Why Argentine health authorities have not followed the French ban on breast implants

Cases of Anaplastic large cell lymphoma (ALCL) began reporting in 2007 and to date, 457 cases have been detected worldwide, according to the Food and Drug Administration (FDA) at an international meeting with 40 references (medical companies, manufacturers and patients) that he did the end of March to badyze the problem, although he has not made any decision for the moment.

The National Health Products Agency of France (ANSM) immediately issued a statement in which it announced the withdrawal of certain models of macrotextured prostheses from six brands because of their relationship with this pathology.

"This is a pathology that originates in the capsule that surrounds the implant and is easily detectable in the early stages., since it manifests itself by a seroma, which is the formation of fluid around the prosthesis, which causes inflammation of the bad, "he had explained to Infobae, president of the Argentine Society of Plastic Surgery, Aesthetics and reconstructive (Sacper), Esteban Elena.

According to the entity, the French agency "has acted excessively in the course of the controversial prosthesis PIP, which this week corresponds to nine years of prohibition and in this case, the regulatory authority had not alert the problem, "said the university's specialist in plastic surgery and director of communication Sacper, Jorge Pedro.

"For the moment, after badessing the available information, The cause of the origin of lymphoma can not be established reliably. Among the possible causes, implants are mentioned with a textured / rough surface and / or with a polyurethane-coated surface, the genetic base of people or possible contamination, "explained the National Administration of Drugs, Foods and Drugs. Medical Technology (ANMAT).) and is committed to organizing meetings with scientific societies and related companies, beginning in the afternoon of yesterday with Sacper, who, directly or through through its regional offices, brings together over 1500 specialists across the country.

This is why ANMAT has so far not ordered the withdrawal of implants from the market, in accordance with the measures adopted by the European Regulatory Agencies (with the exception of the France), the United States Food and Drug Administration (FDA) and, among others, Australia's Therapeutic Goods Administration (TGA) ".

To continue with the subject tracking, Carlos Chiale, National Administrator of ANMAT, met yesterday with the President of Sacper as part of the meeting scheduled to receive from the society of medicine the scientific aspects related to the controversy on the safety of silicone bad implants and its relation to non-Hodgkin's large cell lymphoma.

After a few days, the control organs of the drugs and medical supplies of the main countries of Europe and America as well as the scientific societies of the specialty left aside the French decision which was the only country where silicone implants were limited.

"With regard to this latest issue of relevance and reason for the ANMAT call, we have advanced in the scientific perspective explained by Dr. Esteban Elena, conveying the experience of Argentine surgeons to the use of implants that carry more than 50 years of use and quality improvement but also surgical techniques of bad augmentation and its various variants being currently the most practiced surgery not only in our country, but around the world, "Sacper reported in a statement after the meeting. Elena has also presented to ANMAT authorities the experience of the various main specialty services at the international level. as well as the position of the most important and prestigious scientific societies at the international level

At the local level, eight cases of this type of cancer have occurred in the last 10 years. and regional casuistry was presented, reaching 12 cases in Brazil, 7 in Mexico and 15 in Colombia. In countries like Italy where 51,000 patients were implanted in 2018, 39 cases of the disease have been presented in the last 10 years. This is a country where 95% of textured implants are placed, which is often a problem for the French authority in his country. Prohibited last week.