Sage Journals: Discover world-class research

Abstract

French

Introduction: Use of breast implants has nearly doubled for reconstructive and aesthetic surgery throughout North America. This growing demand highlights the need for breast implant registries to monitor safety and quality of care. Despite wide adoption of implant registries in other countries, there is currently no Canadian system to track implantation of breast prostheses. This review aimed to inform the development and implementation of a Canadian breast implant registry (BIR). Methods: A systematic review was conducted to include searches of Medline Ovid, Web of Science, Embase Ovid and grey literature databases. Data were extracted for: patient participation, registry structure, data quality, funding and reporting outputs. Results: Of 1577 articles, a total of 19 met inclusion criteria. The Dutch, Australian, American, German, United Kingdom and Korean implant registries were analyzed. Opt-out systems were commonly used and correlated with higher capture rates. Data input relied on physician or surgeon data entry. Funding was private for the Dutch BIR through a patient or insurance surcharge, and government funding was used in the United Kingdom, Australian and Korean registries. Finally, all registries disseminated outcomes via annual reports. Conclusion: Based on strategies used in existing registries, it is recommended a Canadian BIR have an opt-out structure, funding from a combination of government or private stakeholders, use a standardized data set and annual reporting.

Keywords

breast database implant mammo prosthesis registry reconstruction

Introduction

Rates of breast augmentation surgery remain high, with over 1.9 million people worldwide having the procedure done in 2023, making it one of the most common cosmetic procedures performed in the world.^1,2 In North America, approximately 300,000 procedures were performed in 2023 for implant-based breast augmentation.^3,4 This growing use of breast implants highlights the necessary public health measures to assess breast implant safety, which can be achieved with a national breast implant registry (BIR). Despite its recognized importance in the House of Commons Parliament session in November 2023, and societal advocacy dating back decades, Canada remains the only G7 country without an established BIR.⁵ BIRs are used globally to study new implant associated risks such as Breast Implant Illness (BII), and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).⁶ The 2010 French Poly Implant Prosthèse (PIP) crisis, in which non-medical grade silicone was used in thousands of implants worldwide, highlighted the consequences of not having a BIR.⁷ The absence of a quality registry delayed efforts to control the situation and contact affected patients, resulting in increased costs, time and resource use.⁷

BIRs have been instrumental in the investigation of modern implant safety concerns, including BII, BIA-ALCL and implant recalls.^6,8–11 BII presents as a constellation of symptoms including fatigue, arthralgia and myalgia after implant insertion, and are alleviated with implant removal.¹² BIA-ALCL is a rare complication associated with the malignant deterioration of the breast implant capsule resulting in 1687 cases and 59 deaths across 51 countries as of 2024.^5,13,14 The American PROFILE registry was successfully created to improve data collection and therefore help researchers characterize and understand this rare lymphoma.¹³ Given the growing spotlight on BII and BIA-ALCL within recent years, patients’ concerns are mounting on implant safety and the absence of a Canadian BIR.¹⁵ Patients have advocated for a formal implant registry to aid in continual breast implant safety research, improve follow-up care for breast implant patients and facilitate improved communication between patients and surgical teams.¹⁵

The aim of this review was to comprehensively describe the design, development and implementation of existing international breast implant registries. Based on this synthesis, evidence-based recommendations are provided to guide the development and implementation of a Canadian BIR.

Methods

In accordance with the methodological checklist by Prisma, this systematic review was conducted to synthesize the evidence on the strategies used for BIR development and implementation.¹⁶ Databases Medline Ovid, Web of Science and Embase Ovid were searched using the following search terms: (breast or mammo) AND (prosthesis or implant) AND (registry or database) in February 2025 with guidance from an academic librarian.¹¹ Grey literature sources were also queried with keywords to identify relevant reports from implant registries that are not stored in academic databases.

Articles were included if they were primary journal articles or reports focused on developing or refining breast implant registries. The registries were required to be national, with specific mention of the methods used for registry data collection. Included reports were required to be published in 2000 or later, written in English, and discuss registry data from adults (>18 years old). Articles were excluded if they used non-breast implant related registries or used BIR data to perform research independent from registry development or design.

