POLYTECH Welcomes Statement by US Food and Drug Administration FDA Opposing Ban on Textured Breast Implants
DIEBURG, Germany, May 15, 2019 /PRNewswire/ — POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will remain available in the US market, In opposition to the recent decision by the French health authority ANSM (Agence Nationale de Sécurité du Médicament) to ban ‘macrotextured’ and polyurethane coated implants from the French market.
“The FDA’s argumentation is in line with our view”, commented Wolfgang Steimel, CEO of POLYTECH Health & Aesthetics, applauding the decision. “Because there is still no sound scientific proof regarding how BIA-ALCL arises and develops, nor of a connection with the implant surface,” Steimel elaborated. Alongside POLYTECH—a leading international breast implant manufacturer and the only manufacturer in Germany—the International Society of Aesthetic Plastic Surgery (ISAPS) also agrees with the FDA’s position as the world-leading professional association for licensed aesthetic plastic surgeons.
The FDA made its recent statement following the public consultation of its Advisory Committee in March 2019. Having examined all available evidence and data on the safety and risks of breast implants, the United States Food and Drug Administration has concluded that there is insufficient data-based evidence to justify a ban on textured breast implants.
Candid dialogue and transparent education
POLYTECH CEO Wolfgang Steimel added: “As manufacturers, we have an ethical obligation to patients, which is why we remain in fully candid dialogue, promoting transparent education regarding this topic. Nonetheless, out of our commitments to both patient safety and satisfaction, we are pleased that the criticisms of textured and polyurethane foam/PU-coated implants have again been refuted by others.”
Thus, in addition to their silicone-surface implants – available with a smooth shell and with two different microtextures – and to the novel Lightweight B-Lite® implants, the company will continue to offer its polyurethane foam/PU-coated implants, which many scientific clinical studies have shown to be safe, with a demonstrably lower complication rate, particularly concerning capsular contracture. In an official statement, Dr. Dirk Richter, President of the International Society of Aesthetic Plastic Surgery (ISAPS), agreed with the FDA’s position. Dr. Richter added:” We believe that a ban on textured and polyurethane-coated implants is an improper decision in terms of overall patient safety, when based on the currently available data.”
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 250 people. For more information visit https://polytechhealth.com/en