All silicones used for manufacturing implants at POLYTECH Health & Aesthetics are certified for long-term implantation. They are of the highest medical quality. Worldwide, there are only two companies that produce these silicones, both are located in the United States. They have had their silicones tested and registered for this purpose by the FDA.
The chemically and mechanically resistant, elastic shell of the implants consists of several layers of a silicone elastomer. In order to maintain a high level of safety, the shell of the silicone gel-filled implants is equipped with an additional diffusion barrier layer. This layer consists of a special silicone that does not allow the particles to migrate through the shell.
Production of the implants is based on a quality management according to ISO 9001 and ISO 13485. All materials used are of implantable medical quality.