The evolution of the humble dermal filler…
The American Society for Aesthetic Plastic Surgery (ASAPS) reported in its cosmetic plastic surgery predictions for 2006 that; “the growth and popularity of cosmetic fillers will dramatically increase as products continue to evolve and new players enter the market.”
We last reviewed the expanding UK dermal filler marketplace back in June 2004, and since then the number of products available has indeed increased yet further; more interesting however is to note that the way in which they are used has evolved from simple “filling” to new state-of-the-art “volumetric” techniques.
So who are the new kids on the block? And, what’s hot in the use of dermal fillers?
Types of Dermal Fillers:
It is agreed amongst experts that ideally a dermal filler product should be biocompatible (compatible with body tissues), non-toxic, non-immunogenic, (not provoke an immune system response), and non-migratory, (i.e. not move to other parts of the body). Hence, various kinds of natural and man-made or synthetic materials have been developed over the years for injection into the skin.
In general, as well as classifying dermal fillers according to their temporary (resorbable) and permanent (non-resorbable) qualities, we can also split the current UK available products into six main groups based on their primary composition.
These are:
- The Collagens, either from human or animal origins - Zyderm®, Zyplast®, Cymetra®, Artecoll® and Evolence™.
- The Hyaluronic Acids - Restylane®, Juvederm®, Hydrafill®, Hylaform®, Dermalive®, Dermdeep®,Matridur®, Matridex® Esthélis®, Reviderm® Intra, Puragen™ and Teosyal.
- The Polyacrylamides - Aquamid™, Bio-Alcamid™, Outline® and Evolution®.
- The Poly-L-Lactic Acids - Sculptra®.
- The Polyvinyl Alcohols - Bioinblue™.
- And, the Calcium Hydroxylapatites - Radiesse™.
Many practitioners are understandably wary about using a permanent filler product, for many reasons, including worries about complications due to a patient reaction, and the concern that the patient may not like the resulting “permanent” enhancement. However, patient criteria for a dermal filler product, as well as cost, has always been heavily influenced by the length of time that a filler product will last and retain the desired correction.
So, to create this middle ground, a so called “semi-permanent” (resorbable) filler niche has arisen, comprising those products that contain a biodegradable carrier substance, such as hyaluronic acid, plus microspheres (small balls if you like) of another substance which give the structure to the correction, which the natural tissues will bond around, giving a more permanent and long lasting effect. Examples of these semi-permanent products include: Radiesse™ (Calcium Hydroxylapatite (CaHA) microspheres), Matridex® and Reviderm® Intra (Dextran microspheres), Dermalive® and Dermdeep® (Acrylic Hydrogel microspheres).
As well as filling or volumising products, a new breed of “stimulators”, which includes the semi-permanent ones listed above, has also become available which through their injection stimulate the body’s production of new collagen meaning natural added volume and correction over time. Unlike the products such as those with a hyaluronic acid base which gives immediate results, and with the microspheres for longer lasting results, there are products which have no immediate volumising effect, yet are designed to cause a foreign body reaction (collagen production) over time to achieve the long lasting effects; examples includeSculptra® and Isolagen®, (although strictly speaking categorised as an autologous cell therapy and not a cosmetic filler).
With the coming of age of so called “baby-boomers”, increased disposable income, increased media exposure and consumer awareness via TV programmes such as 10 Years Younger, the demand for quick, minimally invasive treatments will continue with the emphasis on non-animal, long-lasting, natural and safe cosmetic filler products.
Recent New Launches:
Sculptra® (Formerly New-Fill®)
Sculptra® - previously branded as New-Fill® - was originally launched in the UK in 2000. It was re-branded under the new name Sculptra® in 2004 and is growing in popularity in the UK and Europe.
It is composed of tiny beads of a synthetic (non-animal and non-human) material called Poly-L-Lactic acid (PLLA). PLLA is broken down by the body to lactic acid - a natural substance found in the human body.
The manufacturer, Sanofi-Aventis, claims that the product can help cause new collagen production rather than just mechanically filling depressions. The product itself is not permanent but the effects can be long lasting. Sculptra® is therefore used more as a sculpting agent and tissue stimulator, rather than just as a wrinkle filler. It also has an FDA approval for treating HIV-induced facial lipodystrophy, (sunken features caused by fat loss).
Radiesse™ (Formerly Radiance™)
We reviewed Radiance™ (Calcium Hydroxylapatite) in our feature article on dermal fillers back in June 2004 entitled - Filling the Gap. The product was then being marketed as Radiance™, however towards the end of 2004 Bioform Medical, the US manufacturers re-branded it as Radiesse™.
