“He knows – Vignoli asks – that very often pharmaceutical reps come to us and instead of providing us with scientific literature they provide us with a photocopy of a magazine where it says that such an actress or such an actor uses this product and they say: you see, such an actor uses it and so it's a good product?”
Botox, fillers and slimming. There are many Italians who don't like themselves in the mirror. Those who find themselves dealing with side effects, sadly, too. Every year they are more than 1 million aesthetic operations: 35,000 for the breasts, 31,000 for the eyes, 25,000 for the noses. The rest are tweaks. The 85% of patients arewomen, especially between the ages of 35 and 50, but young women and men are on the increase. The problem, he said Reports in the episode of Sunday 1 November entitled Beautiful from Fear, “is that aesthetic medicine is free land: there are more checks and regulations for the restrooms of a pizzeria than for opening a clinic for human touch-ups. You can only trust the doctor – he summed up Milena Gabanelli -: if he is responsible he uses tested products, if he is more daring he experiments directly on the patient, using the innovations of pharmaceutical companies. If he then uses materials that are prohibited and devastates you, go and prove who did it, because invoices or medical records don't always turn around”.
To tell the other side of cosmetic surgery were competent doctors, other improvised and devastated patients, including Dawn Parietti And Marina Ripa di Meana. At the root of the problem, denounce those directly involved, there is the fact that there is neither surgery nor aesthetic medicine university specializations, as are for example dermatology and plastic surgery, those that are closest to the field of aesthetics. There are schools and specialization masters but they are not mandatory if you practice privately and since the Health Service does not cover aesthetic procedures, the risk of finding yourself in no man's land is not so remote. “The regulation is missing because there is no definition of aesthetic doctor and cosmetic surgeon, – Dr. Vignoli tries to clarify -, there is no regulation because there is no legal definition of where medical acts must be performed”.
Filler: poor controls
The fact is that on these products there are very few controls because they are classified as medical principals, that is, like a syringe or a thermometer, and even experimentation is almost always done directly on the patient. “Unfortunately, aesthetic medicine is a tragic sum of medicine and commerce - explains Maurice Vignoli, plastic surgeon - and the two things together can often get along and become deontology, often they don't get along. There may be great medicine, but a bad merchant”.
In the United States, home of beauty treatments, thefda has authorised 24 fillers; in Italy, the Ministry of Health, 123. “He knows – Vignoli asks – that very often pharmaceutical reps come to us and instead of providing us with scientific literature they provide us with a photocopy of a magazine where it says that such an actress or such an actor uses this product and they say: you see, such an actor uses it and so it's a good product?”.Emanuele Bartoletti, director of the International School of Aesthetic Medicine tries to clarify: “To get FDA approval you need to do a trial on a large number of patients, which means investing a significant amount of money from companies. I believe that to date, what is required by the Ministry is not sufficient to fully demonstrate this security. Unfortunately, some fillers that have been put on the market in recent years and that after six months were quickly withdrawn from the market because they gave problems are proof of this.”.
Cosmetic surgery patients or guinea pigs?
In the meantime, however, the patients have first turned into guinea pigs, then into victims. Because enticed by the prospect of being injected with the latest, perhaps permanent, invention, they overlook the fact that it is more dangerous. On the other hand, the doctor is silent and they trust: "Any filler can give a complication – explains Emanuele Bartoletti -. Even simple hyaluronic acid can give a nodule, it can give a granuloma, it can give an infection. But all of these usually these complications last as long as the filler remains. When the filler is reabsorbed the complication goes away”. If it's permanent, so is the damage.
See the liquid silicone, banned for 20 years, but still used by some doctors: “this is silicone – shows the cameras Mirella Seratini, a ruined patient and now in litigation -, what was taken out of my mouth in 2013, put in formalin because I wanted to see what was inside. They look like snakes, it's a disgusting rubber and I have all these things circulating in my body. I have it in my legs, I have it in my breast, in my armpit, I have it in my eye. And this situation is very serious because as long as external granulomas are formed they can be unsightly or create other problems, but if internal granulomas are formed, near the primary organs such as the heart, liver and brain, since this silicone oil, which is known to be silicone oil, is circulating in the lymphatic system, you die”. One of the most famous victims, fortunately without medical complications but only aesthetic ones, is Dawn Parietti: “my dream was to have a full mouth - tells -. I met a real criminal on my way, and at one point this lady convinced me to get my mouth done saying it was collagen, instead since collagen costs much more…” he injected the immovable silicone.
Slimming cures
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'another sore point struck by Reports is that of slimming treatments: too many doctors prescribe anorectics to quickly remove weight from non-obese patients, often without subjecting them to preventive examinations. These substances can expose patients, unsuspecting, to cardiovascular risks. To the point that the prosecutors are also investigating cases of deaths. One of them is Louis Marzulli, 39 years old, an officer of the Guardia di Finanza, who in 2008 – when it has already been banned for ten years – begins to take phendimetrazine, prescribed by an endocrinologist in galenic preparation: after 9 months of treatment, Luigi, who was convinced that he was undergoing a natural slimming cure, died of cardiocirculatory arrest. The first instance sentence acquitted the doctor of the charge of manslaughter but specified that the dosages were beyond the norm. The appeal is ongoing. While the Public Prosecutor's Office requested the indictment of 5 managers of the Ministry of Health, a captain of the Nas and 4 pharmacists. Investigations also open phenylproponolamine, prescribed to Mrs. Karageorgiou, suffering from cardiovascular collapse. He was 45 years old and had been under treatment for 5 years by Antonio Favella, the VIP endocrinologist, famous for his slimming treatments, now under investigation for this and other cases. Furthermore, in both cases, it would have been cheating on height to classify as obese those who are not obese.
In short, far from wanting to demonize beauty treatments and slimming cures,Reports told the (dangerous) nebula upstream: “We are not making the mess – Gabanelli specifies at the end of the episode -. To say: in 2008, when phendimetrazine was prescribed in galenical preparation, was it forbidden? Well, the director general of the Ministry of Health, Marcella Marletta, wrote in August 2011: 'Yes, it is forbidden'. Well, a few days ago the Ministry itself, which prefers not to respond to us, wrote to us: 'No, it wasn't forbidden'. Then agree”. For the patients to remain so and not turn into guinea pigs who have to deal with the damage and the insult. When it's good, that is.
Ed.: we inform Dr. Vignoli that the representatives of fillers or other materials used in cosmetic surgery are not scientific sales reps of the drug or, as he says, pharmaceutical reps, but sellers of devices (Legislative Decree 46/97). These sellers are not subject to the provisions of the Legislative Decree 219/06 which regulates the activity of the Scientific Representatives of the drug. It would be a bit like confusing cosmetic surgeons with beauticians, with all due respect to the latter (and device vendors).
Related news: Italian Society of Medicine and Aesthetic Surgery (SIES) regarding the episode of the report: Request for Correction
Related news: Medical devices. Court of Auditors reports exceeding the 2014 ceiling of 888 million. Only 4 regions respect the limits
Source: Court of Auditors hearing on the 2016 Stability Law
