Poly Implant Prothèse (PIP) Incidence of Device Failure and Capsular Contracture: A Retrospective Comparative Analysis

Abstract

The Medicine and Healthcare Products Regulatory Agency in the United Kingdom issued a Medical Device Alert (MDA/2010/025) through a press release on 31 March 2010 for clinicians not to use the Poly Implant Prothèse (PIP) implant. Data were collected to analyze PIP and non-PIP implant failures as well as rates of capsular contracture between August 2008 and August 2012. Relevant data were retrieved for 143 patients with PIP (group A) and non-PIP (group B) implants. Group A (PIP): A total of 65 patients had PIP implants removed. The mean patient age was 37.1 ± 8.1 years (range 24-53 years). The mean duration of the implant was 7.2 ± 2.5 years (range 2-12 years), and the mean preoperative implant size was 327.1 ± 69.6 ml (range 255-495 ml). Of the implants in 65 patients, 18 (27.7 %) were damaged, and of the 64 patients with recorded capsular contractures, 16 (25 %) presented with grades 3 and 4 capsular contractures. Group B (non-PIP): A total of 79 patients had non-PIP implants removed. The mean patient age was 34.4 ± 8.0 years (range 19-54 years). The mean implantation time was 5.8 ± 3.9 years (range 0.2-26 years), and the mean preoperative implant size was 348.2 ± 79.0 ml (range 175-555 ml). Of the 79 patients, 6 had ruptured implants (7.6 %) and 21 (26.6 %) presented with grades 3 and 4 capsular contractures. There were no statistically significant differences in mean patient age (p = 0.046), preoperative size of the implants (p = 0.095), duration of the implantation (p = 0.08), or grades 3 and 4 capsular contractures (p = 0.830). The incidence of implant rupture was significantly higher with the PIP implants than with the non-PIP implants (p = 0.01). The PIP implants were more prone to rupture than the other implants, although the incidence of clinical capsular contracture (grades 3 and 4) was not increased.