Avaliação das propriedades física, química e biológicas de próteses mamárias de silicone explantadas.

Abstract

Breast implants are characterized as medical devices that are used to increase the size of breasts or to reconstruct the breast after mastectomy or to correct a congenital anomaly. It is known that deviations in the production process of breast implants and the use of time can reduce the properties of the final product and favor risk of harm to health. Thus, this study aimed to evaluate the physical, chemical, biological and mechanical properties of silicone breast implants explanted. The evaluation criteria were based on NBR 14 760 - 2001 were analyzed nine samples of textured silicone breast implants with different operating times and the assays were performed in triplicate. Characterization tests used were Microscopy Optica - MO, Infrared Spectroscopy in the Region Fourier Transform (FTIR), cohesiveness gel, Mechanical Test (Tensile Strength) and cytotoxicity. In the MO of study there are several standards for texturing the prosthesis, but no significant changes were observed that could compromise the quality of breast implants, as well as in FTIR spectra. Based on the results obtained in the gel assay cohesiveness, it can be stated that only sample C is not in accordance with International Standard ISO 14607.Nos results of mechanical testing, samples A, B, F, G and H found in non-compliance with the standard. Cytotoxicity tests showed that the prostheses are analyzed in accordance with the standard. Thus it is concluded that the samples A, B, C, F, G and H are out of the parameters required by current standards and that the time of use these may have influenced these results, suggesting continuing studies considering this variable .