Polyacrylamide Hydrogel Injection Research Articles

Unacceptable Results with an Accepted Soft Tissue Filler: Polyacrylamide Hydrogel

All injectable volumizing agents and fillers may be associated with immediate or delayed complications (overall rate, \1%) [1]. The complication rate is directly related to the technique of injection as well as to the properties of the injected material. With increased persistence of the material, the possibilities of serious complications become more dependent on the inherent physiochemical characteristics of the material rather then on those of the injection technique. Polyacrylamide is used for protein separation in molecular biology [2]. The clinical use of polyacrylamide gel (PAG) as an injectable filler started as Interfall in the Ukraine in 1983. In small quantities, the gel is well tolerated and slowly absorbed by the body (t1/2, 20 years). Different preparations of polyacrylamide hydrogels have unique characteristics, although they all are a combination of a hydrophilic polyacrylamide and nonpyrogenic water. The PAGs discussed in the article by Manafi and colleagues have very different characteristics in terms of the gel concentration. Interfall (Interfall Ltd., Kiev, UA) is a hydrogel with a variable gel concentration of 3.5% to 9%. The latest PAG that has undergone PMA submission to the Food and Drug Administration (FDA) is Aquamid hydrogel [3], a consistent 2.5% cross-linked polyacrylamide gel manufactured by Contura (Denmark). Aquamid (Contura International, Switzerland) is a gel with a constant PAG concentration of 5%. When the safety profile and efficacy of an injectable material is evaluated, all of its unique characteristics must be discussed so an appropriate conclusion can be drawn. In the article by Manafi and colleagues, the patient basis was biased in the conclusion drawn. Only patients experiencing unsatisfactory results and complications of polyacrylamide hydrogel injections were included in their study. Three different preparations of PAG materials were included, yet the effect of the gel concentration on the complication rate was not discussed. An in-depth discussion on the relationship of the volume injected (200 ml/ breast for case 2 vs. 5 ml/lips for case 1) would have been welcome because our experience and clinical data in relation to permanent and semipermanent fillers supported it [1]. Although this article is of clinical interest, the conclusion drawn is not based on the data presented. Recent data [3, 4] from multicenter double-blind studies of 315 and 101 patients, respectively, have shown injections of polyacrylamide hydrogel for soft tissue augmentation at 12 and 24 months to be safe, efficacious, and without adverse soft tissue reactions. In the United States, PMA has submitted Aquamid hydrogel to the FDA.

Analysis and treatment of the complications caused by polyacrylamide hydrogel injection for augmentation rhinoplasty

Objective To analyze the causes and explore suitable treatments for the complica-tions induced by polyacrylamide hydrogel (PAHG) injection for augmentation rhinoplasty. Methods The causes of the complications of 52 cases who accepted PAHG injection for augmentation rhinoplas-ty were analyzed and summarized. All the patients were treated by surgical operations to remove the injected PAHG. Results The complications included infection, granuloma, skin ulceration, bad shape, pain and serious psychological stress. Each case had 1 to 4 complications. Satisfactory results were obtained after suitable treatments. Some cases had silicone or expanded polytetrafluoroethylene implant augmentation rhinoplasty at the same time or secondary to the PAHG removal. A few cases had sequelae and long time psychological stress or tend pain of nose. Conclusions The complications induced by PAHG injection for augmentation rhinoplasty are various, and may relate to the inherent character of PAHG and the anatomic features of the nasal soft tissue. Surgery can remove the PAHG as completely as possible, which is a better method to treat the complications of PAHG injection for augmentation rhinoplasty. Key words: Polyacrylamide hydrogel; Augmentation rhinoplasty; Complications

Complications from injectable materials used for breast augmentation

Fewer surgical procedures have a history as fascinating and as terrifying as breast augmentation. Initial efforts at augmentation involved injection of substances such as paraffin or oil into the breast tissue, or the implantation of substances including ivory or glass balls, or rubber. More recent efforts have included the injection of liquid silicone or polyacrylamide hydrogel. The current paper reviews four distinct eras of breast augmentation, and provides the current status of these injection materials. A case report is presented on a woman whose breasts were injected with polyacrylamide hydrogel in Iran. The current status of this group of materials is also presented. During the past 110 years, history has repeated itself during each of the four eras of injection.

Complications of polyacrylamide hydrogel (PAAG) injection in facial augmentation

Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation for more than a decade. In recent years, PAAG has been advocated as a safe soft tissue filler for facial augmentation. However, the complications associated with PAAG injection in facial augmentation have not been widely covered in the literature. We present two cases of severe complications associated with PAAG injection in facial augmentation, including bony erosion and facial ulcer. Further studies are required to support the safety of PAAG in facial injection.

