The 501(k): Is it a safe process?As the number of power morcellator lawsuits climb, the GAO has agreed to investigate the FDA's 501(k) approval process. As power morcellator lawsuit numbers grow, the public has been made aware of the U.S. Food and Drug Administrations 501(k) approval process.
The 501(k)This process allows the manufacturers of surgical tools to expedite the approval process by showing that the instrument is essentially equivalent as a previously approved device. If the FDA agrees with that determination, the new device is not required to undergo the normal safety testing and clinical trial procedures.
Today, many women are wondering if the FDA missed a potentially deadly risk associated with the use of a power morcellator by allowing the tool to be approved this way. The power morcellator has been used by surgeons for several decades, but it wasn’t until recently that the FDA announced to the medical community and the public that if the device is used during a gynecological surgery, there was a chance that undetected uterine cancer could be spread through the body cavity.
The GAO InvestigationOn August 7th, 2015, twelve members of Congress sent a letter to Mr. Gene Dodaro, the Comptroller General and the head of the U.S. Government Accountability Office, requesting that the GAO investigate FDA’s approval of the device. Additionally, the question was raised as to why it took so long for the FDA to issue the safety warning. The morcellator was cleared for use in 1991, but the safety warning wasn’t issued until April 2014.
Uterine Cancer and the Power MorcellatorThe safety warning published by the FDA reads, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. ”It was estimated that around 1 in 350 women undergoing hysterectomies or myomectomies to treat uterine fibroids also have undiagnosed uterine cancer.
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