National Breast Implant Registry
NBIR Annual Report
We are very excited to present the inaugural Annual Report of The Plastic Surgery Foundation's (PSF) National Breast Implant Registry (NBIR). The NBIR is a collaborative effort between The PSF, the United States Food and Drug Administration (FDA), patients and breast implant manufacturers to strengthen the post-market surveillance infrastructure for current and future breast implants in the United States.
The NBIR Matters to Our Patients
The Plastic Surgery Foundation has developed the National Breast Implant Registry (NBIR) in collaboration with the FDA, patients and breast implant manufacturers to strengthen the post-market surveillance infrastructure for current and future breast implant devices in the United States.
The NBIR is a quality improvement initiative and safety surveillance registry that collects clinical, procedural and outcomes data at the time of operation and any subsequent reoperations for all US patients receiving breast implants. The NBIR matters. We need everyone who performs breast implant procedures to participate in this very important initiative.
Device Tracking – Available Now!
The NBIR case report form (CRF) was designed to capture data that is required for the purposes of device tracking – a federally-mandated requirement of manufacturers of breast implants. This means physicians can simultaneously fulfill their device tracking requirements for Allergan, Mentor and Sientra by participating in the NBIR. For more information, contact email@example.com or your manufacturer.
Research takes time, which is why the NBIR is important. Regularly updating the NBIR with your breast implant procedure data is essential to ensuring patient safety. We need plastic surgeons to participate in this very important initiative.
Collecting information on breast implant procedures and devices allows plastic surgeons and breast implant manufacturers to identify trends and other information that can be used to improve the safety of breast implants for current and future patients.
Your participation in the NBIR allows you to:
- Satisfy your Practice Improvement Activity of Continuous Certification (instead of your 10 tracer cases) for the American Board of Plastic Surgery (ABPS).
- Replace the Device Tracking Form for most manufacturers, leading to less duplication of work.
- Collect accurate and meaningful data on your own practice, such as rates of reoperation, implant failure and your most common complications leading to reoperation.
- Contribute to patient safety for your own patients and for others across the country
- Be recognized for your commitment with public-facing recognition on ASPS Find A Surgeon
- How to Sign-Up
- How to Use the NBIR Dashboard
- How to Use the Barcode Scanner
- Where to Find the Proper Code to Scan on Mentor Breast Implants Packaging
- How to Register
- How to Navigate the Dashboard
- How to Use the NBIR Barcode Scanner App
- How to Set Your Pin on the App
- How to Run Continuous Certification Reports
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, Mentor and Sientra.