Postoperative management of breast augmentation by polyacrylamide hydrogel injection:a report of 157 cases

Objeetive To discuss a reasonable postoperative management of breast augmentation by polyacrylamide hydrogel (PAHG) injection.Methods The retrospective study was used to analyze 157 cases which received breast augmentation by PAHG injection.MRI was used in all of cases preoperatively.Among these patients,23 were located by three-dimensional (3D) reconstruction,the content of mono acrylamide in the serum of 71 cases were examined in the hydrogel of 23 cases and in the tissue around the hydrogel of 12 cases,respectively.The silicone gel implants were planted after the removal of PAHG in 7 cases.Results MRI-3D could show the injectants location,scope,layer and integrality more intuitional and more detailed.The momo acrylamide was found in the serum with 7 cases,in the hydrogel with 5 cases,in the tissue around the hydrogel with 3 cases.131 cases gained satisfactory results.All the cases received 3 to 6 months follow-up.The scleroma was not found after the palpation of breast.In the 7 cases that were planted with the silicone gel implants immediately,the shape and texture of the breast were both great.Conclusions The preoperative MRI examination is a first-choice,and if possible,3D reconstruction is better.With the detecting methods so far,there is no strong evidence to support the possibility of PAHG resolving into poisonous acrylamide inside the human body.During the operation,the injectant,the integument around the hydrogel and degenerative tissue should be orthoptically cleared-up as much as possible.Sucking the injectant blindly is not commended.The silicon gel prosthesis is planted to reconstruct the shape of breast immediately,but the prerequisite is that the patients have this demand and that the muscle is intact without inflammation. Key words: Polyacrylamide hydrogel; Injection; Augmentation mammoplasty; Management

Breast Cancer Following Augmentation Mammaplasty with Polyacrylamide Hydrogel (PAAG) Injection

Polyacrylamide hydrogel (PAAG) as an implanted material for augmentation mammaplasty has been used for years in China. Many kinds of complications associated with PAAG use have been reported in the clinical literature. This report presents two cases of breast cancer occurring after injection of PAAG in augmented breasts. The delayed diagnosis and more aggressive disease due to PAAG injection should be cause for concern. It is very important to detect breast cancer early when it is covered by the induration of the injected gel and inflammation reaction after PAAG injection. PAAG injection for augmentation mammaplasty may affect the outcome of breast cancer diagnosis and prognosis.

A Late Complication of Augmentation Mammoplasty by Polyacrylamide Hydrogel Injection: Ultrasound and Magnetic Resonance Imaging Findings of Huge Galactocele Formation in a Puerperal Woman with Pathological Correlation

Polyacrylamide hydrogel (PAAG) was widely used for injection augmentation mammoplasty in Eastern Europe and China although uncommon in the western countries. However, the safety of this procedure remained controversial. Herein, we report a 30-year-old woman with a history of augmentation mammoplasty by PAAG injection developed galactoceles during her pregnancy. Ultrasound and magnetic resonance imaging showed huge cystic lesions in bilateral breasts; as a result, the normal breast tissue was almost completely replaced. On the basis of the imaging findings, the patient underwent mastectomy as well as immediate breast reconstruction with satisfactory outcome. It is important to be familiar with the imaging findings of this rare yet severe complication after augmentation mammoplasty in order to make an accurate diagnosis and a proper management.

Change of immunological response and cell proliferation in breast augmented by polyacrylamide hydrogel injection

Objective:To study the change of immunological response and cell proliferation in breast tissues augmented by polyacrylamide hydrogel injection(PHI).Methods:The expression of CD68,CD25 and PCNA in 20 breast tissues with indurations,12 without indurations after breast augmentation by PHI,and 10 normal breast tissues was examined by immunohistochemistry P-V6000; analysis was also done by H-E staining.Results:Hyperplasia of fibrous tissue and infiltration of inflammatory cells and macrophages were found in the breast and adjacent tissues 3-8 years after PHI.Positive cells of CD68,CD25 and PCNA hardly existed in the normal tissues,but the breast tissues around the polyacrylamide hydrogel had many positive cells of CD68 and PCNA,especially in cases with indurations;there were significant differences between the 3 groups(P0.01);and the numbers of cells positive of CD25 were similar between the 3 groups.Conclusion:Long-term implantation of polyacrylamide hydrogel can cause immunological reaction and cell proliferation in the local adjacent tissues.

