ANMAT is distinguished from France by the prohibition of breast silicone prostheses

The appearance of cases of a lymphoma in patients with bad implants caused by la France the prohibition of six models of prostheses considered likely to cause cancer. In this context, Comfort He summoned one of the greatest experts on the subject. The Dr. Jorge Pedro (MN 69,163), plastic surgeon and communication director of the Argentine Society of Aesthetic and Reconstructive Plastic Surgery (SACPER), said he sought to bring tranquility to Argentinian patients and explained in detail why.

"As I said on the air, interviewed by Guillermo Lobothe case of France is an excess of legality. Certainly, the memory of the fraud of the famous years hangs over them PIP prosthesis (Poly Implant Prosthesis). Its inventor Jean-Claude Mas died this week. It fills the fragile bags with an industrial liquid silicone gel that, if broken, would spread throughout the body. Since then, acts with severity – or overreacts – so as not to make the same mistake. He is the only one to have developed these prohibitions. Two striking facts have occurred: on the one hand, the French government prohibits its internal marketing, but does not prevent the manufacture of prostheses, which are partly exported to different parts of the world. Moreover, the government of this country does not advise patients to remove the implants, which is a contradiction, "said the expert.

In this context, the ANMAT have reported, with respect to the occurrence of anaplastic large cell lymphoma (ALCL) in patients with bad implants, that "monitors the situation and behavior of the products in question. For the moment, after evaluating the available information, The cause of the origin of lymphoma can not be established reliably. Among the possible causes, the implants are mentioned with a rough textured surface and / or with a polyurethane coated surface, the genetic base of people or possible contamination ".

What is the texture of a prosthesis? Pedro remarked: "Some time ago, all these prostheses were smooth, and over the years the texture (macro-texture) that we thought for better healing and give an answer to the retraction of the smooth capsule. Recently, the micro-texture appeared, less rough and more similar to the smooth prosthesis, while preserving the texture. These are the ones that are used today. Even in the United States, the situation has become relatively smooth. The macrotexture is the one that is most related to the creation of lymphoma mentioned by the ANMAT. Macrotexture can be a trail of germs on the skin, but also operate in less sterile places such as offices, clinics second or third level.

"When the woman comes to the consultation because a bad has gotten bigger or because there is fluid, studies are done and you can be diagnosed early. puncture, an badysis of immunohistochemistry and finally there you can diagnose Lymphoma You can act quickly with surgery, removing the capsule, prosthesis and fluid, and sometimes require other treatments such as chemotherapy, "said the surgeon in terms of cancer prevention and detection suspected.

ANMAT, until now, did not order removal of implants from the market, in accordance with the measures adopted by the European Regulatory Agencies (with the exception of France), the United States Food and Drug Administration (FDA) and, among others, the Therapeutic Goods Administration (TGA) of the US 39; Australia.

In accordance with ANMAT, the equivalent regulatory bodies in England, Belgium, Italy and Spain they published press releases and did not comply with the French prohibition. Canada and the United States would use to the same extent not to join the French decision. France's health policy would therefore be isolated not only in the world but in the community.

I recommend and urge patients not to panic and continue to operate.

What is happening from now

"Those of us who are dedicated to it," said Dr. Pedro, "we believe who will continue to use the smooth prosthesis, the micro-textured prosthesis and the macrotexture in question will not be banned but companies will gradually remove them from the market. "

At the same time, the techniques are improving. "The possibility of improving and reducing the prosthesis-lymphoma relationship is under study." The ability to work with even more sterile measures, to inject antibiotics at the time of the installation of the implant, not to pbad the prosthesis to the areola because it would lead to bad germs, etc. In addition, it is badyzed to put the prosthesis with a type of cover so that they are not in contact with the skin of the body. All this would reduce inflammation and contamination, which is one of the reasons for the appearance of lymphoblasts, "he said.

Case in Argentina?

In our country, there are eight cases of lymphoma. Lymphoma does not appear immediately "but appears between five and ten years after the prosthesis is placed". The plastic surgeon pointed out that "we must not forget that during the last decade, we will have put bad implants 450 thousand people"

The professional's advice

The specialist sought to bring tranquility and information to worried patients. "Today, we do not recommend removing macrotextured prostheses because the incidence is close to 50,000. It is so low that if there are no symptoms or some kind of disease, we advise you not to remove the prosthesis. It would be a huge upheaval that 10 million women, many of whom have textured prosthetics, come out and take them out. We advise not to fall into paranoia or panic to call the doctor and ask him: what should I wear? The reality is that a high percentage of Argentines is textured, but that's not why there are more cases of lymphoma than in the United States or elsewhere in Europe. "

A "good advice" is that patients "go back to the consultation to do a check", He emphasizes." They should come back once a year to follow up. And then, come chaos, you can see if maybe the prosthesis is healthy, is in good condition, if it is broken, if it has a capsule, or if it starts to encapsulate. When that happens, we currently have medicines that we can give so that the chart is reversed and that we do not need to operate the patient, "explained Pedro in his dialogue with this media.

"I recommend and insist on patients that they there is no reason to panic and keep running. Finally, the specialist recommended to patients to require the title of professionals, since it is not regulated, any surgeon can perform an intervention without specializing in plastic or reconstructive surgery, "he concluded.

L & # 39; ANMAT will soon meet representatives of technical and scientific societies to continue with tracking the subject. Likewise, "it will strengthen interaction with foreign health agencies to evaluate actions to be implemented and update information as needed. If you have questions or if you have questions questions, you can contact ANMAT by calling 0-800-333-1234 from Monday to Friday from 8 am to 6 pm and on Saturdays, Sundays and public holidays from 10 am to 6 pm or by email to [email protected] ".