FDA In Brief: FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
SILVER SPRING, Md., Dec. 29, 2020 /PRNewswire/ -- The following quote is attributed to Jeffrey Shuren M.D., J.D., director of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health:
"Providing women with access to safe medical devices to meet their health care needs is a top priority for the FDA. Today, we've taken two important steps on laparoscopic power morcellators as a result of listening to and acting on public comments to our draft guidance as well as considering the available scientific data.
"Reflecting that feedback and scientific review, our updated recommendations for health care providers include shared decision-making with patients, a thorough preoperative screening with the patient and a warning about the spread of benign uterine tissue, potentially requiring additional surgeries, when using uncontained laparoscopic power morcellators in gynecologic surgeries. We continue to recommend that laparoscopic power morcellation used in gynecologic surgeries only be performed for myomectomy or hysterectomy in appropriately selected patients and only used with a compatible tissue containment system, legally marketed in the U.S. for use during laparoscopic power morcellation.
"The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery. The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries."
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration