Introduction
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,
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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 |
While stakeholders and most peers understand the importance and the value of robust and sustainable CQRs,
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there are also several critics.7
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Their concerns include the increased administrative burden of CQRs, but also high costs and funding complexity, the need for data governance and privacy protection. Despite evidence to the contrary,11
, 12
, - Sirker A
- Mamas M
- Kwok CS
- Kontopantelis E
- Ludman P
- Hildick-Smith D
Outcomes from selective use of thrombectomy in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: an analysis of the British Cardiovascular Intervention Society/National Institute for Cardiovascular Outcomes Research (BCIS-NICOR) registry, 2006-2013.
JACC Cardiovasc Interv. 2016; 9: 126-134
13
, - Mohammad HR
- Matharu GS
- Judge A
- Murray DW
A matched comparison of revision rates of cemented Oxford unicompartmental knee replacements with single and twin peg femoral components, based on data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.
Acta Orthop. 2020; 1-6
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some have argued that registries simply generate ‘meaningless data’ about product details instead of quality data that could help improve the quality and safety of care.7
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However, well-designed CQRs offer important information, which serves multiple purposes. A high-quality implant registry can be defined by the completeness of its nationwide engagement, interdisciplinary use, the ability to collect longitudinal data, including surgical and patient-reported outcomes and its financial independence from the industry. CQRs provide population-level data (including patient-, surgery-, site- and device-related data), which is valuable for the identification or recall of an under-performing device, for regional or nationwide clinical auditing, for medical research and for the accurate and fast identification of patients when a hazard alert is needed due to problems identified with medical devices in situ. CQRs support innovation within the industrial market through the provision of faster, independent and more transparent assessment of device performance. In addition, objective data from CQRs are invaluable to counter the groundswell of subjective information patients can access from social media platforms.
In the past decade, several countries have already established well-functioning registries, while some are now in the pilot phase. The first benchmarked information is now emerging from the functioning registries, which included data on device performance and scientific insights of relevance nationwide and internationally. Therefore, the next challenge for the custodians of these registries will be: ‘how to improve our registries?’. Both clinicians’ and external stakeholders’ feedback can help us identify potential for improvements. Through this editorial, the authors, all active in national breast implant registries, would like to encourage a constructive debate on performance to date and to address how to improve our registries based on the early results and experiences.
Potential areas of improvement
Setting up and maintaining sustainable registries is challenging. First, the existence and success of CQRs depend initially on the motivation and dedication of the initial stakeholders to establish the registry, and then the participation of the clinicians who contribute data to the registries. Therefore, constructive feedback and ideas of these clinical users is critical to progress. Second, the value of a CQR is dependent on its data quality.
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This makes the external stakeholders (those using the data output of the registries) the next important group to consider. This group includes a diverse set of beneficiaries who focus on the output of our registries (i.e. patients, health care institutions, health care inspectorates, national regulators, manufacturers and researchers). Potential opportunities for improvement from both the clinicians’ view and the external stakeholders’ perspectives are considered.From the clinicians’ perspective
Some years after the start of the Dutch Breast Implant Registry (DBIR), which was founded in 2015, a survey was conducted amongst its clinical users. This survey focused on clinician-reported importance of registration, experiences of the clinicians while registering implants, and potential areas of improvement as identified by clinicians. This survey was completed by 69% of all medical institutions registering breast implants in the Netherlands (48 of 70) at the time of sending the survey. The results showed that plastic surgeons considered the registration of breast implants to be very important and of value, despite the administrative burden. However, all respondents suggested that improvements are needed, and recommended focusing on the user interface, user friendliness, automation and data (re)usability as this could reduce the administrative burden.
Currently, in the Dutch registry, over 80% of the clinicians register data online through a web portal. Fundamental principles of a good interface include intuition (reducing cognitive load), consistency (both visual and functional), relevance (simplifying by removing irrelevant items) and support (placing users in control).
