Product News and Recalls

Members of Congress Seek FDA Accountability for Power Morcellator Deaths

members of congress call for accountability in power morcellator deathsAccording to the Wall Street Journal, twelve members of Congress have called upon the U.S. Government Accountability Office (GAO) to investigate why the U.S. Food and Drug Administration (FDA) took so long to warn about the cancer-spreading risks of power morcellators. “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator,” the letter reads.

Laparoscopic power morcellators are a type of medical instrument used in minimally invasive surgery. They are primarily used in hysterectomies and myomectomies to cut up bulky uterine tissue so it can be extracted through small incisions in the abdomen. Power morcellators have been on the market since 1991, when they were approved by the FDA; but it was not until 2014 that the agency finally warned patients and practitioners that laparoscopic power morcellators have a chance of spreading unsuspected cancer in patients. In its safety communication, the FDA estimated that “1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids . . . have an unsuspected uterine sarcoma.” Just a few months later, a Columbia University study reaffirmed the agency’s estimate, claiming as many as 1 in 368 women have uterine cancer at the time they undergo a gynecologic procedure. As a result, surgeons may unknowingly be spreading cancer in hundreds of female patients each year.

An investigation by the GAO would scrutinize how the FDA approved and monitored power morcellators. According to the Wall Street Journal, the agency has cleared at least ten power morcellator devices over the past 24 years. Although the FDA had some data suggesting power morcellators could spread cancerous cells throughout the body, the agency maintains it did not recognize how serious the risks were until 2013. In their letter, the members of Congress question why the FDA’s warning “came decades after some studies were already pointing to a serious problem.” For over 20 years, the FDA and many gynecologists claimed the cancer-spreading risks of power morcellator procedures were low—about one in 10,000. “How did they get it wrong for so long?” the letter asks.

In the meantime, many women have filed power morcellator lawsuits, and plaintiffs in nearly two-dozen power morcellator lawsuits have petitioned the U.S. Judicial Panel on Multidistrict Litigation to centralize their cases in a multidistrict litigation. Last month, one of the first power morcellator lawsuits was settled out of court for an undisclosed amount, and legal experts believe many more settlements will occur.

Were you or a loved one diagnosed with cancer after undergoing a power morcellator procedure? If so, contact the lawyers at Lopez McHugh today to receive a free consultation. We can review your legal options and help find out whether you qualify for compensation in a power morcellator lawsuit.