Quality appraisal and data extraction were completed by two reviewers. Data was collected on patient recruitment, data quality, sustainability, funding, data output reports, international collaboration and patient reported outcome measures (PROMs). Reference lists of published systematic reviews and included articles were reviewed to ensure the quality of our systematic review. Narrative analysis of the data was completed by summarizing the evidence on the structures and strategies used for both the development and sustainability of a functional national BIR.

Results

Study Characteristics

Our search yielded a total of 1577 articles. Once duplicates were removed, 1100 articles were reviewed by title and abstract screening. Sixty-nine articles underwent full text review and a total of 19 articles met inclusion criteria (Figure 1). A total of 19 primary journal articles, and grey literature sources were included (Table 1). Implant registries were identified from the Netherlands (n = 4), Australia (n = 6), United Kingdom (n = 1), Korea (n = 1), America (n = 2), Germany (n = 1) and Denmark (n = 1), or unspecified registry (n = 3). A total of 12 articles discussed how to refine a registry, while others detailed the initial registry development (n = 5) and 2 articles discussed both. Grey literature was also sourced for registries that did not meet inclusion criteria and can be found in Supplementary Tables S1 and S2.

Figure 1.

PRISMA diagram created using the PRISMA flow diagram tool.¹⁷

Table 1.

Aims and Scope of Registries.

Country	Registry	Aims
Denmark	Danish BIR	Develop and refine registry.¹⁸
Netherlands	Dutch BIR	Refine an existing registry.¹⁹
Netherlands	Dutch BIR	Develop and refine registry.²⁰
Netherlands	Dutch BIR	Refine an existing registry.¹⁰
Netherlands	Dutch BIR	Refine an existing registry.²¹
General/Unspecified	General/Unspecified	Strategize registry improvements.²²
General/Unspecified	General/Unspecified	Improve data capture, international collaboration and opt out model.⁷
General/Unspecified	General/Unspecified	Refine registry.²³
Australia	Australian BDR	Refine registry with PROMs.²³
Australia	Australian BDR	Refine registry with PROMs.²⁴
Australia	Australian BDR	Refine registry with PROMs.²⁵
Australia	Australian BDR	Refine registry with PROMs.²⁶
Australia	Australian BDR	Refine registry with PROMs.²⁷
Australia	Australian BDR	Lessons learned from PROMs.²⁸
England, Scotland and Northern Ireland	UK BIR	Develop registry.²⁹
Korea	Korean National BIR	Develop registry.²
USA	American-PROFILE-Registry	Additional Registry. BIA-ALCL registry.³⁰
USA	American National Breast Implant Registry	Additional Registry. Develop registry.³¹
Germany	German Breast Implant Registry	Develop Registry.³²

Characteristics of existing national BIR are summarized and detailed in Supplemental Tables S1 and S2. Evidence-based strengths and weaknesses of each registry are summarized in Table 2. Strengths of a functional BIR include strategies to maximize patient recruitment, optimize quality and completeness of data input, sustainable funding and output reports.

Table 2.

Strengths and Weaknesses of Existing National Breast Implant Registries.

