The First Clinical Study Using a New Biodegradable Implant for the Treatment of Lips, Wrinkles, and Folds

A new tissue augmentation product, made from hyaluronic acid, was clinically evaluated at three clinics in accordance with the new directive, EN 540, for medical implants. One hundred patients were fully assessed following treatments in 285 locations. The treatment was completed when the skin was levelled following one to two injections. At 6 months follow-up of all patients and at 12 months follow-up of a randomized group of the patients all showed that close to 60% of the effect was still there. No serious or permanent adverse events were noted.     

软组织注射填充美容的新发展

能通过微创注射且安全有效地达到纠正人体软组织缺陷的材料,人类不断地寻找了一百多年。期间随着科学技术的迅速发展,各种应用于注射填充软组织方面的材料不断涌现,包括各种人工合成的材料或生物性的材料。获得了很大的进步。但目前使用的注射填充软组织材料仍有各种不尽人意的缺点难以克服。所以,人类仍然在     

Liquid Silicone for Soft Tissue Augmentation

Background. The use of liquid silicone for soft tissue augmentation has been associated with a great deal of controversy and negative publicity. It is hoped that this monograph will clarify some of the substantive issues behind the controversy.
Objective. To outline and discuss the history, legal status, indications, contraindications, technique, and complications associated with the use of liquid silicone for soft tissue augmentation.
Methods. Impressions derived from a 22-year experience involving the treatment of over 3,000 patients using liquid silicone are presented, along with data abstracted from the scientific and the lay literature.
Conclusion. Pure liquid silicone may be superior to any currently available agent in properly selected patients for permanent correction of certain types of defects. Physicians who use it, however, must be advised that the misuse of this agent or other materials masquerading as liquid silicone have created a pervasive climate of distrust and a veritable minefield of extraordinarily unpleasant medicolegal possibilities.     

Scar Tissue Graft as a Filler for Soft Tissue Augmentation

Soft tissue augmentation with autogenous tissue has been used to correct various defects during aesthetic facial contouring and reconstructive procedures. Although dermal grafts have longer survival rates, fat grafts always have been more popular because of the simple harvesting and grafting methods used. The authors aimed to use existing scar tissue as an injectable graft and to compare its effectiveness as a soft tissue filler substance with that of dermal grafts. In this study, scar tissue was created on 24 male Wistar rats. The created scar and normal healthy skin were removed from the rat dorsal scapular donor site. After depithelialization, the harvested tissues were minced until they were thin enough to pass through a 16-gauge needle. The grafts then were injected into the recipient site between the abdominal muscles. Volumetric analyses and histologic evaluation of the grafts were performed 1, 3, and 5 months after transplantation. The first month after the injection, the amount of remaining dermis graft was more than the scar graft, and this difference was statistically significant. However, at the end of months 3 and 5, there was no marked difference between the groups. The remaining volume of injected scar tissue graft was comparable with that of the dermis graft. The scar grafts were composed mainly of dense connective tissue during all the evaluation periods. In this study, scar tissue provided results comparable with those of dermal grafts up to 5 months when used as a soft tissue filler. It seems that neovascularization of the scar graft may be inadequate for maintenance of graft viability, as compared with dermis grafts. On the other hand, the scar graft formed fibrous tissue, which may be responsible for providing adequate volume as a filler. This may have clinical implications for the patient who needs both scar revision and soft tissue augmentation procedures simultaneously.     

Porcine Small Intestine Submucosa for Soft Tissue Augmentation

Objective. Porcine small intestine submucosa was evaluated as a material for soft tissue augmentation in the hairless guinea pig model.
Materials and Methods. Small intestine submucosa was formed into strips and rolls and implanted into the dorsum of the hairless guinea pig. The animals were divided into three groups and the implants were evaluated grossly and microscopically for persistence, infection, and inflammation. A total of 116 implants were evaluated grossly.
Results. Selected samples from the 1- and 3-month cohorts and all identifiable samples from the 5-month cohort were evaluated microscopically. Some implants were not located, likely due to migration. With one exception, the identified implants in the 5-month cohort exhibited minimal inflammation and appeared well tolerated. The eight-ply small intestine submucosa material appears well tolerated and provided increased soft tissue volume at 5 months.
Conclusion. Small intestine submucosa may represent an alternative to autologous and homologous materials for soft tissue augmentation.     

