Adverse Reactions to Injectable Soft Tissue Permanent Fillers

Background

Synthetic injectable facial fillers with a permanent effect are widely atoxic and nonimmunogenic, but they differ with respect to composition and in chemical and biologic characteristics. Yet, they all act as foreign bodies in the tissues eliciting a host response that try to remove the gel. Inflammatory nodules may develop at the sites of injection-for some fillers, many years later, for others, not. Why is that?

Methods

Biopsies were contributed by various plastic surgeons from Europe and Australia after requests were made at international congresses and workshops. The study was based on (a) 5 biopsies from unreactive tissue obtained at different times after injection of polyacrylamide hydrogel (Aquamid); (b) 28 biopsies from intermediate or late inflammatory nodules after injection of polyacrylamide hydrogel (Aquamid) (20 cases), a hyaluronic acid-polyhydroxyethylmethacrylate/ethylmethacrylate gel (Dermalive) (2 cases), and a gel consisting of polylactic acid in mannitol/carbomethoxycellulose (New-Fill) (6 cases); and (c) a review of the literature on adverse reactions after injection with permanent fillers.

Results

Clinically unreactive tissues after injection with Aquamid showed modest or no host reaction. Inflammatory nodules showed an increased foreign body reaction and a bacterial infection after injection with Aquamid, and a combination of moderate foreign body reaction, fibrosis, and in some cases also bacterial infection after injection with Dermalive and New-Fill. According to the literature, inflammatory nodules occur no later than 1 year after injection with polyacrylamide hydrogel, but up to 6 years after injection of combination gels (Artecol), and up to 28 years after injection of silicone gel.

Conclusions

Inflammatory nodules are likely to be caused by a low-grade infection maintained within a biogfilm surrounding the hydrophobic silicone gel and the combination gels. Aquamid gel may prevent formation of a biofilm through its high water-binding capacity, explaining why late inflammatory nodules are not seen after injection of this polyacrylamide hydrogel product.     

Acrylic frontal cranioplasty

The correction of contour defects of the frontal bone has been accomplished with a variety of autogenous and alloplastic materials. We report our experience in reconstructing 11 cases of congenital, traumatic, and postsurgical frontal defects with acrylic. The acrylic was cured intraoperatively within the defect in some patients, or prefabricated into a prosthesis and wired into position in others. The operative techniques for both methods of repair are detailed. The reconstruction was successful in all cases and there were no complications. The acrylic implant has been found to be well tolerated after 2-10 yr follow-up. The value of the construction of a facial moulage is stressed, especially when restoration of the orbital rim is required.     

Acrylic frontal cranioplasty

The correction of contour defects of the frontal bone has been accomplished with a variety of autogenous and alloplastic materials. We report our experience in reconstructing 11 cases of congenital, traumatic, and postsurgical frontal defects with acrylic. The acrylic was cured intraoperatively within the defect in some patients, or prefabricated into a prosthesis and wired into position in others. The operative techniques for both methods of repair are detailed. The reconstruction was successful in all cases and there were no complications. The acrylic implant has been found to be well tolerated after 2–10 yr follow-up. The value of the construction of a facial moulage is stressed, especially when restoration of the orbital rim is required.     

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®.     

Adverse Granulomatous Reaction After Cosmetic Dermal Silicone Injection

BACKGROUND: Various alloplastic injectable implants have been developed for soft tissue augmentation without surgery, but different local or systemic adverse reactions have limited their use for cosmetic purposes. OBJECTIVE: To examine the problems associated with silicone injection. METHODS: Case report and literature review. RESULTS: We describe an adverse granulomatous reaction after the injection of liquid silicone for lip augmentation, causing facial disfigurement. Although the initial response to steroids was poor, after 3 years of follow-up the nodules have almost disappeared spontaneously. CONCLUSION: We advise that silicone injection be performed solely by trained physicians using medical-grade silicone or consider other injectable materials.     

