POLYTECH Health & Aesthetics was founded in 1986 and since has become one of the leading breast implant manufacturers in Europe. The company only sells breast implants made exclusively at its production site in Dieburg, Germany. POLYTECH Health & Aesthetics is the only German manufacturer of implants destined for soft-tissue replacement. In 2008, the complete production had been relocated to Germany. Since then, each single production step has been performed and monitored directly in Dieburg, Germany, be that product development, shell production, gel filling, sterilisation, quality management or regulatory affairs, just to name a few. "This degree of control and product quality may be achieved best in Germany," states Dr Oliver Bögershausen, Managing Director and Head of Quality and Safety Management. The company does not sell breast implants produced in foreign countries.
A Pioneer in Matters of Quality
In 2003, breast implants had been declared class III medical devices in Europe. This means that since 1 March 2004 they have to fulfil the highest safety requirements. POLYTECH Health & Aesthetics received the corresponding approval for its products in December 2003, even before the directive came into force. Moreover, the company had acquired the CE mark for its products as early as 1995, meaning it has since then been complying with the highest quality standards. Annual audits entitle the company to use the CE mark for its products and reaffirm its CE certification. "This is how we live up determinedly to our role as a pioneer in matters of product quality and patient safety," closes Dr Bögershausen.