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Presentation of the ASJ Special Topic from Mark L. Jewell and Bill Adams about Betadine and breast implants
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Veröffentlicht: | 20. September 2018 |
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Gliederung
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The US FDA in the fourth quarter of 2017 reviewed and approved a request by one of the breast implant manufacturers for a change in the Directions for Use (DFU) that removed warnings regarding the use of Betadine (Povidone-iodine, "PI"). Formerly, in 2000, there were concerns by the agency that PI would degrade the silicone elastomer shell. We believe that this change in the DFU represents an important advance that will benefit patients through the permitted use of PI to reduce the risk of bacterial biofilm contamination of implant surfaces.
All implanted devices are at risk for bacterial contamination. Bacterial surface contamination of implants (smooth and textured surfaces) has been implicated as a cause of infection, capsular contracture, double capsules, and late-term breast implant-associated anaplastic large cell lymphoma (BI-ALCL).
Gram positive organisms have been linked to capsular contracture and gram negative Ralstonia picketti for BIA-ALCL. Ralstonia picketti is resistant to aminoglycoside antibiotics, but susceptible to at least a 50% solution of PI.
Antiseptics such as iodine have a broader range of antimicrobial effect than antibiotics.
In order for PI to be effective, the concentration should be a 50% concentration in an irrigation solution.
We believe that the strategy of antisepsis and biofilm mitigation is an integral part of a contemporary approach for breast augmentation along with the other actionable steps that are outlined in The 14 Point Plan [1].
References
- 1.
- Deva AK, Adams WP Jr, Vickery K. The role of bacterial biofilms in device-associated infection. Plast Reconstr Surg. 2013 Nov;132(5):1319-28. DOI: 10.1097/PRS.0b013e3182a3c105