Reconstruction of the chest wall after full thickness resection: a comparison between myocutaneous flap and acrylic resin plate as reconstructive techniques

Thirty-three patients with chest wall malignancies underwent full thickness resection of the chest wall and immediate reconstruction of the defects with either synthetic materials (acrylic resin plate, 16 patients) or with myocutaneous flaps (rectus abdominis flaps, 17 patients). Although the acrylic resin plate proved to be excellent for maintaining stability of the chest wall, five patients suffered from local skin necrosis, requiring skin grafting, and four suffered from persistent foreign body reactions, necessitating ultimate removal of the plate. The patients receiving myocutaneous flap repair had excellent wound healing, acceptable rigidity of their chest wall, and no foreign body reactions throughout the follow-up period. The 50% post-operative survival time for the entire series was 29 months, suggesting that the procedure in an effective treatment modality for breast cancer involving the chest wall. Reconstruction with a myocutaneous flap is indicated as long as the chest wall defect is not too extensive.     

腔镜手术取乳房注射隆胸材料聚丙烯酰胺水凝胶

目的:探讨微创腔镜辅助下注射式隆胸填充物聚丙烯酰胺水凝胶取出的可行性并总结手术经验.方法:9例共17只乳腺注射式隆胸填充物聚丙烯酰胺水凝胶在腔镜辅助下行取出术,对切口选择、手术效果及手术经验进行总结.结果:17只乳房注射式隆胸填充物聚丙烯酰胺水凝胶在腔镜辅助下绝大部分被取出,术中镜下观察创腔无聚丙烯酰胺水凝胶残留,术后3～6月随访,B超检查14只乳腺未发现聚丙烯酰胺水凝胶残留,2只乳房外下象限见少量聚丙烯酰胺水凝胶残留,1只乳房腺体内见低回声结节.结论:微创腔镜辅助下注射隆胸聚丙烯酰胺水凝胶取出术可去除大部分聚丙烯酰胺水凝胶,手术损伤小,安全、可靠,术后切口美观,在临床上有一定的应用价值.     

Lip Augmentation Dermal Filler Reactions, Histopathologic Features

Instances of perioral and labial foreign body reactions to a variety of injectable dermal fillers were selected from the oral and maxillofacial pathology and dermatopathology archives at Pacific Pathology Laboratory of San Diego with the objective being to engender a compilation of histopathologic characteristics that allow the pathologist to identify the inciting materials. All cases of foreign body reactions located in the lips and perioral regions were reviewed by four pathologists, retaining those cases with a history of injection lip augmentation as well as those with histologic features previously documented to represent dermal filler substances. In selected cases, Alcian blue pH 2.5 with and without hyaluronidase pretreatment was performed. Immunohistochemical markers for macrophages (CD 68), adipocytes (S-100) and keratinocytes (AE1/AE2) were undertaken. All instances presented as single or multiple submucosal plaques, nodules or swellings. Natural polymers including collagen, hyaluronate, hydroxyapatite, poly-L-lactate and synthetic polymers including carboxymethyl cellulose, dimethylpolysiloxane, and polyethyl methacrylate induce histologically unique features that allow for their identification. Host histopathologic responses included nodule without foreign body reaction, nodule with chronic inflammation, granuloma with epithelioid histiocytic and multinucleated giant cell reaction. Dermal filler foreign body host reactions in conjunction with the morphology of the foreign materials themselves are unique and can be differentiated from one another microscopically.     

