dermal filler list
Posted 27 February 2004 - 04:18 AM
Posted 27 February 2004 - 05:08 AM
however you missed one every important one that might be used a lot in the future...isolagen.
can people share their experiences with artecoll, isologan...or any other semi-permanent fillers?
Posted 27 February 2004 - 05:56 AM
Isoalgen is not exactly a filler though, it is an injection of your own fibroblasts. You wouldn't get any immediate improvement and the results are very individual.
Posted 27 February 2004 - 09:05 AM
Soft Tissue Substitutes in Perioral Augmentation
David A. Jansen1 M.D. F.A.C.S. , Miles H. Graivier2 M.D. F.A.C.S.
1Section of Plastic and Reconstructive Surgery, Tulane University Health Sciences Center, New Orleans, LA
2North Atlanta Plastic Surgery, Atlanta, GA
Each year the plastic surgery industry has a newer, better, soft tissue filler. Most plastic surgeons are very skeptical about the newest product. The goal is always an injectable, affordable, long-lasting filler. We have recently witnessed a dramatic increase in the available fillers for use in perioral rejuvenation. Thus, it is necessary to discuss state-of-the art fillers now available, the techniques used, potential pitfalls in use, and results. Solutions to problematic areas in perioral rejuvenation are presented. There does not appear yet to be an ideal filler; instead most plastic surgeons have an algorithm for modest, moderate, and dramatic improvement in facial soft tissue needs. Our practice has more recently focused on various combinations of Allodermâ„¢, fat, and hydroxylapitate injectable microspheres (Radianceâ„¢) to fill most of these needs. We strongly suggest that plastic surgeons become facile with three or four fillers to address a wider range of soft tissue needs. We present an in-depth discussion of the most common available fillers and show the risks and benefits we have experienced with each.
An increasing number of soft tissue filler substances are introduced to the cosmetic beauty market. The primary focus for these fillers is to treat the perioral area. Lips, nasolabial folds (NLFs), marionette lines, and vertical rhytids are the most common target areas. We discuss the risks, benefits, and pitfalls of the most commonly used soft tissue filler both inside and outside the United States.
The ideal soft tissue filler substance for volume should be biocompatible, safe, stable at the implantation site, able to maintain volume, remain pliable, induce minimal foreign body reaction, and cause no foreign body granuloma. Resorption or palpability of most implantables has been the rule. The speed of resorption is related to the mitologic reaction induced by the implanted soft tissue filler. For this reason we have classified soft tissue filler substances into six types.
Natural filler substances such as collagen and hyaluronic acids (HAs) are phagocytosed slowly without much histologic reaction.
Autologous fat, which has extreme variability in take. The additive to induce long-term survival of fat cells or stem cells has yet to be discovered.
Fluid fillers such as liquid silicone and acrylamides cause little fibrosis but can dislocate in larger volumes by muscle movement and gravity.
Microspheres from nonresorbable polymethyl-methacrylate (PMMA) or human dermal matrix (Allodermâ„¢) are stimulants for encapsulation and scaffolds for connective tissue formation. These are living implants.
Particulate materials with microspheres containing hydroxylapitate encapsulated in a methylcellulose gel evoke little foreign body reaction and fibrosis. These are pure fillers and slowly resorb.
Permanent implantables such as expanded polytetra fluorethylene (PTFE), which have no resorption at all.
Most defense mechanisms react differently to each filler material, either a cellular-specific immune response (as seen with allogenic tissues) or a nonspecific foreign body reaction (as seen with alloplastic materials). Resorption is dependent on the induced human anatomy response. However, all substances discussed in this article, both resorbable and nonresorbable, appear to be histologically safe. None of these materials are without side effects. Our continuing goal is to find an easy-to-use, semipermanent, low-cost, pliable filler substance. With these goals in mind, we discuss what has worked well for us over the last 10 years of practice, emphasizing the good, the bad, and the useless.
ALLODERM (LIFECELL CORPORATION)
A reliable alternative to autologous grafts is an acellular, structurally, and biochemically intact human dermal graft (Alloderm). This product potentially provides the convenience of an off-the-shelf product with the benefit of a minimal inflammatory reaction in the recipient bed.
The high rate of resorption in transplanted tissue is initiated during the procurement of an autograph. The cells become damaged and release enzymes that further damage the matrix. Inflammation develops as a response to the damaged transplanted tissue and thus the process of resorption is initiated. Terino writes that the â€œpersistence of these grafts is variable, because the degree of damage depends on the extent of graft manipulation and the time between procurement and reimplantation.â€?
Alloderm, processed from cadaver skin, is freeze-dried without damaging the matrix. The biochemistry and structure of this matrix are preserved but are devoid of cells and major histocompatibility antigens. Thus, it is easy to see why the Alloderm graft can act as a template for the recipient cell repopulation and revascularization resulting in soft tissue regeneration without fibrosis or scarring.
In our practices, large volume needs in the perioral area, most notably in lip augmentation, are best accomplished with Alloderm.
Critical to all procedures on the lips is preoperative epinephrine injection into the muscle and ice application to maximize vasoconstriction and minimize edema. We routinely use a 3 Ã— 7 cm piece of Alloderm,which can vary in thickness from 12 to 59/1000 of an inch. We prefer to use thicker pieces in the range of 40 to 50/1000 of an inch for the larger-volume augmentations (Fig. ).
