Tamara Burns  |  October 13, 2015

Category: Legal News

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morcellator-surgery-lawsuitLawmakers have urged the U.S. Government Accountability Office (GAO) to investigate the Food and Drug Administration’s regulation of power morcellators.

Twelve members of Congress wrote a letter to the GAO explaining that, “Hundreds, if not thousands of women in America are dead because of a medical device known as a laparoscopic power morcellator.

They went on to state, “This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”

The investigation should commence in about five months, according to a GAO spokesperson, and the FDA has agreed to cooperate.

What Is A Power Morcellator?

A power morcellator is a medical device used during a minimally invasive surgery, also called laparoscopic surgery. Most commonly used in gynecological surgeries, hysterectomies and uterine fibroid removal are the most common instances where the device is used.

Through a small incision in the body, the power morcellator is inserted. It works by breaking up and dissolving fibroids into small pieces that can then be removed via the small surgical incision.

Problems arise when a woman has previously undetected cancer cells that the power morcellator touches. The power morcellator disturbs the cancer cells and through the power of the machine, disseminates the cancer cells throughout the body.   What started out as a small number of localized cells could quickly become cancer that has spread to multiple areas in the body, causing a much poorer prognosis for treatment and survival.

Power Morcellator Safety Warnings

The FDA, power morcellator manufacturers, and even insurance companies have faced increased scrutiny for these medical products after major safety concerns have been raised.

In 2014, the FDA warned against using power morcellator devices in laparoscopic surgeries for uterine fibroid removal. Reports showed that there is a 1 in 350 risk for uterine sarcoma in women undergoing gynecological procedures with morcellation devices.

In November of 2014, the FDA issued a warning prompting a “black box label” on power morcellators. The federal agency’s recommendation was against using power morcellators for the “majority” of women needing to have fibroid removal or hysterectomy.

Insurance companies Aetna and UnitedHealth no longer cover procedures that use a power morcellation since the FDA warning was issued. This decision was seen as a way to avoid the risk of patients developing uterine cancer.

In the recent request for GAO investigation of the FDA, Congress stated, “In light of these concerns we respectfully request you investigate the root cause failure that ultimately led to the FDA’s black box warning on the use of laparoscopic power morcellators in Nov. 2014—over two decades after it was first approved.”

Many hope that this investigation will provide answers so women and their families do not have after enduring a potentially fatal outcome as the result of a relatively simple procedure.

Filing a Morcellation Cancer Lawsuit

Due to the high volume of power morcellator lawsuits that were filed, cases were consolidated into a multidistrict litigation.

If you or a loved one developed cancer after a surgical procedure involving the power morcellator, you may be entitled to compensation. Lawyers can advise you on filing an individual morcellation lawsuit or joining a multidistrict litigation. All consultations are confidential and are provided at no cost to you.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Join a Free Morcellation Cancer Class Action Lawsuit Investigation

If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.