Clinical Studies

Aquamid® Clinical Studies – Aesthetics

Effect of prophylactic antibiotics on polyacrylamide gel safety in facial augmentation

Polyacrylamide hydrogel has in the last decade gained popularity as an injectable filler for facial augmentation due to its features of non-toxicity, biocompatibility, safety profile, and immediate effect. However, as all types of injections carry the risk of infection and since the polyacrylamide hydrogel is a non-degradable implant, the possibility of bacterial biofilm formation exists. Theoretically, the risk of infection and subsequent biofilm formation can be avoided by using prophylactic antibiotic treatment prior to the time of injection.

METHOD
This retrospective study of outcomes following polyacrylamide hydrogel injections includes 657 subjects from one centre, which had facial injections from 2001 and 2011. Until 2007 prophylactic antibiotics were not given prior to treatment, but in September 2007 a single oral dose of azithromycin (Zitromax) and moxifloxacin (Avelox) was introduced as prophylactic antibiotics. A total of 496 subjects were injected before 2007 without antibiotic prophylactic treatment, and 161 subjects received these two antibiotics prior to treatment from September 2007.

RESULTS
The prophylactic antibiotics (azithromycin and moxifloxacin) significantly reduced the incidence of clinical signs of inflammation/infections from 7 to 2% (P=0.03).

CONCLUSION
Even though the incidence of inflammation/infections following injection of polyacrylamide hydrogel is relatively low, it may be reduced further by using prophylactic antibiotic treatment. Based on our experience, we recommend prophylactic antibiotics to patients who have facial augmentation with polyacrylamide hydrogel in order to avoid infection and risk of biofilm formation due to contamination during injection with naturally occurring micro flora from skin and lips.

Published in J Drugs Dermatol. 2014 May;13(5):571-3 by Nygart JF, Nygart VA, Borggren M, Tvede M.

Bacterial biofilm formation and treatment in soft tissue fillers

Injection of soft tissue fillers plays an important role in facial reconstruction and esthetic treatments such as cosmetic surgery for lip augmentation and wrinkle smoothening. Adverse events are an increasing problem, and recently, it has been suggested that bacteria are the cause of a vast fraction these. We developed a novel mouse model and evaluated hyaluronic acid gel, calcium hydroxyl apatite microspheres, and polyacrylamide hydrogel for their potential for sustaining bacterial infections and their possible treatments. We were able to culture Pseudomonas aeruginosa, Staphylococcus epidermidis, and Probionibacterium acnes in all three gels. When contaminated gels were left for 7 days in a mouse model, we found sustainment of bacterial infection with the permanent gel, less with the semi-permanent gel, and no growth within the temporary gel. Evaluation of treatment strategies showed that once the bacteria had settled (into biofilms) within the gels, even successive treatments with high concentrations of relevant antibiotics were not effective. Our data substantiate bacteria as a cause of adverse reactions reported when using tissue fillers, and the sustainability of these infections appears to depend on longevity of the gel. Most importantly, the infections are resistant to antibiotics once established but can be prevented using prophylactic antibiotics.

Published in Pathog Dis. 2014 Apr;70(3):339-46. doi: 10.1111/2049-632X.12139. Epub 2014 Feb 18 by Alhede M1, Er Ö, Eickhardt S, Kragh K, Alhede M, Christensen LD, Poulsen SS, Givskov M, Christensen LH, Høiby N, Tvede M, Bjarnsholt T.

A 5-year Assessment of Safety and Aesthetic Results after Facial Soft-Tissue Augmentation with Polyacrylamide Hydrogel (Aquamid): A prospective Multicenter Study of 251 patients

5-year European multi-centre prospective study evaluating the safety and aesthetic outcome of Aquamid® for facial soft tissue augmentation. 251 patients enrolled in the initial study, and 116 patients completed the 60-month follow-up. More than 90% of the aesthetic results were assessed as good/very good by investigators and more the 90% of aesthetic results were judged as satisfying/very satisfying by patients.

