Polyalkylimide Gel Research Articles

Late Onset of Lower Limb Infection Caused by Gluteal Augmentation with Polyalkylimide Gel (PAIG), A Case Report

Background: Soft tissue augmentations with liquid injectibles is a common method for the treatment of lipodystrophy in HIV positive patients. Especially PAIG injections in small volumes have been used for this purpose and have been an established treatment. We report an unusual case of a complication 15 years after bilateral gluteoplasty by PAIG injection. PAIG as a volume replacement for aesthetic procedures as well as for the treatment of facial lipodystrophy has been used for a long time. A broad experience has been gained and few complications have been reported so far therefore it is an established and reliable procedure. Today’s plastic surgeon has a wide range of liquid injectibles and alternate procedures to choose from. Volume augmentation by hyaluronic acid, collagen and especially autologous fat grafting are more common in Europe and North America. Material and methods: We present a case report of a patient treated in our department for lower limb infection due to a long term complication after bilateral gluteoplasty by polyalkylimde injection. Verbal consent was obtained from the patient. Results: We report an unusual case of a complication 15 years after bilateral gluteoplasty by PAIG injection. Our case reports a descending abscess on the left inferior member in a male patient of Asian descent. Typical silicone associated granulomas were absent. Histopathology revealed foreign body tissue reaction untypical for silicone. A second survey of the patient’s history indicated previous PAIG injections for gluteoplasty. A radical surgical approach was crucial for the cure. Conclusion: Our case shows that plastic surgeons have to be aware of alternate augmentation methods and procedures in patients of foreign descent especially Asia and its associated potential complications. Those might include unusual materials like PAIG or silicone and respective different injection areas, as well. Treating those patients means to consider material migration with unusual clinical presentation of the complication. Consideration of cultural particularities and thoroughly empathetic and perceptive history taking is a crucial condition for the correct diagnosis and consecutive therapy

Granulomatous Foreign-Body Reactions to Permanent Fillers

Soft-tissue augmentation with permanent fillers can lead to severe granulomatous foreign-body reactions (GFBRs), but the immune pathomechanism of this complication is still unknown. We performed conventional histologic examination and immunostaining for plasmacytoid dendritic cells (pDCs) in skin sections from patients with GFBR to 4 permanent filler agents, which have been widely used in recent decades. Twenty-one skin biopsies were studied from 19 patients with GFBR to polyalkylimide 4% gel (PAIG, n = 10), polyacrylamide 2.5% gel (PAAG, n = 2), hydroxyethyl methacrylate/ethyl methacrylate in hyaluronic acid (HEMA/EMA, n = 4), or liquid injectable silicone (n = 5). GFBRs were analyzed in hematoxylin and eosin stained sections and pDCs detected using CD123 antibodies. Anti-CD11c immunostaining was performed for comparison. Grading of the inflammatory infiltrates observed histologically did not correlate with the clinical features of inflammation. Immunostaining for CD123 did not detect pDCs in 8 of 10 polyalkylimide gel, 1 of 2 polyacrylamide gel, and the 5 liquid injectable silicone biopsies. In contrast, all 4 HEMA/EMA biopsies contained collections of pDCs in lymphocytic infiltrates close to filler particles and adjacent sarcoidal granulomas. Our data suggest that pDCs contribute to the sarcoidal granulomas associated with injected HEMA/EMA. Recruited pDCs may exert their pro-inflammatory effects by the release of interferon-α at the site of these filler deposits.

Patient satisfaction following Bio-Alcamid injection for facial contour defects

Bio-Alcamid, a polyalkylimide gel, can be injected into subcutaneous tissue as an endoprosthesis for correcting contour deformities and soft tissue defects. We have reviewed its facial uses and longer-term outcomes over a 7-year period, including a patient satisfaction survey. 69 patients were included in the study, 89.9% undergoing treatment secondary to HIV-associated facial lipoatrophy. 55.0% of patients responded to questionnaires: 52.5% experienced severe pain associated with injections, and 50.0% experienced at least one complication (migration, hardening, irregularity). 94.4% stated an improvement in their cheek volume, 77.8% would undergo the procedure again, and 86.1% would recommend the treatment to a friend. Despite the relatively high patient satisfaction, we no longer recommend this treatment to our patients for cosmetic indications, due to significant long-term complication rates.

