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Saturday, April 02, 2016

FDA Investigates Counterfeit Materials in Surgical Mesh

April 1, 2016 
 In the meantime, the FDA wants healthcare professionals and their patients to be aware of this investigation and the FDA's plan to review additional data from Boston Scientific so that they can make the most informed decisions about their healthcare.
 The FDA will continue to update its webpage as additional information becomes available.

Healthcare professionals and patients should report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete form online at www.fda.gov/MedWatch/report or call 1-800-332-1088 to request a reporting form, which can then be completed and faxed to 1-800-FDA-0178 or returned by mail.

The MedWatch safety alert, including a link to the FDA's Urogynecologic Surgical Mesh Implants page, is available here.


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