Polyacrylamide Hydrogel Injection Research Articles

Effectiveness and safety of polyacrylamide hydrogel injection for knee osteoarthritis: results from a 12-month follow up of an open-label study

ObjectiveThere are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data.MethodsThis multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0–100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).Results49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (− 17.7 points (95% CI − 23.1; − 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI − 17.0; − 4.9), physical function (18.0 points; 95% CI − 19.1; − 10.6), and PGA (16.3 points; 95% CI − 23.1; − 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.ConclusionThis open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.Trial registration: Clinicaltrials.gov NCT04179552.

Reconstruction of Urethral Sphincter With Polyacrylamide Hydrogel.

Urethral bulking is an alternative to synthetic midurethral sling for the treatment of stress urinary incontinence (SUI) in women. Urethral bulking agents, which are injected in the submucosal tissues of the proximal urethra/bladder neck, have demonstrated less adverse effects with similar satisfaction rates but lower subjective and objective cure rates when compared with midurethral sling. Cystoscopic Reconstruction of External Sphincter Technique (CREST) is a novel technique, which reinforces the natural closure mechanism of the external urinary sphincter (EUS). The aim of the study was to provide safety and efficacy data for injecting polyacrylamide hydrogel (PAHG) in the components of the female EUS. This was a retrospective chart review of patients using CREST with PAHG as initial treatment for SUI by a single surgeon from January 2022 to October 2022. Exclusion criteria are as follows: younger than 18 years, prior SUI surgery, concomitant pelvic organ prolapse or reconstructive procedure, neurological conditions, or history of radiation. Subjective and objective cure rates were measured by patient-reported symptoms and cough stress test. Urinary retention, postoperative urinary infection, and de novo urinary urgency were assessed. One hundred and thirteen consecutive patients met inclusion criteria with median follow-up of 3 months. Eighty-five percent of participants reported subjective improvement, 69% reported subjective cure, and 69% demonstrated objective cure. Nine patients reported transient postoperative retention, 8 reported postoperative urinary tract infections, and 5 reported de novo urgency. There were no serious adverse events. CREST is a novel technique for injection of PAHG, into the EUS to treat SUI. Our data suggest that this technique could improve urethral injection outcomes with minimal complications.

Application of magnetic resonance imaging with intraoperative color Doppler ultrasound in the treatment of patients with polyacrylamide hydrogel injected for breast augmentation: a retrospective study of 204 cases for 12 years.

Polyacrylamide hydrogel (PAHG), which had been used widely for breast augmentation, has been banned for more than 15 years. Patients who had been injected PAHG for breast augmentation need evacuation surgery to remove as much as possible. To provide a series of diagnosis and treatment process MRI and intraoperative color Doppler ultrasound are combined for maximal removal of PAHG. The patients who received evacuation surgery in Peking University Third Hospital from 2010 to 2022 after PAHG injection for breast augmentation were included in this research. MR scanning was performed preoperatively and postoperatively in some of these patients and color Doppler ultrasound was applied to help evacuate PAHG intraoperatively. The mean clearance rate of PAHG was calculated according to the MRI outcomes. Two hundred and 4 patients had received evacuation surgery after PAHG injection for breast augmentation with an average age of 42.8 years and an average body mass index of 21.2 kg/m2. The average PAHG retention time was 13.5 years. Among them, 52 patients underwent pre- and postoperative MRI scanning. The mean three-dimensional (3D) volume of PAHG was 684.8 mL (range, 350.0-1,123.9 mL), and the average residual 3D volume of PAHG was 53.7 mL (range, 12.4-98.3 mL). The mean clearance rate was 92.1%. MRI and intraoperative color Doppler ultrasound can provide effective and precise location information of PAHG for evacuation surgery, which is a reliable method to ensure the maximal removal of PAHG.

