Faulty Breast Implant Scandal Causes Major Concern Worldwide
Not Affected: Breast Implants „Made in Germany“
They, who decide for low cost implants may have to pay dearly in the end
Dieburg, 6 January 2011. BfArM, the German Federal Institute for Drugs and Medical Devices, had already posted an alert in May 2011 regarding the products of the French company PIP (Poly Implant Prothèse)1. For years, PIP used non-medical grade silicone for the production of breast implants in France. Current media updates report that in the meantime several thousands of women are affected. “30,000 French women will probably have to face removal of their silicone implants – these might cause cancer,” states the German TV station ARD in its evening news2. The implants were used for aesthetic purposes as well as for reconstruction after breast cancer.
This is alarming news from a neighbouring country which shows clearly: when using a medical device, quality assurance is crucial.
German quality
German brands enjoy the highest reputation worldwide for superior quality and high-level processing. POLYTECH Health & Aesthetics, the only German breast implant manufacturer, has implemented extensive safety test procedures and guarantees that it adheres to the highest quality standards.
The raw materials we utilize for the shell and gel of our implants are certified for long-term implantation. At our production site in Germany, implants are examined after each production stage to prevent possible errors or defects. The implant is released for sale only when all tests and security checks are passed successfully. In this manner, we consistently ensure high quality and safety for the surgeons and patients.
German standards
POLYTECH Health & Aesthetics is one of the leading implant manufacturers in Europe and has a history of 25 years of breast implant experience. The company is the only German manufacturer of soft-tissue implants. The premises are located in Dieburg (near Frankfurt), and since July 2008, all implants have been exclusively produced in Germany. Concentrating the production in Germany assures high quality in all areas, increases flexibility and reduces development cycles.
German focus
POLYTECH Health & Aesthetics was the first company to receive Mark for their implants in 1995. In 2003, the European Community decided that breast implants were to be classified as medical device class III products, a device class that also includes pacemakers, and heart valves. This means that strict guidelines are to be followed in the production of breast implants. POLYTECH immediately received clearance for its products because it had previously implemented quality standards equal to those valid since the 2003 breast implant reclassification into its production as early as 1995 – i.e. much earlier than any other implant manufacturer.
POLYTECH Health & Aesthetics carries the largest product range in the breast implant market with more than 1,500 implant types, both for augmentation and reconstruction. We focus mainly on breast implants for women; in addition, pectoral implants for men as well as implants for the nose, the chin, the calves, and the gluteus are offered.
References:
1 www.bfarm.de/DE/Medizinprodukte/riskinfo/empfehlungen/Silikon_Brustimplantate_PIP.html
2 www.tagesschau.de/ausland/pip104.html
For further information please contact:
Vivian Breinhild
Director International Sales, EMEA
v.breinhild@polytechhealth.com