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Hope for Anatomic Breast Implants? Designing Positionally Stable Smooth Breast Implants
Tim Y. Li
*, Riley Mayne, Jini Jeon, Sophia Salingaros, Matthew W. Liao, Samuel Medina, Xue Dong, Jason A. Spector
Weill Cornell Medical College, New York, NY
BACKGROUNDThe voluntary recall of textured breast implants due to their association with Breast Implant-Associated Anaplastic Large Cell Lymphoma has eliminated the key benefit of textured surface—positional stability. We have engineered a Positionally Stable Smooth Implant (PSSI), which contains millimeter dimension cylindrical wells on the implant surface for tissue ingrowth and implant stabilization.
METHODSMiniature breast implants were manufactured using polydimethylsiloxane. PSSI were designed with various well dimensions, reported in millimeters in the following variations in width (W), depth (D), and number of wells (in parenthesis): W2D1(52), W2D2(26), and W2D4(13). Comparison groups consisted of smooth and textured implants. Six sterilized implants per group were implanted subcutaneously into the bilateral dorsa of Sprague-Dawley rats. Implant rotation was measured with MicroCT every 2 weeks. Animals were sacrificed at 3 months, and implant-capsule units were explanted en bloc for histological analysis.
RESULTSBetween 1 and 3 months, all PSSI and textured implants had significantly less cumulative positional rotation than smooth implants (
p<0.05). There was no significant difference in rotation between PSSI and textured implants. Upon explantation, microCT and gross examination showed tissue growing into and conforming to the well dimensions of PSSI groups. Significantly higher amount of M1 macrophages was observed in the textured capsule than PSSI and smooth implants. There was no significant difference in M2 macrophages among all groups. Myofibroblast expression was significantly less in PSSI and textured groups compared to smooth implants.
CONCLUSIONThis novel smooth-surface breast implant design provided implant positional stability equivalent to that of a textured implant. The reduced level of pro-inflammatory M1 macrophages observed in PSSI capsules compared to the textured group supports the biocompatibility of the novel implant. These results suggest a promising alternative to textured surface for inducing positional stability in breast implants.
Figure 1: (A) Gross, trichrome (100x), and immunofluorescent staining (200x) of smooth, textured, and W2D2(26) groups. (B) Cumulative implant rotation between 1 and 3 months, as well as quantification of myofibroblasts, pro-inflammatory M1 macrophages, and pro-regenerative M2 macrophages within the implant capsule. *p<0.05.
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