“Dear Comptroller General Dodaro:
Hundreds, if not thousands of women in America are dead because of a medical device known as a laparoscopic power morcellator.”
So began a powerful letter from twelve members of Congress to the U.S. Government Accountability Office (GAO) on August 7, 2015, requesting that the agency investigate laparoscopic power morcellators, a medical device that can spread cancer in women.
Laparoscopic Power Morcellators
Laparoscopic power morcellators are used during uterine fibroid surgical procedures, including removal of the uterus (hysterectomy) and removal of the fibroids (myomectomy). Morcellators work by shredding tissue/fibroids into small pieces for removal through abdominal incisions made during surgery. For more than 2 decades, this was tauted as a safe and routine procedure; however, as stated in the members of Congress letter to the GAO “…if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread the cancer throughout a woman’s body. 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.”
FDA Updates Morcellator Warnings in 2015, Despite Decades Of Product Use
Although power morcellators have been marketed for more than 2 decades, only recently did the FDA prodvide guidance for use, and recommend product labeling to address the cancer risk associated with these devices. In a Safety Communication dated Novemember 24, 2015, the FDA recommended that a “Boxed Warning” indicating that the use of power morcellators during fibroid surgery may spread cancer, and decrease the long-term patient survial should be added to morcellator labeling. The agency also recommended against the use of power morcellators in the majority of women with fibroids who are undergoing fibroid removal or hysterectomy. The FDA stated that its actions were based on an analysis of “currently available data” indicating that approximately 1 in 350 women undergoing this procedure may have an undetected uterine cancer that a power morcellator can spread.
Should the FDA Have Alerted The Public About Power Morcellator Cancer Risks Sooner?
While the FDA stated that their recent power morcellator safety recommendations are based on “currently available data” the members of Congress letter challenged that notion stating “FDA’s warning came decades after some studies were already pointing to a serious problem. For example a 1990 study found about one-in-200 women had a hidden uterine sarcoma, a rare type of cancer. A 1994 study found a one-in-444 risk. Other studies from 1999 and 2008 found the risk to be one-in-462 to one-in-253 women.” The members of Congress further stated “Despite these studies, as late as last year, the FDA, medical device industry and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000.” The members of Congress asked “How did they get it so wrong for so long?”
12 Members of Congress Request Laparoscopic Power Morcellator Investigation
If the GAO agrees to conduct a power morcellator investigation, it will likely focus on the adequacy of the 510(K) approval process whereby a “Premarket Notification” is used to obtain marketing clearance for a medical device that is “substantially equivalent” to device that is already on the market. In other words, a new medical device can “piggyback” on the approval of a marketed device if the new device is to be used for the same intended purpose. This process has been criticized because the device manufaturer is not required to conduct clinical trials that establish safety prior to maketing their product.
In their letter, the members of Congress requested that the GAO consider the following questions as part of a laparoscopic power morcellator investigation:
1.) Did the 510K approval process identify the risks of adverse events before laparoscopic power morcellators were marketed?
2.) Were medical device safety reporting requirements followed by manufacturers, importers, user facilities, and the FDA?
3.) Did laparoscopic power mocellators manufacturers train doctors, and were there professional society standards that applied to training?
4.) What steps is the FDA taking after issuing the boxed warning to determine whether the laparoscopic power morcellator is safe to remain the market?
Contact The Weinberg Law Firm for a Free Laparoscopic Power Morcellator Lawsuit Evaluation
Since 1984, Attorney Eric Weinberg has reprsented personal injury victims, including those injured by defective pharmaceutical drugs and medical devices, obtaining over $800 million for clients.
Our firm is currently investigating claims on behalf of women who have been injured as the result of power morcellator use during fibroid tumor removal and hysterectomy procedures. For a free, nonobligatory power morcellator lawsuit evaluation please call our firm toll free at 877-934-6274. You can also contact The Weinberg Law Firm online by submitting the “Free Legal Calse Evaluation Form” found on this page.
