Filling products or soft tissue fillers
DEFINITION AND PRINCIPLE
Filling products also referred to as “Fillers” are used to add volume and, in certain cases, for their beneficial effect on the skin. Their components have quite evolved and many products presenting different qualities are available today.
In aesthetics, wrinkles, fine lines and creases used to be treated essentially by filling (with collagen-type products) or by abrasion (peeling, dermabrasion). Over the last few years, for better results, treatments have been adapted to the ageing cause. One can thus differentiate between alteration related to sun exposure (actinic) which is treated by resurfacing techniques (laser, peeling, dermabrasion), and ageing resulting from facial movements and expressions, which is treated with Botulinum toxin, surgery and, lately, using the Face Recurve® concept.
However fillers remain indicated alone or associated with other treatment for numerous indications:
Indications of filling products injections in the face
Rejuvenation
• To reduce the depth of the wrinkles and furrows, reduce the visibility of certain fine lines, and attenuate certain folds or hollows . With fairly thick products it is possible, for instance, to smooth over the naso-labial folds, to camouflage the hollow rings under the eyes or to smooth out the lion’s wrinkle, while using finer products it is possible to obtain an effect on the fine mouth contour lines…
• To compensate for the loss of certain tissue volumes and/or reshape the contours that have been modified through ageing or body weight loss . Thinned out lips may thus be made to look pulpy again, sunken temples filled in, cheeks puffed out, the skeletal appearance around the eyes can be treated as well as the way the base of the nose has become enclaved over time in the face can be corrected.
• To smooth out the surfaces and improve the skin appearance. By the superficial application of a very fine reticulated acid, it is possible to smooth out the surface of the lips, to rejuvenate the hands or improve the neckline skin…
The use of filling products or lipostructure, it should be noted, is not indicated to act on marked excess skin in an attempt to avoid a face lift. Actually, in order to make tissues that have become slack over time tense again, it often would be necessary to use considerable amounts of filling volumes. The tense appearance would then be obtained per contra of an obviously non natural looking puffy look.
Conversely, certain thin faces age mainly by hollowing: the fat of the temple, the eye contour, and the cheeks melts away. Filling these sunken areas and thus correcting the emaciated or even “skeletal” facial look is in these cases the key to rejuvenation. For the affected patients, the filling procedure can be associated possibly with some surgical re-draping of the tissues, although re-draping alone should not be attempted as it would yield a “mummified” look because the tightening of the tissues over a face that has become emaciated by ageing will necessarily make the underlying hollowness even more apparent.
Facial enhancement
• One can also use fillers to improve the features by increasing certain volumes . The filling product injections provide for increasing the volume without surgery. For example, a filler could be used to slightly improve the cheekbone line, to make the chin more prominent forwardly, to lift up the corners of the mouth, to compensate for facial asymmetry, to treat a minimal irregularity of the bridge of the nose, to redress somewhat the tip thereof… Experience has shown, however, that caution should be used in order not to disturb the balance between the bone and soft tissue masses.
Particulars pertaining to the use of fillers for reshaping the mouth
Enhance the fullness of the lips
The lips can be re-hemmed, smoothed out or thickened if they are too thin, so as to regain a fleshy look. However, it should be noted that lips that are genetically thin cannot be made to look pulpy without associating surgery to the use of the filler. Only those lips which had once been pulpy and have become thinned out with age may from the use of a mere filler regain their fleshy appearance.
A “Bimbo’s mouth” is obtained by injecting a definitive pro-inflammatory product (e.g. silicone oil). Doctor Le Louarn does not use such definitive pro-inflammatory products and does not approve of them.
Reshaping the mouth
Strategically place injections provide for slightly lifting up the corners and, therefore, for correcting the drooping thereof over time or for allowing the so-called Mona Lisa smile.
The creation of two specifically located volumes in the centre of the lower lip will give a “heart-shaped” mouth resembling that of a very well-known modern actress.
Last but not least, temporary dermal fillers can help to define the lip border, or create a “Cupid’s bow”.
Smoothing out the surface of the lips
Superficial injections of a very fine hyaluronic acid can fill up the fine lines that progressively striate the pulp of the upper lip vertically.