Quality of life and sexual function after tension-free vaginal tape and polyacrylamide hydrogel injection for primary stress urinary incontinence: 3-year follow-up from a randomized clinical trial

Introduction and hypothesisTo assess quality of life (QoL) and sexual function outcomes at 3 years after tension-free vaginal tape (TVT) and polyacrylamide hydrogel injection (PAHG) for stress urinary incontinence (SUI).MethodsIn this randomized trial comparing TVT (n = 104) and PAHG (n = 108), we assessed changes in QoL and sexuality using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and at 3 years. This is a secondary analysis of a randomized, noninferiority trial comparing patient satisfaction after TVT and PAHG.ResultsIn both groups, incontinence-related QoL improved from the baseline (p < 0.00), except for difficulty emptying the bladder and pain/discomfort. Total scores of UDI-6 and IIIQ-7 were lower for TVT compared to PAHG (p < 0.00) indicating better QoL at 3 years. Urinary incontinence with sexual activity or fear of incontinence restricting sexual activity improved in both groups (p < 0.00), with higher scores for physical section subscale in PISQ-12 (p = 0.02) for TVT. Physical and social functioning (RAND-36) improved from the baseline in both groups (p < 0.01) with a better outcome in the TVT group for physical functioning (p = 0.00).ConclusionsBoth TVT and PAHG improve QoL and sexual function in primary SUI with better incontinence and health-related QoL scores in the TVT group compared to the PAHG group at 3 years.

POLYACRYLAMIDE HYDROGEL VERSUS HYALURONIC ACID IN KNEE OSTEOARTHRITIS: A SUBGROUP ANALYSIS OF A RANDOMIZED STUDY

AbstractIntroductionThe effectiveness of single intra-articular injections of polyacrylamide hydrogel (iPAAG) and hyaluronic acid (HA) was compared in subgroups of participants from an RCT based on baseline age, BMI or Kellgren-Lawrence (KL) grade.Methodology239 participants were randomised to 6 mL iPAAG (Arthrosamid; n=119) or 6 mL HA (Synvisc-One; n=120). Participants continued analgesics (except 48 hours prior to visits) and non-pharmacological therapy. Topical therapies and intra-articular corticosteroids were not allowed. Pre-specified subgroup analyses (age: &lt;70 years, ≥70 years; BMI: normal, overweight, obese; KL grade: 2, 3, 4, 2–3) of change from baseline in WOMAC pain subscale at 52 weeks were based on the least squares means for the treatment-by-week interaction effect using a mixed model for repeated measurement with a restricted maximum likelihood-based approach.ResultsAcross all patients, change from baseline in WOMAC pain subscale in the iPAAG group was non-inferior to HA at 26 weeks and approached superiority (p=0.0572) at 52 weeks. Treatment differences for change from baseline in WOMAC pain subscale in favour of iPAAG over HA were statistically significant for the age &lt;70 years (p=0.019), BMI normal (p=0.011) and KL grade 2–3 (p=0.033) subgroups. Treatment differences for all other subgroups favoured iPAAG, except for KL grade 4 which favoured HA, without reaching statistical significance.ConclusioniPAAG approached superiority to HA across all participants at 52weeks, but demonstrated statistical superiority in participants with normal BMI, participants &lt;70 years old or participants with KL score 2–3. iPAAG represents a useful alternative to HA for the treatment of knee OA.

Factors associated with polyacrylamide hydrogel outcomes in women with stress urinary incontinence.