Radiesse™ is not a permanent filler. It is a long lasting, resorbable filler - with the effect claimed to last approximately 2 years depending on the patient and the area treated. Once injected into your skin, the smooth and spherical CaHA particles form a ’scaffold’ which a person’s own tissue grows between. The gel carrier dissolves within a few months and over time, the CaHA particles gradually break down and are completely metabolised by the body, leaving only the new collagen structure.
Esthelis®
Esthélis® is a monophasic double crosslinked hyaluronic acid created in Switzerland by Anteis, and promoted in the UK by Aston Biomed Ltd. (In Germany, Austria, Switzerland, Russia, and Italy it is promoted under the name Belotero.)
Esthélis® has been designed from biofermentation hyaluronic acid, a substance naturally present in our body; which the makers claim makes it safe and completely biocompatible, as well as wholly biodegradable. It is created using Cohesive Polydensified Matrix (CPM) technology, a unique process which gives Esthélis® hyaluronic acid unusual elasticity; (this technology adds to its “mono-phasic” nature). Esthélis® therefore guarantees a considerably better result from the first hours after the injection and over the initial months, in terms of increased volume and wrinkle filling compared to “biphasic” products.
Esthélis® Basic is aimed at volume enhancement treatments and can be used for deep furrows, lip augmentation, facial outlines, naso-labial furrows, glabellar lines and the correction of facial depressions. Whilst Esthélis® Soft is designed for treating superficial wrinkles and can be used for perioral wrinkles, lip commissures, crow’s feet, and forehead wrinkles.
Evolence™
Launched in the UK at the beginning of 2005, EVOLENCE™ is a long lasting, porcine (derived from pigs) collagen-based dermal filler; which the makers claim will last at least 12 months. Manufactured by ColBar LifeScience and distributed in the UK by Clover Leaf Medical Ltd, EVOLENCE™ is composed of highly purified, cross-linked porcine collagen dispersed in phosphate buffered saline solution.
The manufacturer’s state that EVOLENCE™, unlike bovine (cow) derived fillers, is able to mimic the properties of the natural collagen found in the skin and therefore, while an allergic reaction is theoretically possible, it is extremely rare so pre-testing is not required before treatment with EVOLENCE™.
Puragen™
Puragen™, launched by Mentor Corporation in the UK in October 2005, is a Non-animal Hyaluronic Acid (NaHA) dermal filler derived from bacterial fermentation.
It is created using their breakthrough technology called DXL™. The patented DXL™ process double cross-links hyaluron molecules, providing greater resistance to degradation than single cross-linked products available. DXL™ therefore increases the resistance of Puragen™ to breaking down as the doubled network of molecules is not absorbed by the body as quickly, giving Puragen™ a longer lasting ability according to the manufacturers. They also state that Puragen™ is the only dermal filler product which depends on double cross-link chemistry, not particle size, to make it last longer.
Puragen™ is approved as a CE-marked Class III medical device in Europe for the correction of facial wrinkles, folds, and lip enhancement; with FDA approval in the US currently pending.
Teosyal
The Teosyal range, promoted in the UK by Lifestyle Aesthetics, consists of three monophasic hyaluronic acid based products of non-animal origin, which are highly biocompatible, offering patients immediate and long-lasting results with no preliminary testing. Two dermal filler products have been launched alongside Teosyal Meso - a new hyaluronic acid based mesotherapy treatment (see below).
Teosyal 27G is a dense and voluminous implant that is used to fill nasolabial folds, lip augmentation, and facial contouring and Teosyal 30G fills cutaneous fissures such as marionette or perioral lines and facial lines.
Restylane® Lipp
Launched in January 2006, Restylane® Lipp has been specially designed for injecting into the lips for enhancement and contouring. It is a cohesive and dynamic gel, and claims to be structured to withstand the range of mouth movements and strains that characterise the lip area and therefore last longer. As with the rest of the RESTYLANE® range it is comprise of Non-Animal Stabilised Hyaluronic Acid (NASHA).
Differing Techniques:
Volumetric
With the continued rise in consumer desire for quick, minimally invasive, so called “lunchtime” procedures, which feature no down-time but expect almost surgical standard results, it is no surprise that manufacturers have looked at ways of producing products that no longer just fill wrinkles the old fashioned way, but add volume and structure to the crucial facial areas which start to sag or sink as we age.
Dr David Eccleston, Cosmetic Physician and medical advisor to The Consulting Room™ comments; “The three main components of ageing skin are photodamage (sun), leading to fine wrinkles, the deeper lines and wrinkles caused by expression, and loss of facial volume due to facial fat and tissue atrophy, leading to sunken cheeks and the facial skin moving downwards in folds.”.
As discussed in our January feature article - The “Non-Surgical Face Lift” Comes of Age? - it is for this reason that a new breed of volumising or volumetric techniques have emerged alongside the original wrinkle filling procedures. Examples of dermal fillers that are being used to provide more of a volumetric approach to facial correction, rather than a simple line or wrinkle filling, include Sculptra® and Restylane® SubQ, which are both injected deeper than most standard products. These can be used to add volume to areas which traditionally lose volume as we age such as the cheeks, hollows under the eyes or tear trough and chins.
