Combined scientific-research amendment drafting IMC NASc of Ukarine and Pr.Ent. “Polytox”
Rinaplast is registered for production and clinical use by the Ministry of Healthcare of Ukraine (Certificate of State Registration No 6825/2007) and is manufactured at the test production facility of the Institute of Chemistry of Macromolecular Compounds of the National Academy of Sciences of Ukraine in Kyiv according to TU U 33.1-19124650-002:2007 (RINAPLAST hydrophilic polyacrylamide gel). Hydrophilic polyacrylamide gel known under the Rinaplast brand name and the gel’s production method constitute intellectual property of its manufacturer protected by an invention Patent of Ukraine No 83124 the June 10th of 2008. Rinaplast hydrophilic polyacrylamide gel (hereinafter referred to as gel) is intended for volumetric and contouring plastic surgery, elimination of soft tissue defects, both inborn and acquired as a result of traumatic injuries, and for use as a filling matter for endoprosthesis shells during prosthetic replacement of mammary glands and other organs and tissues.Area of use: plastic, esthetic, and reconstructive surgery.
Rinaplast gel comes in:
- 2; 5; 10; 20; 50 cm3 glass bottles;
- 1.0 ± 0.1; 2.0 ± 0.2; 5.0 ± 0.5; 20 ± 2; 50 ± 5 cm3 disposable syringes;
- 25.0 ± 2.5; 50.0 ± 0.5; 100 ± 10 ml polymeric containers.
The new gel formula has a number of advantages comparing to existing polyacrylamide gels (Aqualift, Interfall, Esteform, Aquamid); in particular, it has high viscoelastic properties due to modification of three-dimensional network with polyvinylpyrrolidone. This modification helps retain water in polymer system due to the increase of molecular weight of polymer carrier and avoid hydrogel’s fragmentation during prolonged implantation.
High degree of purity of input reagents used for synthesis of hydrogel material helps receive a chemically pure product with high degree of biocompatibility with human body.
Rinaplast gel underwent comprehensive toxicological study on test animals (implantation test) and for tissue culture at the ISO-accredited Laboratory for Medical-Purpose Polymers (DSTU/ISO 17025) using sanitary and chemical methods of study. The study revealed high degree of biocompatibility, absence of allergic reactions, absence of capsular fibrosis over long study period, and absence of local and general allergic reactions.
Rinaplast was clinically tested on the base of P.L. Shupik National Medical Academy of Postgraduate Education on patients with inborn and acquired deformations of maxillofacial skeleton soft tissue and bones. The clinical and laboratory examination of patients whom Rinaplast was administered for face contouring plastic surgery revealed that the gel does not affect general and local nonspecific resistance of the patient’s body after being injected into soft tissue. The gel does not cause side effects or allergic reactions, and retains initial consistence and volume for the duration of its presence in soft tissue. The surgeons came to conclusion that Rinaplast completely meets requirements to preparations used for soft tissue contouring surgery and may be used to eliminate deformation of soft tissue in maxillofacial region of any origin (A.A. Timofeev, Surgical dentistry, 2007).
Clinical testing proved the gel’s safety, biocompatibility, and universality of use in plastic, esthetic, and restorative surgery with stable cosmetic effect.When used for cosmetic face surgery the gel helps:
Eliminate wrinkles between eyebrows, deep nasolabial folds and aging wrinkles on upper and lower lips;
Increase volume and correct the shape of lips;
Correct dorsum and tip of the nose and outer contour of soft tissue in temporal, buccal, zygomatic, and chin regions.
Contouring plastic surgery using Rinaplast hydrogel is safe in the cases of inborn and acquired, post-traumatic and port-surgery facial deformations.
Rinaplast hydrogel may be used to form esthetic lines in the upper and medium parts of shin, eliminate asymmetry of soft tissue, and correct volume.
Use of Rinaplast for contouring surgery of soft tissue will help achieve stable cosmetic result without disrupting main functions of distal parts of lower limbs and ensure the best cosmetic results.
Rinaplast is used as an injection implant material to correct shape and change volume of female breasts, eliminate inborn and acquired asymmetry and aplasia, correct post-traumatic and other defects and aging changes.
