27 septembre 2011
19 avril 2011
comparison of resorbable soft tissue fillers
Comparison oF Resorbable Soft Tissue Fillers
+Author Affiliations
- Cabinet Médical36 rue de Penthièvre, 75008, Paris, France
- The author is a plastic surgeon in private practice in Paris, France.
- Reprint requests: Catherine Bergeret-Galley, MD, Cabinet Médical 36 rue de Penthièvre, 75008, Paris, France
Abstract
Soft tissue fillers for wrinkle treatment and facial reshaping offer numerous advantages for both doctors and patients. They are extremely well tolerated and efficacious and can produce long-lasting improvement with regular use. In this article a detailed, thorough review of the resorbable injectable filler implants available on the international market isoffered and the most suitable for various treatment areas are identified. The chemical nature, formulation, indications, recommendations for technique, and possible side effectsof each family of fillers are described.
The ideal injectable material for filling wrinkles and restoring volume to the face should not only offer aesthetic, reproducible, and long-lasting results but should also be safe, with minimal complications and risk of migration. It should also be easy to use and reasonably priced.
In recent years, a variety of injectable fillers has appeared on the international market, including both synthetic products and those derived from natural substances or extracted from animal or human cells. I have drawn up a list of the available resorbable filler products, particularly those most frequently used, and have studied their chemical natures, formulations, methods of injection or implantation, most common indications, and possible side effects.
The different families of resorbable filling materials are:
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Collagen-containing fillers, comprising substances containing collagen obtained from human or animal cells;
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Autologous fat;
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Fillers containing hyaluronic acid, either of animal origin or biosynthetic; and
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Products containing polylactic acid.
Products of mixed composition that contain both resorbable and nonresorbablecomponents were excluded from this study.
Human collagen
A number of firms market human collagen, either in the form of autologous collagen obtained from the donor or isogenic collagen obtained from a donor or even cadavers. These products have a very limited distribution in Europe but are used more widely in the United States.
Autogenic human collagen
The use of autogenic human collagen eliminates any risk of virus or prion transmission. However, the preparation time for the product is relatively long and requires a prior surgical procedure for sampling of the material, which is reinjected after treatment by a competent laboratory.
Autologen
Introduced at the end of the 1980s, Autologen (Collagenesis, Inc., Beverly, MA) was the first autologous injectable agent on the market. Autologen is a dispersion of intact collagen fibers and a matrix of collagen tissue obtained from the clean skin of the patient during a plastic surgery procedure (mammaplasty, abdominoplasty, face lift, blepharoplasty). A skin biopsy is inadequate. Because the injected material is autologous and no allergic reactions were reported in a sufficient number of patients, the United States Food and Drug Administration (FDA) does not consider it necessary to perform a test before Augologen injection.
The skin excision, placed in a sterile container, is sent to the manufacturer's laboratory for treatment. As a general rule, 10 to 13 cm2 of excised skin is requred to produce 1 mLof Autologen 5%.
The dermis is sprayed into a sterile buffer to form a dispersion of intact collagen fibers. The dispersed collagen fibers are washed in a sterile phosphate buffer and concentrated by means of centrifugation. The substance obtained is packaged in sterile 1-mL Luer-Lok syringes and labeled with a unique identification code for the donor-recipient. Preparationof Autologen by the laboratory takes 3 to 4 weeks; the practitioner may then store the finished product in a refrigerator for as long as 6 months.
Autologen is injected into the middle dermis with a 30-gauge needle. Because the injection is painful and the preparation does not contain an anesthetic, anesthesia (EMLA, AstaZeneca Pharmaceuticals, Wilmington, DE; or lidocaine injection) of the treatment area is recommended. It is also recommended that the syringe be taken out ofthe refrigerator approximately 1 hour before the injection. At least 3 injections, a few weeks apart, are needed to obtain a satisfactory result, provided that each treatment is overcorrected by 30%.1
A comparative trial between Zyplast (Inamed, Santa Barbara, CA) and Autologen has shown no significant difference between these fillers with respect to clinical persistence 12 weeks after injection. Unfortunately, the trial was not continued beyond 12 weeks.2
A trial in 25 patients demonstrated that 1 injection produced correction of 50% to 75% for as long as 3 months or 50% at 6 months, that 2 injections produced correction of 75% after 6 months, and that 3 injections produced correction of more than 75% at 12 months.3 Fagien1 described results 6 months after treatment of deep glabellar wrinkles with Autologen (4 sessions, 1.5 mL of Autologen in total). This author also noted good results 6 months after injection of 4.0 mL of Autologen (3 sessions) in the treatment ofdeep nasolabial folds.
The duration of treatment depends on the region treated, the injection technique, and the volume of Autologen administered. No significant side effects have been reported. It must be noted, however, that moderately severe erythema may last for 48 hours after the injection.3, 4 Preparation of the autologous collagen from a patient-tissue sample is expensive5 ($995/sample), and yield varies, depending on the individual and the anatomic areas from which collagen is harvested.
Isolagen
Since 1998, autologous fibroblast cultures have been used to correct wrinkles, scars, and other skin defects. Boss et al6 described a method of injecting autologous fibroblasts obtained from a 3-mm skin excision from the retroauricular area, an area protected from UV light. The sample is immediately placed in a culture medium provided by Isolagen Laboratories (Houston, TX) and must reach the laboratory by the day after sampling in an isothermic container. The fibroblasts and type I collagen are developed in a culture medium for 4 to 6 weeks. Six weeks after sampling, an injection test (0.1 mL) is administered to the patient in the forearm; any sign of an allergic reaction is recorded. Two weeks after the test, approximately 1 mL of the autologous material is available for implantation. Additional injections, 1 mL each, are available every 2 weeks until optimal correction is obtained.
Isolagen is a very fluid liquid that is injected into the superficial dermis with a 30-gauge needle. Overcorrection of 300% is recommended for suitable aesthetic results.5, 7 When the material is implanted, the carrier is absorbed and the overcorrection rapidly disappears. As a rule, 4 to 6 injection sessions are required.
The level of correction achieved depends on the defect, the patient's age, and the abilityof the patient's fibro-blasts to create collagen. Patients older than 60 years are not good candidates for this technique because their skin is no longer able to produce vigorous fibroblasts. Boss et al6 reported a study in which 92% of 94 patients were satisfied with the results 12 months after treatment. In another study, histologic sections taken 6 months after treatment (3 1-mL injections administered at 2- to 3-week intervals) demonstrated an improvement in the thickness and density of collagen.8
This technique has several disadvantages. The Isolagen preparation must be injected within 48 hours. It offers more effective correction of periorbital wrinkles or perioral wrinkles than of deep furrows.9 The improvement obtained is poor compared with that ofother techniques, such as bovine collagen implants or hyaluronic acid, and correction is not immediate. Fagien and Elson10 concluded that the results obtained with this technique were rather disappointing. In addition, Isolagen is expensive ($495/1 mL).
Isogenic human collagen
Alloderm and Cymetra
Alloderm (LifeCell, Branchburg, NJ) has been used in the treatment of burns and for transplantation in periodontal surgery. In aesthetic surgery, it is used to increase lip volume, to correct nasolabial folds, and to treat scars. Alloderm is an acellular dermal graft materal obtained from cadavers or from a tissue bank that provides an acellular matrix of dermal components, including collagen, elastin, and glycosaminoglycans. The cell components of the epidermis and dermis that induce an antigenic reaction and implant rejection are removed from the donor tissue.
