BACKGROUND: The body responds to prosthetic materials with an inflammatory foreign body response and deposition of a fibrous capsule, which may be deleterious to the function of the device and a cause of significant discomfort for the patient. Capsular contracture (CC) is the most common complication of aesthetic and reconstructive breast surgery. CC is the source of significant patient morbidity and can result in pain, suboptimal aesthetic outcomes, implant failure and increased costs. The underlying mechanism remains unknown. Treatment is limited to re-operation and capsule excision; however, recurrence rates remain high. Herein we altered the surface chemistry of silicone implants with a proprietary anti-inflammatory coating to reduce capsule formation. METHODS: Silicone implants were coated with Met-Z2-Y12, a biocompatible, anti-inflammatory surface modification. Uncoated and Met-Z2-Y12-coated implants were implanted in C57BL/6 mice. After 21, 90 or 180 days, peri-prosthetic tissue was removed for histologic analysis. RESULTS: We compared mean capsule thickness at three time points. At 21, 90 and 180 days, there was a statistically significant reduction in capsule thickness of Met-Z2-Y12-coated implants compared to uncoated implants (p < 0.05). CONCLUSIONS: Coating the surface of silicone implants with Met-Z2-Y12 significantly reduced acute and chronic capsule formation in a mouse model for implant-based breast augmentation and reconstruction. As capsule formation obligatorily precedes CC, these results suggest contracture itself may be significantly attenuated. Furthermore, as peri-prosthetic capsule formation is a complication without anatomical boundaries, this chemistry may have additional applications beyond breast implants, to a myriad of other implantable medical devices. CLINICAL RELEVANCE: Coating of the silicone implant surface with Met-Z2-Y12 alters the peri-prosthetic capsule architecture and significantly reduces capsule thickness for at least 6 months post-operatively in a murine model. This is a promising step forward in the development of a therapy to prevent capsular contracture.
