FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-increase-safety-laparoscopic-power-morcellators-when-used-gynecologic-surgeries?utm_campaign=022520_Statement_FDA%20Improves%20Safety%20of%20Laparoscopic%20Power%20Morcellators&utm_medium=email&utm_source=Eloqua

FDA Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators when used in Gynecologic Surgeries

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

Today, we are taking several important steps to make the use of laparoscopic power morcellators (LPMs) safer in gynecologic surgeries, including granting marketing authorization for updated labeling of the PneumoLiner containment system (a device that contains tissue to be morcellated during certain gynecologic surgeries), releasing a draft guidance recommending the addition of specific safety information to the product labeling for LPMs, and issuing a Safety Communication recommending that an LPM only be used in certain gynecologic surgeries with a containment system that is compatible with the LPM.  LPMs are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so the tissue can be removed through a small incision site. These devices can be used in a variety of surgeries, including various gynecologic surgeries such as a myomectomy, a surgical procedure to remove uterine fibroids from a woman’s uterus. While laparoscopic surgeries are associated with shorter post-operative recovery time and a reduced risk of infection compared to...

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