The dermis skin is examined in accordance with FDA requirements and regulations relating to human tissue, which include blood tests on the donor for hepatitis B and C, human immunodeficiency viruses 1 and 2, syphilis, and human T-lymphotrophic virus type I. The donor's medical and social history must also be closely examined to identify risk factors for viral infection. In addition, the tissue-treatment process, which comprises 2 stages, is designed to prevent transmission of viral diseases. No cases of transmissible viral disease have been reported in patients who have received this treatment since its introduction in 1992.
Alloderm is offered in the form of sheets that are implanted through an incision in the treatment area. It must be reconstituted in a saline solution approximately 10 minutes before implantation. Implantation requires the use of a local anesthetic. Alloderm is used to increase lip volume, to correct nasolabial folds, and to treat scars.
Infection of the incised/sutured sites has been attributed to abscess formation around the suture rather than to the graft itself.5 Cases of labial herpes have also been reported; prophylactic antiviral therapy must be prescribed for patients with a history of labial herpes.
Alloderm has recently become available in a micronized injectable form, marketed under the name Cymetra (average particle size 123 μm). Cymetra is provided in the form of an aseptic powder reconstituted with lidocaine 0.5% with 1: 200 000 epinephrine immediately before injection. It is injected with a 26-gauge needle.11
A comparative study of treatment with Cymetra (19 patients) versus Zyplast (25 patients) for lip rejuvenation has shown that 1 week after injection, the clinical effects are more visible with Zyplast than with Cymetra. No significant difference was noted between the 2 substances at 3 and 6 months, but it appears that the results at 12 months are better (although more heterogeneous) with Cymetra than with Zyplast.11
Dermalogen
Dermalogen (Collagenesis Corp., Beverly, MA) is obtained from cadaver tissues that have been carefully selected to help eliminate the risks of viral and bacterial infection. Thetissues are then treated to (reportedly) guarantee safety in accordance with a procedure that includes 2 virus- and prion-inactivation stages, followed by sterilization in accordance with standard methods.
The injection technique for Dermalogen is the same one used for Autologen: injection into the middle dermis/deep dermis with a 30-gauge needle. Because the injection is painful, use of a local anesthetic is recommended.12
Clinical indications for the use of Dermalogen include correction of obvious nasolabial folds, perioral wrinkles, glabellar wrinkles, and depressed scars, as well as increasing lip volume. Overcorrection of 20% to 30% is recommended at each session. An average of 3 injection sessions is required for satisfactory correction.
Prolonged erythema and acneiform rashes were noted in 10% of patients in a study of130 patients.13 The manufacturer does not recommend a pretreatment allergy test, although 1 case of foreign-body reaction 4 weeks after a test injection of 1 mL ofDermalogen in the forearm has been described by Moody and Sengelmann.14 Klein15also reported several positive skin tests with Dermalogen and 1 case of secondary reaction characterized by redness, swelling, and hyperpigmentation of the treated sites after Dermaologen implantation.
A comparative study of Dermalogen and Zyplast was conducted by Sclafani et al.12Seventeen patients received 2 injections (0.5 mL of each product) into the periauricular region. No specific clinical differences between the 2 implants were found 12 weeks after implantation.
Facian
Fascian (Fascia Biosystems, Beverly Hills, CA) is a biomaterial extracted from the fascia lata muscles of human cadavers and treated in accordance with FDA standards to help eliminate the any risk of viral or bacterial contamination. The product is available in particles of different sizes (< 2mm, < 1mm, < 0.5 mm) and must be rehydrated with 3 mLof lidocaine 0.3% or a saline solution before injection. The implant is injected into the subdermis with a 16- to 22-gauge needle, depending on particle size. Clinical follow-up of6 to 9 months in 81 patients who received injections of particulate fascia lata demonstrated a satisfactory duration of results for 4 months.16 No local or systemic hypersensitivity reactions were reported in this study. Few other studies of this product have been conducted.
Section summary
Implantable materials containing autogenous or isogenous human collagen have a limited presence on the European market because preparation of the injectable solutions is relatively difficult, only a small number of long-term clinical trials of the substances have been performed, and the cost of these products is relatively high. By contrast, substances such as bovine collagen and hyaluronic acid are offered in ready-to-use syringes and offer both considerable safety and satisfactory efficacy.
Bovine collagen
American bovine collagen is currently the most widely used filler material. Three products, manufactured and distributed by Inamed, are available: Zyderm I, Zyderm II, and Zyplast.
Chemical nature of the molecule
Collagen is the most abundant protein in the human body and is one of the fundamental constituents of connective tissue, particularly of elastic fibers of the skin. A collagen molecule consists of a triple helix of large peptide chains (300 nm long). Each chain consists mostly of glycine (1 of 3 amino acids), lysine, and proline. It does not contain tryptophan. Zyderm and Zyplast consist of a suspension of bovine dermal collagen in physiologic saline solution containing lidocaine. After purification, this collagen is subjected to selective hydrolysis of the peptide ends of the molecule, the most antigenic fractions.
Although the immunogenicity of these products is high compared with that of otherfillers, it varies in different reports.17 The authors of various studies have reported that 1.3% to 5% of patients demonstrate reactions to the implants during the test or, subsequently, at the injection sites. These reactions may occur days or months after the injection, so it is essential to perform 1 or even 2 tests before starting injections. Zyderm and Zyplast must be stored in a constant cold chain between 2°C and 8°C.
Indications and injection techniques
Table 1 summarizes the indications for Zyderm I, Zyderm II, and Zyplast and lists the recommended injection technique for each. After intradermal injection, Zyderm and Zyplast implants mix with the skin's natural collagen and subsequently disappear over the following 3 to 12 months, depending on the nature of the product and individual patient factors.9
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Table 1
Collagen: characteristics and indications
Contraindications and tests
Contraindications and precautions for use for bovine collagen include:
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history of serious allergy and allergies to lidocaine (a component of Zyderm and Zyplast implants),
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autoimmune and inflammatory disorders,
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history of anaphylactic reactions, background of allergy,
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previous skin hypersensitivity reactions to collagen implants,
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immunosuppressant therapy,
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pregnancy or breastfeeding.
Detailed questioning of the patient, including personal and family medical history, is necessary to exclude patients with these contraindications before the patient's reaction to the material is tested. A double test is recommended because positive reactions to treatment have been reported in 0.3% to 1.5% of patients even after clinicial selection and initial testing.18 Pons-Guiraud19 recommends the following protocol, which can take up to 7 weeks to complete.
The first injection (0.1 mL) is given in the anterior aspect of the forearm, followed by a reading at 72 hours. A positive reaction is characterized by a change in the contour of the injected implant, erythema, edema, occasionally pruritus and, rarely, by an indurated papule or inflamed dermal nodule. All positive reactions contraindicate collagen injections. A second injection is given 15 days later, followed by readings 3 days and 4 weeks later.
Any positive reaction to the test or double test contraindicates the collagen injection. If there is any doubt, bovine (ACACB) and human (ACACH) anticollagen antibodies must be measured.
Duration of treatment
The clinical results I have obtained with Zyderm and Zyplast implants are consistent with findings published by other authors.20, 21 Zyderm I corrects fine lines quite well, particularly fine perioral and crow's-feet lines. One of the disadvantages of this product is the white color of the gel. If the implant is injected into very thin skin, it may be seen through the skin, resulting in a slight off-white coloration at the injection site. The results last approximately 3 months. Depending on the quality of the skin and the type ofcorrection, superior efficacy may be obtained over time. In the case of more obvious lines, a superficial multipuncture injection may be performed. Zyderm II, which is designed to correct average lines, offers an average duration of 3 to 6 months. It may also be used in patients with extremely thin, estrogen-deficient skin. This implant may be injected into the middle or deep dermis.
