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.
What is the NBIR?
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. We need everyone who performs breast implant procedures to participate in this very important initiative.
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
3 Pathways to Contribute your Data – NEW NBIR Device Tracking App Available Now!
The PSF and American Society of Plastic Surgeons (ASPS) just launched the NBIR Device Tracking app as another pathway for NBIR Participants use to enter their data into the NBIR. The NBIR Device Tracking app captures data automatically for all cases involving a breast implant placement. This allows users to submit a case to the NBIR while simultaneously registering a device with Allergan, Mentor and Sientra in a matter of minutes. The NBIR Device Tracking app is available for all Apple and Android mobile devices.
Now, NBIR Participants can choose from three different data entry pathways to contribute their data to the registry:
- Manual Data Entry
- Manually enter all of your breast implant procedure data into the NBIR case report form using your computer
- NBIR Barcode Scanner App
- Using a combination of manual data entry and barcode scanning technology, complete the entire NBIR case report form for all procedure types using the NBIR barcode scanner app and the NBIR webtool.
- NBIR Device Tracking App
- Using OCR and barcode scanning technology, seamlessly complete all fields required for device tracking and the registry to submit your breast implant insertion case to the NBIR.
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 firstname.lastname@example.org or your manufacturer.
- How to Sign-Up
- How to Use the NBIR Dashboard
- How to Use the NBIR Barcode Scanner App
- How to Use the NBIR Device Tracking App
- Where to Find the Proper Code to Scan on Mentor Breast Implants Packaging
- How to Register
- How to Navigate the Dashboard
- How to Run Continuous Certification Reports
- How to Use the NBIR Barcode Scanner App
- How to Set Your Pin on the App
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 email@example.com to obtain the necessary documents that are required for your submission.
Support provided by Allergan, Mentor and Sientra.