Improving Outcomes in Hernia Repair by the Use of Light Meshes—A Comparison of Different Implant Constructions Based on a Critical Appraisal of the Literature

Background Despite convincing advantages offered by meshes, their use in hernia surgery remains controversial because of fears concerning the long-term effects of their implantation. To improve biocompatibility, a large variety of newly developed light meshes has been introduced to the market. This overview of the literature aimed to establish whether absolute material reduction (g per implanted mesh), use of absorbable components, and coating by inert materials are evidence-based ways to improve biocompatibility of meshes. Method A review of the current English and German language literature on the outcome of groin und incisional hernia mesh repair was performed. Both basic research and clinical trials were used as sources of data. Meta-analyses and randomized controlled trials were given priority and were referred to whenever possible. Results Operative technique was an independent prognostic factor for the clinical outcome. Mesh construction and composition as characterized by pore size and filament structure appeared to be more important determinants of foreign body reaction after implantation than absolute material reduction of 1 g or more per implant. No data exist about an oncogenic effect of alloplastic materials in humans, but disturbed fertility in animal studies remains an issue of concern and should be further investigated. Conclusions According to data from current randomized controlled trials and retrospective studies, light meshes seem to have some advantages with respect to postoperative pain and foreign body sensation. However, their use is associated with increased recurrence rates. Light meshes offer no advantages with respect to alleviating severe chronic groin pain. At the same time, experimental data reveal that material composition and mesh structure may significantly affect foreign body reaction.     

Successful Treatment with Injected Hyaluronic Acid in a Patient with Lip Asymmetry after Surgical Correction of Cleft Lip

BACKGROUND Surgical repair of cleft lip, while correcting deformity and dysfunction, may leave residual cosmetic imperfections. The resultant asymmetry and low volume of the upper lip can be addressed surgically and via less invasive methods.
OBJECTIVE We present the first reported use of injectable hyaluronic acid to correct the characteristic lip asymmetry and poor volume after surgical repair of a cleft lip.
METHODS AND MATERIALS Using injectable hyaluronic acid, we treated the patient's upper lip to restore symmetry and achieve an augmented volume.
RESULTS We obtained a symmetric correction and aesthetically pleasing volume augmentation in the affected lip. These results lasted approximately 4 months.
CONCLUSION Using a temporary, alloplastic, injectable soft tissue filler such as hyaluronic acid satisfactorily achieves correction of asymmetry and low volume in a surgically repaired cleft lip. For patients who have endured multiple corrective surgeries, this is a novel and less invasive way to improve their cosmetic concerns.     

Materialtechnische Voraussetzungen und biologische Grundlagen für den alloplastischen Kniebandersatz

The biomechanical system “knee joint” which is disturbed in chronic knee ligament instabilities can be repaired by means of synthetic ligaments; however, the correspondent materials have to meet some technical requirements which are described in the present work. The introduction of foreign bodies into tissue incite some defined reactions which may increase or decrease the functional value of the alloplastic ligament prosthesis; the correlations and dependencies are presented. An appropriate alloplastic knee ligament prosthesis is offered taking into account the requirements for material and the biologic reactions described.     

Complications of breast augmentation with injected hydrophilic polyacrylamide gel

Since 1997, the hydrophilic polyacrylamide gel (PAAG), an injectable alloplastic biomaterial, imported from the Ukraine has been used for augmentation mammaplasty in China. There were twelve patients with various complications visiting our hospitals after breast augmentation with injected hydrophilic polyacrylamide gel by other clinics, even though such procedures are not performed in our clinical practices. The complications included four cases of PAAG-induced multiple induration and lumps, and one with lactation, three cases of hematoma, two cases of inflammation (infection), and persistent mastodymia, unsatisfactory contour results and abnormal skin sensations in each case. All patients have been treated by removing the injected gel and giving antibiotics. Other procedures included replacement by silicon breast prostheses, mammotomy, and segmental mastectomy. We suggest that the injectable hydrophilic polyacrylamide gel be contraindications for breast augmentation in any young female who is not married, or without a child, with a tendency to hemorrhage, and with little mammary tissue. Some considerations to prevent and manage these complications are discussed.     

