Silicone Breast Implants with Spider Silk-Based Coating Show Reduced Side-Effects in Preclinical Studies
AMSilk is developing a novel spider silk-based coating, called BioShield-S1, for silicone breast implants designed to reduce commonly known side effects that are initiated when the immune system reacts to the implants. Preclinical tests conducted jointly with the University of Bayreuth, Germany and the Department of Trauma, Hand, Plastic and Reconstructive Surgery of the University of Wuerzburg, Germany, showed the efficacy of the implant coating. A first test in rats showed that coated silicone implants were accepted much better than implants without silk coating. In particular, capsular fibrosis and inflammation at the tissue border to the coated implants were significantly reduced.
A follow-up one-year study, completed in 2012, confirmed the results and the findings are currently being prepared for publication. In this second study it was shown that the capsule formation around the implant differs significantly from controls, resulting in a thinner, more flexible and translucent capsule accompanied by a significant reduction in inflammation markers. Some inflammation markers, as well as fibroblast infiltration, were found to be at lower levels even twelve months after surgery. “This new technology offers a real option for further improving current implants and can be used for nearly all silicone-based products,” says Dr. Philip Zeplin, a surgeon who conducted the study.
The BioShield-S1 coating consists of a thin layer of recombinant spider silk proteins manufactured at AMSilk. It modifies the implant, presenting a more biocompatible surface to the immune system.
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