FDA Posts New Information about Using Laparoscopic Power Morcellators to Treat Uterine Fibroids

PUBLISHED: Dec 14, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office

The US Food and Drug Administration (FDA) has posted the agency’s new review of information related to the use of laparoscopic power morcellators to treat uterine fibroids. Recent medical studies suggest that 1 in 225 to 1 in 580 women undergoing surgery for uterine fibroids may have a hidden uterine sarcoma (a type of cancer). The FDA also estimates that a leiomyosarcoma (a specific type of uterine sarcoma) may be present in approximately 1 in 495 to 1 in 1100 women undergoing surgery for uterine fibroids based on recent studies. These rates are generally consistent with those estimated by the FDA in a 2014 review.

The FDA continues to monitor and evaluate the risks and benefits of laparoscopic power morcellation and the agency’s recommendations for patients and health care providers remain unchanged.

The FDA recommends health care providers share this information with patients, and warns against using laparoscopic power morcellators in gynecologic surgeries to treat patients with suspected or confirmed cancer, and in the majority of women undergoing myomectomy or hysterectomy for uterine fibroids.

The FDA encourages patients, health care providers and manufacturers to continue to report events associated with laparoscopic power morcellators to the agency; such information is critical in the agency’s ongoing evaluation of the risks and benefits of these devices.

For more information, see the FDA’s Laparoscopic Power Morcellators webpage, link provided below. A link to the FDA’s new review is also provided below.

Want to read the full alert and receive alert emails?

Browse Additional Alerts