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Project Title: The National Breast Implant Registry (NBIR)
Principal Investigators: Andrea Pusic, MD, MS; Charles N. Verheyden, MD, PhD
Clinical Coordinating Center: The Plastic Surgery Foundation
Participating Sites: Any site performing breast implant procedures in the United States is invited to participate
Project Description: The Plastic Surgery Foundation has collaborated with the FDA and breast implant device manufacturers to develop the National Breast Implant Registry (NBIR) to strengthen the post-marketing surveillance infrastructure for current and future breast implant devices. The NBIR is a prospective, non-interventional, population-based, outcomes and safety surveillance registry and quality improvement initiative. The NBIR collects clinical, procedural and outcomes data at the time of operation and any subsequent reoperations for all US patients receiving breast implants. Plastic Surgeons that enter data into the NBIR will be able to compare their practice performance and outcomes to the registry aggregate.
Status: The NBIR is currently open for registration!
For additional information about the NBIR, please contact email@example.com.
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Western Institutional Review Board has determined that the NBIR is not research and does not require IRB review. However, if your local IRB requires you submit for further review, please contact firstname.lastname@example.org to obtain the necessary documents that are required for your submission.
Support provided by Allergan, Ideal, Mentor and Sientra.