Poly Implant Prothèse™ (PIP) experience in the United Kingdom: A prospective cohort study into the accuracy of diagnostic imaging findings in comparison to operative findings of 1029 implants

Abstract

The Poly Implant Prosthèse™ (PIP) implants were withdrawn from market use in the United Kingdom on 31st March 2010 following Government issued advice. In June 2012 a final Government report was issued and during this period the majority of patients elected to have their prostheses removed. This study presents the operative findings of three surgeons. 517 patients were identified retrospectively from the implant database as having received PIP implants with a total of 1029 implants. 62 patients (124 implants) declined explantation after consultation and imaging. The data was recorded prospectively for all patients and included the clinical, imaging and operative findings. A total of 905 implants were removed of which 129 were ruptured at the time of explantation (14.25%). 27 implants were intact but the presence of liquid surrounding the prosthesis was noted. 93 implants were reported as being ruptured after diagnostic imaging but were intact operatively resulting in a test sensitivity of 0.82 and a specificity of 0.92 yielding a positive predictive value of 0.59 and a negative predictive value of 0.97 overall. Capsule formation was noted in 27 breasts (3%). Our study showed that the prevalence of PIP ruptures is comparable to other manufacturers. The prevalence of implant rupture predictably increased over time and the prevalence of abnormal capsule formation was similar to other manufacturers.