The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering

Greco, Cinzia

doi:10.1016/j.socscimed.2015.10.068

Cited by 44 publications

(29 citation statements)

References 24 publications

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“…In fact, application of all stages of the IDEAL framework in a more strategic fashion could be possible in technological innovations like the WEB device. To date, the WEB device appears to be efficacious and safe, but a more rigorous and transparent process for the introduction of this type of technology could potentially help prevent deleterious outcomes, as seen with the Poly Implant Prothèse (PIP) breast implants and metal-on-metal hip prostheses [ 4 , 28 , 67 ]. Currently, proof of safety and efficacy is required by the FDA for class III devices (the most invasive devices), but this is not standardized [ 39 , 40 ].…”

Section: Discussionmentioning

confidence: 99%

Innovation in neurosurgery: less than IDEAL? A systematic review

et al. 2017

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BackgroundSurgical innovation is different from the introduction of novel pharmaceuticals. To help address this, in 2009 the IDEAL Collaboration (Idea, Development, Exploration, Assessment, Long-term follow-up) introduced the five-stage framework for surgical innovation. To evaluate the framework feasibility for novel neurosurgical procedure introduction, two innovative surgical procedures were examined: the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms.MethodsThe published literature on EEMS and WEB devices was systematically reviewed. Identified studies were classified according to the IDEAL framework stage. Next, studies were evaluated for possible categorization according to the IDEAL framework.ResultsFive hundred seventy-six papers describing EEMS were identified of which 26 papers were included. No prospective studies were identified, and no studies reported on ethical approval or patient informed consent for the innovative procedure. Therefore, no clinical studies could be categorized according to the IDEAL Framework. For WEB devices, 6229 articles were screened of which 21 were included. In contrast to EEMS, two studies were categorized as 2a and two as 2b.ConclusionThe results of this systematic review demonstrate that both EEMS and WEB devices were not introduced according to the (later developed in the case of EEMS) IDEAL framework. Elements of the framework such as informed consent, ethical approval, and rigorous outcomes reporting are important and could serve to improve the quality of neurosurgical research. Alternative study designs and the use of big data could be useful modifications of the IDEAL framework for innovation in neurosurgery.Electronic supplementary materialThe online version of this article (doi:10.1007/s00701-017-3280-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Innovation in neurosurgery: less than IDEAL? A systematic review

et al. 2017

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“…A specific study has been carried out on the PIP scandal in France, not specifically for reconstructive surgery, showing the interconnection of embodied experience and professional and public policy definitions of medical risk through the concepts of moral economy and biological citizenship. 12 Anderson and Larson, 27 who described patients' reactions to the media coverage of the risks associated with silicone Breast Implants in the mid-90's, observed that all the respondents coped with anxiety mainly by consulting their physicians. Among the 102 participants with Breast Implants in this study, 13 were contacted first by their healthcare providers (including all the women with a PIP Breast Implant), whereas 50 had contacted their healthcare Table 2: Decision-making process about reconstruction and respondents' psycho-social characteristics, depending on the type of breast reconstruction -n=113.…”

Section: Discussionmentioning

confidence: 99%

“…Only the women who had a previous mastectomy and who declared a breast reconstruction before March 2010, the time of the PIP recall by the national regulatory agency in France were eligible to participate in this study. 12 This represents a small subset of the overall ELIPPSE cohorts since a minority of the women had a mastectomy and in this group not so many women had a breast reconstruction completed before March 2010. A specific cross-sectional telephone survey was performed on these women after an initial phone call to check the validity of women's declarations (Figure 1).…”

Section: Participantsmentioning

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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“…Calls for reform in the European process for device approval and post-market surveillance were fueled in 2010 after Poly Implant Prosthèse (PIP), a French company that manufactured silicone breast implants under a CE mark issued in 1991, was found to have switched to industrial silicone rather than medical grade material in their implants. Over 30,000 women received PIP implants, which were implicated in cases of systemic toxicity, as well as cancer (72) . Before PIP changed to lower grade components (sometime in 2001), their implant had been refused approved for marketing in the United States on the basis of a post-market surveillance process.…”

Section: Continuing Challenges To Drug and Device Regulation And Apprmentioning

confidence: 99%

“…When higher than expected complication rates were found, the FDA required all breast implants to undergo evaluation via the stringent PMA approval process. PIP's PMA application failed in 2000, based on an FDA inspection of their manufacturing plant (which resulted in a warning letter to the company) and clinical and safety data that the FDA determined was insufficient 72 , 73 .…”

Section: Continuing Challenges To Drug and Device Regulation And Apprmentioning

confidence: 99%

Drugs and Devices

Norman

2016

JACC: Basic to Translational Science

168

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SummaryThe regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible. The United States and the European Union approach these challenges in different ways. Whereas the United States has always relied on a strictly centralized process through 1 agency, the Food and Drug Administration (FDA), the European Commission synchronized the regulations of 28 different countries as they combined to create the European Union. The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.” Thus, whereas the FDA has the advantages of centralization and common rules, the European Union regulates medical drug and device approvals through a network of centralized and decentralized agencies throughout its member states. This study explores some of the similarities and differences in European and U.S. regulation of drugs and devices, and discusses challenges facing each.

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The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering

Cited by 44 publications

References 24 publications

Innovation in neurosurgery: less than IDEAL? A systematic review

Innovation in neurosurgery: less than IDEAL? A systematic review

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

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