The use of intraarticular forms of hyaluronic acid in degenerative dystrophic and post-traumatic lesions of the joints is a well-studied method with an established safety profile, which has been used for several decades.
In extremely rare cases, the manifestation of local transient inflammatory symptoms (pain, fever, redness and swelling, exudate increment in the joint cavity) are possible. After an intraarticular injection, reversible local reactions may occur, such as short-term restriction of mobility (stiffness), discomfort or heaviness in the joint, hematomas. The local application of ice for 5-10 minutes may reduce these effects.
There are reports of isolated cases of allergic reactions (e.g., itching, rash, urticaria) and anaphylactic reactions, septic arthritis, interstitial hemorrhages or hemorrhages in the joint cavity, tendenitis, phlebitis, paresthesia, dizziness, headaches, muscle spasms, fever, general malaise, peripheral edema after intra-articular injections of hyaluronic acid solutions.
If local or general symptoms appear, consult a physician.
Hyaluronic acid is degraded by a family of enzymes called hyaluronidases most of which are lysosomal, to form monomeric non-toxic degradation substances (primary degradation substances are oligosaccharides and low molecular weight hyaluronates). In humans, there are at least seven types of hyaluronidase-like enzymes. The biodegradation rate depends on the patient's condition and the characteristics of the individual patient’s metabolism. Degradation of the high-molecular-weight extracellular hyaluronate occurs in a series of discrete steps generating hyaluronan chains of decreasing sizes. There is no data about the negative effect of degradation products on the implant or about their systemic effects in the human body. Some degradation substances can be utilized in processes of endogenous resynthesis.
In the case of severe reactions, the removal of an implant from the joint cavity can be recommended, including lavage in accordance with the current clinical guidelines.
If the reaction to the implant was not associated with the individual intolerance to the components of the product, it is possible to inject the implant in 3 weeks after an inflammation subsides.
FLEXOTRON® line implants successfully passed preclinical tests and confirmed their compatibility with biological tissues, cells and body fluids with which they come in contact in an implantable state. Disinfectants containing quaternary ammonium salts should not be used, since hyaluronic acid precipitates in the presence of these substances.
The information about incompatibility with other drugs, substances and intra-articular injected products is currently not available, however, a medical specialist should carefully read the relevant information in instructions for these drugs/substance/products and use with caution.
During the first 2 days after the procedure, it is recommended not to overload the joint, especially to avoid prolonged exertion. In case of fluid aspiration before viscosupplementation therapy the appropriate clinical examination should be conducted to exclude a bacterial etiology of arthritis.
The product does not affect the ability of a person to drive vehicles, to engage in other potentially dangerous activities that require high concentration of attention and speed of psychomotor reactions
The viscosupplement devices are compatible to use in magnetic resonance investigations in magnetic fields induction at least up to 3 Tesla. Radiation, electromagnetic and magnetic fields do not affect directly on the implants FLEXOTRON® Smart and its properties as well as do not trigger any known relevant subsequent effects in a human body.
The viscosupplement devices are not amenable to visualization through radiological, ultrasound and other scanning procedures due to the proximity of their physical properties to the natural components of the human tissues.