We divide the 3 Ã— 7 cm graft using two-thirds to upper lip and one-third to lower lip (Fig. ). Sterile rehydration requires 5 minutes in two separate baths of normal saline. We now do not taper the graft; instead, by twisting and pulling a corner of the graft through the tissue, the rectangular implant naturally tapers at the ends and provides the most bulk centrally (Fig. ). Minimal suturing is key to avoid an inflammatory response (i.e., significant resorption).
Longitudinal stab incisions just medial to the commissure at the wet-dry vermilion-cutaneous bonds are made. Blunt dissection with curved tendon passer in the orbicularis oris muscle located in the anterior quadrant of the dry vermilion is key for volume augmentation (Fig. ). The Alloderm is pulled through the tunnel, twisting as you pass to form a natural roll (Fig. ). Gentle lip manipulation with cutting and burying the ends of the graft under muscle is key to minimize exposure. We prefer a two-layer Monocryl;ot closure of muscle and then mucosa to minimize exposure and inflammation (Figs. , ).
A standard postoperative regimen includes cool compresses (frozen bag of peas or corn) applied 15 minutes each awake hour for the first 24 hours along with Decadron, oral antibiotics, and antivirals for 4 days.
The most common complication we have encountered is exposure of Alloderm at the incisions. This is easily treated with cleansing retrimming and closure of the incisions. No grafts have had to be removed in over 5 years of use. The key seems to be meticulous placement of the Alloderm ends beneath muscle and a solid two-layer closure.
We have discovered that the best way to avoid the early postoperative â€œduck-lipâ€? edema is to prevent it. We cannot stress the importance of preoperative intramuscular epinephrine and external ice applications. A bothersome problem to the patient is the 4- to 6-month palpability of the grafts as they go through a temporary â€œfibrosis phaseâ€? of wound healing. This is managed early with two-finger massage of the area four or five times daily. Most importantly, resorption rates in our hands vary between 30 to 50% at 5 years in mobile areas such as the lip, whereas much lower resorption rates (15 to 20%) are seen in less mobile areas such as the NLFs.
We now recommend Alloderm for large-volume lip augmentations and correction of larger-volume needs with a 25 to 50% overcorrection, depending on the area. The amount of overcorrection must be discussed preoperatively. Patients cannot expect to see final results for up to 6 weeks. To avoid the overcorrected lip, many opt to have a secondary procedure 6 months later with the addition of fat grafts around the Alloderm.
The use of Alloderm in perioral rejuvenation continues to increase. Alloderm seems to integrate into the patient tissue with minimal reactivity. Lower tissue reactivity correlates to less resorption. Preservation of volume is unknown long term. Presently, our experience indicates a 3- to 5-year life span with some residual scar formation. Alloderm is used extensively in our perioral rejuvenation practice for larger-scale volume needs.
This is the micronized form of Alloderm made for injection to augment the soft tissue. This micronized, acellular, human cadaveric dermis comes in a powdered form and requires reconstitution. As with sheet Alloderm, skin testing is not required. Results with this product have been less than satisfactory. Longevity and excessive pricing are the main issues. The only way that we have been able to make the augmentation last more than 3 months is to inject the product with an 18-gauge needle (or 18-gauge Coleman cannula) two or three times in the first year and then administer a once-yearly booster injection to maintain volume.
Artecoll is a combination of PMMA microspheres suspended in a 3.5% atelocollagen carrier. The microspheres are 32 to 40 μm in diameter and have smooth surfaces that have been washed of electrical charges and nanoparticles. The biphasic suspension is 75% collagen and 25% PMMA microspheres. Artecoll's predecessor, Arteplast, which had been used from 1989 to 1994, had an unacceptably high granuloma rate (2.5%) developing 6 to 12 months after implantation. This was due to Arteplast's surface irregularities from adherence of nanoparticles to the surface of the PMMA microspheres. These nanoparticles became adherent because of static electrical charges on the surface of the microspheres. Particles with irregular surfaces and sizes have a much higher incidence of stimulating an inflammatory response. Additionally, Arteplast used a gel carrier for the PMMA microspheres, which had a fast resorption rate. The fast resorption of the carrier gel may have prevented collagen ingrowth around each microsphere, thereby leading to clumping.
The problems with Arteplast led to reformulation of the product as well as changes in the processing of the PMMA microspheres. The new product was introduced in 1994 and called Artecoll (Rofil Medical International). A gelatin carrier was replaced by a more viscous collagen carrier. A complex washing and ultrasound technique removed the surface electrical charges and produced perfectly smooth, homogeneous PMMA microspheres with impurities dropping to between 1 and 2%. This European Artecoll product has been used in 150,000 patients with 15 reported granulomas between 1995 and 2002. This is an occurrence rate of 0.01%. The newest Artecoll product (Artes Medical) began using collagen from the United States in April of 2001 and at the request of the FDA has decreased the PMMA impurities to less than 1%. FDA approval is pending.
After injection, the PMMA microspheres act as a stimulus for fibroblasts as the collagen carrier is replaced by connective tissue. The collagen carrier is dissipated within 3 months of implantation. Each of the individual PMMA microspheres is encapsulated within the patient's own collagen fibers, thus preventing migration; 25% of the volume correction from the implant is due to the PMMA microspheres, whereas 75% is due to the patient's own connective tissue replacing the carrier collagen. Therefore, it may take up to 3 months for the full enhancement to be achieved.