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Clear labels and an appealing layout of the (digital) questionnaire enable easy and efficient data entry. Providing data entry forms in the clinician's native language will also assist, while preferably keeping the data set behind the scenes in a uniform language (i.e., English), to easily enable international comparisons and data sharing.Another area for improvement is automation. A barcode scanner eases data collection through automated data uploads and minimizes data input errors. The U.S. National Breast Implant Registry (NBIR) uses barcode scanning to register devices. However, an obstacle has been that manufacturers display the data identifying the implant in various locations on their packaging. This may create confusion when a surgeon attempts to scan and register the device in the operating room. Other steps in reducing data entry burden include intelligent data collection by automatic data uploading methods. For example, if one registers manufacturer's details and a reference number, implant characteristics such as texture, shape or fill can be deduced automatically if the registry has a complete device catalogue. This happens, for example, in the Italian registry; the breast implants’ distributors periodically upload their catalogue and the surgeons only need to insert the serial number of the implanted device at the time of the operation. The system identifies the implant automatically, and self populates details of the manufacturer and other specific characteristics according to European International Organization for Standardization (ISO) 14,607. However, the governance of such a device catalogue has its own challenges, such as embedding these device characteristics in (inter)national device information systems, like the Global Data Synchronisation Network (GDSN). Additionally, some health care institutions have incorporated the registry in their Electronic Medical Record system, which facilitates automatic data uploads to the registry.
The clinicians also highlighted the importance of data usability. For data to be usable, it is essential to ensure it is complete and of high quality. One option to increase completeness involves having an opt-out system (all patients are included unless they actively opt-out) over an opt-in system (surgeons only enter data after retrieving the patients’ active permission). An opt-out system is considered to result in higher inclusion rates.
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A different approach was chosen in Italy, where the competent authority is working on making the registration of healthcare professionals, patients and implants mandatory. Also in Germany, efforts are being made to legally oblige the registration of implants. Another reason for data incompleteness is manual data entry by the clinician. Therefore, systems should be designed with the purpose of immediate validation checks, i.e., when a surgeon fills out the online form, they can only proceed after all critical fields have been completed. Finally, clinicians desire usable feedback from the registry that enables them to improve their own performance by automatically generated benchmark data (i.e., comparing their data to national data).From the external stakeholders’ perspective
While optimizing data input, a clear focus on output and data analysis is equally important. Relevant to this subject are the FAIR Data Principles. The FAIR data principles were introduced by Wilkinson and colleagues in 2016; FAIR is an acronym for the principles ‘Findable’, ‘Accessible’, ‘Interoperable’ and ‘Reusable’.
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These principles act as a guideline that supports enhancing the reusability of data holdings, i.e., for future research or the verification of the data. These FAIR principles may be used as a guide to improve data management within our registries for the future.To adhere to the first principle ‘Findable’, data should be described with rich metadata (descriptive information). These metadata should clearly include the identifier of the data that it describes, and (meta)data should be registered in a searchable resource, such as an online repository or a metadata catalogue.
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Also, all data should be assigned a globally unique and persistent identifier, i.e., including a unique patient identifier (UPI) while respecting data privacy requirements, and a unique device identifier (UDI) in breast implant registries. Presently, UDIs are still country- or manufacturer-specific. An international task force (the International Medical Device Regulators Forum, IMDRF) is trying to harmonize UDIs globally.To be ‘Accessible’, data should always be retrievable by their identifier using a well-defined standardized and freely available protocol.
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The (meta)data should be accessible after obtaining the right authorization and authentication, e.g. by using open source storage software.Although less related to the FAIR principles, defining the right authorization emphasizes two other important issues: privacy and legislation. Who owns the data, who has access, and how are data protected? For example, national legislation makes data collection with a UPI sometimes difficult, particularly if data linkage to other data sources is required. However, data collection with a UPI should be maintained while demanding at least pseudonymous data handling, secured through encryption by an independent company and complying to the relevant ethical standards and national laws.
