A global perspective
When it comes to dermal fillers, Europe leads the way in terms of innovation, and the US lags behind largely based on the stringent clinical data and safety criteria required to bring products to market. In the category of injectables, the EU ranks second behind the US, followed by Asia and Latin America2. Although the injectable market is considered to be a more mature market with a lot of small players and a handful of global giants, some privately owned companies in Asia are flooding the market with cheaper products that are starting to show up in clinics throughout Europe and the Middle East. This influx of less expensive products is driving the price down in many markets.
In the US, there are 12 injectable products that currently have the FDA nod and being marketed: three neurotoxins and nine filling agents. As expected, temporary hyaluronic acid gels represent the largest group. Several more products are currently in the FDA pipeline, although the process is notoriously slow. In the US, dermal fillers are often used in an off-label manner, mainly because of the limited indications each product is approved for. For example, although using hyaluronic acid based fillers to enhance the lips is a very common treatment, Restylane® and Restylane®-L are the only fillers that are actually approved for ‘lip enhancement in patients over 21 years’3.
Each product has its niche. The most recent addition in the US market was Belotero® Balance, manufactured by Merz Aesthetics, and is widely used in treating superficial lines such as vertical lip lines, as well as the tear trough area, since it is thought to reduce the possibility of a Tyndall effect based on how it integrates into the skin.
As new products continue to gain FDA approval, the question is how many fillers do you really need? All injectors tend to have their favourite ‘go to’ products on the shelf, but not all fillers can address every area and patient, so having a wide range of tools in the toolbox is necessary. This will become even more important as big players continue to invest in large scale direct-to-consumer marketing programmes to generate awareness of brand name fillers.
Injecting new areas requires a different technique, and in some cases, a lighter touch. Some of the new injectable sites include traumatic scars, eyebrows, temples, jawline, nasal dorsum, earlobes, labia augmentation, the soles of the feet, and dorsal hands. Ageing hands that are wrinkled, bony, or prominently veined are a promising arena for rejuvenation treatments.
‘It takes a lot more experience and expertise to treat the hands because you have to inject deeply and be careful to avoid the veins,’ says Forley.
‘Cosmetic fillers have a proven safety record when injected by a properly qualified and trained physician in an appropriate medical setting,’ says Edwin F. Williams, MD, Group Vice President for Public and Regulatory Affairs of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). ‘While injecting dermal fillers is not surgery, it is still a medical procedure that requires the experience of a physician trained in cosmetic procedures of the face. Patient safety must be paramount. Although complications can occur with any filler substance, using only FDA-approved products and good clinical instruction helps to minimise potential side-effects.’
There are nuances for each dermal filler, including ease of use, location of injection into the skin, versatility, and duration of results, as well as potential risks and the management of adverse events. ‘Patient assessment is critical to achieving optimal outcomes with soft tissue fillers. You have to determine what is exactly the problem you are trying to correct, how deep is the fold or wrinkle to be filled, what the ideal options are for each situation, considering the patient’s expectations, budget and history,’ says Steven Fagien, MD, an Oculoplastic Surgeon in Boca Raton, FL.
Natural born fillers
There is no question that autologous fat transfer and platelet‑rich plasma (PRP) take centre stage at aesthetic conferences worldwide, and regenerative medicine is an important segment of the market. This has stimulated a growth industry around fat harvesting tools, innovative centrifuges, fat transfer systems, and syringes. A growing sector of consumers embrace the idea of a more natural approach to anti-ageing treatments using their own tissues. Many plastic surgeons consider fat grafting to be an integral part of their facelift protocol for most patients, except perhaps those with very full faces.
Another subset of patients also want longer‑lasting fillers. Men especially like the idea of treatments that do not require much maintenance. ‘Longer‑lasting products have found their place in facial rejuvenation. There is a group of people who are seeking treatments that last well so they do not have to keep coming back for touch-ups every few months,’ says Steven Cohen, Plastic Surgeon, MD, FACS in La Jolla, CA. Yet many practitioners are wary about using a permanent product owing to concerns over granuloma formation, and the fear that the patient may not like the long-term results. There is a decreasing tolerance of risks and side‑effects, especially as more products have entered the market that are biocompatible, non-immunogenic, and non-migratory. However, permanent fillers are more accepted and widely used in Asia.
Next kid on the block
On 2 May, 2013 the members of the FDA’s General and Plastic Surgery Devices Panel gave their nod to Allergan’s Juvéderm® VOLUMA® XC for the correction of age‑related volume loss in the midface. VOLUMA is well positioned to be the next new filler to be launched in the US market.
‘With the expanding menu of fillers now available and more products currently under clinical investigation, we are learning to treat the whole face with unprecedented results,’ Fagien says. ‘Allergan’s VOLUMA is the latest advance in larger volume hyaluronic acid gel fillers, and is poised to be the next game changer in facial rejuvenation. The main advantages of VOLUMA include its use in larger quantity facial volume restoration, while enjoying the ability to mold and sculpt with greater precision.’
Donofrio agrees with Fagien: ‘The demands of patients and doctors to develop better, longer lasting fillers with superior lifting capabilities (high G Prime) has led to products such as Juvéderm VOLUMA coming to market. Those of us that have been volumising with fat for years feel that this will be the closest approximation of the dramatic results we can achieve with fat transfer. I have patients on a waiting list to be called first. It’s an exciting time to be a cosmetic sculptor.’