Four-Year Follow-Up of Polyalkylimide Gel Use for the Treatment of HIV-Associated Lipoatrophy

Purpose: To evaluate polyalkylamide gel (PAIG) use in treating HIV-associated facial lipoatrophy (FLA) 4 years after its injection in an open-label, randomized controlled trial (RCT). Methods: Five patients were treated with PAIG in a pilot study, and 31 patients were subsequently enrolled in the RCT of immediate or delayed (12 weeks later) PAIG injections. Endpoints included proportion of participants with complications; changes in FLA severity score (FLSS); and quality of life (QoL), depression, anxiety, and satisfaction scores. Infections were classified as “confirmed” if purulent material was extracted and/or an organism cultured. Infections were classified as “possible” if only clinical signs were present without purulent discharge or microbiologic confirmation. Results: Year 4 results were available for 5 pilot and 27 full-scale study participants. Delayed complications included 5 confirmed infections (15.6%), 3 possible infections (9.4%), nodules (25%), and bleeding (3%). No significant changes were observed between years 2 to 4 in patient-graded FLSS, QoL, depression, and anxiety scores. Whereas 94% of participants were satisfied with their overall treatment, only 69% were satisfied with PAIG treatment specifically. Conclusion: Even though PAIG treatment was associated with delayed complications including high rates of infection and nodules, most patients were satisfied with the treatment.

Surgical correction of HIV-associated facial lipoatrophy

Surgical correction of HIV-associated facial lipoatrophy

Early and late complications of polyalkylimide gel (Bio-Alcamid)®

This case report summarises early and late of complications that have developed inpatients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describes the management strategy employed to treat the most serious of these cases.

An Economic Evaluation of Treatments for HIV-Associated Facial Lipoatrophy: A Cost-Utility Analysis

HIV-associated facial lipoatrophy (FLA) is a stigmatizing hallmark for persons living with HIV [PLWH], and can lead to poor social functioning, social isolation, and reduced labour force participation. Treatments for this condition are prohibitively expensive and are not publicly insured in the Province of Ontario, Canada. Information gleaned from an economic evaluation of treatments for FLA could inform policy decision making concerning coverage. Decision-analytic techniques were used to estimate the lifetime incremental costs and quality-adjusted life years (QALYs) gained from use of either Poly-l-lactic acid or Polyalkylimide gel from the perspectives of society and the Ontario Ministry of Health. Disease progression probabilities and utilities were derived from the literature. Costs were obtained through interviews with product distributors and physicians who perform these treatments. Costs were valued in 2009 Canadian Dollars. Costs and outcomes were discounted annually at 3%. Treatments using Polyalkylimide gel exhibit such a cost advantage over those using Poly-l-lactic acid that they more than compensate for the health-related quality of life advantages of Poly-l-lactic acid. From a Ministry of Health perspective, the incremental cost-utility ratios for Polyalkylimide gel or Poly-l-lactic acid compared to no treatment were $45,457 CAD or $57,352 CAD per QALY, respectively, $1.00 CAD = $0.876 USD). From a societal perspective the equivalent ratios were $48,583 CAD and $66,608 CAD respectively. These findings were not altered in the sensitivity analyses. FLA treatments for PLWH enhance QALYs and meet conventional cost-utility thresholds. The incremental cost per QALY for Polyalkylimide gel was lower than that for Poly-l-lactic acid.

Long-Term Effect of Polyalkylimide Gel Injections on Severity of Facial Lipoatrophy and Quality of Life of HIV-Positive Patients

Long-Term Effect of Polyalkylimide Gel Injections on Severity of Facial Lipoatrophy and Quality of Life of HIV-Positive Patients

Long-term efficacy and safety of polyalkylimide gel for the treatment of HIV-associated lipoatrophy

