In vitro degradation of polydimethylsiloxanes in breast implant applications.

BACKGROUND: The durability of breast implant material is associated with failure probability, increasing with time from implantation. The current study avoided the bias introduced by biological factors, to systematically investigate the degradation over time of shell materials. The same fundamental physical and chemical conditions were maintained (temperature and pH) throughout the study, to decouple biological aspects from the degradation process.

METHODS: Six virgin implants of 2 brands were submitted to the in vitro degradation process, mechanical testing of shell materials, surface change analysis (via scanning electron microscopy [SEM]) and chemical composition analysis by Fourier transform infrared (FTIR) spectroscopy.

RESULTS: FTIR results showed that the principal chemical bonds of the material remained intact after 12 weeks of degradation. Apparently the implants' shell structures remained unchanged. Despite this observation, there were statistically significant differences between strain at failure at different time points for the shells of both brands, translated into a stiffening of the material over time.

CONCLUSIONS: Material stiffening is reported as an indicator of material degradation. This altered mechanical behavior, added to the mechanical friction from tissue-tissue and tissue-implant contact and to the external mechanical loading (physical activity), may alter the material performance in women's bodies. Ultimately these changes may affect the implants' durability. Further work is needed to understand the biological aspects of the degradation process and their impact on implant durability.