Improving mouth contour
The fine line around the mouth are best manages early using Botulinum toxin alone; later, by using filler injections associated with the Botulinum toxin (or by a combination of an abrasion technique and Botulinum toxin).
Is Face Recurve® compatible with the use of fillers?
The use of filling products is quite compatible with the Face Recurve® concept and even recommended to counter the effects of structural ageing at the early phase of the ageing process.
At the age of about 30-35 years, the naso-labial fold and the bitterness fold start to become outlined, while the skin remains good-looking and tense. The use of filling products is then recommended in reasonable quantities through deep injections between the muscle and the bone to reconstitute the natural convexity below the muscle and to camouflage the furrows that have been created by loss of fat tissue. Deeply injected filler under the muscle can not only provide for correcting the appearance of the depression but also lengthen the marker fascicle, whereby the latter is slightly weakened and a younger dynamic is regained. Bor better effect, to this mechanic filling technique, it is recommended to associate a chemical action through the injection of Botulinum toxin, in order to weaken the age marker fascicle.
Filling materials are still indicated in more advanced ageing, either for a supplementary action to optimize surgical results, or when surgery is not desired but the effects of age are to be attenuated (though results are obviously more limited then).
A brief reminder of the Face Recurve® theory.
In young subjects, the face expression muscles are curved and long (flexible) at rest; they cover the deep-lying fat tissue that forms important masses, while the superficial fat is regular and thin. When the face takes on an expression, the muscle of interest contracts thereby shortening itself and becoming rectilinear. This movement causes the muscle to press on the deep fat layer.
Over time, when the muscle has thus contracted thus repeatedly, it no longer can relax completely and it loses its natural curvature, become shorter, straighter and more rigid in the elder subject. The muscle resting tone is said to be increased (the muscle remains tense in between the facial expressions instead of relaxing). A the same time, the deep-lying fat is less and less apt to resume its natural position under the muscle between each contraction, thereby creating fat tissue masses on the surface on each side of the muscle concerned (jowls, malar bags…).
To even accentuate this structural ageing process, the mechanism at play is not uniform over the whole surface of the muscle, and it is far more important where the age marker fascicles are located. Thus are formed the hollowed out furrows which promote even more the efficacy of the very phenomenon, whereby the passing of time is made apparent. Unfortunately, this phenomenon is more effective as both shapes thus brought out (the furrow and the fat mass) each enhance the visibility of the other. Thus, as concerns the oval of the face, the shortened muscle causes a hollow to be created that forms the bitterness fold, while the fat volume that has been displaced causes the jowls to appear.
Therefore, the age marker fascicles are primarily responsible for structural ageing of the paramedian region of the face. Through the fat transfer they induce, they are directly implicated in the occurrence of the bags under the eyes, the hollow rings under the eyes, the naso-labial folds, the bitterness folds, the jowls and the cervical bands. Gravity joins in later by acting on the skin and fat tissues that have been damaged by the muscular effect of the marker fascicles, whence facial ptosis results.
For more information on this concept, please refer to the article under the same name.
An alternative therapeutic procedure to using fillers: lipostructure
When dealing with anatomic zones that are not very mobile, it is possible to get a filling effect via lipostructure, i.e., the grafting of autologous (taken from the patients themselves) fat tissue, otherwise referred to as lipofilling, micro-graft, liposculpture, or Coleman’s procedure…
Lipostructure or the injection of fat is definitely the most “natural” or the most “bio” of the filling techniques used, since the patient’s very own fat tissue is implanted by injection, so there is no risk of intolerance to the filling product. However, it should be noted that the long-lasting effect of the results in time can vary and that secondary asymmetry may occur. The volume effect obtained depends on the take of the fat that is grafted and, hence, on the quality of the fat tissue taken, that of the implantation site and, possibly, on a change in the patient’s post-operative body weight.
As the procedure involves more than just an injection that can be done at the doctors’ office without anaesthesia, lipostructure is primarily recommended when the volumes to be gained are very important (cheekbones or buttocks, for example), or when a liposuction procedure or rejuvenation procedure has already been scheduled to take place under anaesthesia (in order not to allow the fat tissue that is removed in the process of liposuction to be wasted or to complete a rejuvenation procedure).
What are the filling products available?