Zyplast is designed to correct deep wrinkles in thick skin and to restore facial volume (lips and outline of the face). It generally lasts 6 to 12 months.
As is the case with all resorbable implants, longevity of collagen implants depends largely on the quality of the patient's skin, the nature of the lesions being treated, and the patient's age. As a general rule, the younger the patient, the longer the interval between injection sessions. In older patients, the interval between injection sessions must be shorter to retain the benefits of treatment.
Side effects
Table 2 summarizes recent reports on the side effects of treatment. A study performed by Castrow and Krull,22 on behalf of 316 practitioners, covering approximately 7,000 patients who demonstrated negative test results revealed a side-effect rate at the injection site of1.5%. The reactions were mostly limited to the injection site: erythema, induration, itching, and pain. In general, these reactions lasted 4 to 6 months; in a few cases they lasted more than 1 year. Other reactions included arthralgia (6.5%) and local granulomas (5%, confirmed in 4 of 5 cases through biopsy). Abscesses were reported at a frequencyof 4 cases per 10,000 patients.23 These reactions develop, on average, 8 to 12 weeks after the injection, after 1 or more collagen injections. They are characterized by a nodule or papule at the injection site, severe swelling, erythema, and induration of the surrounding tissues. The abscess is different from the collagen hypersensitivity reaction, which is also characterized by induration and erythema but is not fluctuant. The punctured or evacuated pus is generally aseptic. The patients carry bovine anticollagen antibodies. These abscesses are considered the expression of a hypersensitivity reaction.
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Table 2
Side effects produced by collagen injections despite negative test-injection results
Cases of necrosis have been reported at a rate of 9 per 10,000.23 The local necrosis reaction after injection of collagen is not related to the implant itself but to obstruction ofa blood vessel or ischemic necrosis.
Bovine collagen remains the reference filling implant, although delayed hypersensitivity is common. However, some patients do not wish to receive a product of animal origin. They are increasingly choosing treatment with fillers consisting of hyaluronic acid ofnonanimal origin.
Autologous fat
Reinjection of autologous fat—the autologous biologic implant par excellence—is a useful technique that has many applications in plastic surgery. Illouz,24–29 followed by Fournier,30 was the first surgeon to use autologous fat extensively as a filler. More recently, Coleman31 developed a technique of short centrifugation that facilitated both implantation of the product (obtaining a true spaghetti of fat to be reinjected) and appeared to increase the implant's longevity by reducing the presence of impurities and the risk of cystic steatonecrosis of the injected fat.
For perfect asepsis, the fat must be removed under locoregional or even general anesthesia in the operating theater. It is then centrifuged and purified to extract the plasma and destroy adipocytes and hemoglobin generated by the microtrauma ofsampling. The purified fat can then be reinjected.
This technique is commonly used in the context of facial liposhaping and can be used to add volume to thin faces when patients have areas from which to extract fat. It may or may not be associated with other surgical rejuvenation procedures such as cervico-face lift followed by augmentation of the cheeks, the cheek-palpebral furrow, the nasolabial furrows, and, possibly, reshaping of the lips. One disadvantage of the procedure is that postoperative side effects of severe edema and bruising prevent patients from returning immediately to their social lives.
Resorption of the reinjected fat is extremely variable. If too much fat is injected, considerable edema and inflammation at the injection site can occur because the technique is relatively traumatic. This in turn results in severe destruction part of the reinjected fat by classical inflammatory mechanisms, including phagocytosis by macrophages, in the first posttreatment weeks. Excess reimplantation also tends to promote local devascularization, which may lead to the development of small clusters ofcystic steatonecrosis.
Optimal technique requires the use of an appropriate volume of filler for augmentation, including moderate overcorrection, followed by a reinjection session 1 year later.
With this protocol, average persistence of 50% of the reinjected product is obtained after 2 years (range 30%–70%). This level of persistance was earlier reported in Illouz' studies. The technique is useful but requires surgical conditions of asepsis, miminal anesthesia, and a patient with an available fat mass. It is not indicated for very thin patients.
Hyaluronic acid
Hyaluronic acid is a ubiquitous molecule present in all connective tissue, the dermis, joints, interstitial membranes, and the vitreous body of the eye. Chemically, hyaluronic acid is a long-chain polysaccharide of high molecular weight formed from repeated disaccharide units of glucuronic acid and N-acetyl glucosamine (Figure). The main biologic function of hyaluronic acid in the extracellular matrix is stabilization ofextracellular structures and formation of the matrix fluid in which collagen and elastic fibers are intermixed. The polyanionic hyaluronic matrix is highly permeable and regulates transport of solutions in the extracellular space, acting as a charged molecular trap for metabolites of different sizes and charges. Hyaluronic acid also plays an important role in regulating the movement and function of cells and in developing and remodeling tissues. The biologic functions of hyaluronic acid are related to its physical and rheologic characteristics of elasticity and viscosity.
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Figure
Chemical structure of hyaluronic acid.
Because of its viscoelastic properties, stabilizing role, and protective action on cell membranes, hyaluraonic acid represents an ideal material with which to fill skin depressions (Table 3). However, it degrades quickly (within days) in skin tissues. Three mechanisms contribute to its degradation32, 33: free radicals; hyaluronidases, specific enzymes; and temperature. For its in situ life to be extended, hyaluronic acid must be crosslinked with multifunctional agents. Crosslinking involves the binding molecules ofhyaluronic acid to each other by chemical bridges at the anchorage sites of the molecule to yield a single molecule. This chemical modification changes the physical and rheological characteristics of the hyaluronic acid but does not reduce its biocompatibility.34, 35 Crosslinked hyaluronic acid remains bioresorbable, although it is resorbed more slowly because the crosslinked material is rendered more resistant to heat and enzymatic degradation than unmodified hyaluronic acid and the enzymes cannot enter the network as easily. In addition, because the molecules are linked there is no possibility for migration.
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Table 3
Hyaluronic acid fillers available on the European market for the filling of skin depressions∗
Products, uses, and associated injection techniques
Products consisting of noncrosslinked hyaluronic acid such as AcHyal (Meiji Seika Keisha Ltd., Japan), Hyaluderm (LCA, La Rochelle, France), and Ial-System and Hyal-System (Fidia SpA, Abano Terme, Italy) are all indicated for use in aesthetic practice. However, they are not designed to fill skin depressions or wrinkles because their longevity is generally less than 3 months; they can be used only for skin rehydration or facial revitalization. Consequently, they will not be discussed further here.
In the European Union, implants for filling wrinkles consisting of hyaluronic acid are classified as medical devices. As such, they must meet the requirements of directive 93/42/CEE relating to medical devices. These products are approved for use in Canada. In the United States, Restylane was recently approved by the FDA, and an FDA panel has recommended approval of Hylaform. The implants available on the European market — ofanimal origin (extracted from the coxcomb) or nonanimal origin (obtained through biotechnology) are listed in Table 4.
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Table 4
Indications for use of the major hyaluronic acid fillers
So that they may offer the most appropriate implants for different types of wrinkles and skin, manufacturers generally offer several products that differ with respect to viscosity and concentration or particle size (Table 5). Juvéderm (Leaderm, Paris, France) is available in hyaluronic acid concentrations of 24 mg/g (Juvéderm 18) or 24 mg/g (Juvéderm 24, 24HV, and 30). Products in the Restylane/Perlane range (Q-Med, Uppsala, Sweden) have a concentration of 20 mg/g. Perlane has approximately 10,000 particles ofgel per milliliter, Restylane 100,000, and Restylane Fine Lines 200,000. The products in the Hylaform range (Hylaform, Hylaform Plus, and Hylaform Fine Lines; Genyme, distributed by Inamed) all have a hyaluronic acid concentration of 5.5 mg/g and differ only with respect to the mechanical properties of the gel. The contraindications for hyaluronic acid products are similar to those for collagen. Hylaform is contraindicated in patients who are allergic to products of bird origin. Unlike collagen, these products are stored at ambient temperature.