Also, as noted at the recent Paris IMCAS meeting in January, cosmetic fillers are now being used where once surgery was the only recommended option - for example, in the new art of non-surgical rhinoplasty or nose jobs. A small number of practitioners are experimenting with the use of filler products to raise the tip of a drooping nose or recontour the nasal profile to camouflage the appearance of a bump or ridge on the nose. Whilst surgery is the only option to permanently alter the structure of the nose, dermal fillers are indeed now seen as a valuable tool for making the nose better fit the face through such volumetric techniques.
Mesotherapy
Hyaluronic acid exists naturally in all living organisms and is a universal component of the spaces between the cells of body tissues, the extracellular space. It can retain 500 times its own volume in water, swelling to plump out the skin and intensively hydrate it from within. This hydrating property not only helps the skin to look and feel firmer, but also aids in the transport of essential nutrients from the bloodstream to the skin cells.
As we age, the amount of hyaluronic acid in the skin diminishes, as the skin cells lose their ability to produce it. A variety of hyaluronic acid based injectable products has therefore emerged, based on cosmetic filler technology, and often as an adjunctive product within an overall filler brand range, to fill the niche market dedicated to rehydration of the skin via the micro-injection technique known as mesotherapy.
Restylane® Vital
RESTYLANE® Vital is a new product offering from the Swedish company Q-Med, aimed at this new approach to skin rejuvenation. Like all the other RESTYLANE® products, RESTYLANE® Vital is made from Q-Med’s patented NASHA (Non-Animal Stabilized Hyaluronic Acid) gel. It is targeted at a broad range of treatment areas including the face, neck, décolletage (the area between the neck and breasts) and hands; designed to replenish the hyaluronic acid lost through ageing, hence hydrating the skin and improving its elasticity and tone.
RESTYLANE® Vital obtained European CE certification in 2004 for the indication of hydration of the skin by injections.
Viscontour®
Sanofi Aventis, the makers of Sculptra™ (Poly-L-Lactic acid) recently introduced an injectable and topical hyaluronic brand - Viscontour®.
The injection of Viscontour® is targeted at a broad range of treatment areas for skin rejuvenation, helping to hydrate the skin and reduce the appearance of wrinkles on the face, neck, décolletage and hands; used in combination with the topical application of Viscontour® (Hyaluronic Acid) Serum.
Teosyal Meso
Launched in the UK in 2005, Teosyal Meso is a non cross linked hyaluronic acid gel which hydrates and revives the dermis of the skin, neck hands and décolletage.
Elastence®
Elastence®, from Inamed, is a hyaluronic acid product aimed at restoring skin hydration, tone, and elasticity to the skin on the face, neck, décolletage and backs of the hands. Treatment using Elastence® is marketed as the Biorevitalisation Treatment Programme.
Juvelift®
Juvelift®, part of the Juvederm® range, is a hyaluronic based product with vitamins designed for micro-injection application on the face, neck, décolletage and backs of the hands to replace lost hyaluronic acid and improve skin hydration and elasticity.
Surgilift® Plus
Surgilift® Plus is a hyaluronic acid based product from Corneal Group, (see more below about their recent product launches) designed for micro-injection application on the face, neck, décolletage and backs of the hands to replace lost hyaluronic acid and improve skin hydration and elasticity.
Although now available in Europe this product has yet to reach UK shores, yet given that is comes from the same company that produces Juvederm®, we can possibly expect to see it’s introduction here in the future.
Future Introductions:
Captique™
In December 2004, Inamed was granted FDA approval to market Genzyme Corporation’s new non-animal stabilised hyaluronic acid dermal filler called Captique™ within the United States. Designed for the correction of moderate to severe facial wrinkles and folds around the nose and mouth and claimed to last up to one year.
Although currently only available in the USA, rumour has it that this product is likely to be available in the UK in 2007.
Cosmoderm® and Cosmoplast®
FDA approved CosmoDerm® and CosmoPlast®, from Inamed, are composed of highly purified human-based collagen (type I and type III) that is contained in phosphate-buffered saline with 0.3% lidocaine, a local anaesthetic. And, unlike bovine collagen based products they do not require a skin test - allowing for same day treatment.
CosmoDerm® is used to treat fine lines, wrinkles and shallow scars and overcorrection of 1.5 - 2.0 times the depth of the wrinkle is often practiced. CosmoPlast® is used to treat deep lines, furrows and scars without overcorrection. Layering of CosmoDerm® over CosmoPlast® can also be performed to eliminate a wrinkle or scar with the need for overcorrection techniques.
Despite the advantage of the natural collagen replacement and lack of skin test requirement, some people may have an aversion to the use of cadaver derived products and will choose an alternative.
