Botox, hyaluronic acid wrinkle ... 600 000 doses are injected per year in France. These injections may cause, depending on the products, reactions. Currently, severe side effects are between 0.1 and 1%.Contents of this article
- Dermal fillers are not medicines
- Resorbable wrinkle products: rare and minor reactions
- The various wrinkle fillers
"After the scandal of PIP prostheses, the next may be that of fillers. "Excessive written statement, probably under the influence of emotion by some newspapers. The French Agency for Safety of Health Products recommends not to confuse. It has also just published the results of its inspection campaign of 2009-2011: the majority of manufacturers and distributors properly control the production, sterilization and traceability of their injectable wrinkle fillers. A hyaluronic acid gel manufacturer did not meet the essential requirements imposed by the CE marking, the agency suspended him.
But as breast implants, the fillers are "medical devices", they follow the same rules as the implants. Clearly, they are not considered drugs and therefore only need the CE mark to be allowed to be placed on the market. Only the botulinum toxin is different because it has drug status.
A medical device, what is it?
Originally, these fillers are from an extension of the use of volumes of filling devices used for bodily or facial reconstruction. Introduced into the skin using a prefilled syringe, and intended to remain in place over thirty days, they must meet the definition of a long-term surgical device. Forcing the manufacturer to provide a certain amount of data proving their manufacturing standards, performance and safety. "Unfortunately, most of the required tests are carried out for short periods, and too few people to ensure the absolute safety of such products," notes Dr. Xavier Deau, vice president of the National Council of the Order of doctors, in charge of relations with the university.
What differentiates the medication?
"Subject to strict regulations, the drug is marketed only after obtaining a permit objective and measurable proving its effectiveness and its direct interest in health through clinical studies conducted over several years, involving thousands people, and a rigorous, repeatable methodology, "commented Dr. Annick Pons-Guiraud, dermatologist allergist. The risk / benefit ratio is not comparable to the product used for cosmetic purposes.
"Above all, because the person is not sick. This does not mean that any product for aesthetic purposes can be placed on the market, recognizes Nicolas Thevenet, head of market surveillance department of medical devices Afssaps. But in ten years we have gone from a rather confidential practice to a growing market, with more than a hundred injectable products marketed in France by twenty-six manufacturers. Hence the need to be more attentive to new substances and to review the CE marking directives. "
That guarantees the CE marking?
This European directive, created in 1993 and amended in 2007, requires manufacturers to provide tests showing the safety and performance of their products, and have them evaluated by an independent body authorized to issue the CE mark. "This is a quality label, but it is insufficient because it provides no guidance on the acceptability, in the short and long term, of a product by the human body. However, an injection is a medical procedure that requires security that goes with it, "says Dr Pons-Guiraud.
"Currently, most studies are performed provided by the manufacturer, adds Dr. Martine Baspeyras, dermatologist. They are neither sufficient medical nor truly independent. Faced with the onslaught of new products, the authorities should therefore require more comprehensive studies, including on tolerance and side effects with, for example, a retrospective study over several years and several countries to rely on a significant number of injected people ".
This marking it is sufficient to ensure patient safety?
" Certainly not. Regarding injectable dermal fillers, Afssaps is in a sort of "no man's land" because the products are not without risk and deserve stricter controls especially made unexpectedly "says Dr. Deau .
For Dr. Patrick Bui, plastic surgeon, CE marking is not sufficient either, because "it does not prejudge any possible side effects." This explains also that some products are regularly withdrawn from the market or by the manufacturer itself as Dermalive, nonabsorbable and causing severe reactions, or at the request of Afssaps, as the recent Novabel . "Medical device manufacturers should be subject to the same constraints as the pharmaceutical manufacturing laboratories, in particular with the obligation to use ingredients known and not vary from batch, said Dr Martine Vigan, dermatologist at the University Hospital of Besancon. Moreover, monitoring after placing on the market, should be more rigorous, and the results of investigations published regularly. "
Good to know: seven pharmaceutical companies manufacture injectable fillers: Allergan, Juniper, Q-MED-Galderma, Merz Aesthetics, Pierre Fabre, Sanofi, Vivacy.
Is the stricter US regulations?
"Yes, she is a good intermediary between the CE marking and the marketing authorization of a drug, as it requires independent clinical studies, more serious, more and over a longer period than those required for CE marking" replied Dr. Bui. A shared view, since during its annual conference held in Paris in January, IMCAS recommended that injectables are submitted as soon as possible to authorization similar to that of the Food and Drug Administration.
The numbers are revealing: while twenty-six labs market their products in France, only the Q-Med Laboratories and Allergan are allowed to sell their range of hyaluronic acid in the United States. "Since we can not limit the market, we want a reinforcement of the European regulation on injectables. We could imagine a process in which the competent authorities, through a committee of European experts could give their agreement on certain products, "offers Nicolas Thevenet.
Like any introduction of a foreign body in the skin, injecting an absorbable hyaluronic acid gel may cause transient skin reactions usually disappear after a few days. The reactions are rare and minor except severely allergic or suffering from an autoimmune disease.
What are the risks ?
In the vast majority of cases, the degradation of hyaluronic acid is complete, and if there is reaction, it disappears with the product. Regarding the volumizing, injections require more precaution to avoid any risk of infection because they are acts of small surgery. "This requires even more precautions and aseptic" insists Dr. Bui.
The most significant risks are related to the injection of a non-resorbable product and remain infrequent. According to available data Afssaps, 600,000 doses are injected per year in France, and severe adverse reactions are between 0.1 and 1%. Making it all the same, from 600 to 6000 problems for interventions aimed to embellish ... and Afssaps acknowledges, the safety data for repeated injections are insufficient.
What to ask the doctor?
On this theme, all opinions converge. Before any treatment, you must tell your doctor your medical history, allergies, and potential treatments. "But also tell him of previous aesthetic treatments because injecting an absorbable product on a nonabsorbable, even many years after, can cause undesirable side effects," said Dr Pons-Guiraud.
It is also important to ask the characteristics of the product he intends to inject its life, potential side effects. Better to avoid too new products, the decline is insufficient to obtain reliable answers. Finally, remember to ask for a quotation, then, on the day, a "treatment logbook" in which will be registered the product name and manufacturer, lot number, indications and the injection site . Much information needed to maintain and provide before you make a new injection.
All injected products that fill wrinkles or give volume are not equivalent, but they nevertheless fall under the same regulatory power despite variable absorption! Botulinum toxin is, too, resorbable, but it obeys the rules of the drug.
The "absorbable" products have a duration of action of three to six months. They are hyaluronic acid gel.
Products "slowly absorbable" have held up to approximately eighteen months. This group includes hyaluronic acid gels prepared to last longer, a product with calcium hydroxyapatite microspheres and based on polylactic acid, whose safety is no consensus.
The "non-absorbable" remain in the skin, as their name suggests. These products are the subject of much criticism, for it is they, above all, that caused harmful allergic reactions. In October 2011, Afssaps still lived both on the French market: Redexis and Aquamid. "It is not, however, be stigmatizing, since they are used in reconstructive surgery, particularly in cases of bone loss. However, their use should be limited to this type of indication. Rightly, Afssaps advises against their use in aesthetics, but this is not enough and should quickly address the issue, "Dr. Patrick Bui nuance.
"Inspections Campaign 2009- 2011. injectable wrinkle filler products", Afssaps, in February 2012.