Storm for the ban in France of the most used breast implants

"As a precaution," the French National Agency of Public Health (ANSM) has today banned the use of several models of bad implants badociated with a rare form of cancer. The decision has put medical companies in several countries on alert and has prompted strong criticism from the International Society of Plastic Surgery (Isaps).

According to AFP, the ANSM has taken this decision "in the face of a significant increase since 2011 in cases of large-cell anaplastic lymphoma (CLLA) badociated with the use of bad implants", a rare form of cancer of the capsule inflammatory surrounding some bad implants and this is often manifested by a spill of fluid around the prosthesis.

At a press conference in Paris, the agency explained that of the approximately 500,000 women in France with prostheses in France, 59 cases of cancer were detected. Three of them are dead. Apparently, the tumors are badociated with macrotextured prostheses. "We have no scientific explanation, but that's what we found," said Thierry Thomas, deputy director for medical devices at ANSM.

For its part, the reaction of Isaps was immediate. In a statement, while respecting the decision taken, notes that "this disease is rare and, above all, easy to treat in the early stages and even in the most advanced cases. (…) We are concerned about the recommendation to use only Smooth implants because, on the basis of factual data, the rates of complications and reoperations badociated with these are higher [que con los texturizados]"

In addition, regulators from England, Belgium, Italy and Spain have stated that they do not support the decision of France.

numbers

According to the FDA, between 5 and 10 million of these prostheses were implanted in the world and 457 of these cancers were registered until September 30, 2018. Among them, 310 were badociated with textured prostheses and at least 24 prostheses, although these figures are not clear.

"In Argentina, there are eight confirmed cases among about 400,000 operated," says Dr. Jorge Pedro, director of communications and press at the Argentine Society of Plastic and Reconstructive Surgery (Sacper). "On March 25 and 26, the FDA has an international meeting with 40 referees (from medical, manufacturing and patient companies) to badyze the problem, but for now, it has not made any decisions. last August with the companies of Mastology, Pathology and Hematology and have developed a joint document that was published in February, we are constantly talking to clarify the rest of this topic. "

Some hypotheses suggest that the inflammation caused by the friction of the implants against the tissues could be the cause of this cancer. On the other hand, it is an immune response, but the truth is that scientists are still navigating in an ocean of uncertainty.

"The first case of" anaplastic large cell lymphoma "was described in 2007 – explains Martín Colombo, coordinator of the committee monitoring this disease of the Sacred and representative of the global network of this disease – This is not a cancer Breast It develops in the lymph nodes around the prosthesis and it is only in 2016 that the WHO gave it a name. "

According to Colombo, the complication surprised them because it was recommended for 20 years to use textured prostheses, not only 20% more expensive, but also considered better. "The incidence of this condition is extremely low," says Colombo, "the texture of the implant seems to be in question, but there may be others of an immunological, genetic and even ethnic nature (the Asians of the is Asian do not present it, but only appear in Caucasians) ".

There are several types of bad prostheses and all plants produce textures. "It was an improvement over smooth surfaces because they had certain advantages: in some cases, they have better esthetic results and avoid certain complications", says Colombo, "given the low incidence of this lymphoma, it is not not indicated to remove the implants, but rather to the patients and to do an annual ultrasound (between 5 and 10% of the women.) For the moment, there is no other recommendation. "

The most common symptom with which anaplastic lymphoma develops is spontaneous bad inflammation. Before the consultation, the doctor indicates a puncture to badyze the fluid surrounding the prosthesis and confirm the diagnosis. Taken at the moment, this type of cancer is cured by surgery. "The implants and the bad capsule are removed, and do not put them back in place."

Until last year, 70% of implanted prostheses were of the textured type; Now this number has dropped to 55%.

The French ban applies to macrotextured (very rough) bad implants of the same type as Allergan's American Biocell, which bore many of the 59 women who developed this cancer, as well as prostheses with polyurethane coating. However, he does not recommend to remove them (because, he badures, "the risk is negligible"), and does not prohibit their manufacture.

In Canada, 22 confirmed cases and 22 suspected anaplastic lymphomas have been recorded. Health Canada, the health authority of this country, will be conducting a review of the prosthesis in question next week.

The numbers that sparked the controversy

• 5 to 10 million: This number of implants is what the FDA has estimated to have achieved with the prosthesis in question around the world. In addition, the agency recorded that there were 457 cases of a rare form of cancer until September 30 last
• 400,000 implanted prostheses: This is the number of operations carried out in the country. Among them, eight cases of this type of cancer have been found
• 500,000 implants: This is the number of prostheses that have been placed in France. Of this total, 59 women with cancer have been identified