ABSTRACT
BACKGROUND: There is societal concern regarding potential health problems associated with breast implants. Much of this distrust climate was a reaction to the Poly Implant Prosthesis (PIP) scandal. Studying the mechanisms of implant rupture is an important step for their improvement. The mechanical behaviour of breast implant shells was studied on explanted and virgin implants. Implants from both PIP and another brand (brand X), currently in the market, were considered. METHODS: To study the mechanical behaviour of the shell, a total of 940 samples from 11 explants and 5 control implants were analysed. The experimental protocol follows the ISO standards for shell integrity and determination of tensile stress-strain properties. Pearson correlation analyses and the multi-factor ANOVA statistical tests were performed using mechanical test data. RESULTS: Both PIP control and explants had significant variations of stress (P = 0.0001) and shell thickness (P = 0.000) throughout the implant. The stress was directly related to shell thickness. Shell thickness varied significantly for PIP implants, exceeding the manufacturer's specifications. Regarding the other brand, thickness variation was within manufacturer's specifications. CONCLUSIONS: The heterogeneous nature of PIP implants was confirmed. The implant shell thickness should be considered as a relevant parameter during the manufacturing process, for quality control purposes. These results may contribute to dispel mistrust and doubt surrounding breast implants, among the medical community and patients. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