Augmentation Mastopexy with Implant and Autologous Tissue for Correction of Moderate/Severe Ptosis

Purpose: Breast augmentation combined with mastopexy is associated with a significantly higher complication rate than augmentation alone. The combination of mastopexy and breast implants has revealed a moderate recurrence of breast ptosis in many patients particularly with use of medium to large implants. Ptosis is the “bottoming out” of the breast tissue with loss of the desired roundness, due to the ptosis of the breast implant and the mammary tissue. In this study, we hypothesize the need for careful planning and careful preoperative surgical execution to minimize this complication. Patients and Methods: Between January 2007 and July 2011, augmentation mastopexy with implant and autologous tissue (“double implant”) was performed for 25 patients with grade III mammary ptosis. All patients underwent inverted-T mastopexy with supramuscular moderately cohesive gel breast implant using an inferior-based flap of de-epitelialized dermoglandular tissue and a superior-based nipple-areola complex pedicle. Results: An inferior-based flap of deepithelialized dermoglandular tissue was used to stabilize the implant and is projection. Breast lifting was performed through a strong anchorage to fascia and to muscle of second intercostal space, improving the profile of the breast. Results were analyzed, no breast ptosis recurrence was noted at 30-month follow-up. Conclusions: Our technique presents the challenge of determining the amount of excess skin to be removed after implantation to create symmetry and provide for skin tightening without compromising tissue vascularization.     

A 52-Month Summary of Results Using Calcium Hydroxylapatite for Facial Soft Tissue Augmentation

OBJECTIVES In this large-scale clinical review, we investigated the safety and efficacy of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds, marionette lines, and other areas of the face.
METHODS After obtaining informed consent from the subjects, CaHA was injected in 1,000 patients (886 women and 114 men, ranging in age from 21 to 85 years) for a variety of facial aesthetic applications over a period of 52 months. Typically, CaHA was administered with a 27-gauge 1/2, or 1 1/4-inch needle.
RESULTS The nasolabial folds were the most frequently treated site, followed by the marionette lines/oral commissure. More than 80% of patients reported persistence of results at 12 months. The most frequently reported adverse events were erythema and ecchymosis. The formation of nodules was rare and was chiefly confined to the lips. Only two patients experienced nodule formation outside the lips.
CONCLUSIONS Over a period of more than 4 years, we found that CaHA performed well, with a favorable safety profile, high patient satisfaction, and good durability.     

Outbreak of Mycobacterium Abscessus Infection After Soft Tissue Augmentation

BACKGROUND: Illicit soft-tissue augmentation performed in New York City resulted in an outbreak of Mycobacterium abscessus infection in 2002. OBJECTIVE: To report two cases of women who developed tender, subcutaneous nodules of the face and buttocks after illicit soft-tissue augmentation with a hyaluronic acid derivative. METHODS: Two case reports are presented, and the literature is reviewed. RESULTS: Empiric treatment with clarithromycin (for M. abscessus infection) and prednisone (for foreign body reaction) resulted in clearance of lesions. CONCLUSION: Contaminated or impure material used for soft-tissue augmentation can result in a clustered outbreak of infection or foreign body reaction.     

Use of Hyaluronic Acid for Soft Tissue Augmentation of HIV-Associated Facial Lipodystrophy

BACKGROUND: Lipodystrophy syndrome is a devastating complication of antiretroviral therapy in individuals with human immunodeficiency virus (HIV). The appearance of the associated facial lipoatrophy can be demoralizing and stigmatizing for the affected individuals to a point at which it may compromise their compliance with antiretroviral medication. OBJECTIVE: We describe the use of hyaluronic acid as an intradermal filler for correction of this disfiguring problem. METHODS: We treated five patients with grade 2 to 3 facial lipoatrophy. Each patient received approximately 5 to 6 cc in total of hyaluronic acid in the malar area via intradermal injection. RESULTS: There were no adverse events. We found that this technique provided a good cosmetic result with high patient satisfaction. At 6-month follow-up, sustained longevity was observed. CONCLUSIONS: We propose the use of hyaluronic acid for HIV-associated facial lipoatrophy as an efficacious and safe, but temporary, option for this problem until a more cost-effective option is available.     

Human Histology and Persistence of Various Injectable Filler Substances for Soft Tissue Augmentation

An increasing number of soft tissue filler substances have been introduced to the beauty market outside the U.S. which lack experimental and clinical data in support of their claim. Ten commercially available filler substances were examined for biocompatibility and durability: 0.1 cc of each substance was injected deep intradermally into the volar forearm of one of the authors and observed for clinical reaction and permanence. At 1, 3, 6, and 9 months the test sites were excised, histologically examined, and graded according to foreign body reactions classification. Collagen (Zyplast) was phagocytosed at 6 months and hyaluronic acid (Restylane) at 9 months. PMMA microspheres (Artecoll) had encapsulated with connective tissue, macrophages, and sporadic giant cells. Silicone oil (PMS 350) was clinically inconspicuous but dissipated into the tissue, causing a chronic foreign body reaction. Polylactic acid microspheres (New-Fill) induced a mild inflammatory response and had disappeared clinically at 4 months. Dextran microspheres (Reviderm intra) induced a pronounced foreign body reaction and had disappeared at 6 months. Polymethylacrylate particles (Dermalive) induced the lowest cellular reaction but had disappeared clinically at 6 months. Polyacrylamide (Aquamid) was well tolerated and remained palpable to a lessening degree over the entire testing period. Histologically, it dissipated more slowly and was kept in place through fine fibrous capsules. Polyvinylhydroxide microspheres suspended in acrylamide (Evolution) were well tolerated, slowly diminishing over 9 months. Calcium hydroxylapatite microspheres (Radiance FN) induced almost no foreign body reaction but were absorbed by the skin at 12 months.Host defense mechanisms react differently to the various filler materials, but all substances—resorbable or nonresorbable—appeared to be clinically and histologically safe, although all exhibit undesirable side effects. Since the mechanism of late inflammation or granuloma formation is still unknown, early histological findings are not useful in predicting possible late reactions to filler substances. Presented at the 33rd Annual Meeting of the Association of German Plastic Surgeons in Heidelberg, Germany, September 21, 2002     

