Safety evaluation and consideration of 4 Pin Multi-needle for meso-therapy

Abstract

This study was conducted according to the method presented in the Republic of Korea Pharmacopoeia 11th Revision, aseptic test method to evaluate the suitability of sterilization for a sterile needle (4 Pin Multi-needle). In this study, four tests were conducted: sterility test, cytotoxicity test, acute toxicity test, skin sensitization test. First, in the aseptic test, the microorganism was not proliferated in the aseptic test of the medium. As a result of the performance test of the medium, it was confirmed that the microorganism developed within 3 days and the fungus was evident within 5 days. Based on this, it was confirmed that the medium was suitable, and as a result of the aseptic test, the development of microorganisms was not observed during the total culture period. Based on these results, tests were conducted which were confirmed to be suitable for aseptic testing because the development of bacteria on the provided samples was not recognized. For cytotoxicity tests ISO10993-5; 2009 (Biological Evaluation of Medical Devices, Part 5: Test for in vitro Cytotoxicity). As a result, the MEM eluate of the test substance caused very slight cytotoxicity to the fibroblasts of the mouse and was judged to be Grade 1 (Slightly cytotoxic) according to the judgment standard of ISO 10993-5. On the other hand, solvent control, negative control and positive control showed the expected results on the test. Acute Toxicity Test Results: It was judged that there was no systemic toxicity change when ICR mice were treated with 50 mL/kg B.W. of the eluate of sterile injectable needle for 72 hours. Skin sensitization test result: The Hartley guinea pig was evaluated as a substance which is evaluated as a substance which does not induce any skin reaction when skin sensitization is applied to the dissected material of the sterile injectable needle and is weak in skin sensitivity. Based on the above tests, we will study the stability and efficacy of more reliable medical devices based on the verification and performance of medical devices.

Safety of Aesthetic Medicine Procedures in Patients with Autoimmune Thyroid Disease: A Literature Review

“…Mesotherapy is a cosmetic procedure involving the intradermal or subcutaneous injection of various substances, aimed at stimulating the regenerative processes of the skin and subcutaneous tissue. It was first performed in France by Pistor in 1952 [94]. The purpose of this treatment is to transport various active substances to the dermis in order to intensify collagenogenesis and fibroblast activity.…”

Mesotherapy: Safety profile and management of complications

“…Mesotherapy is becoming such an increasingly common procedure, that is now widely applied not only by physicians but also by nonmedical personnel in aesthetic institutions. 1,4,53 Most patients, and in some cases even physicians, tend to underestimate the numerous potential side effects that can occur by such methods. 53 In order to minimize the risk of adverse reactions, a standardization of this procedure for each indication is necessary.…”

“…Mesotherapy is a modern treatment with various cosmetic and noncosmetic indications, first introduced in 1952 by French physician Pistor. 1 The aim of this procedure is the direct transepidermal transport of various active substances in the dermis or deeper skin layers, so as to stimulate the fibroblast activity and collagenogenesis, as well as to reverse the degeneration of elastin and the continuous transepidermal water loss, all of which occur during the aging process. 2 The external application of these active substances could not lead to the same results, either due to the impairment of their penetration through the lipid barrier and the stratum corneum, or due to their chemical decomposition on the epidermis surface.…”

“…Mesotherapy is a modern treatment with various cosmetic and noncosmetic indications, first introduced in 1952 by French physician Pistor . The aim of this procedure is the direct transepidermal transport of various active substances in the dermis or deeper skin layers, so as to stimulate the fibroblast activity and collagenogenesis, as well as to reverse the degeneration of elastin and the continuous transepidermal water loss, all of which occur during the aging process .…”