Physical characterization of unimplanted gel filled breast implants. Should old standards be revisited?

Physical characterization of unimplanted gel filled mammary prostheses was undertaken using both destructive and non-destructive test methods. Physical properties measured included mass, volume, optical transmittance, coefficient of kinetic friction, mechanical stiffness, dynamic response to a stationary random vibration, bursting strength, elasticity of the envelopes, and nuclear magnetic resonance relaxation times. The data obtained from this study will provide reference points for quantifying the rate of degradation of prostheses in past and current clinical use. Some of the test methods are suitable for use as routine quality control procedures to improve the uniformity of the properties and performance of breast prostheses. This investigation also showed that some currently used prostheses do not comply with the relevant American Society for Testing and Materials standards, or even with the manufacturers' own stated claims or specifications.