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Lessons Learned From Breast Implant Registries

A Systematic Review

Wurzer, Paul MD, MMS*,†; Hundeshagen, Gabriel MD; Cambiaso-Daniel, Janos MD*; Fischer, Sebastian MD; Hoflehner, Helmut MD*,‡; Spendel, Stephan MD*; Lumenta, David B. MD*; Kamolz, Lars P. MD, PhD*,§; Kneser, Ulrich MD; Hirche, Christoph MD

doi: 10.1097/SAP.0000000000001907
Review Paper

Objective Over several decades, numerous national and international registries on breast implants went online, aiming to collect prospective data to provide increased safety for patients and surgeons. We performed a review of all published data on breast implant registries to assess availability and quality of data and determine its usefulness and impact.

Materials and Methods PubMed, Ovid, and Web of Science were searched to identify all articles containing breast implant registries in English language. The review was registered at PROSPERO (CRD42016041255) and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. There was no limitation by publication date.

Results Eight hundred ninety-five articles were identified; after removal of duplicates, 536 abstracts were screened on breast implant registries in plastic and reconstructive surgery. Unrelated articles, non-English articles, and not breast implant–related studies were excluded. Twenty breast implant registry–related articles met the inclusion criteria; 7 articles contained actual data on breast implants. Compared with international trends, only a minimal percentage of performed surgical breast augmentations is documented in registries, and the overall data quality and availability were low.

Conclusions Only a fraction of performed breast augmentations is documented properly in a registry. Currently, there are no published data based on a clinical quality registry. Sustained funding and reliable administrative governmental structures remain crucial to establish an adequate clinical quality registry for breast implants as currently launched in Australia to analyze outcomes and risk factors for an increased patient safety.

From the *Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria

Department of Hand, Plastic, and Reconstructive Surgery, Trauma Center Ludwigshafen, University of Heidelberg, Heidelberg, Germany

Schwarzl Clinic, Lassnitzhoehe

§COREMED—Cooperative Centre for Regenerative Medicine, JOANNEUM RESEARCH ForschungsgesellschaftmbH, Graz, Austria.

Received November 19, 2018, and accepted for publication, after revision January 29, 2019.

Conflicts of interest and sources of funding: none declared.

Reprints: Paul Wurzer, MD, MMS, Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria. E-mail:

Online date: August 6, 2019

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