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Power morcellators, surgical devices used in minimally invasive gynecologic surgery, are currently under critical scrutiny. In April 2014, the Food and Drug Administration issued a warning to all practitioners and patients regarding their dangers.
When used during surgery on patients undergoing hysterectomies or myomectomies (removal of the uterus or uterine fibroids), these devices can spread a hidden and rare, yet aggressive, uterine cancer. Patients are left with a poor prognosis of recovery.
In July, the FDA convened with the Obstetrics and Gynecological Medical Devices Panel to evaluate whether or not it is safe to continue using power morcellators in gynecologic surgeries. The panel felt that, in most cases, the risks outweigh the benefits.
It recommended that doctors explain to their patients the magnitude of the risk when they agree to surgery, and said they would consider requiring “black box” warning labels — the most severe warnings the FDA has. Leading hospitals nationwide are considering banning their use altogether or restricting how the tools are used.
In addition, Johnson & Johnson, one of the manufacturers of these surgical devices, discontinued all sales of its laparoscopic power morcellators following the FDA warning. J&J products affected by this action include the Gynecare Morcellex Tissue Morcellator, the Morcellex Sigma Tissue Morcellator System, and the Gynecare X-Tract Tissue Morcellator.
Power morcellators are tiny surgical devices with rapidly rotating blades. Often when removing the uterus or uterine fibroids, surgeons insert these devices through a small incision in the patient’s abdomen. The tiny blades then slice the tissue into small pieces that can be sucked out through the opening of a laparoscope.
In the process of slicing up the uterus or uterine fibroid, power morcellators can spread previously undiagnosed cancerous tissues throughout the abdominal cavity. These cancerous growths are of particular concern because there is no way to distinguish them from benign ones until they are removed and evaluated.
In addition, typical symptoms may simply be signs of any number of non-life-threatening conditions. Common symptoms may include:
There are four main types of uterine and endometrial cancers:
Of these, leiomyosarcoma is particularly aggressive and alarming. Endometrial stromal sarcoma is generally slow growing.
If leiomyosarcoma is left undisturbed and intact in its original location when the patient is diagnosed, the five-year survival rate is roughly 63 percent. If the cancer has been disturbed and spread throughout the abdominal cavity by power morcellators, depending on the severity, the five-year survival rate drops from 36 to 14 percent.
There are several significant complications that may arise when power morcellators are used in surgical procedures:
If you have recently undergone a hysterectomy or myomectomy to remove uterine fibroids, you are not alone. Annually, more than 500,000 women may be planning to undergo this type of surgery.
Unfortunately, for a small percentage of women, the complications following such a surgery involving power morcellators can be life threatening.
If you are experiencing severe symptoms or have been diagnosed with uterine sarcoma as a result, you may be entitled to compensation.
At Weitz & Luxenberg, we encourage you to ask critical questions before deciding who can best represent your interests. For example, What is this firm’s prior experience? What philosophy does this firm have when working with clients?
As one of the largest personal injury and mass tort plaintiffs’ firms in the country, Weitz & Luxenberg has been winning billions of dollars in damages for tens of thousands of individuals for more than two decades. With a proven record of consistent and superior results, we believe we can offer you the expertise you deserve.
Read more about these Devices Suspected of Spreading Cancer and how our firm Resolves to Get Justice for Women Harmed By Power Morcellators.
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