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    Area of Science:

    • Plastic Surgery
    • Infectious Disease
    • Biomaterials Science

    Background:

    • The US FDA previously cautioned against using povidone-iodine (PI) with breast implants due to concerns about silicone elastomer shell degradation.
    • Bacterial contamination of breast implant surfaces is a significant risk factor for adverse outcomes, including capsular contracture and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
    • Certain bacteria, like Ralstonia picketti, linked to BIA-ALCL, exhibit resistance to common antibiotics but are susceptible to PI.

    Purpose of the Study:

    • To report the US FDA's 2017 approval of revised Directions for Use (DFU) for breast implants, permitting the use of povidone-iodine (PI).
    • To highlight the benefits of using PI as an anti-infective and biofilm-mitigation strategy in breast augmentation procedures.
    • To underscore the potential of PI in reducing the incidence of surgical infections, capsular contracture, and BIA-ALCL.

    Main Methods:

    • Review of the US FDA's regulatory decision regarding breast implant Directions for Use (DFU) in Q4 2017.
    • Analysis of the antimicrobial spectrum of povidone-iodine (PI) against relevant pathogens.
    • Evaluation of existing outcome data on the use of anti-infectives in breast augmentation.

    Main Results:

    • The US FDA approved a change in breast implant DFU, removing warnings against PI use.
    • Povidone-iodine (PI) is now permitted for use to mitigate bacterial contamination on implant surfaces.
    • PI demonstrates efficacy against gram-positive and gram-negative organisms, including antibiotic-resistant Ralstonia picketti.

    Conclusions:

    • The FDA's revised DFU facilitates the open use of PI by plastic surgeons as an anti-infective and biofilm-mitigation strategy.
    • Implementing PI antisepsis and biofilm mitigation may reduce risks of surgical infection, capsular contracture, and BIA-ALCL.
    • Utilizing anti-infectives like PI can enhance breast implant outcomes, decrease reoperation rates, and lower healthcare costs.