Autologous Fat Injection for Soft Tissue Augmentation in the Face: A Safe Procedure?

Autologous fat injection for soft tissue augmentation in the face is claimed to be a safe procedure. However, there are several case reports in the literature where patients have suffered from acute visual loss and cerebral infarction following fat injections into the face. Acute visual loss after injection of various substances into the face is a well-known complication of such interventions. We report two further patients who suffered from ocular and cerebral embolism after fat injections into the face. For the intravasation of fat particles there are three preconditions: well-vascularized tissue, fragmentation of parenchyma, and, especially, a local increase in pressure in the affected tissue. Fat injections into the face lead to an acute local increase in pressure in highly vascularized tissue. We assume that fragments of fatty tissue reach ocular and cerebral arteries by reversed flow through branches of the carotid arteries after they are introduced into facial vessels. The manifestation of fat embolism appears either immediately after the fat injection or after a latency period. Fat embolism can remain subclinical and may not be recognized, or the clinical features may be misinterpreted. To minimize the risk of such a major complication, fat injections should be performed slowly, with the lowest possible force. One should avoid fat injections into pretraumatized soft tissue, for example, after rhytidectomy, because the risk of intravasation of fat particles may be higher. Metabolic disturbances such as hyperlipidemia may also contribute to the clinical manifestation of fat embolism. Routine funduscopic examinations after fat injections into the face could help to provide data for future estimation of the patient's general risk.     

Combined Use of Hair and Fibrin Glue for Soft Tissue Augmentation: Experimental Study

A vast variety of alloplastic materials together with autogenous grafts have been used for the correction of contour deformities related to aesthetic and reconstructive purposes. Despite a number of well-tolerated materials, the ideal has not yet been reached, although well-tolerated autogenous grafts have higher rates of resorption and distortion. The limited volume of autogenous grafts and concerns about donor-site morbidity may obligate the surgeon to use implantation materials. Covering almost every property of an ideal implantation material, hair, an organic autogenous nonvital tissue, was used for soft tissue augmentation in this experimental study. Hair pellets of 10 New Zealand rabbits were prepared and shaped as 1 × 1 × 1-cm cubes with the help of fibrin sealant, then inserted subcutaneously. The materials were evaluated 4 months later. No complications such as infection or extrusion were seen. The materials were intact, with no signs of resorption, but the shapes were distorted due to the pressure of the surrounding tissues. Histopathologic findings also demonstrated that the hair was well tolerated by the adjacent tissues. Different processes may enable hair to be used as a filler material in clinical practice. Well-tolerated, nonresorbable injectable materials or shaped implants may be obtained at low cost using hair.     

Safety Data of Injectable Nonanimal Stabilized Hyaluronic Acid Gel for Soft Tissue Augmentation

BACKGROUND: Nonanimal hyaluronic acid gel was recently developed for soft tissue augmentation and volume expansion and has been shown to offer several advantages in comparison to other augmentation materials. There are rare reports of adverse events believed to be secondary to trace amounts of proteins in the hyaluronic acid raw material. OBJECTIVE: To determine the safety profile of nonanimal stabilized hyaluronic acid gel (Restylane, Perlane, Restylane Fine Lines, Q-Med AB, Uppsala, Sweden) for soft tissue augmentation using a retrospective review of all adverse events data from Europe, Canada, Australia, South American, and Asia from 1999 and 2000. RESULTS: Data from an estimated 144,000 patients treated in 1999 indicated the major reaction to injectable hyaluronic acid was localized hypersensitivity reactions, occurring in approximately 1 of every 1400 patients treated. In 1999 there was an adverse event reported for 1 of every 650 patients (0.15%) treated. These were temporary events that included redness, swelling, localized granulomatous reactions, bacterial infection, as well as acneiform and cystic lesions. For 2000 there was an estimated 262,000 patients treated with hyaluronic acid gel. The total number of adverse events was 144, corresponding to one adverse event for every 1800 patients (0.06%) treated. The major adverse event was again hypersensitivity, occurring in 1 of every 5000 patients treated. CONCLUSION: According to the reported worldwide adverse events data, hypersensitivity to nonanimal hyaluronic acid gel is the major adverse event and is most likely secondary to impurities of bacterial fermentation. According to data from 2000, the incidence of hypersensitivity appears to be declining after the introduction of a more purified hyaluronic acid raw material.     

