PIP silicone breast implants

Berry, M.G.; Stanek, Jan J.

doi:10.1016/j.bjps.2013.07.026

Cited by 4 publications

(3 citation statements)

References 5 publications

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“…5 , 10 , 12 – 15 Unacceptably high prevalence of rupture has been reason enough for prophylactic explantation of all PIP implants in some countries. 11 , 13 …”

Section: Discussionmentioning

confidence: 99%

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Soft, Brown Rupture

Godwin

Duncan

Feig

et al. 2014

Plastic and Reconstructive Surgery Global Open

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“…5 , 10 , 12 – 15 Unacceptably high prevalence of rupture has been reason enough for prophylactic explantation of all PIP implants in some countries. 11 , 13 …”

Section: Discussionmentioning

confidence: 99%

“…1 – 3 Detection of these clinical signs could raise the suspicion of rupture early rather than assuming that asymptomatic patients can be left to “watch and wait.” USS can then be applied to support or refute clinical suspicion of rupture. 13 , 14 , 16 , 19 …”

Section: Discussionmentioning

confidence: 99%

Soft, Brown Rupture

Godwin

Duncan

Feig

et al. 2014

Plastic and Reconstructive Surgery Global Open

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“…1,3 Several Breast Implant crises were generated in the 90's 4 and more recently the Poly Implant Prosthesis (PIP) Breast Implants in 2010. 5,6 The U.S had not been involved in the PIP crisis, 7 but the European countries and Australia have reacted in different ways to this issue [7][8][9][10] which clinical implications have been reviewed recently. 11 In March 2010, the French national regulation agency (AFFSAPS) requested that doctors' call back all women who had undergone breast reconstruction/augmentation based on PIP implants.…”

mentioning

confidence: 99%

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

Julian‐Reynier¹,

Bouhnik²,

Reynier³

et al. 2016

Women Health Open J

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The Poly Implant Prosthesis (PIP) Breast Implants crisis involved thousands of women 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 Reconstruction decisional outcomes. A cross-sectional telephone survey was performed nested in prospective 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, Decisional Regret, and Satisfaction with Breast Reconstruction. Determinants of regret and satisfaction 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.

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