There are many products available. AMM denotes the official French marketing authorization obtainable after numerous tests, such as those carried out on drugs. “EC” denotes a European authorization which, it would seem, is a little easier to obtain but guarantees nevertheless the certified manufacturing of the product.
Some products are prohibited for use by injection for aesthetic purposes because of the risks involved: e.g., silicone (since 1997). Other miracle products have not been studied in any serious scientific works, so that neither their effects nor their consequences at medium- and long-term (over 2 years) have been put to test prior to marketing.
This is the reason why, even though an injection session can seem to be a trivial act, and even if many of those products are put forth as “working magic” by the medias , the disadvantages and risks associated with each product deserve to be serious discussed and assessed with your doctor, in order to avoid any disappointments both in terms of durability of results and expectations.
Some products act as direct fillers through a volume-creating effect (by filling up the injected zone); others act via the inflammatory reaction they provoke (and not owing to the quantity of product injected). This latter solution is, of course, much more risky since the inflammatory reaction is specific to any patient and may vary from one session to the next.
Another distinction made is between those products that can be absorbed, or biodegradable products (which undergo resorption progressively and completely within a few months) and those which remain permanently, or non-biodegradable products (made to persist for several years or indefinitely).
Some absorbable products are:
– Collagens (Zyderm, Zyplast, Résoplast…). Collagen injections were approved by the FDA in 1981. They have been a very popular non-surgical cosmetic procedure. Injectable Zyderm and Zyplast collagens are natural substances derived from purified bovine (cow) collagen, they essentially replace the natural collagen that the skin loses over time. Human collagens are also available. Collagens have proven to be a very popular non-surgical cosmetic procedure, however since hyaluronic acid have been approved, Dr Le Louarn prefers to use it rather than an ovine or human derived substance, furthermore acid hyaluronic being adapted to all layers of soft tissues (deep, dermal and superficial), it avoids mixing several different substances. Indeed combination can make both diagnosis and treatment pretty difficult in case of adverse reaction.
– Hyaluronic acids (Softline, SubQ, Perlane, Restylane, Hydrafill, Hylaform, Hyaluderm, Juvéderm, Juvéderm Ultra…). Hyaluronic acid is a natural polysaccharide… Juvederm Ultra contains as well some added anesthestic substance (Lidocaine) which reduces patient’s pain during treatment. Hyaluronic acid is certainly not the final answer in the search for an ideal filling product but provides a predictable, safe, user-friendly approach and as such is being widely used. Consequently hyaluronic acid is the filling substance currently recommended by Dr Le Louarn for cosmetic indications.
– Poly-L-lactic-acid (Sculptra or Newfill). Poly-L-lactic-acid is a synthetic substance similar to that used in absorbable medical sutures. It is used to treat lipoatrophy (loss of facial fat) as the result of HIV (human immunodeficiency virus). In this indication the inflammatory reaction is interesting because it reduces the quantity of product needed to cover the fat loss thus diminish the cost of procedure for major fat losses. Poly-L-lactic-acid is commonly used off-FDA approval in healthy individuals for cosmetic purposes. Dr Le Louarn however does not recommend his patients to undertake Sculptra or Newfill injections for aesthetic purposes since he thinks the induced consequent inflammatory reaction may in some cases prove difficult to control.
– Calcium hydroxylapatite (Radiesse). A dermal filler based on calcium micro-spheres suspended in a glycerin gel. The micro-sphere substance is a primary component of teeth and bones. Again Dr Le Louarn does not recommend his patients to undertake Radiesse injections since he feels the induced inflammatory reaction (to stimulate the body to produce new collagen) may in some cases prove difficult to control.
Some permanent products are:
– Polyacrylamide (Aquamid, Bio Alcamid, Outline). Polyacrylamide hydrogels have been available for 3 decades in different countries. Used in Eastern Europe and Russia, those gels had several much documented complications including infection, migration, and release of toxic acrylamide monomers. Many of these complications become aggravated over time and are difficult to treat medically or surgically.
Some 7 years ago, Polymekon, an Italian company bought the rights to an existing acrylamide gel and after reformulation, it claims that the new product, Bio-Alcamid did not release any toxic acrylamide monomers, and obviously did not degrade neither migrate. The product was claimed to be a poly-akylamide and not a polyacrylamide.
