In Argentina, eight cancer cases linked to prostheses have been banned in France

The news has spread like wildfire since the French National Agency for Health Products (ANSM) issued its statement. French Agency for the Safety of Medicines and Health Products banned the use in this country of several models of bad implants badociated with a strange type of cancer.

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.

In Argentina, eight of the 400,000 patients operated in the last ten years have been reported (The choice of the period chosen for follow-up is given because this type of injury appears between eight and ten years after the insertion of the implant).

"It is a pathology that originates in the capsule that surrounds the implant and is easily detectable in the early stages because It manifests itself as a seroma, which is the formation of fluid around the prosthesis, which causes inflammation of the bad, "he explained. Infobae the president of the Argentine Society of Plastic, Aesthetic and Reconstructive Surgery (Sacper), Esteban Elena.

The specialist doctor in plastic surgery and repair said that "the bad is inflamed, so it is easy to detect" and argued that when this occurs "indicates a puncture of this liquid, which is sent to badyze and if the result is positive, it is Remove the capsule and solve yourself. "

"It's a type of cancer that appears in the fibrous capsule that all implant-bearing patients have," added Jorge Pedro, a specialist in plastic surgery at the university and director of communication. to Sacper.

On the possible causes of this type of cancer, Elena badured that "they can be multiple and there are four different theoriesOne point on the texture of the implant, another states that the cause is a conical inflammation around the implant, others on the emergence of the implant. a Gram-negative bacterium in the area or that it's a genetic problem. "

The specialists consulted by this means agreed to emphasize the "low incidence" of this type of cancer. "It's very infrequent (one patient in 50,000 depending on geographic region), he's very smart and he's badociated with implants with macrotexture does not mean that they're the cause," Elena said. , for whom, compared to bad cancer, whose incidence is one case every eight women, "there are many things to take into account is that when the case is badociated with surgery as a aesthetic mastoplasty, it has a lot more impact. "

Pedro has posited the paradox that this type of warning is related to macropersive implants, which are the most recommended in the world "for their proven cases of requiring fewer reoperations, presenting a better postoperative, developing fewer retractable capsules, among other benefits "

And after considering that "the FDA would not determine in principle the ban", just as no other country in the European community has followed the indication of France (Belgium , Britain and Spain have made statements against the ban), he suggested that the French agency "has exceeded the limits of controversy PIP prosthesis, which this week marks the ban was issued this week and in which case the regulator had not alerted the problem. "The controversy surrounding the involvement of PIP implants erupted in 2010, when it was discovered that the prostheses manufactured by the French company Poly Implant prosthesis They were made with industrial grade silicone, without medical grade, without probate.

"From that moment on, whenever something happens with an implant, the French regulator acts preventively," said Pedro, who pointed out that "currently"Most prostheses implanting patients do not appear on the list of prohibited drugs.: microtextures and smooth, which are the most used, are not prohibited.

The problem has been alerting the medical community for more than a decade, as cases have begun to be known, but only recently, because of confirmation of the total number of affected women released by the FDA to : March and the ban launched yesterday by France.

"In the Sacper, we have a special commission set up two years ago for the study, monitoring and surveillance of this pathology, which is why we now have the opportunity to recognize the eight cases existing in the country, "reported Elena, who pointed out This company" collects information on cases and submits them to a global registry in the United States in order to centralize the incidence at the global level. "

Last August, an intercorporate meeting was held between the companies of Mastology, Plastic Surgery, Imaging, Pathology and Hematology.Elena emphasized the development of a joint paper, published in February, and an interdisciplinary approach to this pathology "which is very rare, easy to diagnose and heal when it is detected in time".

Among the cases reported in Argentina, "one or two were more advanced, but we must also take into account many factors, such as the patient sometimes has this implant for bad reconstruction and presents a fundamental pathology such as cancer. bad who already has it immunocompromised with which sometimes in advance can be faster.

Prostheses of controversy
In all there are six manufacturers involved in the measurement. Prohibited prostheses include several models that are no longer used in the country.

The list published by the French health agency The complete list distributed by the French agency includes Natrelle models (anatomical and rounded) of the Allergan brand; the textured monoblock (anatomical and round) of Arion; the anatomical model filled with Sebbin silicone gel; three models of the brand Nagor (round GFX, round Impleo and anatomical Cogel); the Matrix anatomical model of Eurosilicone and four of the brand Polytech (line Poly TXT sublime, anatomical and round shape, Poly TXT diagongel / 4TWO, anatomical shape, and the line Microthane Sublime, anatomical and round and Microthane diagongel / 4TWO, these two products latest of its range of implants coated with polyurethane).

Pedro pointed out that of the above, several models are already out of date and that in Argentina, only "Allergan and Nagor macros, polytech polyurethane, and anatomical Eurosilicone and Sebbin, both macro-textured, used for bad reconstruction" are used.

What are the recommendations for women with implants

"The overall recommendation to patients with implants is not to remove it, but to know that they must be under control, as usually happens with all patients," Elena said.

In so many points Pedro pointed out that "of the total of women operated in the country, only they are controlled annually around 3%" and recommended "consult the surgeon once a year during routine gynecological examinations" since only the specialist will be able to detect early "the beginning of a retractable capsule, a rupture of prosthesis and make the early diagnosis of this type of diseases, which guarantees a total cure".

Women who undergo bad surgery must know that they have a foreign body in their body for life and only annual consultation can avoid complications. "

In addition, Pedro warned "that there are still operations in very small clinics or clinics" and reiterated the advice "to operate in safe places and infrastructure".

"The titles published in the newspapers since yesterday are scary. the last thing to do is to alarm the population"Elena has finished.