97 Risk prediction of implant loss following implant-based breast reconstruction INTRODUCTION Most breast reconstruction techniques after mastectomy involve the use of breast implants.(1) The most serious complication following implant-based breast reconstruction (IBBR) is implant loss, resulting in re-operations, patient suffering, a significant decrease in quality of life, and a possible delay in adjuvant treatment. According to the literature, the incidence of implant loss varies from 1.8 to 16.9% with multiple risk factors described.(2-7) We previously tried to create a risk prediction model using multicenter retrospective data, consisting of the following risk factors: obesity, smoking, nipple sparing surgery and a direct-to-implant approach.(8) However, the subsequent study showed that this prediction model could not be externally validated, so the necessity remained to create a validated tool to predict the risk of implant loss in the preoperative phase. Knowing an accurate estimate of the risk of implant loss for a specific patient is valuable during the preoperative workup and could guide the treating physician in planning the type of mastectomy and reconstruction and in counseling women who consider IBBR. Therefore, nationwide population-based data were used in the present study to identify risk factors for implant loss following direct-to-implant (DTI) or twostage IBBR. Furthermore, these risk factors were used to create and subsequently validate a risk prediction model for implant loss. METHODS Study design This population-based cohort study used data from the Dutch Breast Implant Registry (DBIR). In the Netherlands, all breast implants used for reconstructive or cosmetic purposes are registered in the DBIR. The registry started in 2015 and all Dutch hospitals participate.(9) This study was reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines and was performed in accordance with the Declaration of Helsinki. (10, 11) The study protocol was approved by the scientific committee of the DBIR. Ethical approval or informed consent was not required according to Dutch legislation. Patient selection All patients who had undergone either an immediate two-stage or immediate DTI implant-based postmastectomy breast reconstruction between September 2017 and September 2020 were identified from the DBIR. This timeframe was selected because all relevant patient characteristics were only included in the registry from 7
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