Very unfortunately, it became apparent from reports coming from medical practices around the world, that many physicians and patients were reporting higher than expected adverse effects, mainly infections. Patients should be caution about potential long-term complications with this kind of product. It forms a “pocket” of material that can become a perfect medium for bacteria growth if punctured.
– Acrylic hydro-gel (Dermalife). Here again patients should be caution about potential long-term complications with this product since some cases of severe granuloma have been reported.
– Methyl Polymetacrylate (Artecoll). In the case of Artecoll injection also it has been reported some delayed granulomatous reaction. This side effect is not reversible and should be addressed in the informed consent.
To conclude:
As regards permanent or semi-permanent products, if these are to be used completely safely, it would be advisable to wait for more retrospective information than is available at present.
To our knowledge, the ideal filling product, i.e., one is permanent and completely neutral (long-term stability and effect of which can be assessed at the time of the injection), and one that does not migrate, is yet to be discovered.
Permanent fillers are tempting for their long-lasting effect and are more often proposed for large volume correction (for cost reasons) but patients must consider that for example the OFSP and the Swiss Institute of Therapeutical Products Swissmedic in agreement with the Swiss Society of Plastic, Reconstructive and Aesthetic Surgery, the Swiss Society of Dermatology and Venerology and the Swiss Society of Aesthetic Medicine have issued a warning against injection for aesthetic purpose of filler with non-resorbable components. Any product comprising non-resorbable components such as, for instance, silicone, acrylamide, plexiglas, etc, is concerned with this recommendation.
This is why Dr. Le Louarn recommends, for the time being :
1. to use absorbable products, as these are considered little allergenic ( obviously easier to take care of in case of adverse reaction since it should naturally fade with times),
2. to prefer absorbable fillers obtained synthetically (of a non-animal origin) rather than those derived from human or bovine substance,
3. to avoid to mix filling substances in order to avoid products interferences and difficulties in treatment or diagnosis in case of adverse reaction.
Together these 3 recommendations obviously lead to the choice of using hyaluronic acid as a filling product. The durability of hyaluronic acids is 6 to 9 months when used superficially and 12 months for the same products in a thicker version for deeper injections.
Finally, ISOLAGEN laboratories have proposed to culture the patient’s fibroblast cells. This revolutionary technique provides remarkable cause for hope, although one must be sure of the stability of the results, of the innocuousness over time of the cultured cells, and of the perfect traceability of the manufacturing line. This is why, even though Dr Le Louarn is convinced of the value of this technique, he prefers to wait before prescribing it to his patients.
FILLER INJECTIONS IN PRACTICE
Preparation
The session is contraindicated if you are currently suffering from labial herpes, if you are taking any anticoagulants or if you have had a history of allergy or any contraindication to the product of interest. You must absolutely tell your doctor about the nature and the place of any possible prior injections to avoid contraindicated combinations in the same area.
A bruise or a swell may always develop, which is why it is ill-advised to have this type of aesthetic treatment before some important date.
The procedure per se
The projected quantity of product to be injected varies according to the localization, the cosmetic problem and the effect to be achieved, but the cost for a session is dependent upon the quantity of product used. This is why, when a schedule is worked out, Doctor Le Louarn will indicate to you the approximate quantity of product he intends to inject.
Basically, it is not necessary to have anaesthesia, but it all depends on the personal sensitivity of the patient. It is to be noted, however, that local anaesthesia can provoke increased swelling post-operatively. Hence, in most cases, local anaesthesia is recommended for the oral contour while, topical anaesthesia (Emla cream) is used for the remainder of the face. However, topical anaesthesia may cover up the fine lines due to its hydration effect. It can therefore be used only in furrow filling cases (hollowed rings under the eyes, temples, naso-labial folds) and not on very fine wrinkles.
Any injection may cause ecchymosis (bruise) if the needle touches a deeply lying micro-vessel. Some regions are more prone to develop bruises than others, e.g. the eye contour. In case of bruises, these will fade away without any consequence on the condition that one abstains from sun exposure and from Botulinum toxin injections (risk of product migration caused by the process of resorption of the ecchymosis). It is therefore contraindicated to perform an eye contour treatment using both Botulinum toxin and hyaluronic acid during the same session. Naturally, it is best to avoid taking any medicines that can cause bleeding (aspirin-like) in the days preceding the filler injections, as this could precipitate the occurrence of ecchymosis.
