Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material

AUDIENCE: Surgery, OB/GYN, Risk Manager

ISSUE: The FDA is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material. We are examining these allegations to determine any necessary and appropriate next steps. FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products.

It is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review. However, in light of the allegations, Boston Scientific will conduct additional testing relevant to the safety and effectiveness of the finished product.

The additional testing should be sufficient for the FDA to determine whether or not the urogynecologic surgical mesh manufactured from the alleged counterfeit raw material are equivalent to the urogynecologic surgical mesh manufactured from the original raw material supplier. We expect that this testing will take several months to complete.

In the interim, the FDA believes that health care professionals and their patients should be aware of this investigation and the plan for FDA to review additional data from Boston Scientific so that they can make the most informed health care decisions.

FDA will continue to update this webpage as additional information becomes available.

BACKGROUND: Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue.

RECOMMENDATION: For women who already have Boston Scientific urogynecologic surgical mesh implanted, the FDA is not recommending removal of this device since the available data do not suggest any decreased benefit associated with the device. Moreover, based on currently available information, the FDA believes the additional risks associated with mesh removal outweigh any risk that may be associated with the use of mesh manufactured from alleged counterfeit raw material.

Healthcare professionals and patients are encouraged to 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 and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDAs Urogynecologic Surgical Mesh Implants page, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493784.htm