Ten-Year Safety with Polyacrylamide Gel Used to Correct Facial Lipoatrophy in HIV-Infected Patients

Abstract

Long-term results (>5 years) for synthetic substances used to repair facial lipoatrophy have not been published. We performed a cross-sectional study to evaluate the 10-year safety of polyacrylamide hydrogel (Aquamid) among the 751 patients from our unit who received facial infiltrations at least 10 years ago. Epidemiological and clinical data such as complications and patient satisfaction were collected. We also identified those patients who presented a facial infection at any time after infiltration. A total of 104 patients had received Aquamid at least 10 years ago. Before infiltrations, 24.0%, 41.3%, and 34.7% presented very severe, severe, and moderate facial lipoatrophy, respectively. After a mean (SD) of 10.3 (0.5) years since the infiltrations, 19.2%, 47.7%, and 31.7% of patients reported moderate, mild, and no signs of facial lipoatrophy. The values reported by physicians for the same categories were 1.9%, 10.6%, and 87.5%. Indurations were detected in 6.7% of patients and nodules in 3.8%. Five patients (4.8%) had a local infection. A further 15 patients with a shorter follow-up (less than 10 years) presented local infections (overall incidence considering the 751 patients who received infiltrations of Aquamid, 2.7%); the product had to be withdrawn in three cases. The majority of patients were highly satisfied (74.8%) or satisfied (23.4%) with the cosmetic results; among patients with severe or very severe lipoatrophy at baseline, 31.4% were satisfied and 65.7% were highly satisfied. Infiltrations with polyacrylamide hydrogel (Aquamid) are a safe strategy for the treatment of facial lipoatrophy in the long term. The rate of severe complications was low, and patient satisfaction with the cosmetic results was high. However, facial infections may appear in the long term. Therefore, HIV-infected patients who received synthetic substances should be carefully monitored over time.

Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid®) in the management of stress and mixed urinary incontinence: three year follow up outcomes

“…The other important message from our study is the lack of any reported adverse reactions, indicating the inert nature of PAHG. This good safety profile has been replicated in other studies describing the use of PAHG as a periurethral bulking agent and in its use in other specialities [ 7 , 19 – 22 ]. The durability of PAHG is further backed up by the work of Mouritsen et al who found that PAHG deposits were still visible on vaginal ultrasound in eleven patients eight year post injection [ 23 ].…”

“…Polyacrylamide hydrogel (PAHG) Bulkamid ® is a sterile gel consisting of 2.5% cross-linked Polyacrylamide and 97.5% non pyrogenic water [ 4 ]. PAHG has been used extensively in plastic surgery and has been shown to be biocompatible, non- toxic, and non- resorbable [ 5 , 6 , 7 ]. PAHG was subsequently introduced as a promising periurethral bulking agent by Lose et al in 2006 [ 8 ].…”

Clinical and color Doppler ultrasound evaluation of polyacrylamide injection in HIV patients with severe facial lipoatrophy secondary to antiretroviral therapy

“…Other studies have compared the usage of PAAG with other available therapeutic alternatives. Negredo et al concluded that PAAG has a similar efficacy to that of the autologous fat graft and polylactic acid in a 12 months followup (21), and then reported a 10-year safe usage of PAAG to correct facial lipoatrophy in HIVinfected patients (22). Subsequently, other study has reported in a prospective, multicenter, randomized study similar efficacy between polylactic acid and PAAG (23).…”

Complications Following Non-Surgical Aesthetic Treatments in HIV+ Patients Receiving Antiretroviral Therapy: A 12-Years Experience

“…Nevertheless, short-, medium-and long-term encouraging results have been published over time, leading us to consider polyacrylamide hydrogel filler a good and safe option in facial wasting rehabilitation [26][27][28][31][32][33]. In 2015, Negredo et al presented their 10-year experience with 751 patients, recording indurations in 6.7% of patients and nodules in 3.8%.…”