Post-treatment period
Owing to the reaction specific to each person, transient swelling may cause the effect to be difficult to assess during the treatment session. In this case, a second session will be scheduled a few days hence to optimize the results.
Concerning the surface injections, one may sometimes observe at the injection sites some punctate ecchymoses; with deep injections (rings under the eyes, temples) a real bruise may form if a deep micro-vessel crosses the path of the needle.
The most stable hyaluronic acids are also those that are thicker and which form, at the injection site, micro-pellets. If the same are apparent on the face at rest, they should be pressed down with the fingers to make them disappear. If this is not enough, Dr Le Louarn may remove some of the volume injected.
Risks
Allergy: Foremost with collagen, specific tests should be used when using this product.
Acute or chronic inflammatory reaction : Especially in the case of a secondary injection in a zone already treated with other products, namely non-absorbable ones.
Granulomas : Unfortunately more persistent with non-absorbable products.
Labial herpes : Preventive therapy should be used if you are predisposed to herpes.
Localized necrosis, abscess, persisting redness: A few very rare cases have been reported in the international literature.
Migration: Particles may migrate or displace from the injection site due to facial expression (cf: fat expelling in the Face Recurve® theory). This adverse effect is a tough issue for permanent products, while of course, with temporary treatments the product will have either fade before migration visibility either the dissatisfactory result will vanish by itself with time.
Caution: If you have already had any permanent product injected (bioalcamide- or silicone-type) at any site, it is totally contraindicated to inject the same site with hyaluronic acid or any other product, due to the risks of triggering a localized inflammatory reaction. Such reactions (physical or chemical) may some times persist definitively).
OUTCOME
The aesthetic effect varies depending on the skin condition, the area of the face involved (more or les mobile), the quantity of product injected, the injection technique (deep or superficial), on the patient’s living habits (sun exposure, tobacco-smoking…) and, lastly, on the expression of the zone treated (the durability of the product is usually shorter on the most mobile areas).
Results are generally very quickly significant (from within a few days to one or two weeks). In most of the cases, it will be possible to have an additional filling procedure performed, if desired.
Used with Botulinum toxin, fillers are the mainstay of early anti-age therapy and area still of value in the later ageing stages eligible for surgery (Face lift, Face Recurve® or Face Recurve® Lift) when the patient refuses surgery.
It is very important that you keep a personal note of the exact type of injections performed and of the area of your face which has been injected, so as to be able, if needed some day eventually, to specify these details prior to any medical act (either curative or cosmetic) and thus prevent exposing yourself to any potential negative interactions.
References
Specific information appearing on this website is based on Doctor Le Louarn’s practice and on his scientific works:
1. LE LOUARN C. : Emploi de l’acide hyaluronique selon le concept du Face Recurve® : vacuum technique et interpores technique – Use the hyaluronic acid according to the concept Face Recurve®: vacuum technical and interpores technical
Ann Chir Plast Esthet. 2007 Oct 17;
http://www.ncbi.nlm.nih.gov/pubmed/17942211
http://dx.doi.org/10.1016/j.anplas.2007.05.016
2. LE LOUARN C. : Les cernes comment les combler ? Eyes ring and how to fill them up ? AAWC Anti-Aging World Conference – CNIT : 19-21/3/2004
3. LE LOUARN C. : Non surgical facial rejuvenation : Perlane IPRAS – Sydney – 10 au 15/08/2003 –
In this field, the following publications and works can also be listed (this list is obviously not exhaustive and may be amended):
1 – El-Sayed Ibrahim El-Shafey Complications from Repeated Injection or Puncture of Old Polyacrylamide Gel Implant Sites: Case Reports
Aesthetic Plastic Surgery Vol 32 Num 1 Jan 2008
http://www.springerlink.com/content/f6077j708wq758702 – Rohrich, Rod J. M.D.; Ghavami, Ashkan M.D.; Crosby, Melissa A. M.D. : The Role of Hyaluronic Acid Fillers (Restylane) in Facial Cosmetic Surgery:
Review and Technical Considerations Plastic & Reconstructive Surgery.