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Table 5
Characteristics of fillers containing hyaluronic acid
Duration of results
The authors of a double-blind, randomized multicenter trial involving 138 patients compared the efficacy and tolerability of hyaluronic acid (Restylane) and bovine collagen (Zyplast) in the treatment of nasolabial folds.36 These authors found that for an optimal cosmetic result, a lower implant volume was required for hyaluronic acid than for bovine collagen. The findings also demonstrated that the frequency, severity, and duration ofreactions at the injection site were similar for the two products. On the other hand, the efficacy of hyaluronic acid was superior at 6 months.
In another multicenter trial, this one involving 348 patients, the aesthetic results and tolerability of Restylane in the treatment of wrinkles (glabellar region, nasolabial foldss, oral commissures, upper lip, lower lip, and vermilion border) and acne scarring was assessed.37 Each patient received an average of 1.68 mL per implant. In some cases, a touch-up session was performed 20 days after the initial session. This trial demonstrated that the level of correction fell by 20% between 3 and 6 months and by another 20% from 6 to 10 months. Patients therefore experienced good correction (60 to 70%) at 3 months, slight correction (40 to 50%) at 6 months, and poor correction (10 to 30%) at 10 months.
Piacquadio et al38 conducted a 1-year trial in 177 patients to assess the tolerability and efficacy of Hylaform in filling wrinkles and treating scars. Depending on the practitioner, correction levels of more than 33% compared with the initial stage were obtained in 78%of patients at 3 months, 44% of patients at 6 months, and 8% of patients at 12 months. The satisfaction rate among patients was similar to that among practitioners.
Using implants from the Juvéderm range, Zbili39 obtained a satisfaction rate of 85% at 12 months. He offered his patients with mild to moderate wrinkles a maintenance session every 6 to 9 months after the first 2 sessions, which were performed 1 month apart. For patients with deep wrinkles, he proposed biannual follow-up sessions 30-day intervals after the initial 3 sessions. Using this protocol, Zbili obtained a satisfaction rate of 60% at 12 months.
A retrospective clinical trial of Juvéderm 30, including qualitative and quantitative evaluation by the practitioner and patients, was conducted in 49 patients over the courseof 12 months.40 Seventy percent of patients received 2 injections, 1 to 2 months apart, ofJuvéderm 30; the average amount injected at each session was 0.6 mL. The correction estimated by the practitioner to be better than 50% more than 6 months after the first injection in 45% of patients and better than 50% more than 9 months after the first injection in 20% of patients. Thirty-nine percent of patients were satisfied with the result 8 to 11 months after the first injection.
My experience with hyaluronic acid is similar. Using the most fluid implants designed to correct fine lines, such as Juvéderm 18 and Restylane Fine Lines, I see effective results between 3 and 6 months. The same effective period is obtained with the use of superficial multipuncture injections of these products.
In the case of intermediary (e.g., glabellar, cheek, or perioral) wrinkles, the efficacy of an implant such as Juvéderm 24 or Restylane ranges from 6 to 9 months. For the most noticeable wrinkles, such as nasolabial folds and oral commissures, Juvéderm 30 offers a filling effect that lasts for 12 to 15 months. Perlane appears to be a better volume expander in the immediate postoperative period, although it is thicker and more difficult to inject. It appears to have a considerably shorter duration
To fill moderate wrinkles in patients with thin skin and to correct skin breaks, Juvéderm 24 Haute Viscosité (High Viscosity) offers efficacy lasting 12 to 15 months. It is very fluid, is particularly easy to handle, and offers high-quality filling.
Side effects
As is the case with all filling implants, side effects have been reported after injection ofhyaluronic acid (Table 6).
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Table 6
Side effects reported after injection of fillers containing hyaluronic acid
The authors of a study summarizing the side effects reported after injection of Restylane and Perlane reported a side-effect rate of 1.5% in 1999 (144,000 patients) and 0.6% in 2000 (262,000 patients), including 0.7% and 0.2% hypersensitivity reactions.41 The authors cited 2 causes for the decline in the side-effect rate after 1999. First, dating from the middle of 1999, the composition changed with the introduction of a protein trace content 6 times lower than that of the original formulation. Second, the strain of bacteria used to produce hyaluronic acid for Restylane was changed.
In the report of their clinical experiences with Juvéderm fillers, Zbili39 and Bès40 did not describe any lasting side effects, other than transient redness and edema occurring, as a rule, immediately after injection. In addition, after 2.5 years' use and more than 250,000 syringes of material implanted, the safety-monitoring data provided by the company show a total side-effect rate after injection of Juvéderm of less than 0.1 per 1,000 syringes. These side effects included discoloration (0.04%), edema and swelling (0.05%), 1 case ofinflammatory reaction (0.004%), and 1 case of induration (0.004%). The case ofinduration involved a patient in whom Juvéderm 30 had been used to fill skin depressions. The skin depressions came from in situ injections of corticosteroids prescribed for inflammatory nodules that developed after the injection of a nonresorbable filling implant. The case of an inflammatory reaction, which occurred immediately after the injection, resolved less than 7 days after prescription of oral corticosteroids and antihistamines.
The cases of discoloration of the injected area consisted of redness (40%), hyperpigmentation (40%), and bluish discoloration of part of the nasolabial folds that were treated (20%). In all cases, these reactions occurred immediately after the injection, resolved over a few weeks, and required application of a depigmentary cream in some cases of hyperpigmentation. The bluish discoloration represents traces of hemosiderin associated with vascular injury. This type of discoloration has already been described after the injection of Restylane.42 Before reinjecting an area with this type ofpigmentation, the practitioner must wait until the pigmentation has resolved; otherwise he or she runs the risk of perpetuating it. The cases of edema reported after injection ofJuvéderm all occurred rapidly after the injection. All resolved after a few days, either spontaneously or after oral corticosteroid treatment (64% of cases).
It is interesting to note that the protein concentrations measured in Juvéderm fillers are not the lowest among the published values, obtained with the use of different analytical protocols. The side-effect rate reported after implantation of Juvéderm is, however, less than 1 case per 10,000 syringes). This excellent tolerability is probably due to the choiceof bacterial strain and to the purification processes used throughout the manufacture ofthe Juvéderm implants.
Polylactic acid: Newfill
NewFill (Biopharmex, Luxembourg) is a synthetic implant consisting of a mixture ofpolylactic acid, carmellose, and mannitol (sugars) in the form of microbeads. It is a volume expander that has been used frequently for facial restructuring with a triple therapy.43
The product is presented in the form of a lyophilized powder. The practitioner must prepare the injectable solution by diluting the lyophilized powder in 2.5 mL of distilled water and 0.5 mL of 1% xylocaine. Use of xylocaine is recommended because the injection is quite painful. The manufacturer recommends that the solution be prepared at the time of use, but many practitioners say it is preferable to prepare it 12 hours before the injection through the use of mechanical shaking. Because of the microbeads, the product is injected with 26-gauge needles and requires injection of large volumes.
