Bacitracin for Injection Recall: Impact on Immediate Breast Implant Surgical Outcomes

Abstract

Background. Triple-antibiotic irrigation of breast implant pockets is a mainstay of infection prophylaxis in breast reconstruction and augmentation. The recall of bacitracin for injection due to risk of anaphylaxis and nephrotoxicity in January 2020, a staple component of the irrigation solution, has raised concern for worsened postoperative sequelae. This study aimed to investigate pre- and post-recall implant-based breast surgery to analyze the impact of bacitracin in irrigation solutions on infection rates. Methods. All implant-based breast reconstruction or augmentation surgeries from January 2019 to February 2021 were retrospectively reviewed. In a regression discontinuity study design, patients were divided into pre- and post-recall groups. Patient demographics, surgical details, and outcomes including infection rates were collected. Differences in complication rates were compared between groups and with surgical and patient factors. Results. 254 implants in 143 patients met inclusion criteria for this study, with 172 implants placed before recall and 82 placed after recall. Patients in each cohort did not differ in age, BMI, smoking status, or history of breast radiation or capsular contracture ( p > 0.05 ). All breast pockets were irrigated with antibiotic solution, most commonly bacitracin, cefazolin, gentamycin, and povidone-iodine before recall (116,67.4%) and cefazolin, gentamycin, and povidone-iodine after recall (59,72.0%). There was no difference in incidence of infection (6.4% vs. 8.5%, p = 0.551 ) or cellulitis (3.5% vs. 3.7%, p = 0.959 ) before and after recall. Implant infection was associated with smoking history ( p < 0.001 ) and increased surgical time ( p = 0.003 ). Conclusions. Despite the recent recall of bacitracin from inclusion in breast pocket irrigation solutions, our study demonstrated no detrimental impact on immediate complication rates. This shift in irrigation protocols calls for additional investigations into optimizing antibiotic combinations in solution, as bacitracin is no longer a viable option, to improve surgical outcomes and long-term benefits.

Outcomes After Implant-Based Breast Reconstruction Following the National Institution of a Ban on Bacitracin Irrigation

“…Tirrell et al 4 carried out a study similar in methodology to this one and reported no difference in infection rates before and after the ban on bacitracin irrigation. We replicate the findings of Tirrell et al in a larger patient cohort, thus contributing to the validity of the conclusion that bacitracin may not alleviate infection risk.…”

“…Although some studies suggest a partial benefit, others suggest that there is no benefit, or perhaps even detriment to the patient. 1,4,5 Even others link antibiotic irrigation to numerous negative outcomes, including increased health care costs, nephrotoxicity, damage to healthy tissue, capsular contracture of the breast pocket, and anaphylactic reactions. [6][7][8][9] In debating the benefit of antibiotic irrigation solution to prevent postoperative infection, it has been noted that, because of the transient contact between the topical antibiotic and the microorganism afforded by irrigation, it is highly unlikely that antimicrobial benefit will be achieved.…”

“…The use of antibiotic-containing irrigation itself, as well as specific composition recommendations, remains the subject of controversy. Although some studies suggest a partial benefit, others suggest that there is no benefit, or perhaps even detriment to the patient 1,4,5 . Even others link antibiotic irrigation to numerous negative outcomes, including increased health care costs, nephrotoxicity, damage to healthy tissue, capsular contracture of the breast pocket, and anaphylactic reactions 6–9 .…”

Quasi-Experimental Design for Health Policy Research: A Methodology Overview

“…12 For each design, examples beyond those in the narrative may be found in Table 1. [13][14][15][16][17][18][19][20][21][22]…”