Registry	Strategies	Strengths	Weaknesses
Danish Breast Implant Registry¹⁸	Non-operational		Non-operational. Functioned from 1999 to 2007.⁷ Closed due to lack of funding.
Dutch Breast Implant Registry^10,19–21	Patient Recruitment	Opt-Out.Mandatory participation for board-certified plastic surgeons.¹⁹
	Data Quality	Barcode for data input.ICOBRA minimum data set.Online portal or paper forms for registry data collection.High capture rate.
	Sustainability/Funding	€25 fee. Paid by health insurance or aesthetic clinic.²⁰	Charge may increase patient rejection to participation.⁷
	Data Output Reports	Annual.
UK Breast Implant Registry²⁹	Patient Recruitment	Opt-out (England and Scotland).	Opt-in (Ireland).
	Data Quality	ICOBRA minimum data set.Online dashboard.	Decreased data capture rate due to opt-in system.
	Sustainability/Funding	Government funding via the Medical Devices Registry.²⁹	Potentially unstable funding following government elections.
	Data Output Reports	Annual.
Australian Breast Device Registry^23–27	Patient Recruitment	Opt-out.Voluntary surgeon participation.	Originally opt-in, which led to a poor capture rate.Only 3.4% of individuals were identified during the PIP Crisis.⁷
	Data Quality	Includes PROMs via Qualtrics survey.²⁴ ICOBRA minimum datasets.Specific BIA-ALCL data collection.³³	Cost associated with collecting PROMs via text message. Currently AU$ 0.21 per text.²⁸
	Sustainability/Funding	Government funding via the Australian Commonwealth Department of Health.Regular stakeholder feedback.²⁸	Potentially unstable funding following government elections.²⁰
	Date Output Reports	Annual.
Korea Pilot Registry²a. This registry is not operational currently but was designed as a pilot study to develop a functional breast implant registry.	Patient Recruitment	Opt-out recommended.	Opt-In system was needed for research purposes for pilot project. Led to low participation rates.
	Data Quality	Uses the global device minimum data set.Mobile app program is being developed.²Recommend physician financial incentive.²Recommend that registry data is merged with pre-existing health insurance review and assessment (HIRA) data to improve early detection of BI-ALCL and BII.²	PROMs not included.
	Sustainability/Funding	Government funded.²	Potentially unstable funding following government elections.
	Data Output Reports	Mobile App in progress.²	Unknown.
American PROFILE Registry (Additional Registry)^30,34	Patient Recruitment	Opt-In.
	Data Quality	Open to all physicians who have a patient with breast implants and suspicion of/confirmed breast implant associated anaplastic large cell lymphoma, breast implant associated squamous cell carcinoma or lymphoma or cancer in the capsule surrounding the breast implant.
	Sustainability/Funding	Created by the American Society of Plastic Surgeons, Plastic Surgery Foundation and the Food and Drug Administration.Pilot 2017-2018, ongoing operations.	Unknown current funding model.
	Data Output Reports	Medical Device Reports of BI-ALCL 2023.
American National Breast Implant Registry (NBIR)^31,35	Patient Recruitment	Opt-Out.
	Data Quality	Utilizes barcode scanner with HIPPA compliant phone application.Will be piloting including PROMs in registry, using Australia's BREAST-Q IS.²⁸	Unclear if ICOBRA datasets are used.
	Sustainability/Funding	Steering committee includes representatives from the Plastic Surgery Foundation, Food and Drug Administration and American Society of Plastic Surgeons.	Unclear current funding model/partners.
	Data Output Reports	Annual reports.Upcoming manuscript publishing findings from first 50,000 cases submitted.
Germany Breast Implant Registry (Implantatregister Deutschland) (IRG)³²	Patient Recruitment	Registry is not currently functional, at time of review.Mandatory participation due to the German Implant Registry Law, after two previous failed opt-in registries.
	Data Quality	Data set adopted from ICOBRA.Data owned by the Ministry of Health and interpreted by the Registry Office.	Unclear how data is obtained and input into registry.
	Sustainability/Funding	The initial development of the registry was funded by the Ministry of Health.	Unclear specific financial plan.
	Data Output Reports		Unknown.

Patient Recruitment

In an opt-in registry, patients must actively consent to participate, whereas in an opt-out registry, patients are included by default unless they choose not to be. Opt-out consent systems are noted in the Dutch, American and Australian registries. A mixed system is used in the United Kingdom, where there is an opt-in system in Ireland and opt-out for patients in England and Scotland. The Korean BIR Pilot study was also an opt-in system. Participation in the German registry is mandatory.

Data Quality

All registries studied involve physician or surgeon data input into the registry. The Dutch and American (NBIR) registries use a barcode system for data input. The UK BIR has an interactive dashboard online. The Korean BIR is currently creating a mobile app program for physicians and patients. It is unclear how data input is managed in the German registry. International Collaboration of Breast Registry Activities (ICOBRA) minimum data set requirements are used by the following registries: Dutch, United Kingdom, Australian, Germany and Korea. The Australian BDR was the only registry that used PROMs; however, this is being adopted by the American NBIR.

Sustainability

Private funding is used by the Dutch BIR via a €25 patient surcharge obtained through the patient or insurance. Government funding is used by United Kingdom, Australian and Korean registries. Ministry of Health Government funding was used in the German registry for initial development, but a future financial plan is unknown. The funding sources of the American registries are also unclear.