Published in Dermatol Plast. Reconstr. Surg. 125, issue 6, 1797-1804 (2010) by Pallua N and Wolter T.
Click to download study abstract.

Prospective multicenter study for evaluation of safety, efficacy, and esthetic results of cross-linked polyacrylamide hydrogel in 81 patients 48 month follow-up

This article is the 36-48-month follow-up study on patients from the prospective European multicenter study of 251 patients injected with Aquamid® for facial soft-tissue augmentation. Eighty-one patients were assessable for follow-up. The amount of injected gel ranged from 0.2 to 12 ml. No serious adverse events were detected. The efficacy at 3 and 4 years was similar to 12 and 24 month data with very high patient and investigator satisfaction. Thus, Aquamid® used for facial soft-tissue augmentation appears to be safe and show long-term effect and no loss of filler effect.

Published in Dermatol Surg. 35, 2009 Suppl 1:338-43 by Wolters M and Lampe H.
Click here to download study abstract.

Utilization of Aquamid as a filler for rhinoplasty in Orientals

A short article which described 1,816 Orientals treated with non-surgical rhinoplasty (nose surgery) using Aquamid®. An average of 2.1 ml of Aquamid® was injected (range: 1-5 ml). Patients were followed for 2-3 years and possible complications reported. Complications were one case of infection and one case of transient ischemic change that resolved within two weeks. No allergic or granuloma lesions were observed. It was concluded that Aquamid® was a safe treatment. No efficacy data were reported.

Published in Plast Reconstr Surg. 123:26e-28e, January 2009 by Yagi Y, Kato K, et al.

Use of Aquamid as a filler for facial rejuvenation in Orientals

A prospective study of 4822 Orientals receiving Aquamid® for facial augmentation; the majority (54%) received rejuvenation of the nasolabial folds. The injected volume of Aquamid® ranged from 1-6 ml. Patients were followed up to four years: 45% was followed less than a year, 31% for 1-2 years, 17% for 2-3 years and 6% for more than three years. Possible complications were recorded. Complications were mainly infectious and no allergic reactions and no granuloma lesions were observed. Usage of Aquamid® was concluded to be safe. No efficacy data was reported.

Published in J Plast. Reconstr. Surg. 123: 26e – 28e (2009)

Voice outcomes of polyacrylamide hydrogel injection laryngoplasty

A study on 16 patients with permanent unilateral vocal cord paralysis, who were injected with Aquamid, through the cricothyroid membrane directly into the vocalis muscle. The mean volume injected into each patient was 0.85 ml (range 0.4 –1.2ml).
Follow-up was carried out 6 and 12 months post injection and clinical/functional outcomes as well as possible side-effects were recorded. It was concluded, that PAAG is an easily injectable, convenient and useful method for improvement of voice and voice-specific quality of life with no serious adverse effects.

Published in Laryngoscope 2007 Oct; 117(10):1871-5 by Lee SW et al.

Normal and Pathologic Tissue Reaction to Soft Tissue Gel Fillers

The study is based on observations during 6.5 years from experimental/ clinical studies and biopsies from adverse reactions. Adverse reactions include bacterial infection for the hydrophilic gels and fibrous granuloma for all other gel types. Infectious nodules must be treated with antibiotics. Granulomas must be treated with a combination of both steroids and antibiotics or excision.

Published in Dermatologic Surgery 2007; 33:S168-S175 by Lise Christensen
Click here to download study abstract.

Efficacy and Safety of Polyacrylamide Hydrogel (Aquamid) for Facial Soft Tissue Augmentation

The 24-month follow-up results of the prospective, multi-centre study of Aquamid® conducted in six European countries with 101 patients. The investigators judged the aesthetic results of 92% of the patients to be good or very good, and 91% of the patients were either satisfied or very satisfied with the aesthetic results. No severe side effects were observed during the 24-month follow-up period.

Published in Plastic Reconstructive Surg., Vol 118, 2006 by von Buelow S. & Pallua, N.
Click to download study abstract.