Sensitivity testing should be performed prior to use because of the collagen carrier. The injections are placed into the deep dermis just above the junction between the dermis and subcutaneous fat. Topical or local anesthetic can be used, but injection with a 26- or 27-gauge needle may be uncomfortable without a local block. Nerve blocks may be given, but injecting the lip with lidocaine with epinephrine decreases the rate of hematoma formation. Ice should be applied after the local anesthetic to decrease the swelling from the local. A 1:1 correction is used with Artecoll injections.
Augmentation of the lip with Artecoll is the most technique dependent of all areas. The implant may be injected under the white roll, vermilion, radial lip lines, and under the corners of the mouth. Use of a 26-gauge needle allows smoother flow of the material with less chance for uneven distribution. The lip is grasped and lightly pinched between the nondominant index finger and thumb, thus forming a channel to guide the injected material into the correct position. The needle is inserted from the outer corner of the mouth to the middle of the lip and the implant material is injected as the needle is withdrawn. A steady stream of implant material is placed, leaving a filament or threadlike deposit. The lip is massaged gently after each injection to evenly distribute the implant and decrease the likelihood of lumps. Multiple threads are placed and symmetric injection is carried out from the opposite side. Additional augmentation can be performed on the Cupid's bow.
Under the white roll and dry vermilion, the implant can be injected into the potential space between the dermis and orbicularis muscle. A posterior injection is performed if the lip requires shortening and rolling out of the vermilion. According to Lemperle, Artecoll may be injected along the wet border of the lip adjacent to but not into the orbicularis muscle. He feels that injection into the orbicularis muscle may cause dislocation and nodule formation. The Artecoll is a paste for approximately 3 days, at which time the body starts to encapsulate it. Posterior submucosal injections in the lip are usually palpable with the tongue or teeth.
It is best to use a 27-gauge, 1/2-inch needle to inject under the radial lip lines and to elevate the corner of the mouth. Radial lip lines can be injected vertically. White roll injection helps efface some of these fine lines. At the corner of the mouth, injections are cross-layered (Fig. ). They are first placed into the deep dermis to fill the depression and then deeper from a different direction to bolster and elevate the corners of the mouth. Manual molding is again performed after each injection.
Postoperatively, ice is applied for 24 to 36 hours. Lip rest with minimal motion is advised for 3 days after injection. Lemperle also suggests placement of a band around the mouth, especially if submucosal injection has been performed. Antiviral prophylaxis is also recommended. If nodules form, they are usually palpable after 5 to 7 days. Nodules can be â€œcrackedâ€? at that time, and continued localized massage is recommended. Intralesional steroids can be used after 4 to 6 weeks. If this treatment fails, excision can be performed.
Artecoll has been shown to be an effective implant for the filling of lines, furrows, folds, as well as lips. A 5-year follow-up on 600 patients showed that 89.5% of those patients treated were satisfied and would have the treatment again. The advantage of the product is the longevity of the results. There is minimal down time, and the result is adjustable with the addition of more implant. Granuloma formation has been extremely rare. The main concerns are prolonged redness, inflammation, and visible or palpable nodules. These are most likely due to injections placed too superficially, in the red vermilion. Although the nodules are usually subclinical and not bothersome to the patient, concerns have been raised regarding the frequency of occurrence. Proper technique with delivery of the implant into the appropriate layers of the lip is imperative. The patients must be well informed of the possibility of and treatment for nodules prior to injection.
Perioral rejuvenation using autologous material has been described for years, the most common being fat. When multiple other procedures are being performed, it has been tempting to use readily available materials such as dermal grafts, tensor fascia-lata (TFL), submuscular aponeurotic system (SMAS), breast capsule, palmaris tendon, or vein grafts. The ultimate question of volume preservation depends on the induced inflammatory response. The cellular-specific immune response (as seen with allogenic tissues) or a nonspecific foreign body reaction (as seen with alloplastic materials) is the ultimate determinant in resorption rates of these implanted tissues.
We have used harvested fat extensively and currently describe a 40 to 50% resorption rate depending heavily on user technique and recipient bed vascularity.
Several authors have described the use of resected SMAS in perioral rejuvenation procedures. Harvesting SMAS during rhytidectomy procedures is convenient. We have been tempted to preserve fat on the SMAS for additional volume needs. The idea of SMAS as a carrier for fat and a bulky natural implant seems logical. However, our long-term experience has shown a steady loss of volume, presumably due to the induced tissue graft response during harvesting. The SMAS graft tends to fibrose over time and in many cases resorb completely.
The popularity of breast augmentation with resultant capsule formation also has been described as a readily available autogenous implant. Isenberg notes that 20% of breast implant patients undergo repeat surgery; during these procedures, the fibrosed capsule harvested is easily used for perioral enhancements. The authors describe the lack of donor site morbidity and predictable postoperative volume maintenance. At 16 months over half the patients desired more enhancement, whereas nearly 85% were comfortable with lip texture. Although capsules appear to be a readily renewable perioral implant source, our experience with maintaining volume is much poorer. It is our impression that the intense inflammatory response that helps create the implant capsule is the very source of the high resorption rate.