When used in orthopedic surgery, polylactic acid produces delayed hypersensitivity reactions, resulting in the development of foreign-body inflammatory granulomas.44, 45Similarly, in plastic surgery, many cases of granulomas have been reported after use ofNewFill, particularly after implantation in the lips.42, 46, 47 These granulomas may develop 6 to 12 months after injection.42 The granulomas are characterized by renitent nodules offibrosis SS, which are painful and often inflammatory. They result from the physicochemical configuration of the microbeads and crystallization of the sugars in the beads when they dehydrate. These granulomas are very difficult to treat34, 46 and require injection from the outset of a mixture of corticosteroids and 5-fluorouracil in closely spaced sessions, or even the use of hydroxychloroquinine hydrochloride (Plaquenil°) per os,42 after in situ injections have failed.
Conclusion
The different resorbable fillers reviewed here produce satisfactory results in terms ofefficacy, tolerability, and ease of handling. Their tolerability is good, although some are better tolerated than others. The most widely used implants remain Zyderm bovine collagen, Zyplast, and 3 brands of crosslinked hyaluronic acid: Hylaform, Juvéderm, and Restylane/Perlane. The use of NewFill is on the increase, but reports of its side effects are on the increase as well.
Successful use of resorbable fillers requires scrupulous injection technique to minimize trauma produced during the injection, thorough asepsis, careful patient selection, and avoidance of blatant contraindications. It is also essential to screen patients for contraindications that are not always apparent and that may have few clinical signs, such as Hashimoto's thyroiditis and autoimmune diseases. It is essential to adapt one's technique to the quality of the skin and to avoid performing injections in the presence ofacute disease, infection, or inflammation, even if only a viral infection is involved. Injection should be avoided during exacerbations of acne, herpes, or eczema.
It is desirable to establish injection protocols involving regular management, which maintains the patient's level of satisfaction and increases his or her commitment to the treatment. Finally, common sense dictates that multiple filler products not be used simultaneously in the patient's skin and that traceability labels be maintained in the patient's records to facilitate the identification of any side effect and its possible cause.Resorbable products offer greater safety than nonresorbable products because they produce fewer side effects and because the side effects they do produce are far easier to treat. As a result, their use is particularly advisable if the practitioner has any concerns about the quality of the patient's skin, possible estrogen deficiency, or problems associated with follow-up (eg, patients living abroad, those who seek little medical advice, and those who are noncompliant with postinjection recommendations).
The main limitation of resorbable injectable fillers is the necessity of repeated treatments, which is both expensive and timeconsuming. Despite this drawback, theresorbable products Zyderm/Zyplat/Juvéderm and Resylane/Perlane are the most widely sold implants in Europe and seem to meet patients' demands. They also encourage patient follow-up over time and provide good hydration for the skin, particularly the hyularonic acids.
To use any of these products, a physician requires appropriate training to help ensure optimal patient outcomes. Although some injectable fillers now coming onto the market are described as resorbable by their manufacturers, in reality their chemical nature is incompatible with resorption.
References
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- Fagien S
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- Sclafani AP,
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- et al.
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- et al.
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- Elson ML
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- Moody BR,
- Sengelmann RD
- ↵
- Klein AW
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- Hartmann DJ,
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- Baumann LS,
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- Moscona RR,
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Lowry, et al., eds. European Pharmacopeia. 14 ed. 2.2.5.
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Further reading
-
- Duranti F,
- Salti G,
- Bovani B,
- Calandra M,
- Rosati ML
This Article
-
doi: 10.1016/j.asj.2004.01.006Aesthetic Surgery Journal January 2004 vol. 24 no. 1 33-46
- AbstractFree
- » Full TextFree to you
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- Advances in Nipple-Sparing Mastectomy: Oncological Safety and Incision Selection
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- Browpexy Through the Upper Lid (BUL): A New Technique of Lifting the Brow With a Standard Blepharoplasty Incision
06 septembre 2010
02 juillet 2010
View the result of your operation already at your consultation
Dr. Bergeret-Galley can now offer you a consultation with a simultanous simulation of the future result of your surgery.
You can discuss the looks of your future body and face already before the surgery, thanks to our new computer technology.
You can discuss the looks of your future body and face already before the surgery, thanks to our new computer technology.
18 mai 2010
08 avril 2010
04 février 2010
The woman of the week: Catherine Bergeret- Galley
Article - Gulfnews.com
"I
always wanted to be a plastic surgeon. I used to read a lot about the subject
and found the field very fascinating.
|
|
Catherine Bergeret Galley
Specialist plastic surgeon
"I always wanted to be a plastic surgeon. I used to read a lot about the
subject and found the field very fascinating.
"I like to treat people and make them feel good about themselves. The
image is very important and it is imperative that we enhance it." Dr.
Galley, who is 40 plus, has always tried to look good - an important tenet in
her profession as clients look up to her for correcting their imperfections.
"If I am not in a good shape, they will not come to me. How I look makes a
difference to them."
Dr. Galley has her weaknesses too. "I love good food, but if I have had
many dinners in a week, I try to be on a diet and regularly watch what I eat.
If I eat a heavy meal, I avoid desserts like cakes. I always try and include
more protein than fat in my diet. I eat pasta and rice and avoid foods that
have rapid assimilation sugar and fat."
Dr. Galley also exercises, at least thrice a week. The key is consistency.
"To train for 40 minutes is better but if you don't have time, 30 minutes,
three times a week, is enough!"
The key to healthy living, according to Dr. Galley, "is regular exercise,
a balanced diet, an anti-ageing treatment, multi-vitamin tablets and essential
fat acids, every day. It keeps me in good shape, physically and mentally."
According to Dr. Galley, people have no time to exercise and this can prove
detrimental. Especially after 40, the proportion of fat in the body increases,
there is lose muscle and one may gain weight."
Apart from trying to stay in good shape, it is also vital to take care of the
skin, which means avoiding the sun by using the right sunblock.
"There are plenty of good products in the market today. French products
RoC Dermatologic, Roche Posay and Avene work very well on my sensitive skin -
in cleansing, toning and moisturising." Clinique, according to Dr. Galley
is "excellent for oily skin, it is a good moisturiser and the sunblock, in
particular, is very light and effective.
"To make my skin firmer, I take an injection called Hyaluronic Acid. It
treats wrinkles and hydrates the skin from the inside as well.
"Make-up makes me feel good and allow people to see me better. "I
love Clinique's foundation as it is not greasy. I also love the loose powder
from Lancome and, sometimes, even mix it with a little gold colour to give a
natural shiny look to my skin."
Dr. Galley has discovered the simplest yet most effective manner of looking
good. "Wear colours that complement your hair, eyes and skin tone and
kindle the magic."
Lip colours in beige, beige pink, red, and red orange are her favourites.
"I like emphasising my eyebrows with a brown pencil in keeping with my
hair colour. One must keep the eyebrows soft."
Every woman has her favourites when it comes to cosmetics, and Dr. Galley is no
different. "I like Lancome. I also love Yves Saint Laurent mascara and
eyeliners because they have very soft tones. I like their light browns, prune
and deep green, but very soft."
"I think it is my smile and eyes that convey that I am a happy person.
Sophia Loren has beautiful eyes and I think Queen Rania of Jordan has very
beautiful eyes too. "I like deep expressive eyes. I don't want to change
anything about my face.
I want to stay young and when I need to get a facelift done, I will do
it."
16 juillet 2009
Choosing Injectable Implants According to Treatment Area: The European Experience
Choosing Injectable Implants According to Treatment Area: The European Experience
Catherine Bergeret-Galley, M.D.1
ABSTRACT
There are now many injectable implants for face remodeling since the first product appeared in Europe in 1984.
