PURPOSE: The risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has largely restricted surgeons to using smooth surfaced breast tissue expanders and implants, making the process of tissue expansion less predictable and obviating the application of anatomically shaped devices. Our group has developed a novel smooth breast implant surface that promotes tissue ingrowth into macropores (2-4mm in diameter within the implant surface) which facilitates tissue ingrowth into the shell of the implant and fixes the implant into position without the associated risks of microtextured devices. METHODS: Miniature anatomically (breast) shaped smooth implants (2cc) made from polydimethylsiloxane were designed with pores invaginating into the surface. A range of pore number (per implant), widths and depths were tested. Textured and smooth implant controls with no macropores were included. Implants were placed on the dorsum of wild-type rats (N=4 per group), implant rotation was evaluated monthly, and at explanation, implants were evaluated by gross visualization, histology, and Micro-CT. RESULTS: All macropore conditions demonstrated tissue ingrowth into pores by 1 month. Smooth implants experienced ~80 degrees more rotation than macropore implants at 3 months, and there was no significant difference between macropore and textured implant stability. Lower stability was noted when the macropore density and width decreased. CONCLUSION: We present an innovative design of “macropore” smooth implants which enhance implant positional stability without using the traditional microtextured surface linked to BIA-ALCL. These promising early results have led to ongoing follow-on studies to further identify the optimal macropore configuration that maximizes implant stability.
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