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Publication Detail
Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Comparative Study
  • Authors:
    Yildirimer L, Seifalian AM, Butler PE
  • Publication date:
    05/2013
  • Pagination:
    761, 767
  • Journal:
    Br J Surg
  • Volume:
    100
  • Issue:
    6
  • Status:
    Published
  • Country:
    England
  • Language:
    ENG
  • Keywords:
    Adult, Aged, Breast Implants, Female, Humans, Mammaplasty, Middle Aged, Prosthesis Failure, Silicone Gels, Spectroscopy, Fourier Transform Infrared, Stress, Mechanical, Tensile Strength, Viscosity
Abstract
BACKGROUND: The recent events surrounding Poly Implant Prosthèse (PIP) breast implants have renewed the debate about the safety profile of silicone implants. The intentional use of industrial-grade instead of certified medical-grade silicone is thought to be responsible for reportedly higher frequencies of implant rupture in vivo. The differences in mechanical and viscoelastic properties between PIP and medical-grade silicone implant shells were investigated. Surface characterization of shells and gels was carried out to determine structural changes occurring after implantation. METHODS: Breast implants were obtained from women at the Royal Free Hospital (London, UK). PIP implants were compared with medical-grade control silicone implants. Tensile strength, tear resistance and elongation at break were assessed using a tensile tester. Surfaces were analysed using attenuated total reflectance-Fourier transform infrared (ATR-FTIR) spectroscopy. Spearman correlation analyses and Kruskal-Wallis one-way statistical tests were performed for mechanical data. RESULTS: There were 18 PIP and four medical-grade silicone implants. PIP silicone shells had significantly weaker mechanical strength than control shells (P < 0·009). There were negative correlations between mechanical properties of PIP shells and implantation times, indicative of deterioration of PIP shells over time in vivo (r(s) = -0·75, P = 0·009 for tensile strength; r(s) = -0·76, P = 0·001 for maximal strain). Comparison of ATR-FTIR spectra of PIP and control silicones demonstrated changes in material characteristics during the period of implantation suggestive of time-dependent bond breakage and degradation of the material. CONCLUSION: This study demonstrated an increased weakness of PIP shells with time and therefore supports the argument for prophylactic removal of PIP breast implants.
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