Artecoll Granuloma: A Rare Adverse Reaction Induced by Microimplant in the Treatment of Neck Wrinkles

Background.  Artecoll is now being widely used as an injectable aesthetic microimplant for the treatment of wrinkles because of its long-lasting cosmetic effects and the rarity of late complications, including foreign body granulomas. Recently, however, several cases of Artecoll-induced granulomas on the face have been reported, especially in patients receiving overly superficial or overly correcting implants.
Methods and results.  A 50-year-old Korean woman who had been treated with Artecoll for the correction of the neck wrinkles presented 4 years later with an extensive Artecoll-induced foreign body granuloma along the injection sites in the neck. After three intralesional injections of triamcinolone acetonide, the lesions had almost disappeared.
Conclusion.  To our knowledge, this case is the first report of an extensive Artecoll-induced granuloma on the neck. Our findings suggest that Artecoll not be used as implant material in thin and constantly movable skin, such as that of the neck.     

Facial soft tissue augmentation with Artecoll?: A review of eight years of clinical experience in 153 patients

OBJECTIVE:

Artecoll (Canderm Pharma Inc, Canada) is a semipermanent, injectable, soft tissue filler composed of uniform polymethylmethacrylate microspheres in a bovine collagen gel, which has been used in Europe over the past decade. The authors review their experience using Artecoll as an injectable material for the correction of deep static folds of the face, improvement of nasal asymmetries following rhinoplasty, depressed acne scars and augmentation of the lip.

METHOD:

A retrospective chart review, subjective patient satisfaction feedback and objective findings noted by the senior author were performed over an eight-year period. A total of 153 patients were treated with Artecoll injections; 74 underwent lip augmentation, 21 underwent deep nasolabial fold augmentation, eight underwent glabellar fold augmentation, 26 were treated for minor nasal dorsal irregularities and 24 were treated for depressed acne scars.

RESULTS:

No early or delayed allergic responses were reported. Complications occurred most commonly with lip augmentation, in which 13.5% of patients noted significant noticeable bruising postinjection that resolved completely within one week, 51.3% had detectable implant on palpation, and 13.1% required further intervention with massage, steroid injection and/or local excision to correct for lumpiness. Sixty per cent of patients requiring further intervention responded successfully, while local excision was performed on the two patients who failed to respond after six months of massage and steroid therapy. Overall, a total of 11 patients (14.9%) had minor asymmetries or less than optimal results within the lip augmentation study group. Among other sites, the most common complaint was undercorrection of the fold or wrinkle.

CONCLUSION:

Based on the authors’ experience, Artecoll is a safe, viable option for long-term treatment of deep facial wrinkles, nasal asymmetry, hypoplastic or atrophic lips, and depressed acne scars, and the results have been accompanied by a high degree of patient satisfaction. Although the implant is often palpable, rarely does it cause significant visible lumps. Its use and applications as a semipermanent injectable agent certainly warrant further investigation.     

自体颗粒脂肪移植联合手术治疗重度眉间纹临床观察

目的:探讨针对重度眉间纹效果稳定的矫治方法。方法:采用在眉头部切口离断部分皱眉肌,辅助自体颗粒脂肪注射充填眉间凹陷区域,在动态及静态重度眉间纹形成机理上分别给予针对性治疗,通过二者结合,达到稳定的治疗效果。结果:15例受术者术后随访6月形态满意,眉间较术前饱满,皱眉肌力明显减弱,重度眉间纹根据术前不同程度变浅或消失,眉间部年轻化效果明显。结论:在离断部分皱眉肌基础上辅助自体颗粒脂肪充填,对于重度眉间纹达到了标本兼治的手术效果,减少术后复发,值得推广。     

