RESUMEN
Despite there being many studies that have evaluated breast implant rupture, there is no consensus about causes and incidence. Most studies lack a multifactorial analysis of what causes breast implants to rupture. To fill this gap, an experimental protocol was developed to compare ruptured and intact Poly Implant Prothèse (PIP) breast implants from the same woman. These conditions guarantee that the physical/biological variables are the same for each pair of ruptured and intact implants. A total of 1008 samples from 22 PIP explants (11 intact and 11 ruptured) and three control PIP implants were analysed. The mechanical properties (tensile strength) of the ruptured and intact implants were compared according to brand, lot, implantation time and demographic conditions. In general, statistically significant differences were found between the intact and ruptured PIP implants. Ruptured implants were thinner (0.73 ± 0.10 mm versus 0.91 ± 0.11 mm) and weaker (7.42 ± 2.65 MPa versus 9.59 ± 2.37 MPa) than intact implants. Intact and ruptured implants have shown distinct mechanical behaviours and variations in thickness. Our understanding is that these differences may be associated with the typical manufacturing process of breast implant shells. These results stress the importance of thorough control of the shell thickness. Given its relevance, shell thickness should be used as a quality control measure for homologation purposes. Thus, the homogeneity of the shell should be considered as a relevant parameter during the manufacturing process. This will translate into an improved quality of life for patients and will potentiate safer and longer lasting products.
RESUMEN
Breast implant durability and the mechanisms of rupture are important topics in the medical community, for patients, manufactures and regulatory medical agencies. After concerns about the Poly Implant Prosthesis (PIP) implants, the need for understanding the adverse outcomes and the failure mode to improve the breast implants increased. The objective of this research is to analyze and describe the rupture characteristics of failed explanted PIP implants to study the modes and causes of rupture. Eleven explanted PIP implants were analyzed by visual inspection and scanning electron microscopy (SEM). To simulate hypothetical ruptures caused by cyclic mechanical stress (fatigue) in the implant shell, two control implants were submitted to fatigue tests, and analyzed with SEM. Small ruptures (either Hole or split) striations were found, which normally appear due to fatigue phenomena. Similar striations were also found in specimens (control) tested under laboratory controlled conditions. In the context of this work, the striations found in explants constitute a significant finding as they point to the occurrence of fatigue phenomena associated with mammary implants rupture. This research, also demonstrates that rupture surface analysis of explanted breast implants has the potential to become a useful indicator for assessing implant rupture mechanisms.
