Dr. Reed and her husband speak out against power morcellatorsDr. Reed and her husband, Dr. Hooman Noorchashm, have approached the FBI and GAO regarding power morcellator regulations. In 2013, Dr. Amy Reed was diagnosed with uterine cancer following an operation to remove her uterine fibroids. She and her husband, Dr. Hooman Noorchashm, believe that her cancer was upstaged and spread by the power morcellator used during her procedure. Since her diagnosis, they have both dedicated their time to speaking out against morcellation during gynecological surgeries and warning other women of the risks.
FBI InterviewDr. Reed even reached out to the Federal Bureau of Investigations regarding her concerns and has reported that agents in New Jersey have interviewed her twice. She and her husband also spoke with members of Congress, and convinced twelve of them to sign a letter requesting that the U.S. Government Accountability Office investigate the U.S. Food and Drug Administration’s 501(k) approval process.
The FDA first granted approval for the power morcellator in 1991 under the 501(k). This allowed morcellator manufacturers to put the device on the market without performing any safety testing because they claimed the tool was “substantially equivalent” to a previously approved surgical tool. However, the FDA ended up warning against the use of the morcellator when they released a safety warning in April 2014.
GAO’s DecisionThe GAO has responded to the letter from Congress, agreeing to investigate the 501(k) process and determine if the FDA should continue to approve new devices in this manner. It will be several months before the investigation begins.
The Problems With The MorcellatorMany are wondering why the FDA approved the morcellator for use in the first place. The FDA claims that even though the surgical tool has been used for decades, it wasn’t until 2013 that they became aware of the risks.
The biggest risk associated with morcellation is for women who are undergoing hysterectomies or myomectomies to treat uterine fibroids. While the majority of fibroids are benign, the FDA has determined that nearly 1 in 350 women undergoing these procedures also has undiagnosed uterine cancer. If the morcellator is used, it might disseminate cancer cells throughout the abdominal cavity and upstage the cancer. In the past two years, over 30 women and their families have filed lawsuits against power morcellator manufacturers, all alleging that a morcellator spread their undetected uterine cancer.