The
treatment regions most in demand are the cheeks,
jaws, lips, and the oval of the face. The aging process is due to fat resorption over the
upper two thirds of the face, in addition to the loss of elasticity. Weakness in the skin
and subcutaneous fascia becomes
more apparent over the lower third
of the face. The fat loss together with the slack skin gives the impression of
gauntness and loss of volume under the eyes (i.e.,
the zygomatic and palpebral areas). Treating the zygomatic bone area and subcutaneous tissue by injecting
filler products will increase volume around the zygomatic malar
bone and subcutaneous area. To
choose an implant, we must take into account the patient’s
wishes, hopes (whether temporary or long-lasting effects are required), age, skin
type (dry, moist, greasy, thick, or thin), and the patient’s medical history
to prevent obvious contraindications
in the choice of implant due to type
of product, especially in
the case of allergies, inflamed areas, or any suspicion of autoimmune disease or recent infection.
KEYWORDS: Collagen, hyaluronic acid, polylactic acids, calcium hydroxyapatite, polyacrylamides
The number
of injectable
products that can be
used
as fillers for treatment of wrinkles or as volume expanders on the face has grown
dramatically since the first injectable collagens were put on the market in 1984 for treatment of wrinkles. This abundance
means im- proved treatment
for the patient,
as well as proposing the most adapted treatment. The many products now made by the laboratories have also made prices competitive.
Remodeling the face
using injectable implants has, for more than
5
years, been the number
one
rejuvenation treatment in the world, superseding peel- ings
and surgical lifting procedures.
This situation creates a need for increased awareness by the practitioner and a good knowledge of
the implants.
Most of the main
injectable
implants are all members of the large family
of polysaccharides, which
are sugars and have well-known benefits and complica- tions. New products continue to arrive
on the market with often
incomplete chemical formulas, molecules that
can more or less be
identified, and, what is even more
worrying, a total lack of clinical history with respect to tolerance, harmfulness, and absence or presence of long- term
complication.
Its important to recognize that
we cannot con- sider an injectable
product safe from possible complica-
tions until it has performed through clinical studies over
at least 5 years, which is practically never accomplished.1
Complications from the use of nonresorbable injections may therefore only appear years after the injections or as late as 15 to 20 years after injection, especially those containing silicone (e.g., siliconoma).
Figure 1 Nasolabial folds. Juvéderm Ultra or Surgiderm 24 deep, superficial plane Juvéderm or Surgiderm 18; or Perlane and Restylane (Teosyal, Anthelis, Isogel, etc.); or Zyplast and Zyderm I or Zyderm II or Evolence.
When remodeling the face, filling the troughs, and treating deep nasolabial ridges,
we use volume
expanders. When
deciding on a temporary treatment
for a young or undecided patient, we prefer using resorbable implants: high-density hyaluronic acid over
the periosteal bone, together with lower-density hyalur- onic acid (subdermally). Possible associations are Corneal
Voluma þ Surgiderm 30 or Surgiderm 24 (or Juve´derm
30 or Juve´derm 24) or Restylane SubQ þ Perlane
or Restylane. The results are
excellent for more than
a
year (Figs. 1–3). If, however, we need a more durable result under healthy thick skin, we
could use Radiesse
(particles of calcium hydroxyapatite in a methylcellulose suspension) subcutaneous
injection (Fig. 4) or Derma- Deep (acrylic particles in a hyaluronic acid gel) over the malar bone and Juve´derm or Surgiderm 30 or Surgiderm
24 subcutaneously. Artecoll (polymethylmethacrylate particles in bovine collagen) can also be used for deep injections. We never use collagen as a volume expander; we will usually use reticulated hyaluronic acid. We also use a combination of lactic acid and glucose; New-Fill reticulated or Sculptra give good results in these cases. A new glucose-based injection, Easy Agarose, seems to bepromising. Russian and Ukrainian scientific studies on the complications in using polyacrylamide-based injec- tions on the face and body (breasts, hips, and penis) have shown them to be catastrophic and that all doctors should avoid these types of injectable implants (patient 3). Resorbable implants, especially hyaluronic acid and cer- tain collagens, are very well known when treating mod- erate, superficial wrinkles. We always use the same retrograde injection technique, directing the needle from the deepest point toward the surface, or on the same plane, a method that will prevent contamination of the superficial dermis by the implant, particularly when using nonresorbable implants. Multipuncture techniques are often useful but must be reserved for resorbable products, having proved their harmlessness, essentially hyaluronic acid. These injections must be performed with experience and care.
THE PRODUCTS
We prefer resorbable products over the various injectable volume-filler implant, not only because they are well tolerated, but also because their quality is constantly being improved, in certain cases giving positive effects for as long as between 12 and 15 months, more than enough for a filler implant, especially when it has practi- cally no complications.
Figure 2 Reshaping the face. Juvéderm 30 and Juvéderm 24 HV for the lips, the cheeks, and the jowl line. Voluma on the malar bones (always less than too much) or Restylane and PerlaneþRestylane SubQ. Alternative New-Fill or Sculptra
subcutaneously but not for the lips.
Figure 3 Cheek filling with Juvéderm and Voluma. Left: Before treatment. Right: 15 months after injection.
In this study, I shall detail the different families of
implants frequently used, for which we have sufficiently serious
clinical and scientific history, with respect to their localization. Resorbable injectable implants belong to
four large biochemical families: collagens, hyaluronic acids, sugar and lactic acid associations
(New-Fill, Sculptra), and mixture of methylcellulose and calcium
hydroxyapatite.
The
Collagens
The first on the market were Zyderm and Zyplast (Allergan, Irvine, CA). They are still considered
to be good implants for wrinkle treatment, but not as volume expanders. Zyderm and Zyplast are obtained from bo- vine collagen. This bovine collagen resource has been
tested many times and has proved to be free of prions
causing subacute bovine spongiform
encephalopathy. Moreover, this collagen (class 4
tissue) is extracted from the dermis of animals that have never been infected with prion. Because of the strong species
specificity of collagen, an allergy test is recommended.2
Even if two tests are performed before
the first injection, each should
be 4 to 5 weeks apart. There is still
a 1.5%
risk of allergic reaction
after treatment with
In spite of this, Zyderm and Zyplast are always good collagen fillers
for wrinkles, with an appreciable positive effect around the lips.3
Evolence is extracted from porcine collagen.
Its interest resides in its negligible percentage of allergic reaction occurring after use. This is due to the modifi- cation in its chemical structure. Nevertheless, it is still
possible to have allergic reaction.
The laboratory does not recommend any inject- able test be performed. This implant is an interesting polyvalent filler, for use with small to more noticeable wrinkles, but it must be remembered that it is not considered a volume expander. It can be used in the case of mid to superficial wrinkles (not too superficial) but gives less interesting improvement than does thick hyaluronic acid in deep folds and wrinkles. The stability results of this filler are considered to be longer than those observed with Zyderm also. One should avoid injecting it in the epidermis and under thin skin; the slightest irregularity during implantation leads to a whitish chain of micronodules, which are not only totally unaesthetic but could last for many months, even years. The cystic nodules, proved to be formed by the neocollagen, are
Figure 4 Nasolabial folds. Radiesse in the deep plane + Zyderm I or Juvéderm 18 (second session).
unfortunately to be found in
the nasolabial folds but also jugulopalpebral fissures.4 The lesions may resemble acne
in the nasolabial fold, but this complication
is usually common to all implants and could be due to the fact that this area is rich in pilosebaceous glands. Evolence should not, therefore, be used
in the epidermis or in thin skin.
