DIEBURG, Germany, July 11, 2019 - POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, is working to support a review currently being conducted by the TGA in Australia.
POLYTECH has recently been informed by the Australian TGA that they are conducting a review of multiple manufacturers products including those of POLYTECH. POLYTECH is working to support the TGA's understanding of Microthane® polyurethane coated implants in the Australian market. The TGA is already satisfied with respect to our micro-textured and smooth implants.
POLYTECH has supplied data and samples as required by the TGA and continues to invest significant resources to ensure that the TGA has the information needed to make an informed decision in the best interest of patients. POLYTECH understands that the TGA review of our POLYTECH Microthane® implants is based on one (1) primary anaplastic large-cell lymphoma (ALCL) case in Australia.
Commenting on this review, Wolfgang Steimel, CEO of POLYTECH, stated, "POLYTECH prides itself on our product quality. I have publicly committed to removing any type of POLYTECH implant from the market should a causal relationship to the development of ALCL be proven. To this point there has been no causal link between our implants and ALCL."
"While we take any patient issue extremely seriously it is important to put data into context. In the course of the last 10 years, POLYTECH has sold well over 1,000,000 implants globally. To date worldwide only five (5) patients have presented with primary ALCL with Polytech implants," continued Mr. Steimel.
In conclusion Mr. Steimel stated: "It is important that all stakeholders have ethical and fact-based discussions on this and related topics moving forward. Misinformation impacts patients and surgical communities. We take exception to patients being distressed and in some cases feeling the need for potential unnecessary reoperations due to misleading information."
About POLYTECH Health & Aesthetics GmbH
With a global footprint in over 75 countries, POLYTECH Health & Aesthetics GmbH is an international leader in the development and production of silicone implants. Founded in 1986 in Dieburg, Germany, the company focuses on breast implants, used in both reconstructive and aesthetic plastic surgery. POLYTECH is the only German manufacturer of soft tissue implants. All products are developed exclusively at the company headquarters in Germany, and are manufactured under clean room conditions. The company employs over 280 people.
* POLYTECH products are not sold in the US.