Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on Histopathological Examinations and Retrospective Analysis of Medical Records

Abstract

The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto’s disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto’s disease.

Lip augmentation with hyaluronic acid hydrogel cross-linked with polyethylene glycol diglycidyl ether (PEGDE) in two women with autoimmune disease. Case report

“…An additional observation was the use of these preparations in patients diagnosed with Hashimoto's disease. This is another confirmation of the high safety profile and biocompatibility, which was previously demonstrated in histological and in vitro studies published by Kubik et al [9]. What is important, and what has been emphasized, is that there are no substantive or registration contraindications to the use of fillers with PEGylated HA in patients with Hashimoto's disease.…”

“…Looking at the available publications, a three-year retrospective study of clinical experience with PEGDE-HA for a range of treatment indications demonstrated long-term results without safety concerns, including no nodules, granulomas, or foreign body reactions [12]. PEGDE-HA has been subjected to extensive molecular, chemical, mechanical and histological characterization, but it should be emphasized that few publications shed diff erent light on the use of tissue fillers among patients with autoimmune diseases [9,[12][13][14][15][16][17]. Clinical results confirm the high safety profile of PEG-cross-linked HA, where, as already mentioned, no granuloma, foreign body reaction or other complications were detected during the 3-year follow-up period [12].…”

“…Evaluation of the performance and use of HA soft tissue fillers in patients suffering from autoimmune diseases should be carefully considered as part of the overall safety assessment of these products. However, the first reports on the use of PEGylated HA among patients suffering from Hashimoto's disease [9] are optimistic, although of course, it should still be the subject of further observations.…”

“…Each of the ingredients of dermal fillers may influence the induction and development of the inflammatory reaction. Hyaluronic acid itself, although it is a natural and common component of the body, may have a pro-inflammatory effect [9]. Due to the increased immune response among patients with autoimmune diseases, such treatments using hyaluronic acid-based fillers are contraindicated in this cohort of patients [10].…”

“…In the presented work, the commercially available soft tissue HA filler crosslinked with polyethylene glycol (PEG) was used. PEG or PEGDE (polyethylene glycol diglycidyl ether) as a cross-linking agent for the filler with hyaluronic acid has been shown and proven a high safety profile, even when used among autoimmune Hashimoto patients [9]. PEG-crosslinked HA hydrogel has excellent chemical and mechanical properties and high biointegration.…”