Adverse reactions following injection with a permanent facial filler, Polyacrylamide hydrogel (Aquamid) causes and treatment

A prospective study of case reports presenting 55 patients with adverse events following injection with Aquamid® out of app. 40,000 patients over a period of two years and four months. Adverse events presenting clinically as nodules or swelling later than one week and less than one year after the injection with Aquamid® should be suspected as low-grade infections and be treated immediately with a broad-spectrum antibiotic in high dosage.

Published in European Journal of Plastic Surg. 28, 2006 by Christensen, L., Breiting, V., Vuust, J. & Hogdall, E.
Click to download study abstract.

Rhinoplasty using injectable polyacrylamide gel – a patient study

A 12-month pilot study of injectable rhinoplasty with Aquamid® as a suitable alternative to conventional surgery for nasal correction.  89 patients were treated. The study concluded that Aquamid® is an ideal alternative for those patients whose noses do not require extensive remodelling. The injection of Aquamid® was found to be a highly acceptable alternative to conventional rhinoplasty.

Published in Australian Journal of Cosmetic Surg. Vol. 1, 2005 by Dr. Le
Click to download study abstract.

Adverse Reactions to Injectable Soft Tissue Permanent Fillers

The study showed that late inflammatory nodules are not seen after injection with Aquamid® due to a constant gel/host water exchange thus preventing the formation of a biofilm.

Published in Aesthetic Plastic Surgery, 2005 by Lise Christensen et al.

Evaluation of the Aesthetic Results of Facial Corrective Plastic Surgery with Aquamid, Brazil

129 patients in 13 centres were followed for 6 months after injections with Aquamid®. 99% of the patients achieved the highest score of the satisfaction scale. The final aesthetic results were stable over time with a very high patient satisfaction (100%) and surgeon evaluation (99%).

Presented at several congresses, Investigators: Odo, M. & Accursio, C.
Click to download study abstract.

Evaluation of the Aesthetic Results of Facial Corrective Plastic Surgery with Aquamid, France

An analysis of the short- (up to 3 months) and medium-term (up to 12 months) aesthetic results of facial soft tissue augmentation with Aquamid® in 68 patients.  After one year surgeon evaluations achieved the highest score in more than 90% of the patients, and more than 90% of the women were satisfied/very satisfied with their treatment. No serious adverse events were reported.

Published in Semin Cutan Med Surg. 23, 2004 by Trevidic, P
Click to download study abstract.

A Study on Patients Treated with Polyacrylamide Hydrogel Injection for Facial Corrections

A retrospective study of 104 patients treated with Polyacrylamide Hydrogel (PAAG) for aesthetic facial corrections. 96 patients were included in the overall analysis. All examinations demonstrated that PAAG was very well tolerated and effective for facial augmentation. The examination took place up to 9 years after the facial correction, thus PAAG is a safe and durable product for aesthetic facial corrections.

Published in Aesthetic Plastic Surg. 28, May 2004 by Breiting, V, Aasted, A, Jorgensen, A, Opitz, P & Rosetzsky, A
Click to download study abstract.

Experience with a New Non-Biodegradable Hydrogel (Aquamid): A Pilot Study

Aquamid® was evaluated in 59 patients for aesthetic facial corrections. All patients were satisfied with the results at the 9-month follow up and no long-term side effects were observed. The patients were also satisfied with the consistency and the elasticity of the treated area.

Published in Aesthetic Plastic Surg. 27, Sept/Oct 2003 by de Cassia Novaes W. & Berg, A.
Click to download study abstract.

Aquamid® Clinical Studies – Facial Lipoatrophy

Four-year safety with polyacrylamide hydrogel to correct antiretroviral-related facial lipoatrophy

A retrospective, single center study of 145 HIV+ patients with anti-retroviral related facial lipoatrophy. The patients were treated with Aquamid®– injected three weeks apart. The mean cumulative injected volume was 5.5 ml per patient ranging from 4 to 18 ml.  The mean follow-up time was 50.2 months and clinical outcome and possible complications were recorded. Only one serious adverse event was reported among the 145 patients; a local infection occurring 32 months after injection that was resolved after 15 days with appropriate antibiotic treatment and removal of the product. The most common observed side effect was small palpable non-visible nodules but with an incidence smaller or similar to studies with shorter follow-up time. Aquamid® was concluded to be safe and having long-lasting effect for HIV+ patients with retroviral related facial lipoatrophy.