Artecoll: The Arizona Experience and Lessons Learned

Background. Artefill is one of several new materials being introduced to the US market as a soft tissue augmenting agent.
Objective. The objectives were to evaluate the safety and efficacy of injecting Artecoll (Rofil Medical International Breda, the Netherlands) in facial wrinkles compared with injecting Zyderm or Zyplast (INAMED, Santa Barbara, CA, USA) and discuss the practical lessons learned.
Methods. Thirty-eight patients were randomly selected to receive Artecoll or Zyderm/Zyplast into facial defects. Wrinkles were evaluated by the treating physician, the subject, and masked physician evaluators. Similar evaluations were performed on several collagen patients crossing over to Artecoll. Adverse reactions were recorded.
Results. All evaluators felt Artecoll to be superior to collagen in all treated areas except for the glabella and upper lip lines. In these areas, differentiation by photographs between the two products became more difficult for the masked evaluators. The adverse side effects of Artecoll were almost equal with those of collagen, but most were of minimal consequence. Three patients developed persistent nodules (all in perioral sites), which were treatable with intralesional steroids.
Conclusion. Artecoll treatment of wrinkles and folds was found to be effective, long lasting, safe, and associated with a high percentage of patient acceptance. There is a learning curve in injecting this thicker, more permanent product.     

自体脂肪移植治疗川字纹

目的探索自体脂肪移植治疗川字纹的临床疗效。方法2010年9月至2012年4月．对8例川字纹患者的累及皮肤区域内进行真皮下自体脂肪注射,提升局部皮肤张力。结果8例川字纹患者均随访1年．自体脂肪移植3个月后川字纹皱折消失,局部皮肤平坦;6个月后只有1例患者川字纹复发。结论对于特定类型的川字纹．局部自体脂肪移植可使得发生皱折的皮肤得到充填和支撑,本方法操作简便、安全,疗效良好。     

Prospective Open-Label Study of Botulinum Toxin Type B (Myobloc) at Doses of 2,400 and 3,000 U for the Treatment of Glabellar Wrinkles

BACKGROUND: A previous open-label study evaluated botulinum toxin type B (BTX-B; Myobloc) for the treatment of glabellar wrinkles and showed that it is safe and effective at a dose of 1,800 U. The duration of effect at this dose was approximately 8 weeks, and it was felt that higher doses would result in a longer duration of effect. OBJECTIVE: This is a prospective open-label study to assess the safety, efficacy, and duration of response following BTX-B injection at doses of 2,400 and 3,000 U for the treatment of glabellar frown lines. METHODS: A total of 39 patients were enrolled: 16 patients received 2,400 U. Eighteen patients received 3,000 U, and 5 patients received saline injections (control group). Doses were divided equally among six sites. RESULTS: All subjects had rapid improvement of interglabellar rhytides, with full response seen within 2 to 3 days. The duration of effect was 9.6 and 10.4 weeks with 2,400 and 3,000 U, respectively. Five subjects (two in the 2,400-U group and three in 3,000-U group) reported adverse events related to the BTX-B injection. Three subjects complained of mild pain at the injection site, and two subjects complained about lid droop/ptosis (one with the occurrence of headache). CONCLUSIONS: BTX-B injection is safe and effective for the treatment of glabellar wrinkles. It has a very rapid onset of action, and increasing the dose appears to prolong the duration of response. At 3,000 U, the duration of response was 10.4 weeks and was associated with minimal adverse effects. Adverse events were mild and were similar to those seen in previous studies with BTX-A. Additional studies evaluating BTX-B at higher doses are recommended to prolong the duration of response in the treatment of glabellar wrinkles.     

Effect of Botulinum Toxin Type A on Movement-Associated Rhytides Following CO2 Laser Resurfacing

BACKGROUND: Many patients who undergo CO2 laser resurfacing for correction of rhytides experience recurrence of movement-associated wrinkles within 6 to 12 months following the laser procedure. OBJECTIVE: The purpose of this study was to evaluate the effect of botulinum toxin type A (Botox) injections on movement-associated rhytides following cutaneous laser resurfacing. METHODS: Forty patients who had received full face CO2 laser resurfacing for the treatment of facial rhytides were randomized to receive Botox injections to the glabella, forehead or lateral canthal regions or to receive no additional treatment (control group). Clinical and photographic assessments were performed at baseline and at 3, 6 and 9 months. RESULTS: Enhanced and more prolonged correction of forehead, glabellar and/or lateral canthal rhytides was observed in patients treated with Botox injections postoperatively compared to non-Botox treated control patients. CONCLUSION: The use of botulinum toxin type A following cutaneous CO2 laser resurfacing results in prolonged correction of movement-associated rhytides. It is advised that patients receive information regarding the benefits of maintenance therapy with botulinum toxin as part of their routine preoperative education.     

