FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific

Editor's Note

The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific.

After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on the market does not raise new safety or effectiveness concerns.

In April 2016, the FDA became aware of allegations that the mesh could contain counterfeit raw material.

UPDATED 09/19/2017. After extensive review of data and information from various sources available to the FDA, including data and information from Boston Scientific and results from the FDA's own testing of the finished product, the FDA has determined that the change in supplier of the polypropylene used to manufacture Boston Scientific's urogynecologic surgical mesh currently on the market does not raise new safety or effectiveness concerns.