France is planning to ban textured breast implants, which have been linked a rare immune-system cancer, according to a report from France24.
France’s National Agency for Medicines and Health Products began informing manufacturers on April 2 of its plans to ban manufacturing, distribution, importing, exporting, promotion and wearing of textured breast implants and polyurethane breast implants, according to the report.
The soon-to-be-banned implants have been linked to breast implant-associated anapestic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
France’s ANSM has been tracking individuals with breast implants since 2011, according to the France24 report, the same year the FDA said it began tracking and reporting cases of BIA-ALCL.
In February, the FDA said that it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths.
The ANSM said it has recorded 53 cases of BIA-ALCL, with an over-representation amongst individuals with textured breast implants, according to the report.
Breast implant maker Polytech Health & Aesthetics responded to the ban saying that it objects to the conclusions of the ANSM, despite the fact that both textured implants are an “integral part of the company’s portfolio.”
“The ANSM decision is not based on any scientific proof and surgeons and their patients in France will now be offered very limited options, that may not allow them to achieve a safe and optimal surgical result,” Polytech said in a prepared statement.
The company said that it will continue to sell its POLYsmooth and MESMOsensitive micro-textured implants in France.
“As a leading manufacturer of breast implants, it is our obligation to educate both surgeons and patients on the subject of BIA-ALCL, with evidence-based information, recent medical publications and our gathered knowledge. Even as it is a very rare complication, we take the appearance of BIA-ALCL very seriously. However, we believe that a ban of textured and polyurethane-coated implants is a false decision in terms of the overall patient safety, when it is based on the currently available facts,” Polytech CEO Wolfgang Steimel said in a press release.
Last December, Allergan (NYSE: AGN) removed its textured breast implants from the market in Europe following a recall request from French regulators.