Mechanical analysis of explanted saline-filled breast implants exposed to betadine pocket irrigation

Background: Because of concerns that exposure to povidone-iodine (Betadine) may lead to early breast implant failure, the Food and Drug Administration announced in 2000 that any contact between implants and Betadine is contraindicated. The evidence cited by the Food and Drug Administration primarily referred to Betadine added to saline implant filler solution and not to povidone-iodine used for pocket irrigation. Objective: Thirteen explanted Mentor saline solution-filled devices that had been exposed to Betadine pocket irrigation during implantation were studied for any loss of implant shell integrity. Methods: The 13 explants had been in place 1 week to 55 months, and none had intraluminal Betadine exposure. Twelve of the 13 explants were intact when removed, and one had leaked through the anterior valve. All were examined for any signs of patch-shell delamination. The mechanical properties of tensile strength, percent elongation, force-to-break, tear resistance, and patch bond strength were also measured. Results: No shell delamination or disruption of the sealing patch bond was found in any of the 13 explants placed in Betadine-irrigated pockets. In addition, the measured mechanical properties of the explants exceeded American Society for Testing and Materials requirements, with the exception of the textured explants (n = 2), which failed to meet the minimum elongation standards. Conclusions: We found no evidence of patch or shell delamination in Mentor implants that had extraluminal contact with Betadine irrigation and were later explanted. We believe that the lower mechanical properties of the two textured implants are probably related to the texturing process rather than to Betadine pocket irritation.