France will withdraw some models of breast implants from the market due to its potential risk of causing cancer. It involves certain textured or rough implants and others with the surface covered with polyurethane. The decision, announced by the National Agency for Medicines and Health Products (ANSM) and that it will take effect this Friday, has been taken after "numerous investigations" that link these products to a form of lymphatic cancer. The authorities have indicated that this is a "precautionary" measure and they emphasize that they do not consider preventive extraction necessary for women who already have them in place, since although it is a serious risk, it is at the same time unusual.
Until 2017, in France there were 400,000 women with breast implants. Every year 70,000 implants are sold in this country. According to the ANSM, since 2011, 59 cases of anaplastic large cell lymphoma (ALCL) "associated with breast implants" have been confirmed. The American Association of Plastic Surgeons (ASPS) reported in March that, from the first reported case, in 1996, 688 cases have been identified worldwide, of them 270 in the United States.
The investigations carried out around the diagnoses in France have led to the conclusion that "the roughness of some macrotextured implants and implants with the surface covered with polyurethane constitutes a risk factor in the appearance of ALCL". The rougher the surface of the implant, the greater the risk, adds the Gallic agency. Of the 59 cases of this rare but aggressive lymphoma recorded in France, almost all of it was suffered by women with rough or textured implants. Three of those diagnosed have died, according to French media.
The decision to prohibit the sale of certain implants affects products from six brands in France. It is "less than 30% of all breast implants," the deputy general director of the ANSM, Christelle Ratignier-Carbonneil, told Agence France Presse. Among the products that will be removed from Friday are several models from the manufacturer Allergan with the differentiated texture Biocell, a brand registered by this American company. This type of rough texture, which has its equivalent in other brands, is considered by experts to be the main cause of lymphoma.
The ANSM, which has reiterated its recommendation to use smooth implants both for aesthetic and reconstruction operations, it cites in this sense a report sent in February by a committee of experts that analyzed the situation. "Taking into account the doubts expressed by the health professionals, it is convenient to prohibit the use of the Biocell texture of Allergan," they wrote. They also urged to maintain "as much prudence as possible regarding mammary implants of equivalent textures and polyurethane implants".
In addition to the rugged Allergen products, the ANSM cites various models of the Arion, Sebbin, Nagor, Eurosilicone and Polytech brands among the forbidden implants. Two models of polyurethane cover implants from Polytech are also prohibited as of this Friday.
In 2018, 27% of the implants made in France were of macro-textured models like the one now prohibited. Another 3% had polyurethane cover.
In the world of breast implants there is a before and after the scandal of the French prosthesis PIP, the company that between 2001 and 2010 fraudulently manufactured implants of poor quality manufactured with an industrial silicone gel not approved for medical use, something that caused serious health problems to more than 300,000 women in at least 65 countries. The founder of the French company Poly Implants Prothèses (PIP), Jean-Claude Mas, died Thursday at the age of 79, his lawyer told Agence France Presse.
"His partner told me that he died in the clinic where he had been admitted for an operation," Yves Haddad explained, according to which Mas suffered heart problems and diabetes. Laurent Gaudon, one of the lawyers for the victims of the fraudulent implants, regretted that Mas died without serving his sentence for the health fraud. "Has died. He did not spend a single day in prison after his sentence. It leaves behind thousands of victims, "he commented on social networks.
But he served eight months of preventive detention in 2012. In May 2016, he was sentenced to four years in prison and a fine of 75,000 euros, but he did not even reach a day of that sentence, AFP points out. The judicial process for the scandal of the implants follows its course. Last October, the French Court of Cassation ordered a new trial against the German certifier TÜV Rheinland and its French subsidiary, which granted PIP the necessary European certification, and to which the victims of the defective implants claim a millionaire compensation.