The laboratory
is enlarging its range with Evolence
Breeze for rejuvenation of the lips (patient 4). As in all collagens, its injection
is slightly painful in this region. It is
therefore recommended that an injection of local
anesthetic be proposed to the patient. The
results are very limber, aesthetic, and lend themselves to a natural,
soft, and homogenous appearance.
CosmoDerm and CosmoPlast are collagens ex- tracted from the human dermis (prepuce
skin).
These are good products, but of no particular interest in comparison with Zyplast. The collagen clearly guards an important
immunologic specificity for the human being. The occurrence of an allergy
in this type of collagen remains possible, but its duration
is not considered to be longer than
that occurring after the use of Zyderm or Zyplast.
The autologous collagen Autologen5 was first
marketed in the United States, followed by Isolagen. It is formed from a collagen taken from the patient himself (Autologen) or taken from collagen-producing fibroblast cultures, both taken from a
skin biopsy. The
production
of 1 mL of Autologen requires a fairly large skin surface. Isolagen6 is the most successful autologous collagen. The fibroblast culture is obtained
after
excision
of the skin from the retro-auricular area. The sample must be handed
to the laboratory in an isothermal container on the second day and cultured for 6 weeks. Five milliliters of Isolagen can thereby
be obtained. A 1 mL syringe of autologous collagen can
be reinjected during 2 to 3
sessions at
1-month intervals. They are conserved by the laboratory and
then transferred to the doctor handling the patient.
Autologous collagens are the products of an interesting
technology,
but which is costly
and not proven to be beneficial when compared with reference collagen (Zyderm, Zyplast).
The
Hyaluronic Acids
The best hyaluronic acids for use as fillers
and volume expanders are reticulated hyaluronic acids. Hyaluronic acids are polysaccharides;
the chemical reticulation
allows the polysaccharide chains to bond together. The most commonly used reticulating agent is butanediol diglycidyl ether (BDDE). Other reticulating agents are being
progressively abandoned
because of complications, as with vinyl sulfur and formaldehyde. The reticulation of
hyaluronic acids
means they are resistant to degrada-
tion by heat or enzymatic
action. The enzyme respon- sible for its degradation is
hyaluronidase, but other
enzymes may also interfere, not forgetting hydroxyl
radicals produced by inflammation, during
which their action is rapid. We can divide the hyaluronic implants into two major groups, depending on their three-dimen-
sional nature of reticulation:
the biphasic or
monophasic implants.
THE BIPHASIC IMPLANTS:
RESTYLANE, PERLANE,
RESTYLANE SUBQ, AND HYLAFORM
Restylane (Q-Med)
was the first hyaluronic acid to be
As for Perlane and Restylane
SubQ, the particles
are bigger, with smaller particles floating in the fluid
suspension. Nevertheless, it is always the same concen- tration of sodium hyaluronate (20 mg/mL), and it
is only the size and number of the particles that change accord- ing to the implant. The U.S. Food and Drug Admin- istration (FDA) authorized Restylane
for cosmetic use1,7–10 in the United States in 2001. Restylane SubQ has
bigger
particles, 1000
particles/mL gel,
whereas Perlane has an average of
10,000 particles/mL. Restylane SubQ is considered one of the high-volume expansion hyaluronic acids and is very difficult to inject (Fig. 5). A large-bore needle has to be used, 16 to 19 gauge,
or else with small catheters. Local anesthesia is highly recom- mended, and disinfection of the site should be done very carefully.
Hylaform, which is produced by Genzyme,
later acquired
by Allergan,
contains
hyaluronic acid
extracted from rooster combs.
Some allergic incidents
THE MONOPHASIC
IMPLANTS
Voluma, Surgiderm, Juve´derm, Hydrafill, Teosyal,
Anthelis, Puragen, Isogel, and so forth, are considered as a continuous polysaccharide
chain related in a linear structure by reticular particles. These chains can be more
or less thick with respect to the desired
results, both in terms of their viscosity, elasticity, and according to the intensity of
the implant and the amount of reticulation.
The injection is theoretically more
homogenous
and easier to do.
The experience of the surgeon or doctor in guid- ing the hand and choice of the needle is of the utmost importance. The reticule is BDDE. The monophasic implants are numerous, for repetition, Juve´derm, Hydra- fill, Surgiderm, and Voluma, which are all produced by the same laboratory, Corneal (France), acquired by Allergan (USA). The products are derived from the
Figure 5 Botulinum toxin forehead, glabella, and periorbital area. Restylane SubQ on the malar bones. Juvéderm 30 on jowl line.
same concept. Surgiderm was born from a long evalua- tion of the biochemical concept of Juve´derm,1 in the knowledge that the implant is very liquid, with an optimal degree of linear crosslinking allowing homo-
genous implantation and durability.
Voluma can be compared with Restylane SubQ, as it is a
very voluminous
implant. Its action is derived from a thick
hyaluronic acid
reserved for deep planes (Fig. 6).
Between each chain there will always be reticules of BDDE nearby, together with smaller chains of poly- saccharides. The reticular concentration is increased, but so is its effectiveness. The product has very good volume. A 16-, 19-, or 21-gauge needle should be used, or a small cannula after microincision of the skin using local anesthesia, or locoregional as with other thick injectable implants such as Restylane SubQ. The injection can only be performed on the periosteum or subcutaneously, but never within the dermis or thin skin. When using hyaluronic acid, effects such as localized edema may persist for more than 2 years. All hyaluronic acids absorb water and can multiply their volume by 5 at the very least; this effect is most noticeable when using thick hyaluronic acid. In conclusion, hyaluronic acids are resorbable injectable implants for both wrinkles and volume. They are all good quality as a rule, however, some are better than others; the complications related to this type of implant are mainly due to the permanence of protein residues from the bacterial strain and residual concentration while reticulating (toxic). We are very careful when mixing hyaluronic acid with macromole- cules of the dextran type, which can block the arterial and venous capillaries, causing very significant inflam- matory reactions and possible cutaneous necrosis of vascular origin. Several incidents have been reported. Products such as Matridex Beauty Sphere are to be prescribed.
Figure 6 The jaw line. She needs a face-lift, but we can improve with fillers. Voluma or Restylane SubQ on the cheekbone,
Juve´derm or Perlane in the cheeks, marionette lines, and the chin.
Polylactic Acids
Sculptra and New-Fill are two applications
for the same implant. Sculptra is used for aesthetic purposes, whereas New-Fill, registered and reimbursed in France, is used for facial Lipo-atrophy in HIV-positive patients. Bio- pharmex Biotech, acquired by Sanofi Aventis, produces the product. These are polylactic acid molecules associ-
ated with
sugar, carmellose, and mannitol in
micro- spheres. It is a sterilized, freeze-dried powder that
rehydrates using sterile water and a little Xylocaine
(lidocaine). The injection is painful given the presence of lactic acid. Local anesthesia is recommended. It is best
to mix the preparation 24 hours before the injection.
The follow-up is rigorous and requires that the patient
keep their appointments. It is primarily a
volumizing product, so it must not be injected for wrinkle treatment or lip
augmentation because its accumulation, particularly under
thin skin, will lead to inflammatory granulomas, which can be unfortunately spectacular. The product is likewise capable
of migrating to the nasolabial folds as well as the oval of the face.
As a volumizing agent, New-Fill injections will require three to four sessions with 1 month in between
to get
an
optimal result. These injections should be
repeated (5 times a year) to obtain the best results. The product is
expensive, but the duration of the product is sufficient for
HIV-positive patients who are socially
handicapped by their facial lipodystrophy.