Case report: adverse granulomatous reaction (Granuloma formation) and pseudomonas superinfection after lip augmentation by the new filler DermaLive®

In recent years, there has been a huge increase of injectable filler materials on the aesthetic market to correct wrinkles, aging lines, or volume deficits in the face. Despite their nontoxicity and low immunologic reactivity, they can induce a foreign body reaction and formation of inflammatory nodules or granulomas. We report a case of severe complications with granuloma formation and bacterial superinfection after lip and cheek augmentation with the new injectable filler DermaLive®.     

爱贝芙注射除皱的效果评价

目的:探讨爱贝芙对面部不同部位的除皱效果。方法:226例应用爱贝芙进行面部除皱的患者,根据药物注射部位的不同进行分组,比较面部不同部位之间除皱效果的差异,综合分析爱贝芙注射除皱的效果。结果:爱贝芙注射除皱的方法适合额部抬头纹、眉间川字纹、鼻梁横纹、鼻唇沟皱纹等的除皱;对颈部皱纹和眼角鱼尾纹的除皱效果欠理想。结论:应用爱贝芙进行注射除皱适合面部大部分皱纹。     

Foam During Reconstitution Does Not Affect the Potency of Botulinum Toxin Type A

BACKGROUND: Among factors that may affect the potency of botulinum toxin A (Botox), it is said that foam, together with bubbles, may cause surface denaturation of the toxin. OBJECTIVE: To determine whether the muscle relaxation effect of Botox is preserved and has the same duration when it is reconstituted in the presence of foam. METHODS: Six female volunteers, aged 42 to 56 years old, were treated for glabellar and periocular wrinkles. Each half of the face was treated with 16 U of Botox divided in four sites: three at the lateral orbital area and one at the medial brow, in the glabellar region. The right side received Botox gently reconstituted with saline to avoid foaming formation. The left side of the face was treated with Botox that was rapidly reconstituted in order to achieve as many bubbles as possible, even with shaking. Blinded observers compared pretreatment and posttreatment photographs and answered assessment-related questions. The results were analyzed clinically and statistically. RESULTS: There was no difference in muscle paralysis between treated sides in all patients, neither in early (15 days) nor late (4 months) follow-up evaluations. CONCLUSION: Botox maintains its potency even in the presence of foaming during the reconstitution process.     

A型肉毒毒素治疗鼻唇沟纹的临床应用

目的 研究A型肉毒毒素治疗鼻唇沟纹的方法，以期达到较佳的除皱效果。方法采用A型肉毒毒素行面部肌肉多点注射，3～6个月可重复注射。结果本组28例患者，治疗后48～72h起效，随访3～6个月。鼻唇沟纹去除效果满意。结论A型肉毒毒素稀释后定点、定量注射用于治疗鼻唇沟纹，安全有效，操作方法简单，并发症少。     

Cutaneous Hypersensitivity Reaction to Injectable Hyaluronic Acid Gel

BACKGROUND: Injectable hyaluronic acid gel is a non-animal biomaterial used for soft tissue augmentation. OBJECTIVE: The dermal implantation of this naturally occurring polysaccharide is reported to be well tolerated by patients, with a longer duration in tissue than bovine collagen without any major local or systemic side effects. We report a case of an acute hypersensitivity reaction in a woman after her third injection for improvement of melolabial fold wrinkles. METHODS: An adverse granulomatous-like response to the intradermal injection of a modified hyaluronic acid gel is described. RESULTS: The patient developed indurated and erythematous papulocystic nodules in the melolabial folds bilaterally at the sites of injection. CONCLUSION: Injectable hyaluronic acid gel can be associated with severe allergic reactions and patients should be warned of this possible treatment side effect.     

ArteFill® Permanent Injectable for Soft Tissue Augmentation: II. Indications and Applications

Patients ask for procedures with long-lasting effects. ArteFill is the first permanent injectable approved in 2006 by the FDA for nasolabial folds. It consists of cleaned microspheres of polymethylmethacrylate (PMMA) suspended in bovine collagen. Over the development period of 20 years most of its side effects have been eliminated to achieve the same safety standard as today’s hyaluronic acid products. A 5-year follow-up study in U.S. clinical trial patients has shown the same wrinkle improvement as seen at 6 months. Long-term follow-up in European Artecoll patients has shown successful wrinkle correction lasting up to 15 years. A wide variety of off-label indications and applications have been developed that help the physician meet the individual needs of his/her patients. Serious complications after ArteFill injections, such as granuloma formation, have not been reported due to the reduction of PMMA microspheres smaller than 20 μm to less than 1% “by the number.” Minor technique-related side effects, however, may occur during the initial learning curve. Patient and physician satisfaction with ArteFill has been shown to be greater than 90%.     

