiomyosarcoma cases in all 50 states.
Free Morcellator Leiomyosarcoma Lawsuit Evaluation: Again, if you or a loved one developed leiomyosarcoma 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.