Knowledge of factors associated with superior outcomes in women treated with urethral bulking agents for stress urinary incontinence (SUI) remains limited. The aim of this study was to examine associations between post-treatment outcomes in women who had undergone polyacrylamide hydrogel injections for SUI, and physiological and self-reported variables captured during pre-treatment clinical evaluation. A cross-sectional study was undertaken in female patients treated for SUI with polyacrylamide hydrogel injections by a single urologist between January 2012 and December 2019. Post-treatment outcome data were gathered in July 2020 using the Patient Global Impression of Improvement (PGI-I), Urinary Distress Inventory-short form (UDI-6), Incontinence Impact Questionnaire (IIQ7), and International Consultation on Incontinence Questionnaire Short Form (ICIQ SF). All other data were gathered from women's medical records including pre-treatment patient-reported outcomes. Associations between post-treatment outcomes and pre-treatment physiological and self-reported variables were investigated using regression models. One hundred seven of the 123 eligible patients completed post-treatment patient-reported outcome measures. Mean age was 63.1 years (range 25-93 years), and median time between first injection and follow-up was 51 months (inter-quartile range 23.5-70 months). Fifty-five (51%) women had a successful outcome based on PGI-I scores. Women with type 3 urethral hypermobility pre-treatment were more likely to report treatment success (PGI-I). Poor bladder compliance pre-treatment was associated with greater urinary distress, frequency and severity (UDI-6 and ICIQ) post-treatment. Older age was associated with worse urinary frequency and severity (ICIQ) post-treatment. Associations between patient-reported outcomes and time between first injection and follow-up were trivial and not statistically significant. Severity of pre-treatment incontinence impact (IIQ-7) was associated with worse incontinence impact post-treatment. Type 3 urethral hypermobility was associated with a successful outcome, whereas pre-treatment incontinence impact, poor bladder compliance and older age were associated with poorer self-reported outcomes. Long-term efficacy appears to hold in those who responded to initial treatment.

Augmentation Mammoplasty Using Polyacrylamide Hydrogel Injection Can Mimic Breast Cancer After 20 Years: A Case Report

Polyacrylamide hydrogel (PAAG), an injectable, jelly-like, medical hydrogel, has been popular in some countries as a non-surgical method of mammoplasty since approximately 2000. Particularly in China, many patients underwent mammoplasty using PAAG during a 16-year period until 2006, and studies on its course and complications were also conducted. However, evidence regarding the relationship between PAAG mammoplasty and malignancy is lacking, and only a few cases have reported the possibility of this association. Herein, we present a case in which malignancy was suspected because of complications 20 years after PAAG injection mammoplasty.

Analysis of breast follow-up results in patients after polyacrylamide hydrogel (PAAG) or silicone prosthesis removal

BackgroundPolyacrylamide hydrogel has been prohibited since 2006 due to numerous complications. Unsatisfactory breast contour was always observed in patients after PAAG removal. The same occurred in patients after silicone prosthesis removal. We attempt to compare and analyze the difference in postoperative breast conditions and pathology between the two groups. MethodsWe retrospectively reviewed the data of patients who underwent PAAG or silicone prosthesis removal between 2011 and 2021. The BREAST-Q was used to evaluate the follow-up results, including satisfaction with breasts, physical well-being, psychosocial well-being, sexual well-being, and the operation. ResultsA total of 63 patients were analyzed. The PAAG group complained of more lumps or indurations (p = 0.004), benefited less from operations as for symptomatic relief (p = 0.002), and had more chronic inflammation(p = 0.000) than the silicone group. No breast cancer was found. All the Breast-Q scores were lower in the PAAG group than in the silicone group, and there was a significant difference in satisfaction with physical well-being (p = 0.035). Besides, patients without symptoms tended to score higher in all aspects of Breast-Q than patients with symptoms after removal. The two groups (symptom & no symptom) differed in psychosocial well-being (p = 0.043) and satisfaction with operation (p = 0.048). ConclusionsThe breast contour of patients after PAAG or silicone prosthesis removal was worse than before. Early removal of PAAG before complications arise may result in a better surgical benefit. There is no doubt that PAAG are harmful both physically and psychologically. All patients are suggested to have PAAG injections removed.

Tension-Free Vaginal Tape and Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: 3-Year Followup from a Randomized Clinical Trial.