Polyacrylamide Hydrogel Injection in the Management of Human Immunodeficiency Virus–Related Facial Lipoatrophy: A 2-Year Clinical Experience

Facial lipoatrophy is defined as the reduction in buccal and orbital fat pads along with a more global loss of fat within the subcutaneous tissue. It is the most common and distressing sign of human immunodeficiency virus-associated lipodystrophy. Injectable polyacrylamide hydrogel (Aquamid) is a synthetic nonbiodegradable polymer consisting of a minor backbone of 2.5 percent cross-linked polyacrylamide and 97.5 percent nonpyrogenic water and is used for cosmetic facial contour correction. Favorable results with maximum aesthetic gains with the use of polyacrylamide hydrogel for reconstruction of facial lipoatrophy on the face in significantly immunocompromised individuals are being reported. These results are attributable to its use in limited volume injected at multiple sites and in multiple sittings. Aquamid has been used for the correction of severe nasolabial folds and mid and lower facial volume loss in patients affected by human immunodeficiency virus-associated lipodystrophy. Fifty patients were enrolled and treated, with a mean follow-up of 13.1 months. Results were evaluated clinically, by standardized ultrasonography, and by psychological tests (visual analogue scale, Beck Depression Inventory, and Assessment of Body Change and Distress questionnaire) to quantify patient satisfaction. No significant side effects or issues such as swelling, infections, allergies, or nodule formation were noted over the follow-up period. Aquamid has provided a minimally invasive, effective, long-lasting facial contour correction that significantly improves the quality of life in human immunodeficiency virus-infected patients.

Analysis and treatment of complications following polyacrylamide hydrogel injection for breast augmentation

目的 探讨注射聚丙烯酰胺水凝胶(polyacrylamide hydrogel,PAH)隆乳术后各种并发症的发生原因、处理原则及操作方法.方法 对41例55只乳房注射PAH隆乳术后出现并发症的患者进行分类、处理、总结和分析;对要求同期隆乳者,行硅凝胶假体置入术.结果 注射隆乳术后感染的5例患者,均在治疗2～3周后,炎症消退,引流切口愈合,随访6个月至2年未再复发.24例无感染仅行取出PAH者,无1例出现继发性感染,但单纯抽吸PAH者22%仍有缩小的硬结;手术取出者无1例出现硬结,无感染.要求同时行隆乳者12例,术后随访6个月至2年,手感和外形均较满意,无感染和硬结等.结论 注射隆乳术后并发症的处理,以手术取出PAH为主,根据PAH的层次、范围、是否有包膜等决定手术的方式。

Efficacy and Safety of Polyacrylamide Hydrogel for Facial Soft-Tissue Augmentation in a 2-Year Follow-Up: A Prospective Multicenter Study for Evaluation of Safety and Aesthetic Results in 101 Patients

Polyacrylamide (Aquamid) is a nonabsorbable soft-tissue filler. It consists of a polyacrylamide hydrogel. Safety and aesthetic results after injection of polyacrylamide hydrogel for facial soft-tissue enhancement were analyzed in a clinical trial. In a prospective multicenter study, 251 patients were enrolled for injection of polyacrylamide hydrogel (Aquamid). The results of the first year follow-up have been described previously. One hundred one of 251 initially enrolled patients could be recruited for follow-up 24 months after the first injection. Standardized photographs were taken, and blood and urine samples were collected before treatment and during follow-up visits. Common sites of injection were nasolabial folds, lips, glabella folds, and other sites. The amount of injected gel ranged from 0.2 to 12 ml. A course of 24 months was followed in 101 patients. Results were judged to be good or very good by the investigators in 93 patients. Eighty-six patients judged the aesthetic outcome as satisfactory or very satisfactory. No severe side effects were observed during the 2-year follow-up period. Transient local reactions that resolved spontaneously were detected in several patients. In one case, burning sensations after lip augmentation were reported lasting up to the 24-month follow-up visit. Polyacrylamide hydrogel (Aquamid) yielded satisfying aesthetic results in more than 90 percent of patients. There was no difference in efficacy between 12 and 24 months' follow-up. No adverse soft-tissue reaction was observed. The study group may be biased, as patients with bad results may have refrained from further follow-up. Long-term follow-up is necessary.

Late Complications After Polyacrylamide Hydrogel Injection into Facial Soft Tissues

Late Complications After Polyacrylamide Hydrogel Injection into Facial Soft Tissues

Commentary on “Late complications after application of polyacrylamide hydrogel” by Evstatiev

This paper is a summary of different complications noted after injections of polyacrylamide hydrogel into different parts of the human body; these were all performed by doctors in other countries or institutions. Unfortunately, there is a total lack of anamnestic data. The paper does not give any information on who administered the injection or where the injections had been placed or how many injections had been given originally. It is essential to know the origin of the gel, its sterility, and the conditions under which the gel was originally injected. There are no pre-injection or even pre-complication photos and no information on indications for the injection. It would also be important to know how many times the patients with these complications had been injected at the same site and if these injections had been performed under pressure. The success of the result after gel injection is totally dependent on the physician who uses it; this is borne out by the finding of pathogenic microorganisms in seven cases.

