Effectiveness of the Implementation of a Bundle Protocol for the Reduction of Postmastectomy Reconstruction Failures

Immediate breast reconstruction with implants after mastectomy offers significant clinical and psychological benefits. However, implant loss due to infection or complications remains a major concern. Variability in surgical practices may contribute to this issue. This study aims to evaluate whether implementing a standardized protocol (bundle) of intra- and postoperative measures reduces the rate of reconstruction failures within 12 months of surgery.

A retrospective observational cohort study was conducted at a single institution, including 102 patients who underwent 119 implant-based breast reconstructions between January 2022 and May 2024. Outcomes were compared before and after implementation of a surgical bundle designed to minimize infection and complications. The bundle included measures such as intraoperative sterility practices, implant handling protocols, and prolonged antibiotic prophylaxis. The primary endpoint was the rate of implant loss and moderate-to-major complications. Multivariate logistic regression was used to assess associations between bundle implementation and outcomes.

Patients in the postbundle group had significantly fewer moderate-to-major complications (6.8% versus 24.6%, P = 0.008) and lower rates of implant loss (3.4% versus 14.8%). Bundle implementation was associated with a 6.4-fold reduction in the odds of experiencing a moderate or major complication (odds ratio, 6.40; 95% confidence interval, 1.81-22.62). No significant differences were found in baseline clinical characteristics between groups.

Implementing a standardized protocol significantly reduced complications and implant loss in immediate postmastectomy reconstruction. These findings support adopting surgical safety measures to improve reconstructive outcomes. Further multicenter studies are needed to confirm long-term effectiveness.