The long-term safety and efficacy of products used in the correction of HIV-associated facial lipoatrophy (FLA) are largely unknown. The purpose of this study was to describe the long-term efficacy and safety of polyalkylimide gel (PAIG) in the treatment of HIV-associated FLA. In this open-label, randomized, single-center study, 31 HIV-positive individuals (median age 48 years (interquartile ranges (IQR) 45, 55, 97% male) with FLA were randomized to immediate (week 0 and six) or delayed (week 12 and 18) PAIG injections. Week 96 endpoints included change in FLA severity scores (FLSS) (five-point scale), proportion of patients with adverse events, and changes in quality of life, depression and anxiety using validated surveys. Results at week 96 were available for 28 patients. Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of three days following the injection. At week 96, median changes in physician and patient FLSS scores were −2 (IQR −3, −1; p<0.001 vs. baseline) and −2 (IQR −2, −1; p<0.001 vs. baseline), respectively. Physician and patient FLSS scores were not significantly different between the groups at week 96. Significant improvements in patient's anxiety (p<0.001), depression (p<0.001) and mental health (p=0.01) were observed from baseline to week 96. In conclusion, treatment with PAIG was associated with sustained improvements in both the physical and psychological components of FLA through 96 weeks of follow-up.

Cost consequences of HIV-associated lipoatrophy

HIV-associated lipoatrophy may affect up to 35% of patients who have received antiretroviral (ARV) regimens for more than one year, and may result in depression, social isolation, and career barriers. Interventions including the injection of dermal fillers for restoration of facial fat loss are being used for treating HIV-associated lipoatrophy. Since reimbursement is often lacking, patients must consider the pros and cons of such interventions, weighed against the other costs of daily life. The primary goal of the study is to provide reliable estimates of the costs of treating HIV-associated lipoatrophy, specifically facial lipoatrophy. Costs are provided for a single site and are estimated from published studies reporting administration patterns of dermal fillers, publicly available list prices, and physician service fees for similar subcutaneous injections of the face. Fourteen studies were identified that reported experience with five dermal fillers used to treat HIV-associated facial lipoatrophy: poly-L-lactic acid, calcium hydroxylapatite, polyalkylimide gel, hyaluronic acid, and silicone oil. Typical courses involve four physician visits, but could vary from 1 to 13. The cost of a course of dermal filler treatment at a single site ranges across four products (all other than hyaluronic acid) from $3690 to $16,544, and is typically not covered by the payers. Physician fees for an entire course of similar outpatient procedures reimbursed by insurers are approximately $500, and may vary according to location, specialty, and market conditions. These procedures need to be repeated per site injected with intervals of 1–3 years. Treatment of HIV-associated lipoatrophy may represent a considerable out-of-pocket expense for many patients with HIV. This could have implications for deciding whether to undergo a restorative procedure, which procedure to undergo, and whether to pursue other options that may include switching ARV regimens.

Long-Term Effect of Polyalkylimide Gel Injections on Severity of Facial Lipoatrophy and Quality of Life of HIV-Positive Patients

Highly active antiretroviral therapy (HAART) is associated with facial lipoatrophy, which is potentially stigmatizing for HIV-positive patients. We assessed the long-term effects of polyalkylimide gel injections on the severity of lipoatrophy and quality of life of patients on HAART. A prospective study was performed of 17 HIV-positive patients with grade 2 and grade 3 facial lipoatrophy. A mean volume of 14 cc of polyalkylimide gel (Bio-Alcamid) was injected subcutaneously at one or more sites of the face in a single stage. Each patient was seen for follow-up after 3, 12, 24, and 48 weeks. The severity of lipoatrophy and the quality of life was assessed using a self-report questionnaire containing the relevant parts of the SF-36, MOS-HIV, and CES-D. The severity of facial lipoatrophy decreased significantly from baseline over 48 weeks. Quality of life improved significantly from baseline over 48 weeks for mental health and social functioning. Depression at week 48 was significantly correlated with the extent to which lipoatrophy had disappeared at week 48. Individualized volumes of polyalkylimide gel injected in one session significantly decreased the subjective severity of lipoatrophy and improved the quality of life of HIV-positive patients with grade 2 and 3 lipoatrophy, even in the four patients who had complications.

