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Improving Breast Implant Safety through International Collaboration of National Registries - A Review of over 85000 Patients and 200000 Implants from Four Countries.

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BACKGROUND . Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that… Click to show full abstract

BACKGROUND . Growing awareness about breast implant-related adverse events has stimulated the demand for large, independent data resources. For this, data from breast implant registries could be combined. However, that has never been achieved yet. METHODS . Real-world data from four currently active national breast implant registries were used. All permanent breast implants from the Australian, Dutch, Swedish and American registries were included. A sub-population present across all registries between 2015-2018 was subsequently selected, including only permanent breast implants inserted during primary surgery for breast reconstruction or augmentation in patients without previous breast device surgery. Nationwide coverage, patient and implant characteristics, infection control measures, and revision incidences were analyzed. RESULTS . A total of 207189 breast implants were registered. Nationwide coverage varied between 3-98 percent. The sub-population included 111590 implants (7 percent reconstruction, 93 percent augmentation). Across the registries, mean patient age varied between 41-49 years (P <0.001) for reconstruction and 31-36 years (P <0.001) for augmentation. Variation was observed in implant preferences across the countries and over the years. Infection control measures were most frequently registered in Australia. Cumulative revision incidence at two years ranged from 6-16 percent after reconstruction and 1-4 percent after augmentation. CONCLUSION . For the first time, independent, national, registry-based data from four breast implant registries were combined. This is a powerful step forward in optimizing international breast implant monitoring, evidence-based decision-making, and patient safety.

Keywords: breast implant; safety; implant registries; breast; reconstruction; augmentation

Journal Title: Plastic and reconstructive surgery
Year Published: 2023

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