Published in AIDS Res Hum Retroviruses. 25:451-5 (2009) by Negredo E, Puig J, et al.
Click here to download study abstract.

Polyacrylamide Hydrogel Injection in the Management of Facial HIV-Related Lipoatrophy: A Two Year Clinical Experience

A study to evaluate the efficacy of Aquamid® injections up to a 24 months period and to demonstrate an improvement in the quality of life of HIV infected patients. Furthermore to determine the long-term tolerance, durability and safety of polyacrylamide injections. At present, aesthetic procedures represent by far the best possible solution to minimize the psychological effects of this complex metabolic syndrome. Aquamid provided a minimally invasive, effective, long-lasting facial contour correction that significantly improved the quality of life in HIV infected patients.

Published in Plastic and Reconstructive Surg. 121, Feb 2008 by De Santis, G. et al.
Click to download study abstract.

Lipodystophy and its impact on Health-Related Quality of Life

Clinical experience suggests that lipodystrophy can have a profound influence on health related quality of life. Facial correction is a necessary option for the treatment of HIV-related lipoatrophy and should be considered as an integral part of the management of patients with HIV infection.

Published in European Infectious Disease, 2007 by Giovanni Guaraldi

Long-Term Psychometric Outcomes of Facial Lipoatrophy Therapy: Forty-Eight-Week Observational, Nonrandomized Study

299 were followed for 48 weeks. All Patients were treated with either autologous fat, polylactic acid or polyacrylamide. The study showed a statistically significant improvement in facial aesthetic satisfaction and psychosocial life in all patients.

Published in AIDS PATIENT CARE and STDs, 2007 by G Orlando et al.

Reconstructive Treatment for Antiretroviral – Associated Facial Lipoatrophy: A Prospective Study Comparing Autologous Fat and Synthetic Substances

A study of 105 HIV+ patients injected with Aquamid, 8 injected with autologous fat and 15 with poly-lactic acid at 48 weeks follow-up. Similar results in regard to patient satisfaction and quality of life were observed for all 3 fillers, but Aquamid gel provided the best and longest lasting filling effect. No serious adverse events were detected with any of the substances.

Published in AIDS PATIENT CARE and STDs, Volume 20, Number 12, 2006 by Negredo E, Higueras C, et al.

Comparison of three different interventions for the correction of HIV-associated facial lipoatrophy: a prospective study

The objective was to compare autologous fat transfer, injection of reabsorbable (polylactic acid) and non-reabsorbable (polyacrylamide hydrogel (Aquamid)) filler materials for the treatment of HIV-related facial lipoatrophy. 59 patients were followed for 24 weeks. Four serious adverse events were reported in the autologous fat transfer group. All three interventional techniques were highly effective in improving the aesthetic satisfaction. Longer follow-up is necessary to determine the most durable and suitable treatment.

Published in Antiviral Therapy 10, 2005 by G Guaraldi et al.

The Utilisation of Polyacrylamide Gel in the Recovery of Volume in Patients with Facial Lipodystrophy – A Clinical and Histological Study

A study to evaluate volumetric correction of the loss of face fat provoked by the intake of antiviral medication used in HIV positive patients and to analyse histologically the impact of implantation of Aquamid® into the subcutaneous tissue. Aquamid® proved safe for facial application, allowing the correction of large areas which had suffered from considerable loss of facial volume. After one year of evaluation the result remained stable, providing the patients with an improvement of their self-esteem.

Published in Revista Official da SBME, May 2003 by Tariki V., Uip D., Falzone R
Click to download study abstract.