The use of laparoscopic power morcellators during a hysterectomy or fibroid removal surgery may increase the risk that women will develop endometrial stromal sarcoma, a cancer of the uterus. As a result of these problems, the U.S. Food & Drug Administration (FDA) has warned surgeons to avoid using power morcellators during laparoscopic surgeries.
Free Morcellator Endometrial Stromal Sarcoma Lawsuit Evaluation: If you or a loved one was diagnosed with endometrial stromal 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’s the Problem?
A power morcellator is a tissue-cutting device that removes uterine tissue through a small incision. Morcellators are typically used during a laparoscopic hysterectomy or myomectomy. According to the FDA, about 50,000 women undergo fibroid removal surgery each year with a morcellator. Unfortunately, some of these women may have undetected cancerous tumors, which may be spread throughout the pelvis and abdomen during the surgery, greatly impacting the patient’s health and reducing her chance of long-term survival.
FDA Warning: Morcellators May Spread Cancer
In April 2014, the FDA issued a Safety Communication urging surgeons to avoid using morcellators during hysterectomies and myomectomies because there is no reliable way of determining which women may have unsuspected cancerous tumors before the procedure. The agency estimates that about 1 in 350 women who undergo a hysterectomy or uterine fibroid removal have undiagnosed uterine sarcoma.
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis,” FDA said in its warning. “For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, 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.”
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HCA Hospitals Ban Use of Power Morcellators for Fibroid Removal
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.
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.
What is Endometrial Stromal Sarcoma?
More than 95% of cancers of the uterus are carcinomas. If a carcinoma starts in the endometrium, the lining of the uterus, it is referred to as endometrial carcinoma. These cancers are rare, representing less than 1% of all uterine cancers. Endometrial tumors are low grade — the cancer cells appear normal and tend to grow slowly. Women with these types of tumors tend to have a better outlook than those with other uterine sarcomas.
Signs and symptoms of endometrial stromal sarcoma include:
- Abnormal vaginal bleeding
- Enlarged uterus
- Lower abdominal pain
- Post-menopausal bleeding
- Abnormal vaginal secretions
- Pain during sex
- Back pain
- Weight loss
- Painful urination
Power Morcellator Recall
IN July 2014, Johnson & Johnson subsidiary Ethicon announced a power morcellator recall after it concluded that there was no way of using the devices safely without the risk of spreading cancerous tissues. Ethicon, which controlled over 70% of the market, urged surgeons and healthcare facilities to return all of its morcellator products, stop using them immediately and said it was exiting the power morcellator market until new technology or techniques make the process safer for women.
Morcellator 510(k) Approval Process
The problems associated with power morcellation emerged only after thousands of such operations were performed. This fact has refocused criticisms of the FDA’s controversial 501(k) approval process, which requires no clinical studies so long as the device in question is “substantially equivalent” to one already on the market. Critics have suggested that 510(k) amounts to a legal loophole that has allowed a severe health risk to go unnoticed for far too long.
Can I File a Morcellator Endometrial Stromal 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 endometrial stromal 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 endometrial stromal sarcoma, 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 Endometrial Stromal 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 endometrial stromal sarcoma cases in all 50 states.
Free Morcellator Endometrial Stromal Sarcoma Lawsuit Evaluation: Again, if you or a loved one developed endometrial stromal 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.