Efficacy and Safety of Polyacrylamide Hydrogel for Facial Soft-Tissue Augmentation

Polyacrylamide is a nonabsorbable soft-tissue filler that has been used for body contouring for more than 10 years. Aquamid is a soft-tissue filler containing polyacrylamide hydrogel. Safety and aesthetic results after injection of polyacrylamide hydrogel for facial soft-tissue enhancement were assessed at a 1-year follow-up. In a prospective, multicenter study, 251 patients were enrolled and assigned for injection of polyacrylamide hydrogel (Aquamid) as a means of facial augmentation and enhancement of facial contours. Subjects with facial contour deformities or soft-tissue deficiencies caused by aging, acne, trauma, surgery, or other causes were included. Persons presenting with connective tissue disorders, skin disorders affecting the face, uncontrolled diabetes mellitus, compromised immune functions or acute inflammatory diseases, known substance abuse, or mental disorders were excluded from participation in the study, as were those who had experienced treatment with any nonabsorbable filler within 6 months before the start of the study. To assess the safety and efficacy of the treatment, follow-up visits were scheduled for day 7, day 28, and 3 months, 6 months, and 12 months after the first injection. Standardized photographs were taken before treatment and during month-3 and month-12 visits. Blood and urine samples were collected and analyzed before injection and at 6 and 12 months after injection. The most common sites of injection were the nasolabial folds (48 percent) and lips (25 percent) followed by glabella folds (8 percent) and other sites. The amount of injected gel ranged from 0.2 to 12 ml. Two hundred twenty-eight patients were followed for 12 months after treatment. In 93 percent, results were judged to be good or very good by the investigators and satisfactory or very satisfactory by the patients. Adverse events that could be ascribed to the treatment were observed in 37 cases, most commonly presenting as transient swelling, hematoma, redness, and pain or itching. In one case, a slight change of skin color at the site of injection was reported. No severe adverse events related to the gel were observed. In one case, neutropenia was detected in month-12 blood samples. The other values were within the normal ranges. Aquamid is an easy-to-use soft-tissue filler. The effect of tissue enhancement lasted over the entire study period. Transient local tissue reactions observed were attributable to the injection procedure rather than the chemical properties of the gel. During the first year after treatment, no permanent soft-tissue reaction was observed. Long-term results need to be evaluated in the future.

Comparison of Three Different Interventions for the Correction of HIV-Associated Facial Lipoatrophy: A Prospective Study

To compare autologous fat transfer (AFT), injections of reabsorbable [polylactic acid (PLA)] and non-reabsorbable [polyacrylamide hydrogel (PAAG)] filler materials for the treatment of HIV-related facial lipoatrophy. Eligible individuals with enough residual subcutaneous fat in the abdomen or in the dorso-cervical region were offered AFT surgery. Other individuals were blindly assigned to two different surgical teams, who administered a set of PLA or PAAG injections every 4 weeks. The primary endpoint was the measurement of Bichat's fat pad region, determined by the result of dermal plus subcutaneous thickness. Secondary endpoints included body image evaluation (determined by ABCD questionnaire), facial aesthetic satisfaction (determined by Visual Analogue Scale), and aesthetic pre- and post-picture comparisons by independent reviewers. All variables were measured at baseline and at 24 weeks after the last treatment session. Twenty-four individuals received AFT and 35 were selectively randomized to PLA (20) or PAAG (15) infiltrations. PLA and PAAG groups received a mean of 5 and 6 injections respectively (P = NS). The mean change in dermal and subcutaneous thickness was 3.3 +/- 4.1 mm, 3.5 +/- 4.0 mm; 2.1 +/- 3.0 mm (P = 0.687), respectively. The mean change in ABCD score result was poorer in the AFT arm, but there were no other differences in other measured factors. Four serious adverse events were documented in the AFT arm only. All three interventional techniques were highly effective in improving the aesthetic satisfaction of the patients. Longer follow-up is necessary to determine the most durable and suitable treatment.

Adverse Reactions to Injectable Soft Tissue Permanent Fillers

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? 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. 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. 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.

A study on patients treated with polyacrylamide hydrogel injection for facial corrections.

Polyacrylamide hydrogel (PAAG) has been used as a tissue filler in facial corrective surgery and for breast augmentation in Kiev, Ukraine, for more than 10 years with reportedly very good results. These results, however, have not been published in peer-reviewed journals. A Danish/Swedish group of plastic surgeons with special interest in facial corrective surgery did a retrospective, systematic, pre-planned investigation of 104 patients treated at the center in Kiev. All data were entered into a pre-programmed database for data processing. The mean age of this population was 37.4 years and the mean time since the gel injection was 3.9 years. An average of 5.7 ml of PAAG was injected prior to the investigation. The gel was well tolerated and assessment of the outcome was judged to be very good by 78% and good by 22%, by both physicians and patients. It is concluded that PAAG is well tolerated and seems to be a promising product for facial corrective surgery. Currently, the product (Aquamid) is being studied in several prospective clinical trials, one of which is completed and in the process of preparation for publication.