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These issues should be addressed nationally, while aiming for potential collaborations with other registries nationally and internationally. As breast implant registries have matured, the authors encourage collaborating with other plastic surgery registries, e.g. the U.K. Flap Registry to complete the data set of breast reconstruction patients, and other specialties with well-known and sustainable (implant) registries, such as the registries of orthopaedic surgeons and cardiologists. We can learn from their way of handling data following national legislation, and sharing data and integrating systems may support automation and efficiency.The principle ‘Interoperable’ means that data should use a formal, accessible and shared language, for which it should follow the FAIR principles in using shared vocabulary (i.e., using Global Medical Device Nomenclature, GMDN), and that it should include references to other data, which support both understandability for machines and humans.
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This principle underscores the great benefit of the International Collaboration of Breast Registry Activities (ICOBRA) lean clinical data set: it is an English language dataset freely available for use by any national breast implant registry, and provides a harmonized dataset that is internationally comparable.19
The next step for this dataset is to define the data using official ontology (defining concepts and relationships within a domain to enable human and computer communication).20
Implementation of standardized content, using for example SNOMED CT (Systemized Nomenclature of Medicine – Clinical Terms), increases FAIR-ness and comparability.Finally, data should be ‘Reusable’. This principle focuses on the rich description of (meta)data, with multiple accurate and relevant attributes supporting easy understandability and linkage to other data sources.
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Data would be even richer if a functionality was developed that supports automated linkage to other national CQRs, such as oncological registries, on a de-identified patient level, particularly if required by local legislation. On a larger scale, global efforts should be made to enable safe and effortless connection between the different national breast implant registries to discover global trends swiftly. Another requisite for data to be ‘Reusable’, is that a clear data usage licence and user protocol should be accessible through the registry, i.e., providing a clear codebook and description of methods.18
In addition to adherence to the FAIR principles, there are other challenges in the support of maintenance and improvement of data quality and sustainability of our registries. First and foremost, data completeness is obviously an important issue that was also previously identified.
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A dataset should contain a comprehensive collection of relevant data and should ensure data correctness. ICOBRA critically designed their lean clinical dataset with this same intent, but also deliberately considering the balance between registration burden and added value to optimize reliable physician participation.19
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This dataset can be updated as required. Furthermore, by embedding the registries in healthcare systems by making data collection an integrated part of clinical work flow and care delivery, we can work towards the minimisation of missing data and reusing data of Electronic Medical Records, an aspirational goal of some major health systems attempting to learn from all patients all the time.22
Education and engagement of plastic surgeons and residents are integral in this process.15
Another solution to engage clinicians is to invite them to a national feedback conference.Second, the CQRs’ data should serve all stakeholders, i.e., patients, clinicians, manufacturers, insurers, governments, national regulators, researchers (i.e., in support of Registry-based Randomized Controlled Trials
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) and academics. Therefore, registries must present their data in various valuable ways, e.g. using an interactive dashboard showing hospitals their own data as compared to a national benchmark (Figure 1), or the provision of clear datasets for researchers. Following the Swedish experience, it should be noted that coverage might be compromised if the registry provides reports on individual clinics` outcomes openly from the start of the registry, as colleagues might fear exposure, and might not be willing to participate. External stakeholders could benefit from national reports of interest to industry, governments and the general public. In addition, registry data could potentially act as post-surveillance studies without the conflict of manufacturers recruiting and funding clinicians.
Figure 1(A) An example of the dynamic monitoring dashboard of the Dutch Breast Implant Registry, with options for cohort selection using patient, surgery and implant filters, and immediate feedback with the Dutch benchmark. In this part of the dashboard, different outcomes can be examined for both inserted devices or explanted devices. Results of own health care institution are presented in dark blue, results of the benchmark in light blue. (B) example of the dynamic monitoring dashboard of the Dutch Breast Implant Registry, with options for cohort selection using patient, surgery and implant filters, and immediate feedback with the Dutch benchmark. In this part of the dashboard, different trends can be examined for both inserted devices or explanted devices. Trends of own health care institution are presented with a solid blue line, trends of the benchmark with a dotted line.