Although available in the USA this product has yet to reach UK shores.
Surgiderm®
Recently launched and heavily promoted at IMCAS this year, the Surgiderm® range by Corneal Group, is based on their patented cross-linking process called “3D Hyaluronic Acid Matrix Technology”, which is claimed to allow for a tighter, more uniform, and greater number of cross-link structures - allowing greater resistance to degradation.
The range consists of Surgiderm 18 for fine lines, Surgiderm 24 XP for medium depth wrinkles and enhancing lip contours, Surgiderm 30 for treating deep skin depressions and volume enhancement through injection into the deep dermis, and Surgiderm 30 XP which can be used to treat medium and deep skin depressions and enhance facial volume and lip contours.
Also within the range is the newly launched Surgilips®, which prior to the introduction of RESTYLANE® Lipp was the only injectable product available specifically designed for treating the lips. Corneal claim that the results, as well as looking more natural, last longer at 9 - 12 months on average, compared to less than 6 months for other hyaluronic acid fillers used in the lips.
Although now available in Europe this product has yet to reach UK shores.
Voluma®
Also recently launched alongside Surgiderm® by Corneal Group is Voluma®, which they are marketing as the “D.R.E.A.M. sculpture®”. This product, based on their hyaluronic acid technology is designed for face volume restoration. Little more is known about it at this time.
REDEFYNE™
Anika Therapeutics Inc, recently received CE Mark approval to market its cosmetic tissue augmentation product, REDEFYNE™, in the European Union; American FDA market approval is still pending. The product is based on hyaluronic acid and incorporates lidocaine, a local anaesthetic. We have no news yet on any plans to start promoting this in the UK.
Hylanew®
The HylaNew® range from the Canadian company Prollenium features the highest concentration of cross-linked non-animal based hyaluronic acid gel available. It also incorporates Hypromellose (an eye lubricant) which makes the gel easy to inject and is said to cause less bruising and swelling for the patient.
The range is formulated into three products. HylaNew® is best used to fill superficial imperfections such as fine lines, forehead wrinkles, crow’s feet, and perioral lines, and is claimed to last 6 months. HylaNew Ultra is a high viscosity, longer lasting product used for smoothing out deeper wrinkles and for lip augmentation, and is claimed to last 9 months. HylaDex has the same hyaluronic acid base but with the addition of Dextronomer beads, making it the longest lasting of the three fillers. The Dextronomer beads stimulate the production of the body’s own new tissue. HylaDex is used for medium to deep sized wrinkles and folds and is ideal for chin/cheek augmentation, and is claimed to last 12-15 months.
Although only available in Canada and with US FDA market approval pending, this product can be found in some UK clinics.
Summary:
The UK dermal filler market place, estimated to be worth between £15-20 million, is still dominated by Q-Med with the tried and trusted temporary dermal filler range, Restylane®. Since its UK introduction in 1996, this hyaluronic acid has taken significant market share from Inamed, who promote bovine collagen (Zyderm® and Zyplast®) due to the lack of sensitivity testing required for this non-animal derived product.
There are now 9 different actively promoted purely hyaluronic based product lines available in the UK, (and counting), highlighting the success of hyaluronic acid as an effective and safe dermal filler compound, and collectively they account for the vast majority of dermal fillers used in the UK. Increasing choice is fragmenting the market to some extent, although the Restylane® brand still appears to own the lions share.
Differentiation relating to product performance may now only be noticed in practice by high volume, experienced users - hence additional features relating to training support; costs and marketing or brand support are now being used by suppliers to promote their brand to clinics and practitioners.
In addition, recent national reports commissioned by the Chief Medical Officer, Sir Liam Donaldson, on the provision of cosmetic surgery procedures have recommended that “remodelling techniques using cells or tissue i.e. cosmetic fillers” be brought into the regulatory framework of the Healthcare Commission. This is planned to come into force in October 2006. This will mean that like those clinics currently offering laser/IPL or cosmetic surgery procedures, those offering dermal fillers will be required by law to be registered and annually inspected.
We believe this to be good news for both practitioners and the public, giving peace of mind for the public and continuity of the standard of filler administration for clinics.
Lorna Jackson is Editor of The Consulting Room™ http://www.consultingroom.com/ -the UK’s largest aesthetic website providing clear and unbiased information to the public on a wide range of surgical and non-surgical cosmetic treatments, combined with a directory of UK & Ireland based clinics and surgeons. The Consulting Room™ Shop http://www.consultingroomshop.com/ is the first aesthetic online store backed by FACT not FICTION and offers a simple and secure online shopping experience for all the latest in at-home, clinically proven skincare, suncare, post cosmetic surgery after care, laser hair removal and hair growth devices, slimming garments and a wide range of other aesthetic products.
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