Immediate versus delayed polyalkylimide gel injections to correct facial lipoatrophy in HIV-positive patients

To evaluate the safety and efficacy of polyalkylimide gel (PAIG) in the treatment of HIV-associated facial lipoatrophy. A randomized, open-label, single-centre study. HIV-positive individuals with facial lipoatrophy (based on physician assessment) were randomly assigned to immediate (weeks 0 and 6) or delayed (weeks 12 and 18) PAIG injections administered into the subcutaneous plane. Outcome measures included a change in facial lipoatrophy severity scores (five-point scale), adverse events, photographic assessment, and changes in quality of life (QoL), depression and anxiety using validated surveys. Thirty-one patients (median age 48 years, 97% male) were enrolled and completed 48 weeks of follow-up. Overall, the median volume of product injected bilaterally was 16.0 ml. Adverse events, including swelling, redness, bruising and pain, were mild, and resolved after a median of 3 days. There were no cases of necrosis, nodules or infection. Compared with patients randomly assigned to delayed treatment, patients in the immediate therapy group had significantly lower physician-rated facial lipoatrophy scores (0 versus 2; P < 0.0001), improved QoL (P = 0.01), and lower anxiety (P = 0.02) at week 12. At week 48, median physician and patient facial lipoatrophy scores were 0 and 1, respectively, for the entire cohort, and were not significantly different between the groups. Significant improvements in patient anxiety (P = 0.001) and depression (P = 0.01) were observed from baseline to week 48. Treatment with PAIG was effective and safe and led to improvements in facial lipoatrophy grading, QoL, anxiety and depression scores in HIV-infected patients with facial lipoatrophy.

Use of a Biopolymer Polyalkylimide Filler for Facial Lipodystrophy in HIV-Positive Patients Undergoing Treatment with Antiretroviral Drugs

To evaluate the efficacy, overall esthetic effect, and safety of a new permanent, polyalkylimide dermal filler in HIV-infected patients with severe facial lipodystrophy. Eleven subjects with severe facial lipodystrophy secondary to HIV infection were injected bilaterally with 15 and 30 cm3 of a polyalkylimide gel into the buccal, malar, and temporal areas of the face in an attempt to restore their facial contour. The youngest treated subject was 31 years of age and the oldest 73 years of age. All 11 subjects received an immediately acceptable therapeutic esthetic effect. Injections were generally well tolerated, with only three adverse events (swelling and bruising) recorded. Subjects, assessed at 3 and 18 months after treatment, continued to show improvement. The immediate benefits of a polyalkylimide gel in the correction and restoration of facial contour in subjects having severe HIV-related facial lipodystrophy were demonstrated. This improvement was still noted at 18 months. The efficacy, ease of injection, and safety profile of polyalkylimide gel make this filling material a potentially attractive treatment for lipodystrophy. These data must be tempered with the need for significant further safety studies to determine whether this long-term filler has a safety profile consistent with other currently popular fillers.

Use of a Biopolymer Polyalkylimide Filler for Facial Lipodystrophy in HIV-Positive Patients Undergoing Treatment with Antiretroviral Drugs

OBJECTIVES To evaluate the efficacy, overall esthetic effect, and safety of a new permanent, polyalkylimide dermal filler in HIV-infected patients with severe facial lipodystrophy. METHODS Eleven subjects with severe facial lipodystrophy secondary to HIV infection were injected bilaterally with 15 and 30 cm3 of a polyalkylimide gel into the buccal, malar, and temporal areas of the face in an attempt to restore their facial contour. The youngest treated subject was 31 years of age and the oldest 73 years of age. RESULTS All 11 subjects received an immediately acceptable therapeutic esthetic effect. Injections were generally well tolerated, with only three adverse events (swelling and bruising) recorded. Subjects, assessed at 3 and 18 months after treatment, continued to show improvement. CONCLUSIONS The immediate benefits of a polyalkylimide gel in the correction and restoration of facial contour in subjects having severe HIV-related facial lipodystrophy were demonstrated. This improvement was still noted at 18 months. The efficacy, ease of injection, and safety profile of polyalkylimide gel make this filling material a potentially attractive treatment for lipodystrophy. These data must be tempered with the need for significant further safety studies to determine whether this long-term filler has a safety profile consistent with other currently popular fillers.