Temporary Dermal and Soft-Tissue Fillers. 120(6S) Supplement:41S-54S, November 2007.
http://www.plasreconsurg.com/pt/re/prs/abstract.00006534-200711001-000083 – FAGIEN S., KLEIN A.W. : A brief overview and history of temporary fillers: evolution, advantages, and limitations
Plast Reconstr Surg. 2007 Nov ; 120(6 Suppl) : 8S-16S
http://www.ncbi.nlm.nih.gov/pubmed/180903384 – Institut suisse des produits thérapeutiques : Recommandations concernant les produits injectables non-résorbables pour le comblement des rides
http://www.swissmedic.ch/md/pdf/vi-fill-f.pdf5 – US FOOD AND DRUGS ADMINISTRATION : Alert 12-29-2007: Liquid injectable silicone 12-29-2007
http://www.fda.gov/ora/fiars/ora_import_ia8909.html6 – WARIS E. , PAKKANEN M., LASSILA K., TORMALA P. , KONTTINEN Y. T., SUURONEN R. , ASHAMMAKHI N. : Alloplastic injectable biomaterials for soft tissue augmentation: a report on two cases with complications associated with a new material (DermaLive) and a review of the literature
European Journal of Plastic Surgery – Vol 26 n°7 Dec 2003
http://www.springerlink.com/content/bpu2p92q5twhd2m27 – NICOLAU P.J.: Long-lasting and permanent fillers: biomaterial influence over host tissue response
Plast Reconstr Surg. 2007 Jun; 119(7):2271-86
http://www.ncbi.nlm.nih.gov/pubmed/175197318 – GOMEZ DE LA FUENTE E., ALVAREZ FERNANDEZ J.G., PINEDO F., NAZ E., GAMO R., VICENTE MARTIN F.J., LOPZ ESTEBARANZ J.L. : Cutaneous adverse reaction to Bio-Alcamid implant – Actas Dermosifiliogr. 2007 May;98(4):271-5.
http://www.ncbi.nlm.nih.gov/pubmed/175069609 – KLEIN A.W. : Soft tissue augmentation 2006: filler fantasy
Dermatol Ther. 2006 May-Jun;19(3):129-33
http://www.ncbi.nlm.nih.gov/pubmed/1678451110 – DE BREE R., MIDDELWEERD M.J.R., VAN DER WAAL I. : Severe Granulomatous Inflammatory Response Induced by Injection of Polyacrylamide Gel Into the Facial Tissue
Arch Facial Plast Surg. 2004;6:204-206.
http://archfaci.ama-assn.org/cgi/content/abstract/6/3/20411 – WOLFRAM D., TZANKOV A., PITA-KATZER H. : Surgery for foreign body reactions due to injectable fillers
Dermatology. 2006;213(4):300-4
http://www.ncbi.nlm.nih.gov/pubmed/1713573512 – CHRISTENSEN L., BREITING V., JANSSEN M., VUUST J., HOGDALL E. : Adverse reactions to injectable soft tissue permanent fillers
Aesthetic Plast Surg. 2005 Jan-Feb ; 29(1):34-48
http://www.ncbi.nlm.nih.gov/pubmed/1575909613 – ASCHER B., BUI P., FLAGEUL G. et coll : « Les produits injectables »
Section 2 dans : « Le rajeunissement facial : techniques de complément et de substitution à la chirurgie »
49ème Congrès national de la SOF.CPRE (rapport annuel) sous la présidence du Pr M. PANNIER:
Ann Chir Plast Esthet. 2004 (5)14 – ANDRE P. : Hyaluronic acid and its use as a “rejuvenation” agent in cosmetic dermatology
Semin Cutan Med Surg. 2004 Dec;23(4):218-22
http://www.ncbi.nlm.nih.gov/pubmed/1574522815 – ALCALAY J., ALKALAY R., GAT A., YORAV S.: Late-onset granulomatous reaction to Artecoll
Dermatol Surg. 2003 Aug;29(8):859-62.
http://www.ncbi.nlm.nih.gov/pubmed/12859389