FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

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FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

04/07/2016 12:47 PM EDT

The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.

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