TFL and temporal parietal fascia (TPF) have a long, strong history of use in perioral volume enhancements. Similar to SMAS, we frequently harvest these biologic implants when in the general vicinity.
The TPF provides a modest amount of implantable material, whereas the TFL can provide significant tissue. The harvest technique for TFL requires two small incisions and a blind push-cutting maneuver to obtain the graft (Fig. ). The TPF is frequently harvested during rhytidectomy and forehead procedures (Figs. , ).
Overall complication rates have been low using TPF. At harvest, injury to follicles can lead to alopecia. Although rare, thigh muscle herniation through the TFL defect has been seen in well-muscled patients (Fig. ). Our experience with palmaris tendons and vein grafts is minimal. Finally, the use of biologic donor materials is usually limited by the donor site harvest morbidity and the inconsistent volume maintenance. Our most common biologic implant remains meticulously harvested fat, especially in combination with implantables such as Alloderm or SoftFormâ„¢.
BIOENGINEERED HUMAN COLLAGEN (COSMODERM-1 NST, COSMODERM-2 NST, COSMOPLAST NST; INAMED AESTHETICS)
CosmoDerm-1 NST, CosmoDerm-2 NST, and CosmoPlast NST are new bioengineered human collagens derived from donated human foreskins. The first collagen implant that does not require skin testing, it will be used as a dermal filler in the same fashion as its bovine counterparts. The downside to these implants is again the longevity, which appears comparable with the bovine collagen equivalents. Approved for licensing in Canada in December of 2002, application to the FDA is currently pending.
BOVINE COLLAGEN INJECTIONS (ZYDERM I, ZYDERM II, AND ZYPLAST; INAMED AESTHETICS) Because of its safety record and widespread use, collagen has remained the gold standard for lip and perioral tissue augmentation. Collagen is the soft tissue filler agent against which all other implant materials are compared.
Bovine collagen comes in three thicknesses: Zyderm I (35 mg/cc), Zyderm II (65 mg/cc), and Zyplast (cross-linked with glutaraldehyde). In Zyplast, the collagen is cross-linked with 0.0075% glutaraldehyde, which produces covalent bonds between 10% of the available lysine residues of the collagen. This cross-linking makes the collagen more viscous.
Bovine collagen is contraindicated in patients with meat allergies and those with a history of anaphylaxis. Because bovine collagen injections contain lidocaine, they should not be used in patients with lidocaine allergy. Patients with connective tissue diseases may have an increased incidence of hypersensitivity and possibly have an increased rate of clearance of the bovine collagen implant. There have been several case reports of new occurrences of connective tissue diseases following bovine collagen injection. Studies have not confirmed a causal relationship between bovine collagen use and the development of these diseases.
Hypersensitivity reactions have been reported between 1.3 and 5.6% of patients who are skin tested prior to treatment. Redness and soft tissue swelling present after 24 hours that persists for 6 hours is considered a positive test. Approximately 75% of localized skin reactions occur within 72 hours of testing. Even with negative initial skin testing, reaction to collagen injection at the treatment site has been noted in 1 to 3.1%. Typically, the majority of reactions are localized and occur after the first or second collagen exposures. Delayed hypersensitivity has also been noted in 1.3%. Bovine collagen injections are contraindicated in patients with sensitivity reactions at the test or treatment sites.
Prior to bovine collagen treatment, a skin test of 0.1 cc of Zyderm is placed intradermally in the volar forearm. Treatment can be performed after 4 weeks of observation of the test injection site. However, because most reactions occur within the first two exposures, it may be more prudent to retest after 4 weeks and then wait another 2 to 4 weeks for signs of reaction. This decreases the rate of reaction of the treatment site.
Zyplast is the collagen of choice to augment the lip vermilion, white roll, and corners of the mouth. Our preference is to place a topical anesthetic agent such as Emlaâ„¢, Betacaine, or Lasercaine with an occlusive cover for at least 30 minutes prior to injection. The injection is performed with a 30-gauge needle into the potential space under the vermilion and white roll. The lip is gently pinched with the nondominant index finger and thumb while the Zyplast is gently injected. We find it preferable to inject a steady stream of material while the needle is withdrawn as opposed to a serial puncture technique. Gentle molding is done after injection of each filament of collagen. The injection is started centrally and continued all of the way to the commissures. The Cupid's bow is usually accentuated. The philtral columns can also be augmented. We usually try to elevate the corners of the mouth with cross-layered injections of Zyplast. Radial lip lines can be filled with Zyderm I injections placed into the superficial dermis. Correction with Zyplast should be 1:1, but overcorrection with Zyderm I and II is indicated as some of the volume is due to the lidocaine and buffered saline and there is a higher degree of resorption. The implant material is refrigerated, and touch-up injections can be performed after 2 or more weeks. The FDA does not recommend reuse of remaining collagen in a syringe. However, studies have shown that syringes of collagen stored for repeat use rarely become contaminated with bacteria.
There are several advantages to bovine collagen injections. First and foremost is the ease of treatment with almost no down time. The patient can have a 15-minute office treatment and look good without signs of injection after as little as 8 hours. Lip volumes can be easily adjusted by adding more implant material to achieve the desired effect.
One of the biggest drawbacks of collagen is the short-lived nature of the product. Bovine collagen is almost always highly dissipated in 3 to 6 months. Results, however, may be additive as repeat injections often become less frequent in time.
