Aging of non-implanted Natrelle™ gel breast implants

Abstract

This study questions the aging of non-implanted breast prostheses for a period of 9–60 months. Every 6 months, two non-implanted Natrelle™ prostheses were tested to measure the strength at break, the elongation at break, and the thickness of the shell. Then, the breaking stress was calculated from the preceding quantities. All these quantities were observed by separating the samples taken from the anterior and posterior sides of the prostheses. One-way ANOVA analyses (analysis of variance) were performed to define the influence of aging duration, lot membership, and side. In addition, the elongation at break and the thickness of the shell showed significant variations as a function of aging regardless of the side but without any trend emerging. For other quantities, there were significant disparities between the anterior and posterior sides of the prostheses, differences between prostheses from different lots, and similarities between prostheses from the same lot. Finally, the thickness is an important parameter. Since manufacturing is a manual process, it is necessary to check the thickness, which must be homogeneous on both sides. Always weaker on the anterior side than on the posterior side, it influences the mechanical properties. We recommend, like other studies, that its control be part of the quality controls during manufacturing.