The perfect filler still elusive despite a myriad of choices

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Some European fillers promise a high safety profile, then later demonstrate unwanted adverse events
As a result, many aesthetic physicians overseas have become wary of new products and have downsized the list of fillers they offer

Dr. Wu

The definitive safety of a dermal filler needs to be proven to the FDA in no uncertain terms, a fact reflected in the sometimes arduous road to approval. Because of this strict process, overseas physicians may seem to have an advantage over their U.S. colleagues, as receiving a CE mark can be somewhat easier to achieve. This results in more devices — thus more aesthetic options — for cosmetic practitioners abroad than their U.S. counterparts have. However, the strict FDA guidelines sometimes justify their rigidity when some European fillers that at first promise a high safety profile later demonstrate unwanted adverse events. Polyalkylimide, for example, is a compound that a recent study showed has a much higher incidence of adverse events than originally thought. As just the latest example, many aesthetic physicians overseas have become wary of new products and downsized the list of fillers they offer to stay on the safe side.

THE NEW CONSERVATISM "I'm not an advocate of any of the new fillers and have become very conservative over the years mostly due to adverse events that occur from new fillers that over-promise and under-perform," remarks Woffles Wu, M.D., of the Woffles Wu Aesthetic & Laser Center, in Singapore. Instead, he advocates the NASHA technology found in fillers such as Restylane, Perlane and Macrolane, as the safety profile of these fillers is proven and consistent. Many of the new fillers either rehash the hyaluronic acid (HA) technology, increase the number of cross-linkages, increase the saturation of the particles or mix the particles into an HA substrate. Microparticles of different sizes are used to prolong their effect. Dr. Wu tells Cosmetic Surgery Times that having these particles in the body opens up a Pandora's box and may result in foreign body granulomas later in life — anywhere from a month to years following the procedure.

"I find that those fillers that have microparticles in them also tend to have more complications," Dr. Wu states. "I believe that the disadvantages with these newer fillers that do not use HA overshadow any of the advantages they supposedly promise. We need to be extremely judicious in the fillers we use and it is simply more advantageous to stick to fillers proven to work and avoid these terrible adverse events."

Dr. Bergeret-Galley

A PERMANENT NEED "The good fillers are definitely the resorbable fillers because if complications occur, the complications will not last forever," says Catherine Bergeret-Galley, M.D. "Nevertheless, permanent fillers are needed in certain cases such as in HIV patients with lipoatrophy and their pathology may require an overzealous approach in treatment." Dr. Bergeret-Galley is a board-certified plastic surgeon, senior resident and clinical assistant at the faculty René Descartes (Paris V), a consultant in plastic post-traumatic and handicap surgery in Garches, France, and, additionally, is in private practice in Paris.

Understandably, HIV patients do not want to receive repeated injections to correct their lipoatrophy condition, making them perfect candidates for permanent fillers. However, choosing the proper filler is not easy because, according to Dr. Bergeret-Galley, none of the permanent fillers now available on the international market is totally safe. "HIV patients exhibit a low level of complications most likely due to their compromised immune status. These 'good' results should not be erroneously thought to be achievable when injecting immune-normal patients with the same filler," Dr. Bergeret-Galley explains. Newfill (not FDA approved) and Sculptra (FDA approved for lipoatrophy) are two resorbable fillers that may not be ideal for fine wrinkles and lip augmentation but, if injected deeply and very homogeneously, can achieve good cosmetic results in the lipoatrophy patient.

RARE BUT SIGNIFICANT In the past, Dr. Bergeret-Galley used Dermalive (a competitor of Artefill), Dermadeep and Novasoft (none FDA approved) in her patients, although adverse events were infrequent, they were significant. She notes that a deeper placement of the filler produced less of a reaction and most reactions occurred when the injections were given in very thin skin for periorbital wrinkles, glabella or lips, as well as superficially in nasogenian folds.

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The perfect filler still elusive despite a myriad of choices

Article-The perfect filler still elusive despite a myriad of choices

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