We sought to determine whether polyacrylamide hydrogel (PAHG) is noninferior to tension-free vaginal tape (TVT) in the treatment of women with primary stress urinary incontinence (SUI). In this noninferiority trial, 223 women eligible for operative SUI treatment were randomized for TVT (110) or PAHG (113). Primary outcome was patient satisfaction and the noninferiority margin for the difference was 20%. Secondary outcomes were effectiveness and complications. At 3 years, 188 (84.3%) women attended the followup. The satisfaction score (visual analogue scale 0-100) median was 98.5 (IQR 90-100) in the TVT group and 90.0 (IQR 70-100) in the PAHG group, whereas a score ≥80 was reached in 87 (94.6%) and 65 (67.7%), respectively (difference 26.9%, 95% CI 16.7% to 36.8%). Thus, PAHG did not meet the noninferiority criteria set in our study. The cough stress test was negative in 88 (95.7%) of TVT patients vs 75 (78.1%) of PAHG patients (difference 17.5%, 95% CI 8.6% to 26.9%). Any peri- or postoperative complication before crossover between the groups was detected in 40 (43.5%) women in the TVT group and 23 (24.0%) women in the PAHG group (difference 19.5%, 95% CI 6.8% to 31.4%). In midterm followup, PAHG did not reach in patient satisfaction the noninferiority set in our study. Furthermore, mid urethral TVT slings show better subjective and objective cure rates than PAHG. However, complications were more often associated with TVT. Since the majority of PAHG treated women were also cured or improved, primary SUI women can be offered PAHG as a safe and durable alternative treatment.

Retracted: Polyacrylamide Hydrogel Injection for Breast Augmentation: Another Injectable Failure.

This publication has been retracted by the Editor as it erroneously describes the effects of an injectable polyacrylamide gel.Reference:Zhenxiang Wang, Shirong Li, Lingli Wang, Shu Zhang, Yan Jiang, Jinping Chen, Donglin Luo. Polyacrylamide Hydrogel Injection for Breast Augmentation: Another Injectable Failure. Med Sci Monit, 2012; 18(6): CR399-408. DOI: 10.12659/MSM.882910.

A PROSPECTIVE STUDY OF POLYACRYLAMIDE HYDROGEL FOR KNEE OSTEOARTHRITIS: RESULTS FROM 2 YEARS AFTER TREATMENT

Purpose: In previous clinical studies intra-articular injection of polyacrylamide hydrogel (Arthrosamid®) has been investigated using 2 injections of 3 ml separated by a month. The primary objective of this study was to evaluate the efficacy and safety of a single injection of 6 ml intra-articular Arthrosamid on knee symptoms in participants with moderate to severe knee OA. The study has been extended to evaluate the long-term efficacy and safety of Arthrosamid for up to 5 years after treatment.

ONE-YEAR PERFORMANCE OF POLYACRYLAMIDE HYDROGEL VS. HYALURONIC ACID: A RANDOMISED CONTROLLED STUDY

Purpose: To compare the effectiveness of one intra-articular injection of polyacrylamide hydrogel (Arthrosamid®) with that of one injection of hyaluronic acid (Synvisc-One®) in a randomised controlled study.

ONE-YEAR PERFORMANCE OF POLYACRYLAMIDE HYDROGEL VS. HYALURONIC ACID IN AGE, BMI AND KELLGREN-LAWRENCE SUBGROUPS: A SUBGROUP ANALYSIS OF A RANDOMISED STUDY

Purpose: To compare the effectiveness of one intra-articular injection of polyacrylamide hydrogel (Arthrosamid®) with that of one injection of hyaluronic acid (Synvisc-One®) in subgroups of participants based on age, BMI or Kellgren-Lawrence (KL) grade at baseline by assessing changes from baseline in transformed WOMAC pain subscale scores (0-100 score where 100 was worst).

