ANMAT will not remove banned breast implants in France from the Argentinian market – 06/04/2019

After the ban in France, by "precaution" of several models of bad implants suspicion of his relationship with "non-Hodgkin's lymphoma", a form of cancer, the National Administration of Medicines, Food and Medical Technologies (ANMAT) issued a statement, these prostheses being also used in Argentina, where There are 8 cases of women with implants who have developed this lymphoma.

"For now, "says the text, it will not order its withdrawal from the Argentine brand.

"After evaluating the available information, the cause can not be reliably established lymphoma of origin, "says the release, although they specify that the ANMAT monitor the situation and the behavior of the products questioned with regard to the occurrence of cases of anaplastic large cell lymphoma (CLLA) in patients with bad implants.

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Possible causes of this type of cancer include textured / rough surface or polyurethane coated implants. But also the genetic base (the history of cancer) and possible contamination of the prosthesis.

"Therefore, until now, ANMAT has not ordered the withdrawal of implants from the market, in accordance with the measures adopted by European regulatory agencies (with the exception of France), the Food and Drug United States Administration (FDA) and, among others, Australia's Therapeutic Goods Administration (TGA), "the statement said.

The The ban concerns six prosthesis manufacturers, also used in Argentina. Affected prostheses include several models from the American manufacturer Allergan type Biocell. This texture is the Main cause of the onset of anaplastic large cell lymphoma (ALCL). Other models banned in France are macrotextured or polyurethane implants manufactured by Arion, Sebbin, Nagor, Eurosilicone and Polytech.

ANMAT calls people who have bad implants to "continue medical examinations and, in case of unexpected effect or problem, "go to the doctor.However, he says," this type of lymphoma badociated with bad implants it's a rare disease"

Among them symptoms they highlight the abrupt increase in bad volume, capsular contracture, ulceration, nodule / mbad, inflammation, pain or localized dermatological alterations.

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In the coming days, the Argentine organization will reopen representatives of technical and scientific societies to continue with the follow up of the subject. At the same time, "this will strengthen the interaction with foreign health agencies to evaluate the actions to be implemented".

ANMAT also emphasizes the responsibility of surgeons and patients. "It is important to remember that health professionals evaluate each of their patients in particular and inform them of the possible risks badociated with the use of this type of product, while evaluating in each case the relevance of the product. It is important to remind patients that they must follow their doctor's instructions and carry out routine checks, especially in the following cases: the occurrence of an adverse effect for its early evaluation. "