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Plast Reconstr Surg 2020 Aug;146(2):255-67

Toward international harmonization of breast implant registries: international collaboration of breast registry activities global common data set.

Spronk PER, Begum H, Vishwanath S, Crosbie A, Earnest A, Elder E, Lumenta DB, Marinac-Dabic D, Moore CCM, Mureau MAM, Perks G, Pusic AL, Stark B, von Fritschen U, Klein H, Cooter RD, Rakhorst HA, Hopper I


BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Category: Journal Article
PubMed ID: #32740572 DOI: 10.1097/PRS.0000000000006969
Includes FDA Authors from Scientific Area(s): Medical Devices
Entry Created: 2020-08-09