Exhibits: Teresa Stevens Citizen Petition, U.S. Food and Drug Administration

 

The below Exhibit Index provides a document description for each exhibit related to Teresa Steven’s Citizen Petition to the U.S. Food and Drug Administration. You can find the Stevens’ Citizen Petition filed on April 12, 2016here.

In response to the Stevens’ Citizen Petition, the FDA issued a Safety Warning on April 1, 2016, acknowledging the allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material and stating it is examining these allegations to determine any necessary and appropriate next steps.