Strong evidence demonstrates safety and efficacy of hyaluronic acid filler

New evidence-based surveillance findings confirm that MaiLi hyaluronic acid (HA) fillers offer safe, natural-looking results with minimal adverse events (AE).¹

The research, undertaken between February 2021 and April 2023, found that there was just one Adverse Event (AE) in every 3,698 syringes – an overall adverse incidence of 0.027%.

Post-market surveillance for MaiLi found:

• No product defects were responsible for any AE reported to Sinclair
• No treatment was discontinued as a result of a product-related issue following an AE report
• One case of vascular compromise was reported with the root cause confirmed as user error
• No events were assessed as reportable to the competent authorities

MaiLi’s OxiFree technology preserves the long molecule HA chains. The highly efficient crosslinking of HA with low BDDE (1,4-butanediol diglycidyl ether) creates a supple, spring-like gel¹ offering volume and suppleness alongside projection², meaning less product is needed for more natural outcomes^3,4. It also delivers long-lasting effects of up to 12 months, including in the lips⁵.

The MaiLi range comes in four efficacies: Precise to treat fine lines*; Define for deep wrinkles or lip structuring; Volume for facial volumising; Extreme to sculpt and shape the face.

The post-market surveillance is in addition to a recent, year-long study, A Preliminary Report on the Safety and Efficacy of a Novel MaiLi HA Filler for Facial Correction of Wrinkles, Folds, Volume and Lips**, conducted with 45 patients in 2021, concluded that the MaiLi HA fillers proved to be well-tolerated and safe, with long-lasting effects.

Notable properties revealed in the one-year follow-up were MaiLi’s projection capacity and suppleness, as well as ease of use and longevity, resulting in full patient satisfaction. It also concluded there were no edematous reactions following the injections, nor were there any lymphatic circulation disorders.

References:

1. Sinclair Pharma. MaiLi physician leaflet, 2021
2.  Gavard Molliard S, Bon Bétemps J, Hadjab B, Topchian D, Micheels P, Salomon D. Key rheological properties of hyaluronic acid fillers: from tissue integration to product degradation. Plast Aesthet Res 2018;5:17
3. Sinclair Pharma, data on file
4. Bon Betemps J, Marchetti F, Lim T, Hadjab B, Micheels P, Salomon D, Gavard Molliard S. Projection capacity assessment of hyaluronic acid fillers Plast Aesthet Res 2018;5:19
5. Clinical data, results at 12 months
6.  MaiLi® An expert’s Guide 2022

**A Preliminary Report on the Safety and Efficacy of a Novel MaiLi HA Filler for Facial Correction of Wrinkles, Folds, Volume and Lips: Patrick Micheels and Mickaël Poiraud.