Other Fillers
Bioinblue is one of these new confidential products. It is
manufactured by Polymekon, an Italian laboratory. It is a
polyreticulated alcohol, semiresorbable
implant, and takes
the form of a homogeneous viscoelastic product, marketed as
a lip and nasolabial fold filler. It is a biphasic water saturated implant producing a purely
mechanical filling. The pain inflicted by the injections together with
the significant inflammation, have lead to this product being dropped.
Radiesse is a semiresorbable implant containing calcium hydroxyapatite. It is manufactured by BioForm.
Calcium hydroxyapatite has long been used for osteo- genesis in semisolid protheses. When used for aesthetic purposes or in urology (for the bladder sphincter), where
volume, fibrosis, or neocollagenesis is important,
the concept is different.13,14 The particles of calcium
hydroxyapatite (45%)
are suspended in
a carboxymethyl-
cellulose gel (65%). The implant
is completely synthetic and biodegradable, but
some macrospheres will not resorb. The product
is whitish in color,
thick, and difficult to inject, requiring 26-
or 27-gauge needles.
The irritation caused in the tissue can on the one hand increase collagen, but can also lead to the formation
of granuloma. Taking its biochemical nature
into account, this interesting implant
has restricted aesthetic indication
properties. Filling
the nasolabial fold, especially
when the skin is thick and the fold is deep, is an excellent
indication. The
filler can perform for more than
15 months. This product should be avoided in other areas, such as
the lips, the area surrounding the mouth, thin
skin, estrogen deficiency, and skin with acne. It is
too early yet to speak about perfect harmlessness.
Implants containing nonresorbable
fillers must be avoided on the face. We know that silicone liquids and paraffin are forbidden both in Europe and in the United States except for particularly well-documented studies concerning HIV-positive patients (two studies currently in the United States for injectable silicones).
Acrylate
gels, such as Artecoll, ArteFill, Derma- Live, DermaDeep,
and
Novasoft, must
be used with
caution.
I wish
to spend
a
little
time
with
respect to polyacrylamides, because although currently in fashion
in Europe and the Middle East, they have been the cause
of human disasters in the Ukraine, Russia and China.
Inoffensive nonresorbable implants remain to be found, so one must avoid their use for rejuvenation and facial embellishment.
CHOICE
OF IMPLANT ACCORDING TO
ITS INDICATION
Facial skin is unequal in nature, i.e., the cheeks,
chin, and cheekbones are very different from the
area sur- rounding the lips and periorbital areas, which are com- posed of thin skin with very fragile
lymphatic capillaries.
The questionnaire and the medical history of the patient are essential,
and photos should be taken prior to the first injections, and, if possible,
1 to 2 months after
each new
series of injections. One
should make an appointment
to see the patient 4 to 6 weeks after an injection, and then 3 months later to see the result. This will also give
the practitioner the opportunity to check
on tolerance of the product and to add a small amount when required. One should
always inform the patient of the nature of the product and the expected duration, this should be done prior to the patient signing the informa- tion application,
the consent form, and the estimate with all
of the information at hand.
The medical history of each patient allows us to be informed of any prior medical incidents or to suspect
that they have a potential problem thus avoiding con- traindication. The notion of hyperactive
autoimmune system or inflammatory
diseases in either the patient or his or her immediate family are also important. Non- absorbable as well as some absorbable implants
are contraindicated. Even a reticulated
hyaluronic acid of moderate
density may trigger immediate inflammatory reactions (edema, redness),
or later lead to nodules and inflammatory granuloma over
an immune-deficient area.
Normally, injecting these types of patient should
be avoided,
but if it should prove necessary, it
is best to use hyaluronic acid,
which
can be controlled.
Similarly, any infectious disease, either diffuse or local, is considered
to be a veritable temporary contra- indication.
Sinusitis,
dental abscess, herpes or other cutaneous eruptions
are known to reactivate nodules and granulomas and can also create cystic lesions
con- taining sterile pus as is the case of facial
subcutaneous infection with Bio-Alcamid.
The nasolabial folds are a relatively simple indi- cation,
but all depends on the nature of the skin (thin, thick, dry, greasy, healthy, or pathologic).15,16
When performing a deep injection, use a thick reticulated hyaluronic acid, together with a reticulated or nonreticulated hyaluronic acid on the surface, from the same manufacturer if possible.
Possible associations are
Perlane þ Restylane17 in
the middle plane and Restylane Touch on the surface, or
Restylane Vital to the subcutaneous tissue.
Juve´derm
30 or Surgiderm 30, Juve´derm 24 in- jected in the middle dermis if needed.
Juve´derm 24
HV or normal
or
Surgiderm 18 injected superficially in the dermis. The same goes for
Teosyal, Isogel, or Anthelis, where the denser product should be injected into the deep dermis. Zyplast collagen is given subcutaneously and Zyderm I or Zyderm
II more superficially. Evolence should be used for the deep or middle dermis.
Other associations are also possible whenever the patient has already proved good tolerance
to the implant, knowing that allergic reactions
arise most commonly
when an alternative implant with a different chemical composition is injected on the same site or in a different cutaneous plane.18
Radiesse is best adapted by itself to the deep folds
and can eventually be complemented with a
fine hyalur- onic acid.
Certain implants should not be used
for the lips: Biocalmid, Radiesse,
Beautysphere, and New-Fill. Others must be avoided even when patients insist on the nonabsorbable implant. The most efficient implants are the hyaluronic acids (except for the volume expand- ers), and collagens such as Zyplast, Zyderm, Evolence, or
Evolence Breeze, which are designed for the lips.
Only fluid nonreticulated hyaluronic acids should
be used for the forehead, particularly as mesotherapy.
The cheeks,
the cheek bones, the brow, and the oval of the face are easy areas for treatment with respect
to volume reconstitution, as long as one respects the following:
thick
or nonabsorbable implants injected
deeply, and the more fluid implants
injected into deep
dermis or subcutaneously Under-correction is
better than secondary overcorrecting due to implant excess or
the positioning of the latter (hydration and enzymatic
reaction will
cause secondary edema of the
viscous
hyaluronic acid; patients 6 and 7).
For the over-periosteal area we choose
Voluma þ
Juve´derm or
Surgiderm 30 or Surgiderm 24 for subcuta- neous, or Restylane
SubQ or Perlane for the subcuta- neous plane and Restylane for the deep plane.
Acrylates as Artecoll or DermaDeep could
be injected deeply in the cheeks
and temporal area.18,19
Finally, the orbital area is extremely fragile
and requires great experience and care. The collagens leave a
white deposit and so should be avoided (patient
8).
The hyaluronic acids or the autologous fat tissue
are the best adapted, as this is such a dangerous and difficult area to implant (cases
of blindness have been reported).
Hyaluronic acid is used thick and deep on the periosteum, and fluid but reticulated superficially. Thus, we can treat the palpebral
circle, sunken eyes, and eyelids (Figure 7).
Figure 7 Periorbital rejuvenation. More difficult than expected especially after two eyelid surgeries; exclusively hyaluronic acid.
Wrinkles in the corner of the eyes can be treated by
mesotherapy (intradermic
or subcutaneous) or
by
injection of the superficial dermis with Juve´derm or Surgiderm 18 after treatment with botulinum toxin to get the best results.
CONCLUSION
Injectable implants contribute to facial
beauty. Never- theless, the following laws apply: caution
and prudence at all times. Progressive training
of injection technique is essential. Never inject an implant that
you do not know. Always check the CE
(Conformite Europe´enne [CE-marking
indicates that the product complies
with European safety
standards]) norms and
the technical
leaflets provided with the implant
packaging and check
on traceability stickers.
Finally, carefully balance
the patient’s demands with respect to their medical history and the state of
his or her skin.
____________________
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