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,
1
,
2
,
3
and is supported by the European New Regulation on Medical devices.
4
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.
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.
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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Article Info
Publication History
Published online: October 17, 2020
Accepted:
October 10,
2020
Received:
November 22,
2019
Identification
Copyright
© 2020 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.
