France, São Paulo and Brasilia France banned the sale and use of textured silicone implants from six manufacturers associated with rare cancer, according to the National Agency for Health Products (ANSM).
Despite the decision, the agency does not recommend removing women with implants of this type as a preventative measure because the risk of illness is low.
Since 2011, there have been about 60 cases of large cell anaplastic lymphoma (ALCL) in the universe of 500,000 women with prosthetics. The disease usually occurs after fluid leakage around the prosthesis. Almost all cases included women with prosthetic prostheses; three died.
The right vet includes less than 30 percent of all breast implants sold in France and is used as a precautionary measure to "reduce women's exposure to textured and rougher implants that are a risk factor," said Christelle Ratignier-Carbonneil. , Deputy General Director of ANSM.
Forbidden dentures include several models of the American Allergan manufacturer, the type Biocell. Other prohibited models are macro-textured or polyurethane implants that produce Arion, Sebbin, Nagor, Eurosilicone and Polytech.
In December, Allergan's textured dentures lost the EU's certificate of conformity.
In the statement, Anvis (National Sanitary Inspectorate), which is responsible for prosthesis regulation in Brazil, reports that it "has contributed to all the information available in the world about the safety profile of these products."
One of the producers notified by the French agency, Allergan is the subject of a recent agency analysis.
On December 21, 2018, the agency temporarily suspended the import, marketing and use of four company implants after the first decision of the French agency.
The measure, taken preventively, was revised at the end of March. According to Anvisi, data from the company was requested during the suspension period. The Agency also consulted the positioning of regulatory agencies from other countries and requested studies from Fiocruz.
Product Safety is a recent topic of two international forums.
"It has been established that there is no proven correlation between the use of different types of implants and the development of ALCL (anaplastic lymphoma of large cells)," he said.
Anvisa also says she consulted Notivise, a reporting system of side effects, looking for problems with the implants.
In this case, out of 32 valid breast implants registries in the country were 151 notifications; two are related to the textured breast implant. The agency did not specify the content of the notice, but stated that it was a problem.
Níveo Steffen, chair of the SBCP (Brazilian Plastic Surgery Association), says the decision of the French agency has no international community certificate and the rate of cancer associated with the implants is low. "There are 457 cases of this lymphoma cataloged in the world, 12 cases in Brazil. There is nothing that justifies urgent action and puts patients insecurity and nothing indicating that they must remove dentures."
Behind the scenes, the toughest measure of the French agency is seen as a reflection of the scandal in the country in 2010 with PIP prostheses filled with industrial silicone. Brand implants can be easier to break, causing irritation and inflammation. In 2010, French authorities banned the bankruptcy factory.
According to Steffen, Brazil has 250,000 breast augmentation operations per year – in the United States there are about 300,000 operations. He says it has been observed that denture textures, which can give a more natural appearance, can cause a more intense inflammatory reaction and so-called capsular contracture. "But then this kind of denture proved to be very reliable, safe and resistant."
Allergan says he does not agree with the decision to restrict the use of textured implants for breast and polyurethane implants in France because no new scientific evidence has been presented. "Allergan firmly believes in the profile of the risks and benefits of its products, including all textured breast implants."
In a note published by the Brazilian Plastic Surgery Society in December, the company reported lymphoma events in a ratio of 1 case to 500,000 operations in 1.6 million breast implants worldwide.
According to Fiocruz's studies, quoted by Anvis, the use of prosthesis increases the risk of anaplastic lymphoma of large cells associated with breast implants, although it is not possible to establish a causal relationship.
Prostate Questions and Answers
How do I know the type or type of your prosthesis?
Generally, information is available on the surgical and implant card report delivered after surgery. If you do not have them, go to the surgeon or hospital where you had surgery.
What are the signs that there are problems?
The woman may feel a softened, flattened breast or denture hardening. Not always women show symptoms, so monitoring should be constantly in consultation with the gynecologist.
What's the problem in French prostheses?
The French health monitoring agency has decided to ban textured implants by linking them at greater risk of large cell anaplastic lymphoma (ALCL). Since 2011 there were 60 cases in the universe of 500,000 women
Do I have to change the implant?
No, the French agency does not recommend the exchange. In case of doubt or symptom it is advisable to look for a plastic surgeon
Can textured prosthesis cause cancer?
International health studies and agencies, including Brazilian Anvis, say it is not possible to establish a direct link between implants and cancer