Staged Stem Cell-enriched Tissue (SET) Injections for Soft Tissue Augmentation in Hostile Recipient Areas: A Preliminary Report

Background  

Autologous fat transplantation is frequently used for a variety of cosmetic treatments and difficult reconstructive indications such as involutional disorders, hemifacial atrophy, sequelae of radiation therapy, or similar problems. However, the limitations of fat transplantation are well known in such difficult cases, particularly the long-term unpredictability of volume maintenance. The ideal method of preparing autologous fat grafts optimizes tissue survival and reduces the variability of outcomes. We propose that enriching traditionally prepared fat grafts with adipose-derived regenerative cells (ADRCs) represents one such method.     

即刻种植和早期种植对前牙美学区种植体周围软组织的影响

分析即刻种植与早期种植对前牙美学区种植体周围软组织的影响。方法 选取平邑县中医医院2021年6月-2022年6月收治的28例单颗前牙缺失患者为研究对象,按照随机数字表法分为参考组及试验组,每组14例。其中参考组采取早期种植,试验组采取即刻种植,比较两组软组织美学效果、骨吸收水平、修复满意度。结果 两组种植成功率比较,差异无统计学意义（P ＞0.05）;试验组治疗1、3、6、12个月PES评分高于参考组（P ＜0.05）;两组治疗1、3、12个月骨吸收水平比较,差异无统计学意义（P＞0.05）;试验组治疗6个月骨吸收水平低于参考组（P＜0.05）;试验组修复满意度为100.00%,高于参考组的57.14%（P ＜0.05）。结论 相较于早期种植,即刻种植在改善前牙美学区种植体周围软组织的美学效果方面具有良好优势,该种植方法具有较高的种植成功率及安全性,能够有效降低种植后早期骨吸收水平,患者对其修复效果表示非常满意。     

Ten-Year Experience Using Injectable Silicone Oil for Soft Tissue Augmentation in the Philippines

Background. No ideal, permanent filler is approved by the US Food and Drug Administration. Repeated injections of new temporary fillers make this cosmetic procedure expensive.
Objective. To show that silicone oil is effective, safe, economical, and permanent.
Materials and Method. The age, sex, number, indications, sites, adverse reactions, total amounts injected, and clinical cosmetic results of 206 cases were tallied.
Results. Females (82%) outnumbered males (18%). The majority were in the 21- to 30-year age group. Fifty-five percent had acne scars, 42% nasolabial grooves, 13.5% marionette lines, 12.6% glabellar lines, 9.8% postvaricella scars, 9.3% inframalar depressions, 1.8% post-traumatic scars, 1.4% lipodystrophy, 1% lip augmentation, 0.9% sleep lines, and 0.4% contour defect. Fifty-one percent had ≤ 0.5 cc, 22% 1 cc, 7%≤ 1.5 cc, 7%≤ 2 cc, and 12% > 2 cc. Clinical improvement was graded excellent (76–100%), good (50–75%), fair (26–50%), and poor (< 25%). Seventy-two percent had excellent results, 18% good, 2% fair, and 0.5% poor. Seven percent were lost to follow-up. Two percent (  n = 5  ) had transient erythematous papules lasting 2 to 6 weeks, with the exception of two patients.
Conclusion. Silicone oil injected with the correct indications and techniques and with microdroplet injections is a safe, economical, and permanent dermal and subcutaneous filler. Rare permanent erythematous papules and transient ecchymoses appear on deep dermal injections.     

Radiance FN: A New Soft Tissue Filler

BACKGROUND: Calcium hydroxylapatite has been used in various forms in facial reconstruction, radiologic procedures, stress urinary incontinence, and vocal cord problems. OBJECTIVES: To demonstrate the effectiveness and safety of calcium hydroxylapatite as an aesthetic soft tissue filler. METHODS: Sixty-four consecutive patients from two centers were treated with Radiance FN over a 6-month period in various facial areas. RESULTS: All patients showed clinical improvement. Side effects were minimal, consisting of mild bruising or swelling. There was a low incidence of complications, consisting of lip nodularity and tear trough overcorrection. CONCLUSION: Radiance FN offers a new alternative as a deep soft tissue filler. Aesthetic correction was immediate with little downtime. Patient satisfaction was high with minimal side effects. Lip nodularity was the main complication. Correction in all patients has persisted to date, with our longest follow-up being 6 months.