Immediate autogenous cartilage grafts in rhinoplasty after alloplastic implant rejection

BACKGROUND: It is accepted in rhinoplasty that complications are more common with alloplastic implants than with autografts. There is little guidance in the literature on how to deal with the cosmetic and/or functional problems that follow alloplastic implant rejection. The conventional advice has been to remove the allograft and not place any graft at the same time. The present article presents our experience treating allograft rejection and immediately repairing any structural defect with autografts. OBJECTIVE: To demonstrate that immediate nasal reconstruction using autogenous cartilage is a good technique when an alloplastic material has to be removed because of rejection, inflammation, or infection. DESIGN: A retrospective analysis of outcome for a case series. METHODS: A retrospective review of the management of 8 patients who presented to 2 tertiary referral centers with alloplastic implant rejection following rhinoplasty. In 7 cases, the alloplastic implant had to be removed because it had migrated and caused a foreign body reaction; in 1 case, the implant had caused a bacterial infection. RESULTS: In all 8 cases, the nasal deformity that followed the removal of the allograft was so marked that the nose was immediately reconstructed with autogenous cartilage. The patients all made a good recovery after immediate reconstruction, although skin changes associated with the alloplastic implant remained after a mean follow-up of 3 years 3 months. CONCLUSION: The use of autogenous cartilage is a good option for nasal augmentation immediately after the removal of an alloplastic implant.     

Novel fabrication of antibiotic containing multifunctional silk fibroin injectable hydrogel dressing to enhance bactericidal action and wound healing efficiency on burn wound: In vitro and in vivo evaluations

The development of biologically active multifunctional hydrogel wound dressings can assist effectively to wound regeneration and also has influenced multiple functions on wound injury. Herein, we designed a carbon‐based composited injectable silk fibroin hydrogel as multifunctional wound dressing to provide effective anti‐bacterial, cell compatibility and in vivo wound closure actions. Importantly, the fabricated injectable hydrogel exhibit sustained drug delivery properties, anti‐oxidant and self‐healing abilities, which confirm that composition of hydrogel is highly beneficial to tissue adhesions and burn wound regeneration ability. Frequently, designed injectable hydrogel can be injected into deep and irregular burn wound sites and would provide rapid self‐healing and protection from infection environment with thoroughly filled wound area. Meanwhile, incorporated carbon nanofillers improve injectable hydrogel strength and also offer high fluid uptake to hydrogel when applied on the wound sites. In vitro MTT cytotoxicity assay on human fibroblast cell lines establish outstanding cytocompatibility of the injectable hydrogel and also have capability to support cell growth and proliferations. In vivo burn wound animal model results demonstrate that the hydrogel dressings predominantly influenced enhanced wound contraction and also promoted greater collagen deposition, granulation tissue thickness and vascularization. This investigation''s outcome could open a new pathway to fabricate multifunctional biopolymeric hydrogel for quicker burn wound therapy and effectively prevents microenvironment bacterial infections.     

Advances in cranioplasty: a simplified algorithm to guide cranial reconstruction of acquired defects

The search for a universal reconstructive material and the application of a routine approach leaves the surgeon limited in cranial reconstruction. Facility with a variety of implant materials and approaches helps optimize surgical management. The variability of surgical defects and challenges in cranial reconstruction highlights the importance of a strategic approach to evaluate both the defect and the clinical circumstance. Among the numerous alloplastic materials available, the utility of titanium mesh, hydroxyapatite cement, and prefabricated custom acrylic implants have remained at the forefront. The onus of responsibility remains on the surgeon to evaluate each clinical scenario and select the optimal course for management.     