Botulinum Toxin Type B for Dynamic Glabellar Rhytides Refractory to Botulinum Toxin Type A

BACKGROUND: Botulinum toxin type B (BTX-B; Myobloc) has recently been introduced for the treatment of dynamic rhytides. This serotype is structurally similar to botulinum toxin type A (BTX-A; Botox) and appears to produce equivalent muscular paralysis. Because of the fact that some patients may become resistant to the effects of BTX-A with its continued use or may require large doses of type A to exert adequate muscular paralysis, the use of BTX-B may prove beneficial in these cases. OBJECTIVE: To determine the effect of BTX-B on glabellar rhytides refractory or showing decreased clinical effect to treatment with BTX-A. METHODS: Twenty females (mean age, 43 years) with vertical glabellar rhytides showing decreased or negligible clinical effect to BTX-A were treated with intramuscular injections of BTX-B. Five standardized intramuscular sites (procerus, inferomedial corrugator muscles, superior middle corrugator muscles) received a total dose of 2,500 U. Patients were evaluated at pretreatment and 48 to 72 hours, 1 week, and 2 and 4 months after injection. RESULTS: All glabellar rhytides improved after treatment with BTX-B injections. Peak clinical effect was noted 1 month after treatment, with 50% of peak effect evident at the 2-month follow-up. Near complete dissolution of effect was seen at 4 months after treatment. Side effects were transient and were limited to moderate injectional pain and rare bruising and frontal brow tightness. CONCLUSIONS: BTX-B is an effective treatment modality for glabellar rhytides refractory or exhibiting decreased clinical effect to BTX-A. The duration of effect using the 2,500 U dosing schedule described herein was shorter than that typically achieved after equivalent BTX-A injection.     

A Double-Blinded, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B)-Purified Neurotoxin Complex for the Treatment of Crow''s Feet: A Double-Blinded, Placebo-Controlled Trial

Crow's feet develop with age and are one of the earliest signs of the normal aging process. Botulinum toxin type A, approved by the Food and Drug Administration for the treatment of glabellar wrinkles in April 2002, has been used off-label to treat facial wrinkles since 1981. Botulinum toxin type B (BTX-B, Myobloc) was Food and Drug Administration-approved for use in cervical dystonia in the United States in December 2000 and has subsequently been used in an off-label indication to treat facial wrinkles. There are sparse data in the literature evaluating the safety and efficacy of BTX-B for the treatment of facial wrinkles. In this pilot study, participants with moderate or severe crow's feet wrinkles were treated with Myobloc versus placebo. The duration of correction and side effect profile are reported.     

The Use of Combined Nasolabial V-Y Advancement and Glabellar Flaps for Large Medial Canthal Defects

BACKGROUND: Reconstruction of the medial canthal area presents many challenges for surgeons. It has many functional and cosmetic peculiarities. The combined use of glabellar and nasolabial V-Y advancement flaps is an effective method for repairing large medial canthal defects. OBJECTIVE: To describe and illustrate a technique to repair medial canthal defects. METHODS: Our experience with combined usage of nasolabial V-Y flap and glabellar flaps for medial canthal closure after tumor resection in 23 patients is reported. RESULTS: All resections and reconstructive procedures were performed under local anesthesia. All patients were treated without any complications such as flap loss, wound dehiscence, lymphedema, or ectropion. Fine results were achieved from both the functional and aesthetic point of view. CONCLUSION: This combination has many advantages over skin grafts and other local flaps. It is easy to design, reliable, and offers good cosmetic results. This combination is recommended to plastic surgeons as a safe and effective procedure for reconstruction of medial the canthal area.     

Fascian

Fascian is preserved particulate fascia derived from the gastrocnemious fascia that extends from the Achilles tendon. Over 50,000 syringes of material have been sold to physicians over the past six years with an impeccable safety record. The material has been used for wrinkles, scars, fat atrophy, diffuse depressions, paralyzed lips and tongues, nasolabial folds, cellulite, and other problems. Solid fascia grafts are routinely replaced with native collagen and a similar effect may be achieved with Fascian, especially after repeat injections. The FDA classifies the material as a tissue product, so injections may be made anywhere in the human body at the physician's discretion. Injections may last from a few months to permanently, depending on the volume of material, location, particle size, skin layer, and technique.     