Bovine collagen is clearly not the ideal material for lip augmentation. There is an ever-expanding list of new filler implants currently or soon to be available that avoid the longevity and hypersensitivity issues of bovine collagen. Its use for short-term augmentation does give patients the opportunity to experiment to see if they like the result. It still remains a good test before proceeding with longer-lasting injections or more invasive procedures.
DERMALIVEâ„¢ AND DERMADEEPâ„¢ (DERMATEC, INC.)
Dermalive and Dermadeep are injectables consisting of polymethacrylate (PMA) acrylic hydrogel in HA of bacterial (nonanimal) origin. The fragments of PMA account for 40% of the volume with 60% from the HA. The particle size in Dermalive ranges from 20 to 120 μm with the majority in the 45- to 65-μm range. In Dermadeep, the majority of PMA particles are larger, in the 80- to 110-μm range. PMA size greater than 45 μm helps prevent particle migration.
Dermalive has been used in France and the rest of Europe since 1998 with satisfactory results. Dermalive is injected in the deep dermis with a 27- or 30-gauge needle, whereas Dermadeep is a subdermal injection with a larger needle (26 gauge). Overcorrection is not recommended even though 60% of the implant volume (HA) is usually resorbed after 3 months. Two or three repeat injections with at least 3-month intervals are recommended for complete correction. Even though satisfactory results have been shown with this treatment regimen after 3 years, histologic studies after 9 months reveal only a few clusters of Dermalive surrounded by macrophages and lymphoid cell clusters. Approximately one-tenth of the remaining implant volume consisted of cells and fibers.
Hypersensitivity reactions to the HA and late formation of palpable nodules have been reported at 0.12%. The nodules usually occur at least 6 months after injection and can be treated with intralesional steroids. To obtain complete correction of the most superficial lines, an injection into the mid- or superficial dermis with Zyderm or a pure HA product may be necessary.
FASCIANâ„¢ (FASCIA BIOSYSTEMS)
Allograft fascia-lata has been used since the early 20th century, described first by the French surgeon Nageotte. Because of continued improvements in tissue preservation, donor screening, and safety issues, preserved fascia implantation is now commonplace.
Burres introduced the use of fascia grafts for dermatologic problems initially for pitted acne scars and later for lip augmentation. Histologically the preserved injectable fascia grafts (Fascian) provoke host fibroblasts to replace the graft over several months with a vascularized sheet of native collagen. Various Fascian particle sizes are available.
It is our experience that large Fascian particles have a similar take rate as fat, whereas the smaller Fascian particles can last twice as long as collagen substitutes. We do recommend repeat injections to maintain volume.
Allergic reactions have not been reported. Three undocumented reactions to Fascian, consisting solely of edema, have been reported. Temporary local hyperpigmentation may be anticipated in dark-skinned ethnic groups but can be permanent if areas of posttraumatic hyperpigmentation are seen elsewhere.
Fascian is hydrated with 2 cc 1/2% lidocaine. The larger particles are injected through a 14- to 18-gauge needle, and the finer particles can pass through a 20- to 27-gauge needle (Fig. ).
Needle tunnels and dissection are necessary to create a space for particle deposition. Clogging of the material frequently occurs. Changing needles or aspirating saline can resolve clogging. Cold pressure is applied to the area for 10 minutes. We usually prescribe a 5-day steroid taper with 15 minutes of ice therapy every 2 to 4 hours for the first 24 hours.
The volume needed to correct or augment is frequently underestimated. We use the dry volume of injectables such as Fascian when estimating volume needs. Conversely, graft remodeling that occurs with all injectables often causes mismatch to the contour of the defect and may actually â€œball upâ€? the injectable material if excessive quantities are confined in too small an area.
The obvious benefits of fascia are clear: low cost ($125/cc), no donor site issues, easy preparation, and ease of use. The major down side is a resorption rate similar to fat.
EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE; GORE-TEXâ„¢)
Gore-Tex has been used extensively in vascular surgery and, more recently, soft tissue augmentation. This is a porous material that provides local stability in the recipient site with moderate ingrowth of connective tissue. Initially, Gore-Tex suture material was threaded into the subdermis, and then additional authors described experience with trimmed Gore-Tex strips. Subsequently, preconstructed hollow tubes of Gore-Tex (SoftForm facial implants) and porous filled tubes (Advantaâ„¢) have become available. SoftForm is delivered over a trocar into the subdermal plane, whereas Advanta is passed through tissue while attached to a trocar. SoftForm is available in 2.4-, 3.2-, and 4-mm diameters with varying lengths of 50, 70, and 90 mm. SoftForm is an excellent choice for moderate NLF improvement, whereas Advanta can give excellent large-volume increases in lip augmentations.
Following implantation, granulation tissue invades the lumen of the implant. It is later replaced by mature connective tissue. We feel it is imperative to pretreat all patients with oral antiviral medications, antibiotics, and oral steroid. A 4-point trigeminal nerve (C.N.V) block is necessary. Most critical to minimize edema is infiltration of all recipient sites with 1/2% lidocaine epinephrine 1:200,000 solution, 15 minutes of ice packs, premanipulation. The trocar easily enters the subdermal or submucosal plane and sharply dissects (Fig. ). We can better position the graft by securing the ends with clamps and then massaging the graft into position. SoftForm is most useful in NLF augmentation and creating a superior rolling of the vermilion border with increased red lip show. Two pieces can be placed lateral to the Cupid's bow peak for a more chiseled look or, more commonly, one piece can be placed across the entire lip for a more â€œpoutyâ€? look (Figs. -).