Alloplastic ureter substitution and limitations in clinical application. A status analysis

Operative ureteral replacement with the patient's own body tissue or by reconstructive ureteral surgery is indicated relatively often. The operative methods applied vary: they include pelvic flap pyeloplasty, caudal transposition of the kidney, interposition of the small intestine, trans-ureterostomy, calico-ureterostomy, of bladder flap transplantation and autotransplantation of the kidney. When the indications are correctly observed with reference to the kind and location of the ureteral lesion all these methods are successful. The methods of alloplastic replacement of the ureter, in contrast, have lost clinical importance and should be performed only in rare, isolated cases, mainly as a short-term solution. Possible indications are a poor general condition in patients for whom alloplastic ureteral replacement is the only alternative to permanent nephrostomy and malignant tumours requiring immediate irradiation, which cannot be postponed until definitive wound healing has taken place following a plastic operation. It is important that problems of biocompatibility have now been largely overcome. Segmental ureteral replacement with alloplastic materials is not possible, however, and the functional difficulties with urinary transport have not been solved in the long term, even in models with pumps and reflux-preventing mechanisms.     

Long-Term Complications of Polyethylene Glycol Injection to the Face

Currently, filling, smoothing, or recontouring the face through the use of injectable fillers is one of the most popular forms of cosmetic surgery. Because these materials promise a more youthful appearance without anesthesia in a noninvasive way, various fillers have been used widely in different parts of the world. However, most of these fillers have not been approved by the Food and Drug Administration, and their applications might cause unpleasant disfiguring complications. This report describes a case of foreign body granuloma in the cheeks secondary to polyethylene glycol injection and shows the possible complications associated with the use of facial fillers.     

Material properties in unconfined compression of human nucleus pulposus, injectable hyaluronic acid-based hydrogels and tissue engineering scaffolds

Surgical treatment for lower back pain related to degenerative disc disease commonly includes discectomy and spinal fusion. While surgical intervention may provide short-term pain relief, it results in altered biomechanics of the spine and may lead to further degenerative changes in adjacent segments. One non-fusion technique currently being investigated is nucleus pulposus (NP) support via either an injectable hydrogel or tissue engineered construct. A major challenge for either approach is to mimic the mechanical properties of native NP. Here we adopt an unconfined compression testing configuration to assess toe-region and linear-region modulus and Poisson’s ratio, key functional parameters for NP replacement. Human NP, experimental biocompatible hydrogel formulations composed of hyaluronic acid (HA), PEG-g-chitosan, and gelatin, and conventional alginate and agarose gels were investigated as injectable NP replacements or tissue engineering scaffolds. Testing consisted of a stress-relaxation experiment of 5% strain increments followed by 5-min relaxation periods to a total of 25% strain. Human NP had an average linear-region modulus of 5.39 ± 2.56 kPa and a Poisson’s ratio of 0.62 ± 0.15. The modulus and Poisson’s ratio are important parameters for evaluating the design of implant materials and scaffolds. The synthetic HA-based hydrogels approximated NP well and may serve as suitable NP implant materials.     

Comparative investigation of alloplastic materials for hernia repair with improved methodology

Background: A variety of alloplastic materials are used for hernia repair. We discuss the long-term stability and possible shrinkage of these materials. In the past, measurement of pore sizes was used to study the physical properties of alloplastic meshes. The aim of this study was to evaluate the measurement of pore sizes with regard to its correlation to possible mesh alteration. Methods: The water absorption of different polypropylene (PP) and polyester (PE) mesh materials under defined conditions was studied. For shrinkage studies, meshes were stored in formaldehyde, distilled water, saline solution, trypsin solution, urea solution, and hydrogen peroxide. The measurement of the relation between material and pore was evaluated to investigate the potential shrinking and enlargement processes. This material–pore index (MPI) before as well as 1, 7, and 14 days after incubation was measured. Results: In comparison to measuring single pore sizes, MPI determination is the more efficient method to evaluate the possible shrinking or enlargement processes of alloplastic materials. With this technique, incorrect determination of pore sizes due to the dynamic textile structure of meshes and to shrinkage or enlargement, is excluded. All tested alloplastic materials showed an insignificant increase in water absorption under the condition of rehydration up to 0.4%. We did not observe variances in the material in shrinking or enlargement. Conclusions: MPI was found to be more reliable than measuring single pores to investigate possible external influences on polymer materials. Biomaterials such as PP and PE proved to be absolutely inert under various in vitro conditions.