Finally, the FDA has not followed France's guidelines and will not suspend macro-textured prostheses

After the public hearings held by the Food and Drug Administration (FDA) March 25 and 26 on the relationship between some models of silicone prostheses and a type of cancer, the long-awaited resolution of the US regulator finally arrived yesterday.

The agency has published a report stating its position on the Relationship between the formation of anaplastic large cell lymphoma (ALCL) and some models of macrotextured prostheses.

The report was expected with hope after the controversy sparked by the suspension by the National Agency of Health Products of France (ANSM) of specific models of six brands of implants, decision that was not followed by no other European regulatory body. nor international and has been criticized by scientific entities around the world.

We think that there are more than 15 million bad implant patients worldwide over the last ten to fifteen years, a period during which cases of the disease began to appear, reports of which began in 2007 and, to date, 457 cases have been detected worldwide.

"International studies indicate the multicausality at the origin of lymphoma, there is no conclusive evidence that it is only the type of texture on the surface of the prosthesis that causes the disease, including including genetic, racial, inflammatory or infectious causes, the type of access and placement of implants among others. ", the FDA said in its statement.

The main conclusions of the statement made yesterday by the North American agency are:

– secured that women have access to the information they need about bad implants to make informed decisions. Continue to promote the production of scientific evidence that will help the FDA make appropriate regulatory science decisions.

– Focus on the generation of scientific evidence.

– Improve the information available to women and health professionals about the risks badociated with bad implants.

– Periodically update reports on known global medical devices for ALCL.

– Inform gynecologists, dermatologists, internists and pathologists of the risks badociated with bad implants.

– Change the way bad implant manufacturers submit medical device reports to the FDA.

– Join unwanted event records such as PROFILE and NBIR for more scientific evidence.

– Do not prohibit any type of bad implant based on any scientific data and information available to date.

– Based on scientific data: Although the majority of women who develop ALCL lymphoma have a textured implant, there are some known cases in women with smooth-surface implants and many reports do not include the type of texture of the implant at the time of diagnosis.

The Argentine Society of Plastic, Aesthetic and Reconstructive Surgery (Sacper) said it was "busy and concerned about the presentation of eight cases in the last 15 years on about 500,000 to 600,000 implanted women". "We have created a national registry, which is informed online of international entities and the FDA that carry out the most important research in this area.We are constantly informing the scientific community and plastic surgeons of our country," said the specialist in surgery. plastic and repair and president of Sacper, Esteban Elena.

"We held consensus meetings in 2018 and we are in direct contact with the Argentine Mastological Society and the Argentine Society of Pathology and Hematology and we have written a very comprehensive joint report published earlier this year" , he added.

Jorge Pedro, specialist in plastic surgery and director of communication for Sacper, stressed that "Of the total number of women operated in the country, only about 3% are controlled each year" and recommended "consult the surgeon once a year, during routine gynecological badessments" because only the specialist will quickly detect "the beginning of a retractable capsule, a rupture of the prosthesis and proceed to the early diagnosis of this type of diseases, which guarantees total healing ".

Women who undergo bad implant surgery need to know that "they have a foreign body in their bodies for life and only annual consultation can prevent complications," he concluded.