Figure 1(A) An example of the dynamic monitoring dashboard of the Dutch Breast Implant Registry, with options for cohort selection using patient, surgery and implant filters, and immediate feedback with the Dutch benchmark. In this part of the dashboard, different outcomes can be examined for both inserted devices or explanted devices. Results of own health care institution are presented in dark blue, results of the benchmark in light blue. (B) example of the dynamic monitoring dashboard of the Dutch Breast Implant Registry, with options for cohort selection using patient, surgery and implant filters, and immediate feedback with the Dutch benchmark. In this part of the dashboard, different trends can be examined for both inserted devices or explanted devices. Trends of own health care institution are presented with a solid blue line, trends of the benchmark with a dotted line.
Third, in 2019, Ng et al.
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published the results of an interesting next step in the improvement of our registries. The results of their pilot study showed that it is feasible to assess patient-reported outcome measures (PROMs) and patient-reported symptoms through registries. PROMS are now being collected nationally in Australia and Sweden. PROMs are designed to aid in assessing breast device performance and to identify a potential signal of harm earlier than waiting for revisions to occur. PROMs can also serve as a quality indicator for breast device surgery, and can be used by clinicians to benchmark the quality of care.15
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They also give us insight into patient satisfaction, and can provide direct feedback to external stakeholders about device or surgeon performance from the patients’ perspectives. Efforts are being made to introduce PROMs in several breast implant registries, including the U.S. NBIR and the DBIR, and to optimize their response rate.21
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Finally, for FAIR data management and stewardship within our CQRs, sustainable funding is essential but also the most challenging to address. As in Denmark, the combination of private and public data has made it difficult to agree on a model for funding. Funding should be long-term and preferably independent from the industry. There are various ways in which breast implant registries are funded.
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While countries such as Australia, Sweden, Germany and Italy have government funding for their registries, the Dutch registry receives funding through a surcharge on all cosmetic breast implants paid by patients and through medical insurance companies for implant-based breast reconstructions.5
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Global transparency on funding sources between registries could help other registries to develop and improve.As a final comment, mature registries continue to support each other and registries in earlier phases of development. The largest international breast implant registry collaboration was built by ICOBRA, originally funded by the Australasian Foundation for Plastic Surgery, and currently part of the patient safety initiatives of the International Confederation of Plastic Surgery Societies (ICOPLAST). ICOBRA has successfully grown using a shareware mentality, and its success underscores the importance of connectivity in all layers: dataset, data definitions, data analysis and outputs. Thus far, ICOBRA facilitates the first opportunities to aggregate data from different countries, which allows collective analyses, with the benefit of agreed data definitions. Together we are stronger, which therefore allows us to best serve our patients.
Conclusions
Clinical breast implant registries are important and valuable for tracking breast device performance, for patient safety and for quality of care. Breast implant registries provide evidence that supports clinical decision-making, and they have value for all stakeholders, including patients, clinicians, manufacturers and governments. Registries are continually improving to maximize their effectiveness and to optimize their usability and sustainability. Clinicians’ experiences with breast implant registries are critical to identify the potential for improvement and to move breast implant registries forward. In the current phase, the improvement of registries should focus on user interface, user friendliness, automation and data (re)usability, thereby adhering to the FAIR Data Principles. The authors encourage both advocates and critics of breast implant registries to continue the dialogue, to publish about breast implant registries and how to improve them. Only by critical constructive comments and open discussions are we able to move forward with the meaningful data from our registries to provide the best possible evidence-based care to our patients.
Declaration of Competing Interest
The authors certify that they have no affiliations with or involvement in any organisation or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership or other equity interest and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.
Funding source
This editorial received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
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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.
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