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

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Citation: Breast Journal. 2022:1389539, 2022.PMID: 36105366Institution: MedStar Health Research Institute | MedStar Washington Hospital CenterDepartment: MedStar Georgetown University Hospital/MedStar Washington Hospital Center | Plastic Surgery Residency | Surgery/Plastic SurgeryForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Breast Implants | *Breast Neoplasms | Anti-Bacterial Agents/ae [Adverse Effects] | Bacitracin/ae [Adverse Effects] | Breast Neoplasms/dt [Drug Therapy] | Cefazolin | Female | Gentamicins | Humans | Povidone-Iodine/tu [Therapeutic Use] | Retrospective Studies | Treatment OutcomeYear: 2022ISSN:
  • 1075-122X
Name of journal: The breast journalAbstract: 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.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. Copyright © 2022 Abigail R. Tirrell et al.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).All authors: Bekeny JC, Fan KL, Song DH, Tefera EA, Tirrell ARFiscal year: FY2023Digital Object Identifier: ORCID: Date added to catalog: 2022-10-20
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Journal Article MedStar Authors Catalog Article 36105366 Available 36105366

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.

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. Copyright © 2022 Abigail R. Tirrell et al.

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).

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