Output Reports

Annual public output reports based off registry findings are released by the Dutch, United Kingdom, Australian and American (NBIR) registries.

Discussion

Recruitment and Opt-Out System

An opt-out system is one where all patients who have received breast implants are automatically enrolled in the implant registry, and can be observed in the American NBIR, Dutch, United Kingdom and Australian registries.¹⁸ The German registry is the first registry with mandatory participation, although this registry is not yet functional.¹⁹ In contrast, the Korean registry used an opt-in system due to study design, but recommended the use of an opt-out system.¹ To highlight the importance of an opt-out system we can compare capture rates between the Canadian Joint Replacement Registry (CJRR) and Australian Joint Registries. The Canadian registry had an implant capture rate of 68.2% from 2020 to 2021; a lower capture rate than the opt-out Australian National Joint Replacement Registry of 97%.^7,20,21 In general, countries that use an opt-in system have significantly lower capture rates, leading to the premature closure of previous registries; for this reason, we recommend an opt-out system for a Canadian registry.^7,22

Administrative Burden

High administrative burden for plastic surgeons has limited registry participation and data accuracy in existing registries, prompting proposed solutions like barcode data entry systems and financial incentives.^23–25 Though it is widely recognized that registry participation includes increased administrative burden for participating surgeons, a survey for the Dutch BIR users reported that participation was of value despite this burden. Recommendations for increased surgeon participation and data accuracy are discussed below.

While the registries included in this review do not offer financial incentives to participating physicians or residents, such incentives are recognized as one of the most important motivators for physician participation.^25,26 The use of a barcode system can be seen in the Dutch BIR where the barcode automatically adds the unique device number, global trade number, expiration date, lot number and serial number into the registry form.^23,26,27 Notably, the American National Breast Implant Registry endorses multiple pathways of secure data input into their registry including: manual data entry, a barcode scanning app and a device tracking app. The device tracking app is a new feature which allows physicians to fulfil the federal requirements for breast implant device tracking which is simultaneously forwarded to implant manufacturers.²⁸ As registry design evolves to reduce administrative burden, equal attention must be given to ensure data security. In the Report of the Standing Committee on Health by the House of Commons Canada, published November 2023, the Canadian Institute for Health Information (CIHI) suggests that greater government infrastructure and legislation are needed to ensure adequate registry privacy and confidentiality.^5,25

Data Quality: ICOBRA, PROMS, FAIR

The use of minimum international datasets through ICOBRA are also highly recommended to facilitate better data linking between countries; a strategy that is already used by the CJRR.^7,21,25 This includes collecting data on patient demographics, patient history, patient outcomes, surgical procedure and intraoperative techniques such as glove changing.^7,10,29,30 Though not included in ICOBRA, to account for factors influencing quality of care, surgical and institutional details could be recorded. Overall, it is important to ensure that the development of a Canadian BIR uses internationally acceptable datasets, to prepare for future international collaborations.

The introduction of PROMs in registries has been a quality improvement initiative adopted by ICOBRA, Australian and American (NBIR) registries, and we recommend this in a Canadian registry.^28,31 PROMs are classified as outcome measures reported in a registry directly from the patient without any interpretation from the clinician.^32,33 PROMs in the Australian registry allow patients to comment on their satisfaction level as it pertains to implant look, feel, rippling, pain and tightness after surgery and can be reported on a patient mobile dashboard.^31–34 This captures important feedback from patients as it pertains to implant satisfaction and performance.^10,32

To ensure registry data is usable and accessible FAIR principles must be considered during the data collection phase. This ensures data is findable, accessible, interoperable and reusable. This would allow physicians to evaluate their own patient outcomes as they can easily view and evaluate their own provision of surgical care, which in turn may encourage registry participation.²⁶

Funding and Governance

The importance of continual long-term funding must be emphasized, as registries in the past have halted activity due to funding constraints, as seen in Austria.⁷ Registries can be funded by the government, patients, or grants. Government funding is used in the United Kingdom, Australian, German and the Korean Pilot BIRs; although, a noted weakness of government funding is that it is dependent on the political climate. Government involvement can also be useful in the development of a registry through their ability to mandate hospital, clinic and surgeon participation in the BIR which would lead to increased participation rates.²² Alternatively, consistent funding can be maintained from patient contribution, as showcased by the Dutch BIR where there is a €25 charge per implant; however, a patient surcharge could cause the patient to refuse participation in the registry.²² Finally, funding can also be accessed through grants, as seen in the Dutch BIR where a €130,000 non-government grant was used for the initial development of the registry.²⁷

