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J Plast Reconstr Aesthet Surg. 2018 Sep;71(9):1362-1380. doi: 10.1016/j.bjps.2018.05.048. Epub 2018 Jun 12.

High risk device registries: Global value, costs, and sustainable funding.

Author information

1
Dutch Institute for Clinical Auditing (DICA), Poortgebouw Zuid, 2nd floor, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands; Dutch Breast Implant Registry (DBIR), Poortgebouw Zuid, 2nd floor, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands; Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. Electronic address: b.becherer@dica.nl.
2
Dutch Breast Implant Registry (DBIR), Poortgebouw Zuid, 2nd floor, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands; Department of Plastic and Reconstructive Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
3
Department of Plastic Surgery, Lister Hospital NHS Trust, Coreys Mill Lane, Stevenage, Hertfordshire, SG1 4AB, United Kingdom; Breast and Cosmetic Implant Registry (BCIR), 1 Trevelyan Square, Boar Lane, Leeds, LS1 6AE, United Kingdom.
4
Breast and Cosmetic Implant Registry (BCIR), 1 Trevelyan Square, Boar Lane, Leeds, LS1 6AE, United Kingdom; Department of Plastic, Reconstructive and Burns Surgery, Nottingham University Hospitals NHS Trust, City Hospital campus, Hucknall Road, Nottingham, Nottinghamshire, NG5 1PB, United Kingdom.
5
Department of Molecular Medicine and Surgery, Karolinska Institutet, SE-171 64, Stockholm, Sweden; Swedish Breast Implant Registry (BRIMP), Karolinska Institutet, SE-171 64 Stockholm, Sweden.
6
Department of Plastic and Reconstructive Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston MA 02115, United States of America; National Breast Implant Registry (NBIR), 444 East Algonquin Road, Arlington Heights, IL 60005, United States of America.
7
Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29-34, A-8036, Graz, Austria.
8
Department of Epidemiology and Preventive Medicine, Monash University, 553 Saint Kilda Road, Melbourne, Victoria 3004, Australia; Australian Breast Device Registry (ABDR), Level 2, 553 Saint Kilda Road, Melbourne, Victoria 3004, Australia.
9
Dutch Breast Implant Registry (DBIR), Poortgebouw Zuid, 2nd floor, Rijnsburgerweg 10, 2333 AA, Leiden, The Netherlands; Department of Plastic, Reconstructive and Hand Surgery, Medisch Spectrum Twente/Ziekenhuisgroep Twente, Koningsplein 1, 7512 KZ, Enschede, The Netherlands. Electronic address: h.rakhorst@mst.nl.

Abstract

BACKGROUND:

Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders.

METHODS:

Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries' designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability.

RESULTS:

Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure.

CONCLUSION:

This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved.

PMID:
29945828
DOI:
10.1016/j.bjps.2018.05.048

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