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Moving breast implant registries forward: Are they FAIR and Functional?

Published:October 17, 2020DOI:https://doi.org/10.1016/j.bjps.2020.10.001
      Several national breast implant registries, designed as Clinical Quality Registries (CQRs), have been founded over the past decade, including Australia, Netherlands, Denmark, Sweden, the United States, the United Kingdom and Italy (Table 1). This occurred in response to worldwide breast implant controversies,
      • McLaughlin JK
      • Lipworth L
      • Murphy DK
      • Walker PS
      The safety of silicone gel-filled breast implants: a review of the epidemiologic evidence.
      • Martindale V
      • Menache A.
      The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks.
      • Prantl L
      • von Fritschen U
      • Liebau J
      • von Hassel J
      • et al.
      Concept for a national implant registry to improve patient safety.
      and is supported by the European New Regulation on Medical devices.

      European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending directive 2001/83/EC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC (text with EEA relevance). In: EUR-Lex, ed2017. Retrieved from: http://data.europa.eu/eli/reg/2017/745/2017-05-05. Last accessed: May 24, 2020.

      More recently, questions about breast implant safety have been raised in mainstream and social media related to breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), breast implant illness (BII) and the limitations of pre- and post-market approval studies. These factors have led to demands from patients, legislators, clinicians and industry for a stricter monitoring of breast implant performance and quality of care.
      Table 1Current clinical breast implant registries.
      Country Name Registry Year of Foundation Opt-out Status (Estimated) number of registered implants annually Registration coverage (% of medical centres) Registration of Tissue Expanders (Estimated) number of breast implants nationally sold annually
      National Registries
      Austria Austrian Breast Implant Register (ABIR) 1992 No Operational > 3 years Unknown Unknown Yes < 10.000
      Australia Australian Breast Device Registry (ABDR) 2014 Yes Operational > 3 years 20.000 – 25.000 75%-100% Yes 30.000–40.000
      Denmark Danish Registry for Plastic Surgery of the Breast (DPB) 1999 No 1999, however, closed in 2011 due to lack of funding 1.000–1.500 (cosmetic and reconstructive) 50% - 75% of private clinics, 100% of public hospitals Yes < 10.000
      France French breast implant registry 2018 Unknown In pilot phase Up to 25.000 0%-25% of private clinics, 25%-50% of public hospitals Yes 50.000–100.000
      Germany Implantatregister Deutschland (IRG) Funding approved 2020, will start 2021 No (mandatory) In pilot phase- operational from 2021 All 100% of private clinics and public hospitals Yes 60.000
      Italy Registro Nazionale delle Protesi Mammarie (RNPM) 2019 No In pilot phase Total of 3.500 since start 0%-25% No 50.000
      Netherlands Dutch Breast Implant Registry (DBIR) 2015 Yes Operational > 3 years 20.000–25.000 95% of private clinics, 100% public hospitals Yes 20.000–30.000
      Russia Russian breast implant registry 2019 Yes In pilot phase Unknown Unknown No < 10.000
      Spain Sistema de Registro Español de Implantes de Mama (SREIM) 2013 Yes Operational 2 – 3 years Unknown 0%-25% of private clinics and public hospitals No 10.000–20.000
      Sweden Bröstimplant Register (BRIMP) 2012 Yes Operational > 3 years 5.000–15.000 50%-75% private clinics, 75%-100% public hospitals Yes 10.000–20.000
      United Kingdom Breast and Cosmetic Implant Registry (BCIR) NHS Digital 2016 Yes Operational > 3 years > 15.000 between July 2018 and June 2019 75%-100% private clinics, 50%-75% public hospitals Yes 30.000–50.000
      United States US National Breast Implant Registry (NBIR) 2018 Yes Operational < 2 years Total of 10.000 since start 0%-25% No 50.000–100.000
      International Registries
      Various countries International Breast Implant Registry (IBIR) 2002 Opt-in Operational Unknown Unknown Unknown Unknown
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