Breast Augmentation with Autologous Fat Grafting Immediately after Removal of Polyacrylamide Hydrogel and Fibrotic Capsule in 162 Patients

Objective: In this study, we investigated the feasibility and efficacy of immediate breast augmentation with autologous fat grafting after removal of polyacrylamide hydrogel (PAAG) and fibrotic capsule. Methods: A retrospective study was conducted on 162 female patients who underwent removal of breast filler PAAG and the fibrotic capsule which produced after injection of PAAG via areola omega-shaped incision. Then autologous fat grafting was immediately performed evenly and radially around the areola via the same incision into different layers (subcutaneous, submammary tissue, pectoralis major intramuscular, and inferior pectoralis major space) except the empty cavity. The cavity left by removal of PAAG and fibrous capsule was closed with negative pressure drainage tube and slight external pressure. Results: All patients recovered well without severe complications. The average score of postoperative satisfaction with physical well-being: chest was 99.83 (total score: 100) compared with the average satisfaction score of 71.69 (total score: 100) preoperatively by means of BREAST-Q™ evaluation (p < 0.01). All patients were satisfied with their postoperative breast shape. Conclusions: Removing as much as possible is critical for patients who underwent the PAAG injection. Our experience in immediate breast augmentation with autologous fat grafting after removal of PAAG and fibrotic capsule proved useful and effective to maintain the balance between removing the PAAG as much as possible and retaining soft tissue to reshape breasts. Level of Evidence: IV.

Remote migration of breast filler to the inguinal area: a case report

Polyacrylamide hydrogel (PAAG) is an injectable material for breast augmentation that was developed in the 1980s. It was widely used until the 2000s, but subsequently lost its popularity due to high complication rates. In this case report, we share our experience of a patient complaining of hard and asymmetric breasts who had received PAAG injections 7 years ago. Surprisingly, we found that the filler in the left breast had migrated to the left inguinal area. Although breast fillers have lost ground in recent years, we think that long-term complications of fillers, as observed in this case, will still arise in the future. Therefore, young plastic surgeons who do not have direct experience with this material should be aware of its possible complications.

Comparing risk of repeat surgery for stress urinary incontinence after mid‐urethral slings and polyacrylamide hydrogel

Over the last two decades synthetic mid-urethral slings (MUS) have become established as the main surgical method for correcting stress urinary incontinence (SUI). However, transurethral injections with polyacrylamide hydrogel are gaining popularity. We used surgical codes from a national registry to explore potential differences in risk of later surgery for SUI comparing retropubic slings, obturator slings, and polyacrylamide hydrogel injections. This cohort study used surgical codes from The Norwegian Patient Registry. All women recorded as having had surgery for SUI coded as retropubic sling, obturator sling, or polyacrylamide hydrogel injection from 2008 until end-of-study censoring in 2017, were included. Main outcome was time to any recorded new SUI procedure later in the study period. Unadjusted comparison between groups was done using Kaplan-Meier. A Cox regression analysis was then performed to adjust for hospital unit size and patient age at surgery. The unadjusted analyses showed significant differences between the chosen index method and the risk of later SUI surgery favoring retropubic slings (p<0.01). The proportions of patients without any recorded new SUI procedure at 1 and 5years were 99.3% and 97.7% for retropubic MUS, 98.7% and 96.1% for obturator MUS, and 82.7% and 72.4% for polyacrylamide hydrogel injections. The majority of women having a repeat procedure for SUI after a polyacrylamide hydrogel injection underwent repeat treatment within 1year (63%). After adjusting for age at time of surgery and hospital size, obturator slings (hazard ratio 1.8, 95% CI 1.4-2.4) and polyacrylamide hydrogel (hazard ratio 23.1, 95% CI 17.6-30.3) remained associated with a higher risk of later incontinence surgery. Both retropubic and obturator slings have low long-term risks of repeat incontinence surgery compared with polyacrylamide hydrogel injections. Retropubic slings were found to have superior longevity of the surgical result.

