More than 300,000 breast implant surgeries including augmentation and other reconstructive procedures are conducted annually in the US18. Given recent concerns related to these devices there is a need to evaluate these technologies and improve quality of care for patients that undergo breast implant procedures. To address these gaps, the NBIR was developed as a collaboration of FDA, The Plastic Surgery Foundation (PSF), The American Society of Plastic Surgeons (ASPS), as well as patients and breast implant device manufacturers. The NBIR database is a prospective, opt-out, non-interventional, population-based, outcomes and safety surveillance registry and quality improvement initiative. It collects data at the time of operation and any subsequent reoperations for all US patients receiving breast implants. Collecting this information will allow the NBIR, plastic surgeons, and breast implant manufacturers to identify trends and other helpful safety information.
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. NBIR collaborates with breast implant manufacturers that can use the registry to further investigate the device safety and improvement. The manufacturers can use the registry for Device Tracking purposes required by the FDA. Additional aims of the NBIR include serving as a potential infrastructure for post-market studies. NBIR data can be used to study trends related to all breast implant procedures.
The main objectives of the NBIR are to strengthen the national infrastructure for post-market surveillance of breast implants and communicate timely, accurate, systematic, and prioritized assessments of breast implants throughout their marketed life. The NBIR is aiming to 1) leverage high-quality, standardized and structured data; 2) identify potential safety signals in near real‐time from a variety of privacy‐protected data sources; 3) reduce the burdens and costs of medical device post-market surveillance; and 4) facilitate the clearance and approval of new devices, or new uses of existing devices. Additional aims of the NBIR include serving as a potential infrastructure for post-market studies; as well as providing an infrastructure for device manufacturers to facilitate the post-implant component of their device tracking data collection.
III. Partnership Structure
NBIR CRN has partners from government agencies such as the FDA, professional societies like the ASPS, The PSF, and MDEpiNet, as well as the device manufacturers and industry partners, Allergan, Sientra, and Mentor, and patient groups.
NBIR CRN is led by Andrea Pusic (Harvard Medical School) who also co-chairs the NBIR Steering Committee with Charles Verheyden (Baylor Scott & White Health). The NBIR Steering Committee is responsible for developing and implementing the strategic goals of the NBIR and is the governing body that oversees registry operations, including the successful implementation, monitoring, and management of resources and activities.
IV. Data Infrastructure
The NBIR patient population includes patients who have had breast implant procedures in the US. There are thousands of patients already registered with the registry.
Electronic Case Report Form (eCRF): The NBIR Data is collected at two key clinical points: 1) Initial Implant Procedure and, 2) Any subsequent Reoperation. It also collects other information about the patient and patient procedure, including their contact information for manufacturer follow-up related to device tracking, information about their medical history, their breast implant operation and the implant itself, and any complications that may have occurred from the patient’s breast implant operation.
NBIR Barcode Scanning App: Another source of data is the NBIR Barcode Scanning App, which can be used to assist NBIR participants with the data entry of implanted device-specific data elements. The app scans and decodes both Linear and 2D breast implant device barcodes and pushes the data contained within the barcode to the NBIR directly from FDA’s Global Unique Device Identification Database (GUDID). Electronic data captures with bar code scanning to help decrease burden and improve data quality. More information on how to use the app can be found in the following link: https://www.thepsf.org/documents/Research/Registries/NBIR/how-to-use-the-nbir-barcode-scanner.pdf.
PROFILE Registry: The Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) is based on scientific reports of possible association between Anaplastic Large Cell Lymphoma (ALCL) and breast implants. ASPS/PSF and FDA have collaborated to conduct research and launch the PROFILE to increase the scientific data on ALCL in women with breast implants. The primary goal of this registry is to better understand the role of the breast implants in the etiology of primary ALCL in women with breast implants. It can also help identifypotential risk factors and criteria detection and management of this disease. Additionally, the confirmed cases in the registry of primary ALCL in women with breast implants will be available for analytical epidemiological studies.
Just as NBIR, the PROFILE Registry captures data necessary to describe patient demographic characteristics and other medical history, implant procedure information, characteristics of the implant, clinical presentation, pathologic findings, and clinical course, treatment and treatment outcomes of patients with primary Breast Implant Associated ALCL.
V. Current Projects and Plans
In October 2018, the NBIR was launched broadly for use by everyone who performs breast implant procedures in the US. One-year post-launch, the NBIR now has over 500 sites registered to participate and over 4800 patient visits. An annual report summarizing key findings from year one of registry operations is currently underway. As of July 1, 2019, the NBIR can be used as an infrastructure for device tracking. Through this mechanism, we can increase registry participation among surgeons and minimize duplicate data entry in the operating room. The NBIR Steering Committee continues to strategize methods to increase participation and case capture.
ASPS/PSF is in the process of developing a breast implant symptom severity scale to examine common signs and symptoms that patients receiving breast implants may encounter. Upon completion of a Delphi Panel to identify these common symptoms, we will pilot the inclusion of PRO measurement tools for these symptoms within the NBIR. We will identify 10-20 high performing NBIR sites and invite them to participate. Upon completion of the pilot, which we anticipate could take between 12-18 months, we will broadly open up PROs within the NBIR.
International effort: The International Collaboration of Breast Registry Activities (ICOBRA) CRN based in Australia aims to encourage a collaborative approach to sharing registry science and registry data, and support emerging and existing breast device registries to enhance their effectiveness. The US was an inaugural signatory and there are now over 20 signatories. International collaboration including data points from six countries: Australia, Austria, The Netherlands, Sweden, United Kingdom, and United States as well as close partnership with the Australian Breast Device Registry helps identify data sources for this effort. Some of the benefits of a collaborative approach are a standardized minimum dataset, amplified dataset, facilitated data linkage and data comparison, enabled development of evidence-based international early warning systems.