Live Breaking News & Updates on Laparoscopic Power

Date issued: December 29, 2020
The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.
On December 29, 2020, the FDA issued the final guidance,
Product Labeling for Laparoscopic Power Morcellators. The final guidance provides recommendations concerning the content and format for certain labeling information to better inform patients and health care providers of the device s risks.
The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the United States for use during laparoscopic power morcellation and performing these procedures only in appropriately selected patients. The recommendations for health care providers below have been updated from the February 2020 safety communicat ....

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