Botulinum Toxin Type B for Glabellar Wrinkles: A Prospective Open-Label Response Study

BACKGROUND: Botulinum toxin type B (BTX-B) is U.S. Food and Drug Administration (FDA)-approved for the treatment of cervical dystonia. There are no published studies investigating its efficacy for treatment of glabellar (frown) wrinkles; however, anecdotal reports of its efficacy are promising. OBJECTIVE: The current pilot study is an initial screening study to assess the safety and efficacy of a single, set dose of BTX-B in the treatment of glabellar (frown) lines and to document current clinical experience with BTX-B. METHODS: Thirty subjects (28 women, 2 men) were injected in six sites with 300 U per site for a total dose of 1800 U. RESULTS: At 2 and 4 weeks, patient and physician assessment scores showed an average score of 2 ("complete disappearance of wrinkles"). Three patients reported mild adverse events. CONCLUSION: Injections of BTX-B proved to be very efficacious, with rapid onset, with all patients responding within 3 days (mean 1.5 days). Adverse events were mild. The mean duration of effect with this low dose of BTX-B was 8 weeks. Since the duration may be dose related and minimal adverse events were observed at 1800 U, further studies are in progress to look at the duration of response resulting from higher doses of BTX-B in the treatment of glabellar wrinkles.     

An Unusual Case of Self-Injected Bovine Fat in Liquid Form to the Face for Cosmetic Reasons

A 45-year-old woman injected bovine fat in liquid form in to her periorbital area and nasolabial folds near the lip margin and glabellar area to look younger. She was influenced by a TV program about fat augmentation of the aging face and collagen injection to the wrinkles. Major depression had been diagnosed for this woman 5 years previously, after which she used antidepressants and hypnotics irregularly. The prolonged edema of her face subsided within 3 months, along with the erythema, itching, and firmness at the injection sites. No liposuction of the injected material was planned because it had changed to solid form as soon as it was injected. Additionally, it was thought that surgical excision of the fat would not be effective and could harm the facial nerve branches because magnetic resonance imaging showed diffuse enlargement of subcutaneous tissue. Therefore, a conservative approach, such as medical treatment with close follow-up evaluation was preferred. The reported case is presented not only to add an interesting self-injection case to the literature, but also to show that patients with psychological problems may harm themselves by using inappropriate methods for cosmetic reasons under the effect of inaccurate information obtained from TV programs, press, family, and friends.     

Does Laser Inactivate Botulinum Toxin?

BACKGROUND: Botulinum toxin is a popular and effective treatment for dynamic rhytids. It is a neurotoxic protein complex that exerts its effect by inhibiting acetylcholine release at the presynaptic neuromuscular junction. Nonablative resurfacing treatments have also become well liked by patients and physicians owing to the minimal downtime associated with treatment. Currently, same-day nonablative laser treatments are performed prior to botulinum toxin injection owing to the concern that the laser may inactivate it. On occasion, it may be desirable to perform nonablative laser after the botulinum toxin has been injected (ie, patient afterthought, scheduling concern). OBJECTIVE: To determine whether the use of nonablative rejuvenation laser or intense pulsed light (IPL) immediately following botulinum toxin injections has any effect on the efficacy of the botulinum toxin treatment. METHODS: Nineteen subjects received botulinum toxin injections to either the glabellar or crow's-feet areas. One side of the treated glabellar or periorbital area was treated with either VBeam laser (Candela, Wayland, MA, USA), SmoothBeam laser (Candela), CoolGlide laser (Cutera, Brisbane, CA, USA), or an IPL or radiofrequency (RF) device within 10 minutes of botulinum toxin injection. Pretreatment and 2-week post-treatment photographs were compared. RESULTS: No decrease in the efficacy of botulinum toxin denervation was observed when glabellar or perioral areas were treated with VBeam laser, SmoothBeam laser, CoolGlide laser, or an IPL or RF device within 10 minutes of botulinum toxin injection. CONCLUSION: Patients may be treated with several nonablative lasers and IPL or RF devices immediately after botulinum toxin injection without loss of efficacy or other apparent untoward effect.