The smaller-diameter SoftForm tubes can be palpable as a cord beneath the mucosal surface, whereas the larger-diameter Advanta seems to create a more diffuse palpability. Advanta is more commonly used when a larger vermilion volume is needed. Critical to the use of these products is minimal trauma to the longitudinal positioned labial artery; injury causes significant edema and bruising. Advanta should be placed deep in the muscle with the ends well tucked beneath the orbicularis muscle and mucosa (Figs. , ).
Lip edema is common for 5 to 7 days, and patients should be advised about possible diminished dynamic lip motion. The patients may complain that the lips are tight on wide mouth opening. This is easily treated with lip-stretching exercises after all incisions are well healed. Superior movement of the implant in up to 10% and some concerns with pyogenic granuloma formation have been reported, but we have not experienced either problem to date.
Infection is the most serious issue we have encountered with ePTFE products, often requiring removal. The culprit is always incisional site dehiscence. It is imperative to use intraoperative irrigation of incisions with betadine and implant soaking in antibiotic solution for 15 minutes (Fig. ). Despite these precautions we are cautious in our patient selection and overeducate our patients as to this possible sequela. In the event of dissatisfaction or infection with these implants removal is simple and makes this material attractive in larger augmentations of the perioral area.
HYALURONIC ACID GEL (RESTYLANE/ PERLANE/RESTALANE FINE LINE, Q-MED; HYLAFORM/HYLAFORM PLUS/HYLAFORM FINE LINE, GENZYME BIOSURGERY) In that study of 138 patients, 56% reported superior results and longevity on the Restylane side compared with 9.5% preferring the Zyplast side. HA gels appear to offer other advantages over bovine collagen including increased longevity and fewer hypersensitivity reactions.
Several types of HA gels are available, including (Q-Med products) Restylane, Perlane, and Restylane Fine Line and (Genzyme Biosurgery products) Hylaform, Hylaform Plus, and Hylaform Fine Line. Restylane, Perlane, and Restylane Fine Line are nonanimal products produced from bacterial fermentation (streptococci). The Hylaform products are derived from the HA of rooster combs. The resultant HA gels consist of hyaluronan polymer molecules cross-linked to provide stability. The HA products are metabolized in the liver to form CO2 and water. The HA is resorbed over a 4- to 12-month period, although the results may last longer with the thicker fillers (Perlane and Hylaform Plus). The results also vary with the location of implant placement. In the lips, the implant usually lasts 9 to 12 months and sometimes in the NLFs up to 18 months. A unique property of HA is its ability to bind water and form hydrated polymers of high viscosity. HA has an isovolemic degradation pattern. The hyaluronan polymers bind more water as the concentration in the dermis decreases. Therefore, the augmentation effect lasts until most of the HA is eliminated.
At present, hypersensitivity testing has not been required prior to using these products. Studies have shown delayed inflammatory skin reactions to both of these product lines ranging from 0.15 to 0.42%. These included granulomatous reactions to foreign bodies, chronic inflammatory reactions including redness and swelling, bacterial infection, and development of acneiform lesions. The reactions are believed due to trace amounts of by-product proteins from the manufacturing process. These proteins had been less in the Hylaform than Restylane, but the formulation of Restylane was changed approximately 3 years ago. This more purified form of Restylane, Perlane, and Restylane Fine Line has dropped the reaction rate to approximately 0.06%. Even with the relatively low rate of allergic reactions, pretreatment skin testing would decrease these occurrences.
There are three thicknesses of each brand of HA implants. Perlane and Hylaform Plus consist of the larger gel particles in more viscous solutions. These products are injected into the subcutaneous dermal junction usually with a 27-gauge needle. These injections are effective for deeper furrows and depressions such as the NLFs and in patients who desire larger-volume lip augmentation. Restylane and Hylaform are the middle-thickness products that are useful for deeper lines and lips including the white roll and radial lip lines. The injection is into the mid-dermis with a 30-gauge needle. Restylane Fine Line and Hylaform Fine Line are the thinnest implants and are used for very fine lines such as superficial radial lip lines. The injection is into the superficial dermis with a 30- or 32-gauge needle.
PERMACOLâ„¢(TISSUE SCIENCE LABORATORIES)
Permacol porcine collagen implant is a flexible sheet of porcine dermis that is converted into a dermal collagen matrix. The cells are extracted and the three-dimensional collagen matrix and its constituent lasting fibers are cross-linked with hexamethylene diisocyanate for stability prior to gamma radiation. Permacol is biocompatible, nonallergenic, and nontoxic. It does not stimulate a foreign body response but instead is colonized by host tissue cells and vascular ingrowth. The implanted sheet, once colonized and integrated into the host tissue, is highly resistant to resorption.
Permacol has had FDA approval since February of 2000 and has been used mainly for abdominal wall and hernia repair. It is also used in gynecologic and urologic procedures. The FDA granted Permacol approval for head and neck use in January of 2002. It has been used for recontouring procedures such as augmentation of the nose, chin, and cheeks as well as the lips. Permacol sheets come in a variety of sizes and thicknesses, but it is the thin (1-mm) sheet that is reconstituted, rolled, and inserted into a tunnel beneath the vermilion. Not enough lip augmentations with long-term follow-up have been done to provide significant data, but the material appears to have promise. An injectable form of Permacol is also being tested.
