Diagnosing PIP breast implant failure: a prospective analysis of clinical and ultrasound accuracy.

ABSTRACT

INTRODUCTION: The risk of Poly Implant Prosthesis (PIP) breast implant failure has been quantified by the Department of Health as 2-6 times greater than other brands. In the UK, removal of PIP breast implants is recommended when failure is suspected from patient history or clinical findings. Owing to conflicting reports of accuracy in current literature, ultrasound is not recommended as a routine investigation. We aimed to evaluate the accuracy of patient history, clinical impression, and ultrasound at diagnosing implant failure in a large consecutive series of women against the reference standard. We aimed to provide evidence in response to current guidelines and help guide best practice. METHODS: All patients from January 2012-January 2013 who underwent PIP breast implant explantation at the Spire Murrayfield Hospital were prospectively evaluated. Operative findings were correlated to pre-operative results of patient history, clinical impression and ultrasound imaging. Sensitivity, specificity and accuracy were calculated with 95% confidence intervals. RESULTS: A total of 192 women who underwent 384 PIP implant explantations from January 2012 to January 2013 were included. Twenty-three patients (12.0%) reported a positive patient history pre-operatively. In 35 patients (18%), failure was pre-operatively diagnosed clinically. Intra-operatively, 80 implants (21%) in 63 women (33%) had failed. The sensitivity of patient history, clinical impression and ultrasound was 12%, 34%, and 91%, respectively. The specificity was 88%, 89%, and 97%, respectively. Ultrasound was 96% accurate at diagnosing PIP implant failure, whilst patient history and clinical impression were 63% and 71% accurate, respectively. CONCLUSION: Ultrasound provides a far more reliable test of implant failure than patient history or clinical impression. Considering the availability, cost and number of women in the UK with PIP implants, we would recommend high-resolution ultrasound be implemented as a routine investigation.