Health Canada's Medical Devices Directorate stated that the financial cost of such registry is unknown until a registry scope was determined.³⁵ To gain perspective on potential financial implications of a Canadian BIR, we can adopt the funding model used by the CJRR which receives funding from Health Canada and provincial/territorial governments.^20,36 Although the financial needs of a registry may seem costly at first, the development can reduce total public health spending.⁷

Proper registry governance is another essential component of a successful registry, as it can aid in superior development and maintenance of a BIR.²⁵ The Australian and American registries are good examples as they have continual stakeholder support which includes a steering committee, university partners, data publications committee and a regulatory board.^33,37 For the governance of a Canadian BIR, we can look to the CJRR for guidance. The CJRR is governed by an advisory board comprised of orthopedic surgeons, and representatives from the Ministry of Health, Arthritis Society, Canadian Orthopedic Association and the Canadian Orthopedic Nurses Association.³⁶ Similar stakeholders for a Canadian BIR could include: plastic surgeons, patients, CIHI, The Breast Implant Safety Alliance, Canadian Institute of Health Research, Canadian Society of Plastic Surgeons, Canadian Society for Aesthetic Surgery, Public Health and University partners.

Output Reports

It is recommended that Canada includes annual output reports of registry findings. The use of output reports has been noted in many successful implant registries such as the Dutch, United Kingdom, American and Australian breast implant registries. The American NBIR has a committee including an epidemiologist and statistician responsible for data reporting, research and publications to guarantee prompt and accurate output reports.²⁸ These reports can be made publicly available for clinicians, implant manufacturers and patients to promote research dissemination.

Limitations

This study was limited to the inclusion criteria specified in our database research. As a result, we did not assess some successful breast implant registries such as those in: Austria, Italy, France, Sweden, Spain or Russia. To account for this, we have added information in Supplementary Table S2. The results and recommendations for a Canadian BIR, may benefit from the perspectives of these registries. Further, some included studies were published in the early 2000s and the registry design may have been updated since. To address this bias, we reviewed grey literature sources to include the most updated information on existing registries.

Conclusion

We recommend the development of a registry that has low administrative burden, incentives for participating physicians, continual funding partners, governance with relevant stakeholders, an opt-out system and the inclusion of PROMs and ICOBRA minimum dataset.

Supplemental Material

sj-docx-1-psg-10.1177_22925503251355977 - Supplemental material for Recommendations for a Canadian Breast Implant Registry

Supplemental material, sj-docx-1-psg-10.1177_22925503251355977 for Recommendations for a Canadian Breast Implant Registry by Victoria M.S. Rea, Raveena Gowda, Emma Nicholson and Kathryn V. Isaac in Plastic Surgery

Footnotes

Acknowledgments

Dr Kathryn Isaac is holder of the Dr Patricia Clugston Chair in Breast Reconstruction Surgery at the University of British Columbia and would like to acknowledge the support of VGH & UBC Hospital Foundation's donors and partners who made this Chair possible.

Author Contributions

Victoria M.S. Rea did data collection, data analysis, manuscript writing, review and editing manuscript.

Raveena Gowda did data collection, data analysis, manuscript writing, review and editing manuscript.

Emma Nicholson did project conception of protocol and data review.

Kathryn V. Isaac did project administration, supervision, conceptualization, manuscript writing, review and editing manuscript.

All authors have read and approved the final manuscript.

Data Availability Statement

Data sharing not applicable to this article as no datasets were generated or analyzed during the current study.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethical Considerations

This article does not contain any studies with human or animal subjects.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Victoria M.S. Rea

Kathryn V. Isaac

Statement on Related Presentations

This abstract was presented at the 2023 Canadian Society of Plastic Surgeons Annual Meeting.

Supplemental Material

Supplemental material for this article is available online.