The comparative analysis of MRI data in the early period after lumbar microdiscectomies with epidural injection of polyacrylamide hydrogel

Objective: To perform a comparative analysis of MRI data obtained in the early postoperative period after repeated lumbar microdiscectomies in patients with and without epidural injection of “Nubiplant” polyacrylamide hydrogel (HG). Material and methods: The MRI data of the lumbar spine in the early postoperative period after repeated removal of herniated disc (on the 3-15th day) in 84 (100%) patients were analyzed: 30 (35,7%) patients were injected intraoperatively epidurally with “Nubiplant” HG to prevent epidural fibrosis (main group (MG) and in 54 (64,3%) patients the HG was not injected (control group (CG). Results: Comparative analysis of MRI data on the 3-15th day after surgery showed that the frequency of epidural edema and hemorrhage signs within the postoperative area in the MG was significantly lower as compared to the CG (p = 0,0444 and p = 0,0288 respectively). To assess the accuracy of the epidural administration of an artificial biopolymer Nubiplant during lumbar microdiscectomy, in the early postoperative period the following MRI criteria could be helpful: i) absence of the dural sac deformation and dislocations of the spinal root; ii) well-defined margin of the adjacent spinal root; iii) homogeneous MRI signals of the Nubiplant zone; iv) absence of Nubiplant areas outside the postoperative area; v) sufficient sectoral coverage of the adjacent root with epidurally administered Nubiplant (optimally &gt;1800). Nubiplant” HG in the patients of the MG was evaluated, and MRI criteria for assessing the correctness of its introduction were proposed. Conclusions: In the early period after repeated lumbar microdiscectomies (on the 3-15th day), intraoperative epidural injection of “Nubiplant” HG was accompanied by a significant decrease of epidural edema and hemorrhage signs within the postoperative area. The proposed criteria of correctness of HG “Nubiplant” introduction allow unifying the approaches in radiological assessment of this patients.

Polyacrylamide hydrogel injection for knee osteoarthritis: results of a 52 week prospective study

Purpose: Intra-articular (IA) injection of polyacrylamide hydrogel (PAAG) has been suggested as a possible treatment for symptomatic osteoarthritis (OA). Previously IA PAAG has been investigated using 2 injections of 3 ml separated by a month. The primary objective of this study was to evaluate the efficacy and safety of a single injection of 6 ml intra-articular PAAG on knee symptoms in participants with moderate to severe knee OA.

Polyacrylamide Hydrogel Injection for Knee Osteoarthritis: A 6 Months Prospective Study

Objective: Intra-Articular (IA) injection of polyacrylamide hydrogel (PAAG) is a possible treatment for symptomatic Osteoarthritis (OA) of the knee. This study evaluated the efficacy and safety of a single injection of 6 ml intra-articular PAAG over 26 weeks. Methods: Open-label study in patients with symptomatic and radiographically confirmed knee OA . Primary outcome was change in WOMAC pain after 13 weeks. Secondary outcomes were WOMAC stiffness and function subscales, Patient Global Assessment of disease impact (PGA) and proportion of OMERACT-OARSI responders. Follow-up time points were 4, 13 and 26 weeks. Results: 49 patients (31 females) received PAAG, with 48 patients completing the 13 and 46 the 26 weeks assessments. Mean change in WOMAC pain after 13 weeks was -18.3 points [95% CI-23.4 to -13.3]; P<.0001 and at 26 weeks -20.8 points [95% CI -26.3 to -15.3]; P<0.0001 with similar benefits for WOMAC stiffness, physical function, and PGA. After 13 weeks 64.6% were OMERACT-OARSI responders and this was maintained at 26 weeks.. During the 13 weeks, 18 patients reported 23 adverse events, 13 of which were related to PAAG, none severe. Two serious adverse events, atrial fibrillation and gastrointestinal pain, were assessed as ‘not related’ to PAAG. Conclusions: PAAG can be delivered in a single 6 ml injection and this non-randomized trial in patients with knee OA demonstrated beneficial clinical effects at 13 and 26 weeks. No serious adverse events were seen with PAAG. These encouraging results need to be confirmed in controlled studies.

Breast augmentation complications following polyacrylamide hydrogel injection and fat grafting: Clinicopathologic report of 2 cases

Breast augmentation complications following polyacrylamide hydrogel injection and fat grafting: Clinicopathologic report of 2 cases