The president of the Federal Council of Medicine (CFM), José Hiran da Silva Gallo, criticized the decision of the Regional Council of Medicine of the State of São Paulo (Cremesp) to ask the National Health Surveillance Agency (Anvisa) to determine the prohibition of the sale of products based on polymethyl methacrylate, known as PMMA, in general health or aesthetic procedures.
The request made by Cremesp to Anvisa was made last Friday (5), in the same week that digital influencer Aline Ferreira, 33 years old, died after complications resulting from the application of PMMA to her buttocks.
In a letter sent by Gallo to the president of Cremesp, Angelo Vattimo, the CFM says that it received with “extreme astonishment and dismay” the news about the request made by the state council to Anvisa “by unilateral act and without prior consultation”.
The CFM classified Cremesp’s request as a “unilateral act and devoid of prior consultation” and asked that Cremesp “not usurp the powers and competences of this Agency, limiting itself to acting on regional issues specific to the state of São Paulo and respecting the competence of the CFM at a national level”.
“In view of the above, we determine that this Regional, within a non-extendable period of 24 hours, promote the withdrawal of the aforementioned legal action and, additionally, rectify the notification sent to ANVISA, rendering it ineffective”, says the letter.
“If the steps are not taken within the established period, we will proceed with the formal public and official disauthorization of the acts issued by this Regional”, he adds.
In the message to Cremesp, Gallo stated that he would have a meeting last Thursday (11) with the president of Anvisa, Antônio Barra Torres, to discuss the PMMA issue.
What does the CFM say?
Wanted by CNN the CFM says that it “remains firm in its crusade” with Anvisa “to restrict access and sale of these substances to non-physicians” and points out that, in the organization’s understanding, “only physicians have the training and qualifications for the use of these substances, as well as the preparation to act – in an emergency manner – to reverse any adverse effects resulting from them”.
The federal council states that it “considers that the problems arising from the use of these substances are not related to them themselves, but to the lack of preparation of individuals who use them inadvertently, putting the health and life of the population at risk”.
“The CFM’s decision to the São Paulo Regional Medical Council (Cremesp) to suspend civil action against Anvisa addresses a question of legitimacy and jurisdiction of administrative and legal acts. It is up to the CFM, as the head of the medical council system, to conduct acts at the federal level. At the state level, each CRM can and should act, but in the case of Anvisa, this responsibility falls to the CFM, under penalty of illegality of other initiatives,” says the federal council.
“Aware of its duty to protect the health of the population and to defend the ethical and competent practice of medicine, the CFM will continue to act – in all possible instances – for greater control and rigor in the access, commercialization and sale of phenol, PMMA and other substances used in invasive aesthetic procedures, which, when performed by non-physicians, have resulted in countless cases of sequelae and even deaths of patients”, he concludes.
What does Anvisa say?
Anvisa did not comment on the letter sent by CFM to Cremesp, but confirmed the meeting held last Thursday with the president of the Federal Council of Medicine, “in which several topics within the jurisdiction of the two agencies were discussed”.
“The Agency is analyzing all the evidence and information presented, reiterating its commitment to the mission of guaranteeing the safety, efficacy and quality of products used in the health area, aiming at the protection of the consumer patient”, states Anvisa.
Regarding Cremesp’s request to suspend the sale of PMMA, the regulatory agency said that it “is aware of the concerns raised and has begun a detailed assessment of the case”.
Cremesp was approached by CNN but did not respond.
Source: CNN Brasil
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