References

Song

Kang

Seo

BMF

Choi

Lee

. Pilot study of the Korean national breast implant registry: experiences and lessons learned. J Plast Reconstr Aesthet Surg. 2022;75(6):1833–1841. doi:https://doi.org/10.1016/j.bjps.2022.01.024

ISAPS International Survey on Aesthetic/Cosmetic Procedures Performed in 2023; 2023. https://www.isaps.org/media/rxnfqibn/isaps-global-survey_2023.pdf

Aesthetic plastic surgery national databank statistics 2023. Aesthetic Surg J. 2024;44(Suppl. 2):1–25. doi:https://doi.org/10.1093/asj/sjae188

2023 ASPS Procedural Statistics Release; 2023. https://www.plasticsurgery.org/documents/news/statistics/2023/plastic-surgery-statistics-report-2023.pdf

Casey

. Strengthening the Oversight of Breast Implants: Report of the Standing Committee on Health. Vol. 44th Parliament; 2023:46. Accessed May 28, 2024. https://www.ourcommons.ca/Content/Committee/441/HESA/Reports/RP12719274/hesarp16/hesarp16-e.pdf.

Rubin

. New breast implant safety concerns. JAMA. 2022;328(15):1492–1492. doi:https://doi.org/10.1001/jama.2022.15477

Cooter

Barker

Carroll

, et al. International importance of robust breast device registries. Plast Reconstr Surg (1963). 2015;135(2):330. doi:https://doi.org/10.1097/PRS.0000000000000885

Magnusson

Cooter

Rakhorst

McGuire

Adams

Deva

. Breast implant illness: a way forward. Plast Reconstr Surg. 2019;143(3S):74S–81S. doi:https://doi.org/10.1097/PRS.0000000000005573

Lee

Ponraja

McLeod

Chong

. Breast implant illness: a biofilm hypothesis. Plast Reconstr Surg Global Open. 2020;8(4):e2755–e2755. doi:https://doi.org/10.1097/GOX.0000000000002755

10.

Spronk

PER

Becherer

Hommes

, et al. How to improve patient safety and quality of care in breast implant surgery? First outcomes from the Dutch breast implant registry. J Plast Reconstr Aesthet Surg. 2019;72(10):1607–1615. doi:https://doi.org/10.1016/j.bjps.2019.06.023

11.

Wurzer

Hundeshagen

Cambiaso-Daniel

, et al. Lessons learned from breast implant registries: a systematic review. Ann Plast Surg. 2019;83(6):722–725. doi:https://doi.org/10.1097/SAP.0000000000001907

12.

Wee

Younis

Isbester

, et al. Understanding breast implant illness, before and after explantation: a patient-reported outcomes study. Ann Plast Surg. 2020;85(S1 Suppl. 1):S82–S86. doi:https://doi.org/10.1097/SAP.0000000000002446

13.

Clemens

Miranda

. Coming of age: breast implant associated anaplastic large cell lymphoma after 18 years of investigation. Clin Plast Surg. 2015;42(4):605–613. doi:https://doi.org/10.1016/j.cps.2015.06.006

14.

Clemens

Myckatyn

Di Napoli

, et al. American Association of Plastic Surgeons Consensus on breast implant–associated anaplastic large-cell lymphoma. Plast Reconstr Surg. 2024;154(3):473–483. doi:https://doi.org/10.1097/prs.0000000000011370

15.

Steve

Temple-Oberle

Yeung

Lafreniere

A-S

Harrop

. “You helped create this, help me now”: a qualitative analysis of patients’ concerns about breast implants and a proposed strategy for moving forward. Plast Reconstr Surg. 2021;147(1):16e–24e. doi:https://doi.org/10.1097/PRS.0000000000007422

16.

Page

McKenzie

Bossuyt

, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Br Med J. 2021;372(n71):1–9. doi:https://doi.org/10.1136/bmj.n71

17.

Haddaway

Page

Pritchard

McGuinness

. PRISMA2020: an R package and shiny app for producing PRISMA 2020-compliant flow diagrams, with interactivity for optimised digital transparency and open synthesis. Campbell System Rev. 2022;18(2):e1230–e1n/a. doi:https://doi.org/10.1002/cl2.1230

18.