POLYLACTIC ACID HYDROGEL (NEW-FILLâ„¢; BIOTECH INDUSTRY SA)
Polylactic acid (PLA) is a synthetic polymer that, as well as polyglycolic acid, has been used in suture materials (Vicrylâ„¢, Dexonâ„¢) and in resorbable plates and screws. It is biocompatible and immunologically inert so it does not require skin testing. New-Fill comes in a powdered form of PLA microspheres that are reconstituted with approximately 4 cc of sterile water or saline to form a hydrogel with a methylcellulose carrier. The PLA hydrogel is injected to stimulate dermal fibrosis as a foreign body reaction. Undercorrection is performed and a minimum of two treatments is required, usually 3 to 4 weeks apart. The PLA particles are degraded over the first 6 months. The thickened fibrous dermal layer producing the augmentation effect persists for 9 months or longer. New-Fill is not currently FDA approved for use in the United States.
Radiance comprises smooth 25- to 40-μm spheres of synthetic calcium hydroxylapatite (CaHA) suspended in gel with sodium carboxymethylcellulose media. CaHA is a synthetic analog of the inorganic constituents in bone and teeth. It is a readily injectable soft tissue bulking agent extensively used in otolaryngology (vocal cord injections) and urology (bladder neck injections).
The mechanism of action of Radiance injection is the bulking of soft tissue to change anatomic shapes. CaHA particles act as a scaffold for tissue ingrowth but do not cause fibroblasts to differentiate and become osteoblasts, thus producing a noncalcified soft tissue matrix histology. The macrophage activity with the gel carrier subsides with time. By 12 months, the carrier is gone with CaHA particles fixed in place by a thin connective tissue without a reaction in surrounding tissue. There was no evidence of migration.
CaHA follows the same metabolic pathway as bone debris left behind in orthopedic craniofacial reconstruction and bone fractures. CaHA is biocompatible, with ultimate dissolution to calcium and phosphate ions that are controlled through normal homeostatic mechanisms. Bladder neck and vocal cord studies seem to demonstrate a 7-year period before complete resorption.
We have used Radiance as a soft tissue filler over the entire face, forehead, tear troughs, NLFs, lips, commissures, and midface check areas on over 390 patients for the past 16 months. Although early, we feel the results are promising.
We prefer a fan-fold technique for all regions of the face except the lips, where we prefer a linear placement of parallel strands.
The injections were performed using a 1-cc syringe and a 25-, 27-, or even 30-gauge needle. Augmentation of the lip with Radiance is very technique dependent. It is most common to place under radical lip lines, the white roll, and the red vermilion lip. The lip is grasped and lightly pinched between the nondominant index finger and thumb, forming a channel to guide the needle from either commissure or from a central entry point. The key is to provide steady pressure on the plunger during withdrawal to provide a smooth strand of filler. Each pass of the needle usually lays down .05 to .1 cc of product, up to a total of 1 cc in the upper lip and 0.6 cc in the lower lip (Fig. ).
Subdermal injections in the NLF and vertical rhytids are more straightforward. A continuous stream of product is laid down at a depth of 5 to 7 mm and multiple passes are usually necessary. Again, postinjection massaging and manipulation are the norm and allow for even distribution in the subdermal plane (Figs. -).
One of the major advantages of Radiance is the 1:1 correction. There is minimal resorption or migration of product. Therefore, we can mold, shape, and sculpt the lips and face without the need to overcorrect. We feel this aspect of Radiance gives it a clear advantage over many other products. In some aspects this could be a â€œlong-term collagen.â€?
The ability to mold the injected product also allows for postoperative correction. We frequently pinch and roll the vermilion-cutaneous border of the lip to concentrate the augmentation in the red vermilion and avoid a duck bill lip fullness. This molding helps us salvage a lip with poorly placed injectable CaHA. Nodule formation can occur with superficially placed CaHA within the mucosal vermilion (Fig. ). It seems to be of more common concern to the surgeon than the patients. Nodules appear within 2 to 4 weeks must be treated with aggressive â€œsmashingâ€? of the nodules by patient and surgeon. This helps redistribute to the deeper areas of the lips. If nodules persist a low-dose steroid injection helps. If the nodule persists simple needle prick and expressing the paste can treat this simply.
We have on rare occasions had to extract a superficially placed mucosal injection refractory to the previous regimen. To date, our complication rate has been low due to a planned conservative approach. We feel that, with any long-term injectable product, it is always easier to add more than attempt a difficult removal. Any unused product can be sealed, labeled with the patient's name, and used later for touch-ups.
Our enthusiasm for this product is tempered only by our short-term (16 months) results, and we anxiously await our long-term results.
