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International Importance of Robust Breast Device Registries

Cooter, Rodney D. F.R.A.C.S.; Barker, Shane B.Sc., M.B., Ch.B.(U.C.T.), M.Med.(Stell); Carroll, Sean M. M.D.; Evans, Gregory R. D. M.D.; von Fritschen, Uwe M.D.; Hoflehner, Helmut M.D.; Le Louarn, Claude M.D.; Lumenta, David B. M.D.; Mathijssen, Irene M. J. M.D., Ph.D.; McNeil, John Ph.D.; Mulgrew, Stephen M.Phil.; Mureau, Marc A. M. M.D.; Perks, Graeme F.R.C.S.(Plast.); Rakhorst, Hinne M.D., Ph.D.; Randquist, Charles M.D.; Topaz, Moris M.D., Ph.D.; Verheyden, Charles M.D., Ph.D.; de Waal, John F.R.A.C.S.

Plastic and Reconstructive Surgery: February 2015 - Volume 135 - Issue 2 - p 330–336
doi: 10.1097/PRS.0000000000000885
Breast: Original Articles
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Discussion

Background: Breast implants are high-risk devices that have been at the epicenter of much debate and controversy. In light of the Poly Implant Prothèse crisis, data registries among 11 national societies around the world are cooperatively calling for the urgent need to establish robust national clinical quality registries based on international best practice within a framework of international collaboration.

Methods: A survey was conducted on the historic and current status of national breast device registries. Eleven countries participated in the study, illustrating different data collection systems and registries around the world. Data collection was designed to illustrate the capabilities of current national registries, with particular focus on capture rate and outcome reporting mechanisms.

Results: A study of national breast implant registries revealed that less than half of the participating countries had operational registries and that none of these had adequately high data capture to enable reliable outcome analysis. The study revealed that the two most common problems that discouraged participation are the complexity of data sets and the opt-in consent model.

Conclusions: Recent implant crises have highlighted the need for robust registries. This article argues the importance of securing at least 90 percent data capture, which is achievable through the opt-out consent model. Since adopting this model, the Australian Breast Device Registry has increased data capture from 4 percent to over 97 percent. Simultaneously, it is important to foster international collaboration from the outset to avoid duplication of efforts and enable the development of effective international early warning systems.

Adelaide, Australia; Cape Town, South Africa; Dublin, Ireland; Orange County, Calif.; Berlin, Germany; Graz, Austria; Paris, France; Rotterdam, The Netherlands; Melbourne, Australia; London and Nottingham, United Kingdom; Saltsjöbaden, Sweden; Tel-Aviv, Israel; Temple, Texas; and Auckland, New Zealand

From the Association of Plastic and Reconstructive Surgeons of Southern Africa; the Irish Society of Plastic Surgeons; the American Society of Plastic Surgeons; the German Society of Plastic, Reconstructive and Aesthetic Surgeons; the Austrian Society for Plastic, Aesthetic and Reconstructive Surgery; the French Society of Plastic, Reconstructive and Aesthetic Plastic Surgeons; the Dutch Society of Plastic Surgeons; the Department of Epidemiology and Preventive Medicine, Monash University; the Breast Implant Registry Pilot, Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency; the British Association of Plastic, Reconstructive and Aesthetic Surgeons; the Swedish Association of Plastic Surgeons; the International Breast Implant Registry; the American Plastic Surgery Foundation; and the New Zealand Association of Plastic Surgeons.

Received for publication February 2, 2014; accepted July 22, 2014.

Disclosure: The authors have no financial interest to declare in relation to the content of this article.

Rodney D. Cooter, M.B.B.S., M.D., Australian Society of Plastic Surgeons, 503, Level 5, 69 Christie Street, St. Leonards, New South Wales 2065, Australia, rdcooter@plasticsurgeryadelaide.com

©2015American Society of Plastic Surgeons