Hormonal implants divide medical entities after CFM restrictions
The debate on the use of hormonal implants and manipulated hormones gained strength with a clash between medical entities, specialists and regulatory bodies in Brazil following the recent restrictions imposed by the Federal Council of Medicine (CFM) for therapies for aesthetic purposes, gaining muscle mass and improving performance.
The topic also occurs amid discussions about access to treatment for Endometriosis, a disease that affects millions of women in the country.
While part of the medical community warns of risks and lack of scientific evidence, other professionals say that patients with chronic diseases may be harmed by discussions around the topic.
On the one hand, traditional medical councils and entities state that there is not enough scientific support for the use of manipulated implants in different situations and warn of health risks.
On the other hand, doctors linked to the Brazilian Society of Personalized Medicine (SBMP) defend the practice, speak of the "demonization" of hormone therapy and claim that patients with chronic diseases can be harmed.
CNN Brasil sought out regulatory bodies, medical societies and experts to understand the case.
Restrictions target aesthetic use, according to council
In a note to the report, the CFM (Federal Council of Medicine) stated that CFM Resolution No. 2,333/2023 "prohibits, in the practice of Medicine, the prescription and dissemination of hormonal therapies with androgenic and anabolic steroids when used for aesthetic purposes, gaining muscle mass or improving sports performance."
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In practice, according to the council, doctors cannot prescribe or promote this type of therapy when the objective is, for example, muscular hypertrophy, rejuvenation, weight loss or improvement in physical performance without recognized clinical indication.
The council also informed that the rule also prohibits "the use of testosterone without diagnostic proof of deficiency, the prescription of hormones advertised as 'bioidentical', in 'nano' formulation or with commercial nomenclatures without scientific proof of clinical superiority, in addition to the prescription of SARMs for any indication".
Despite the restrictions, the agency states that hormonal treatments remain permitted when there is proven medical indication.
"The CFM emphasizes that the rule does not prevent duly indicated medical treatments. Hormonal therapies continue to be permitted when there is a diagnosis, precise clinical indication, causal link between the deficiency or condition treated and the clinical condition, in addition to scientific evidence of benefit and safety."
According to the advice, diseases such as endometriosis, adenomyosis, menopause and other recognized clinical conditions can still be treated. The agency also stated that the measures are not intended to limit patients' access to necessary treatments.
The council also added that it monitors "with concern the use of generic clinical justifications to cover up aesthetic or performance purposes."
Diagnosis takes years
The debate about hormonal treatments occurs amid challenges related to the diagnosis and treatment of Endometriosis in Brazil.
A survey carried out by the Ipsos Institute, at the request of Bayer, revealed that 4 in 10 Brazilian women do not know details about the condition. The survey also highlights obstacles in diagnosis and access to treatment.
Among people diagnosed with a uterus, 77% say their symptoms have been minimized or disregarded. According to the research, this happens mainly in the family environment (41%) and in medical care, with 32% pointing to gynecologists as a source of invalidation.
Almost half of those interviewed (46%) heard that the symptoms could be the result of stress or tiredness, while 45% were classified as "dramatic" or "exaggerated".
Endometriosis is one of the main causes of infertility - d3sign/GettyImages
Gynecologist Rodrigo Mirisola states that "even with so many advances in discussions about women's health, we still see great negligence when it comes to pain and discomfort."
Chronic inflammatory disease affects around 10% of people with a uterus of reproductive age in the world, equivalent to approximately 190 million people. In Brazil, data from the Ministry of Health indicate a prevalence of between 5% and 15% of women living with the condition. On average, the diagnosis takes 3 to 8 years to be established.
The research also points to inequality between access to treatment in the public and private networks. While 50% of SUS users were prescribed contraceptive pills, the rate rises to 67% in the private network. More complex procedures, such as videolaparoscopy surgery, were offered to 20% of SUS patients, compared to 55% in the private network.
Experts dispute the use of manipulated products
FEBRASGO (Brazilian Federation of Gynecology and Obstetrics Associations), one of the main gynecology entities in the country, told CNN Brasil that it has maintained a position against the use of manipulated hormonal implants since 2018.
In the entity's assessment, the main problem is the fact that these products, when prepared individually in compounding pharmacies, do not go through the same process of clinical tests, industrial control and monitoring required for registered medicines.
In the report, the president of the entity, Dr. Maria Celeste Osorio Wender stated: "Febrasgo is probably one of the oldest entities in Brazil that is against the use of hormonal implants and manipulated hormones in gynecology."
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"We started the first positions in 2018, when we opposed the use at the time, which was somewhat restricted, there weren't as many as there are today, the main thing at the time was the subcutaneous implant of gestrinone."
The doctor states that, according to the entity's understanding, there is still a lack of studies capable of showing how these hormones are absorbed by the body, how long they remain active and what effects they can cause in the long term.
"These hormonal implants and all hormones made in compounding pharmacies, they are devoid of quality control, from Anvisa's point of view, there are no safety studies showing what the daily absorption rate is, what is the maximum peak they reach, what is the duration and what is the stability of these hormonal levels in the blood."
"And above all we don't have any kind of study showing clinical efficacy."
When asked about the possibility of patients running out of therapeutic options if these implants are no longer used, the entity's president said she does not see this risk.
Favorable group talks about "demonization" and impact on patients
In the opposite direction, the Brazilian Society of Personalized Medicine (SBMP) states that the debate around hormonal implants would go beyond the aesthetic discussion and could affect patients with chronic diseases.
In material sent to CNN Brasil, the organization states that "at least around 10 million Brazilian women who suffer from endometriosis" may have "their right to treatment threatened".
Society argues that, after the discontinuation of an industrialized medicine used to treat the disease, many patients began to depend on compounded medicines, including hormonal implants.
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The entity's president, Walter Pace, stated: "It is urgent to separate the wheat from the chaff in the public debate."
According to him, "the misuse of hormones for aesthetic purposes by unethical professionals cannot serve as a pretext to punish women who suffer from chronic diseases."
Endocrinologist Guilherme Renke, vice-president of the entity, stated:
"Trying to ban this practice in Brazil is ignoring global scientific consensus, legislation and the right of doctors and patients to personalized medicine."
The entity also raises the hypothesis of economic interests behind the debate and questions whether part of the resistance to implants could be linked to a "market reserve".
Offer remains visible on networks
Even after the restrictions imposed by the council, CNN Brasil found videos on public profiles on social networks of doctors associating hormonal implants with benefits such as improved performance, mood, libido and body composition.
In one of the videos analyzed by the report, a professional presents implants as an alternative for different clinical and quality of life objectives.
The report chose not to identify the professional at this time. The National Health Surveillance Agency was also contacted, but did not return.
Source: CNN