FDA updates safety guidance, labeling requirements for power morcellators
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The FDA today issued a safety communication for patients and their health care providers that stresses the importance of shared decision-making regarding use of laparoscopic power morcellators during gynecologic surgeries.
The safety communication also included two other new points — that uncontained power morcellation may spread benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, and that clinicians should conduct a thorough preoperative screening prior to using the device.
The guidance continued to emphasize that power morcellation be used only for selected women, and that it should be performed only with a legally marketed laparoscopic power morcellation containment system, which places removed tissue into a sealed bag to avoid its dissemination into the abdominal cavity during morcellation.
“Reflecting [public] 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,” Jeffrey Shuren MD, JD, director of FDA's Center for Devices and Radiological Health, said in a press release. “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.”
Power morcellation requires a small incision through which a tiny instrument with a rapidly rotating blade enters the uterus to grind up uterine fibroids. Compared with open surgery, power morcellation is associated with a quicker recovery, fewer adverse effects and a lower rate of morbidity.
However, FDA guidance first issued in 2014 recommended that manufacturers of laparoscopic power morcellators include a boxed warning to acknowledge that undetected leiomyosarcomas or other malignancies within uterine tissue can be disseminated throughout a woman’s pelvic and abdominal cavities during morcellation.
The FDA today also issued final guidance on labeling for power morcellators, recommending that a boxed warning inform clinicians that uterine tissue may contain unsuspected cancer and that use of laparoscopic power morcellation could spread cancer and reduce long-term survival. Also, the FDA recommended that manufacturers include label information on the risk of power morcellator use related to age, the risk for spreading malignant and benign uterine tissue, and the use of containment systems.
“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,” Shuren said. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
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