Impact of the Poly Implant Prosthesis Breast Implants Recall in Women With Breast Reconstruction: A South-Eastern French Cross-Sectional Survey Nested in a Prospective Cohort

Abstract

The Poly Implant Prosthesis (PIP) Breast Implants crisis involved thousands of wom
en in the countries concerned, women with breast cancer in particular. It was proposed here to 
investigate the impact of the PIP Breast Implants recall on women who had undergone Breast 
Reconstruction at the time of the recall and to analyze the determinants of their Breast Recon
struction decisional outcomes. A cross-sectional telephone survey was performed nested in pro
spective geographically based cohorts, which consisted of women from the southeastern France 
with breast cancer. Women were selected who had Breast Reconstructive surgery just before 
the PIP recall occurred. Dependent variables were the Psychological Impact of the event, Deci
sional Regret, and Satisfaction with Breast Reconstruction. Determinants of regret and satisfac
tion were analyzed using simultaneous equations. Among the 148 eligible women, 113(76%) 
participated. At the initial reconstruction, 90% (n=102) had a Breast Implant, 10% (n=11) had 
an autologous reconstruction. The PIP recall induced less intrusive thoughts, measured with the 
Impact of the Event Scale, in the non-PIP groups compared to the PIP one (p=0.025). Regrets 
about Breast Reconstruction were expressed by 57%; they occurred more frequently when the 
decision-making was not felt to be sufficiently proactive (adjusted Odds Ratio (ORadj) 5.1; 
95% Confidence Interval (CI) (1.2-20.9)) and in those who were dissatisfied with their Breast 
Reconstruction (ORadj 0.7(95% CI (0.5-0.9))). Satisfaction was significantly lower in women 
with a Breast Implant, those whose trust in doctors had decreased, in the information-seekers 
and in less health-literate women. The PIP recall was not found to affect intrusive ideas or 
denial in women who did not have a PIP Breast Reconstruction. The high frequency of regrets 
could be reduced by involving women more strongly in the initial decision-making process. 
Using existing data-bases to assess the impact of new devices on patients’ health is an option 
which organization deserves to be discussed.