Facts about Dermal Fillers You Did Not Know
Injectable medical devices for filling skin depressions are used for the most part in filling facial wrinkles by injecting a gel in the dermis. Since they are invasively introduced using a syringe, they meet the definition of a long-term invasive surgical device and are supposed to remain in place for a period of at least thirty years. They also follow the same classification rule as implants.
They come from an extension of the use of devices for filling body volumes, qualified as medical devices by their action of anatomical modification of the patient, and used for reconstructive purposes in the treatment for example of facial lipoatrophy, scar or morphological asymmetry.
The benefit-risk balance of a medical device in a medical indication is different from that of a device used solely for cosmetic purposes, such as wrinkle-filling products. While the benefit provided by a device in a medical application is objective, measurable, and has a direct interest in the health of the patient, the success of an aesthetic intervention is mainly related to the feeling of the person.
As for the risk assessment, an acceptable risk with regard to a significant medical benefit will no longer be considered with respect to a single aesthetic improvement.
Their “invasive” characteristic and their wide use for people imply potential complications. These devices, therefore, require special surveillance by health authorities in terms of market control and vigilance.
Today, dermal fillers are a big part of cosmetology, and a number of specialists are actively conducting practices of treating skin with dermal fillers. Dr. Chloé Sylvestre is a specialized medical professional who has benefitted from a rich experience of over nine years in cosmetic dermatology and aesthetic medicine.
She is the Founder of Clinique Chloe in Montreal, a highly reputable cosmetic dermatology clinic in Montreal, Canada. She is a renowned expert, having handled over 50,000 patients and attending to their cosmetic needs. Dr. Chloé has also widely contributed to the development of aesthetic medicine, raised awareness about the contemporary facts about dermatological treatments, as well as helped doctors across Canada to establish their careers in aesthetic medicine.
Products based on hyaluronic acid
The first wrinkle-filling products were based on the collagen of bovine origin, for which a preliminary skin test was important in order to prevent allergic effects. Quickly, manufacturers have sought to obtain weakly non-allergenic products hence the appearance of the first compounds based on hyaluronic acid (HA). Indeed, HA is a natural component of connective tissue and synovial fluid in humans as well as in many animal species. In wrinkle repair products, the HA used is not in its native form.
Initially, HAs were extracted from a rooster’s crest. In particular, to increase productivity, they are now manufactured by bacterial bio-fermentation. To increase the duration of the filling effect, the HA thus produced is chemically modified by molecules called “crosslinking agent.” It is different from naturally occurring HA in the cells of the body.
Sterility and injection
The products for filling wrinkles are most often in the form of syringes pre-filled with gel ready for use. They are sterile and must meet the requirements of the pharmacopeias anywhere in the world, that is to say, be limpid (absence of particle suspension) and pyrogen-free. Some products require, for their part, a solution prior to their injection.
The injection of the product into the skin is of the conventional “intra-dermal” type, but it requires to comply with the instructions given in the leaflet, particularly about the location of the injection of the product. It depends both on the vascularization of the injected area and the nature of the material that mainly consists of the filling gel.
