Following recent concerns that have been raised about a possible connection between textured breast implants and the rare condition known as anaplastic large cell lymphoma (BIA-ALCL), the French government agency responsible for medicines and health products (ANSM) announced today that it will, until further notice, ban the sale in France of what they classify as macro-textured breast implants manufactured by several companies. While respectful of the French regulators’ position, and consistent with a long-standing focus on patient safety, GC Aesthetics (“GCA”) will immediately suspend the sale in France of the affected products. GCA is also committed to working with ANSM to demonstrate the long-term safety record of the affected products.
GCA has for almost 40 years offered the broadest range of breast implants in the industry, including smooth implants with the latest innovative gel technology, as well as a large offering of textured products that are not impacted by this recent ANSM decision, across both our Nagor and Eurosilicone brands. These products, which together serve a significant portion of GCA customers in France, will continue to be sold in France. Given this broad offering and market share of unaffected GCA products in France, the company is confident that the impact of the ANSM action on GCA and our customers should not be significant.
GCA is able to support our safety claims with the only two large scale prospective European studies of both textured and smooth breast implants, with 10-years of patient follow up. Furthermore, with over 3 million implants sold over the last 10 years across 70 countries, the rate of BIA-ALCL incidence for GCA textured implants is less than 0.0007%, and it is 0% for GCA smooth implants over the same period.
The proven and long-standing safety record of GCA’s products has enabled the company to provide a platform for continuous investment into our robust research and development activities. These activities have enabled GCA to ensure that our products are safe and highly effective in achieving the needs of our doctors and patients.
With patient safety as our top priority, we will continue to closely monitor the incidence of BIA-ALCL and participate in collaborative global research. GCA is committed to continuing to be well positioned at the forefront of the industry with a permanent focus on patient safety.