Failure of silicone gel breast implants: Is the mechanical weakening due to shell swelling a significant cause of prostheses rupture?

Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants

“…Nevertheless, the present data demonstrated mechanical weakening of PIP shells compared with medical‐grade shells and variability within the PIP cohort. Although differences between intact and ruptured PIP implants were not significant statistically, this trend should not be underestimated; a larger implant cohort may have resulted in a statistically significant difference, as demonstrated by Necchi and colleagues. Clinical observations have previously suggested the presence of two distinct subpopulations of PIP implants: those manufactured from suboptimal industrial silicone that are more susceptible to rupture and those containing ‘normal’ appearing silicones.…”

Characterisation of breast implant surfaces and correlation with fibroblast adhesion

“…Necchi et al (2011) obtained the shell mechanical properties of silicone gel-filled breast implants by means of tensile, dynamic mechanical and tear tests. Prager-Khoutorsky et al (2011) measured the rigidity of PDMS substrates with an Instron (Instron Ltd, UK) universal testing machine.…”

On the failure of silicone breast implants: new insights by mapping the mechanical properties of implant shells

“…Furthermore, standard failure statistics according to Weibull statistics (Fig. ) can be utilized to reveal reliable data due to the higher amount of data taken into consideration per implant in contrast to former studies where only about one to 13 tensile specimens per implant were analysed: …”

“…Therefore, after extraction of the silicone that had diffused into the shell from the gel, the mechanical properties of the shell were almost restored. Necchi et al investigated the failure of the recent implant generation being implanted between a half and 13 years. This group confirmed the results of Brandon and co‐workers but came to the conclusion that the weakening of the shell due to swelling is the major reason for the failure of silicone breast implants.…”

“…One of the key assumptions of all studies on the mechanical properties of silicone breast shells is that the properties are independent of the location of the specimen under investigation. Therefore, previously published studies on the mechanical properties used only about one to 13 tensile specimens per implant . No attention was paid to the orientation of the specimen in the shell.…”