PEREIRA, L. R.; PEREIRA, Leandro Rodrigues.
Resumo:
Since the late nineteenth century, various materials were used for breast
augmentation. Polyurethane, polyethylene, glass balls, gutta percha, among
others materials were used. The use of silicone for breast augmentation
purposes began in 1961 and, since then, companies have developed
innovations to the manufacturing process of breast implants including the
insertion of barrier layers to prevent migration of silicone gel. In 2012 was
published the ANVISA Resolution RDC No. 16 which established minimum
requirements for identity and quality for silicone breast implants. Thus, this
study aims to evaluate six brands of regularized breast implants in Brazil and
perform morphological, structural and mechanical caracterization in accordance
with current standards. Optical Microscopy - MO, Electron Microscopy Scanning
- SEM with Energy Dispersive Spectroscopy- EDS and evaluation of the
mechanical behavior when subjected to tensile test according to ISO
14607:2007 standard. Based on the results obtained in this study, it can be
concluded that all the membranes of breast implants had to be suitable for use
as a biomaterial, complying with regulatory requirements. There is also an
opportunity to improve the ISO 14607:2007 standard, establishing a minimum
performance requirement for testing elastomer shell tear resistance.