BRIMP, the Swedish Breast Implant Registry, started in May 2014, thereby initiating the first systematic post-market monitoring of breast implants in Scandinavia. It is a non-profit organization without any industry related funding. An important objective for BRIMP is to offer patients- with need of breast implants objective information about the various types of implants available on the market. Based on the statistics provided by BRIMP surgeons are provided with objective and well substantiated data for optimal decision-making in relation to each patient’s specific needs.

Another important purpose of BRIMP is to provide statistics and detect trends in terms adverse events such as early ruptures, unexpected rates of capsular contracture, ALCL and other potentially harmful events.  Hopefully, this will contribute to avoiding the type of catastrophic events previously experienced in the field of implant surgery.

BRIMP also offers the opportunity to follow the long-term effects of implants on breasts. Surgeons can continuously evaluate their own data in relation to total aggregated data in real time by logging into a web module for primary surgery and reoperations. We are also working on a tool for patient reported outcome measures (PROM). Questionnaires will be sent out at 6 months and at 5 and 10 years after the operation. These will address the patient’s quality of life and her experience with her specific implant over time.

Over the past years, the consolidation of data in BRIMP has continued. An active teamwork with personal support to reporting units has improved both compliance and completeness of data in BRIMP. At present, all University departments and 90% of private surgeons (members of SFEP, The Swedish Association of Aesthetic Plastic Surgery) report in to the registry. As of July 2017, we monitor a total of 9000 primary operations and 2700 reoperations.

BRIMP has also started to cooperate with the International Collaboration of Breast Registry Activities (ICOBRA). ICOBRA was started 2013 by Rod Cooter in Australia and works on a minimum dataset based on international best practice as well as on quality parameters.

The implant industry will undoubtedly gain interest in breast implant registries as our international network improves and intensifies and independent evidence based knowledge will be obtained. The contribution of BRIMP will be to add de-individualized pooled registry data on complications, patient-reported symptoms and decisions taken at the time of reoperation.

Sweden has a long tradition of more than 100 quality registries in the medical field. We are glad that BRIMP is one of them, adding breast implant knowledge, safety and security for patients and surgeons.

 

Birgit Stark: MD, PhD

Department of Plastic and Reconstructive Surgery

Karolinska University Hospital Stockholm Sweden

 

Heléne Fägerblad: Coordinator of BRIMP

Jonas Lekander: Project manager

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