Breast Implant Registries: The Problem with Ambition.

Abstract

An International Breast Implant Registry (IBIR) has existed since 2002 to develop a basis for continual discussion concerning the safety of different breast implants.1 Prior to this, various national bodies contributed to its development, and also maintained their own registries. Thirteen years after its inception, the IBIR remains in a pilot phase, and the data it produces is not robust enough for clinical use.2 The cost of duplicating international and national registries is considerable, and countries such as Australia, which represents only a fraction of the entire international market, have sought to align their data collection with that of the IBIR. This has been recognized by the formation of the International Collaboration of Breast Implant Registries (ICOBRA), which plans to use one standardized data set for registration of all breast implants, to be agreed and reviewed by the group on an annual basis. In 2011, the American Society of Plastic Surgeons proposed a national registry for breast implants in collaboration with the Food and Drug Administration to respond to concerns over anaplastic large cell lymphoma (ALCL). The registry is a planned, focused clinical quality registry known as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE). In addition, there is development of a National Breast Implant Registry (NBIR) to track all outcomes and complications related to breast implants (silicone and saline). Scheduled to launch late in 2015, the NBIR “will benefit consumers and industry and assure that clinical conclusions regarding complications resulting from breast implants are only drawn from unequivocal scientific evidence.”3 We believe that there are some significant issues with the proposed ICOBRA plans, specifically those relating to a registry based on the Australian system. In the past, the United Kingdom (UK) Breast Implant Registry took a lot … Corresponding Author: Dr Tim Brown, 8-12 Gibb Street, Suite 2, Berwick, VIC 3806, Australia. Email: tim{at}timbrown.com.au