INJECTABLE SILICONE (SILKSKIN; ALCON LABS)
Facial soft tissue augmentation with silicone injection was first popularized in the 1960s and 1970s with the introduction of medical-grade silicone by Dow Corning. There was and is no national or international standard for silicone oil purity. Numerous disastrous complications have occurred with silicone dermal injection. Injections have been performed without FDA approval for decades in the United States as well as internationally with varying degrees of purity of the silicone oils. Complications such as chronic cellulitis, granulomas, palpable masses, draining ulcers, migration, and chronic infections have been reported as late as 20 years after the injection. Silicone gel may cause the least foreign body reaction of all of the fillers. The silicone gel often is encapsulated only by a thin layer of fibroblasts. Droplets may coalesce into larger globules that may migrate by gravity. Silicone can also migrate via lymphatic or vascular route to distant organs and lymph nodes. Sudden ingrowth of connective tissue, macrophages, and foreign body cells can occur years after injection, causing granulomas (siliconomas). Siliconomas are difficult to remove surgically but have been noted to respond to repeat steroid injections or antimitotic agents. Even with the potential for complications, microinjections of medical-grade silicone have been used on thousands of women in Europe and Asia with good results.
There are currently two liquid silicone formulations approved for intraocular use: Silikon 1000 (Alcon Labs) and Adatosil 5000 (Chiron Corporation). Phase I trials for the FDA are under way on the cutaneous injection of silicone using Silikon 1000 (SilSkin).
The recommended technique for use of silicone as a dermal filler is to perform serial microdroplet injections separated by at least 1 month between treatments. A 27-gauge needle is most commonly used. The microdroplet injections are used in an attempt to decrease the inflammatory response to the silicone as well as to avoid overcorrection as the silicone is permanent.
The trouble with silicone is that it is permanent, unpredictable, and irreversible (Figs. , ). It may look great for years and then develop a complication. Although thousands of women worldwide have been treated with silicone successfully, it is often that one patient with a problem from silicone injection that will make a practitioner question his choice of filler materials.
DEEP NASOLABIAL FOLDS
The anatomy of and causation of prominent NLF have been well reviewed and debated in the literature. When the folds are of modest depth we prefer to fill the subcutaneous space with injectable soft tissue fillers such as Radiance. Multiple parallel passes are necessary (Fig. ). This product is especially attractive due to the malleability and molding after injection. The luxury of having a 1:1 correction allows for more precise sculpting of the area. When more augmentation or flattening of the fold is needed, ePTFE (SoftForm) works the best (Figs. -). It is critical to taper and bury the implant ends meticulously; otherwise, there is a higher possibility of infection. Potential complications of infection/extrusion of ePTFE are easily treated by removal. Uneven placement requires removal and replacement 6 weeks later. It has been our experience that, once an implanted SoftForm is infected, the only successful treatment is removal.
NLF augmentation has already been an integral part of our perioral rejuvenation practice. We feel the described two products give good to excellent improvement in this relatively straightforward problem area.
EXCESS UPPER LIP LENGTH
Facial harmony is an ambiguous description of a pretty face (in some type of balance). Thus, to describe or apply a formula for what makes facial harmony would be dangerous. Instead, it is critical for the experienced plastic surgeon to distinguish among a long-face syndrome, midface hypoplasia, and excess upper lip height. Frequently, loss of incisor show indicates an excess of upper lip height.
There is no ideal treatment plan that can correct excess across the entire upper lip. It is the excess lateral lip height that is the most difficult to correct aesthetically. The central excess is treated with a perialar skin-lift excision of usually 2 to 4 mm (Figs. -). There is a very fine line between too much and too little. Extreme caution is advised in central lifts or excisions. Aggressive massage downward can alleviate any overcorrected central lip excess.
Lateral excess lip height is difficult to treat without direct skin excision leaving scars at the lateral vermilion-cutaneous border. Sometimes an injectable augmentation along this vermilion-cutaneous border incision causes a gentle â€œrolling outâ€? of this border. In combination, these procedures can put the entire lip in better balance, but we urge restraint when using injectable fillers. A modest improvement will occur with injectables into the white roll causing a â€œturning outâ€? of this area. The long upper lip will still present but can appear less with this technique. Any volume added to the mucosa in the patient with long upper lip is risky and can create a â€œptoticâ€? lip. We prefer an excisional technique combined with some filler added to the vermilion.
Loss of lip volume can be congenital but is more commonly associated with declining estrogen levels. The treatment of thin lips changes yearly as the products evolve.
Five years ago we treated most thin lips with fat. Three years ago Alloderm plus or minus fat was most common. Now we use Radiance, Alloderm, and fat alone or in combination most of the time.
Radiance works well as an office procedure for small to moderate improvement in volume (Figs. , ), although Alloderm plus or minus fat still gives the best results for large-volume improvements (Figs. -).
Potential pitfalls include exposure of Alloderm, which is easily treated with trimming and reclosure. Radiance placed too superficially on the mucosal surface can easily be treated with aggressive massage. Poorly positioned Alloderm needs repositioning surgically, whereas Radiance has the luxury of being easily manipulated and molded.
The aesthetic beauty of a full, youthful lip is attainable with present-day fillers. Questions remain about longevity. We have presented state-of-the-art fillers and hopefully provided some solutions to this intriguing problem.
Posted 27 February 2004 - 03:18 PM
however you missed one every important one that might be used a lot in the future...isolagen.
can people share their experiences with artecoll, isologan...or any other semi-permanent fillers?
isolagen was listed above.
Posted 27 February 2004 - 05:25 PM
Posted 04 January 2011 - 08:26 PM
Must you see a derm for this treatment? I have rolling scars and in the military, so i'll probably have to pay out of pocket for any treatments