Did the National Ban on Bacitracin Irrigation Affect Infection Rates in Implant-Based Breast Reconstruction? An Analysis of a National Database

Abstract

Introduction: The current standard of practice in implant-based breast reconstruction is irrigation of the mastectomy pocket with antimicrobial solution before implant placement. Prior to being banned and formally recalled in January 2020, bacitracin was a very commonly utilized antibiotic. This study characterizes the effects of the national bacitracin ban on implant-based breast reconstruction infection rates by using a nationwide database to compare complication rates before and after bacitracin was banned.

Materials and methods: The American College of Surgeons National Surgical Quality Improvement (ACS-NSQIP) database was queried retrospectively for all patients who underwent implant-based breast reconstruction before the bacitracin ban (2012-2019) and afterwards (2020). Demographics, comorbidities, and complications were collected. Univariate analysis and multivariate analysis were conducted to determine if there were significant changes in wound complications, local wound infections, and systemic infections between the 2 case-control matched cohorts.

Results: A total of 37,126 patients were in the pre-ban cohort and 6333 patients were in the post-ban cohort. Before matching, there were significant differences in race distribution, BMI, ASA class, inpatient vs. outpatient status, preoperative smoking, and preoperative diabetes mellitus (all P < .05). After case-control matching, there were 6313 patients in each cohort. Univariate analysis revealed differences in postoperative superficial and organ space surgical site infection, wound complications/infections, all cause complications, and reoperations (all P < .05). Multivariate analysis showed that patients who underwent breast reconstruction before the ban had decreased odds of having wound infections, related infections, all cause complications, and reoperations (all P < .05).

Conclusion: This study provides a macroscopic view into the effects of the formal injectable bacitracin ban on breast reconstruction outcomes. Patients who underwent implant-based breast reconstruction after the ban of injectable bacitracin had higher odds of developing wound infections, related infections, and reoperations. More study into suitable alternatives to injectable bacitracin for surgical site antimicrobial irrigation is warranted.

Keywords: Bacitracin ban; Breast implant infection.