Vishwanath

Pellegrini

Parker

, et al. Breast device surgery in Australia: early results from the Australian breast device registry. J Plast Reconstr Aesthet Surg. 2021;74(10):2719–2730. doi:https://doi.org/10.1016/j.bjps.2021.03.035

19.

von Fritschen

Rakhorst

Stark

Ahern

Prantl

Fricke

. The mandatory German breast implant registry law: a model for sustainable implant registries. Aesthetic Surg J. 2023;43(11):NP858–NP865. doi:https://doi.org/10.1093/asj/sjad242

20.

Bohm

Dunbar

Bourne

. The Canadian joint replacement registry—what have we learned? Acta Orthop. 2010;81(1):119–121. doi:https://doi.org/10.3109/17453671003685467

21.

NA. Canadian Joint Replacement Registry Metadata. Accessed May 2, 2023. https://www.cihi.ca/en/canadian-joint-replacement-registry-metadata

22.

Hopper

Ahern

Nguyen

, et al. Breast implant registries: a call to action. Aesthetic Surg J. 2018;38(7):807–810. doi:https://doi.org/10.1093/asj/sjx153

23.

Barati

Vrolijk

Becherer

, et al. Using a digital implant catalog improves data quality and reduces administrative burden in the Dutch breast implant registry. Aesthetic Surg J. 2022;42(5):NP275–NP281. doi:https://doi.org/10.1093/asj/sjab336

24.

Bargon

Becherer

Young-Afat

, et al. The national Dutch breast implant registry: user-reported experiences and importance. Eur J Plast Surg. 2020;43(6):751–766. doi:https://doi.org/10.1007/s00238-020-01689-x

25.

Song

Kang

Seo

Choi

N-K

Lee

. A systematic review of the national breast implant registry for application in Korea: Can we predict “unpredictable” complications? Medicina (B Aires). 2020;56(8):370.

26.

Bargon

Becherer

Young-Afat

, et al.

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

J Plast Reconstr Aesthet Surg. 2021;74(1):4–12. doi:https://doi.org/10.1016/j.bjps.2020.10.001

27.

Rakhorst

Mureau

Cooter

, et al. The new opt-out Dutch national breast implant registry – lessons learnt from the road to implementation. J Plast Reconstr Aesthet Surg. 2017;70(10):1354–1360. doi:https://doi.org/10.1016/j.bjps.2017.04.003

28.

NA. The National Breast Implant Registry Annual Report 2021. 2021.

29.

Australian Breast Device Registry Form. Australian Breast Device Registry; 2015.

30.

Spronk

PER

Begum

Vishwanath

, et al. Toward international harmonization of breast implant registries: international collaboration of breast registry activities global common data set. Plast Reconstr Surg. 2020;146(2):255–267. doi:https://doi.org/10.1097/prs.0000000000006969

31.

Hansen

Ahern

Gartoulla

, et al. Identification of predictive factors for patient-reported outcomes in the prospective Australian breast device registry. Aesthetic Surg J. 2022;42(5):470–480. doi:https://doi.org/10.1093/asj/sjab314

32.

Kirkman

Fisher

, et al. Establishing the acceptability of a brief patient reported outcome measure and feasibility of implementing it in a breast device registry—a qualitative study. J Patient-Reported Outcomes. 2019;3(1):1–8. doi:https://doi.org/10.1186/s41687-019-0152-z

33.

Pusic

Parker

, et al. Patient-reported outcome measures for breast implant surgery: a pilot study. Aesthetic Surg J. 2019;39(8):NP314. doi:https://doi.org/10.1093/asj/sjz023

34.

Elena

Maria

Jessica

, et al. User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care. BMJ Surg Interv Health Technol. 2022;4(1):e000119. doi:https://doi.org/10.1136/bmjsit-2021-000119

35.

Van Dyk

. House committee begins study of possible breast implant registry; 2023. https://www.ctvnews.ca/politics/house-committee-begins-study-of-possible-breast-implant-registry-1.6370825 .

36.

NA. Canadian Joint Replacement Registry Privacy Impact Assessment; 2021. https://www.cihi.ca/sites/default/files/document/cjrr-pia-en.pdf

37.

NA. Australian Great Device Registry Webpage. https://www.abdr.org.au

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.05 MB