The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

Martindale, V. H.; Menache, André

doi:10.1177/0141076813480994

Cited by 29 publications

(18 citation statements)

References 10 publications

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“…There have been various incidents of (avoidable) health risks for patients in different countries, particularly with regard to women who received breast implants [19,20]. In our investigation period, the number of reports on this kind of scandals almost equalled the number of articles centered on medical progress.…”

Section: Discussionmentioning

confidence: 83%

“…Consequently, statements about the future were mostly formulated as calls for action or change (instead of neutral forecasts). Interestingly, these very critical reports mentioned breast implants much more frequently than other types of implants, which suggests that the recent scandals in plastic surgery have been an important cause of this type of coverage [20].…”

Section: Resultsmentioning

confidence: 99%

“…Specifically, news media have reported on implant failures in the context of plastic surgery, disclosing scandals of corporate fraud, failure of authorities and institutions of quality control, and large numbers of suffering patients (e.g. [19,20]). Likewise, the negativity bias in journalism [13] suggests that news media will selectively report on (single) cases of medical implant failures -those failures that Biofabrication methods and materials are envisioned to prevent in the future -and neglect their beneficial aspects for patients' health and quality of life.…”

Section: Research Objectivementioning

confidence: 99%

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Communication as integral element of biomedical implant innovation

et al. 2016

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Abstract:The success of medical implant innovation as a complex field of science and technology requires efforts and strategies in accompanying communication. Fostering public understanding and acceptance of biomedical research and its methods (animal experimentation in particular) is important to counteract wrong assumptions and expectations that journalists, lay people, and (future) patients may hold and that could impede effective takeup of true innovation in the clinical context. Two studies on media coverage of the term "personalized medicine" (n = 118 newspaper articles) and on medical implants (n = 256 newspaper articles) in Germany (published between 2008 and 2013) illustrate patterns of how journalists offer diverse frames of interpretation to lay audiences. Scholars in biomedical implant innovation and their institutions can benefit from taking these frames into account in order to bridge gaps of missing background knowledge or to counteract overgeneralization of past scandals with (breast) implants. This way, empirically informed communication strategies will satisfy public requirements for transparency and science-public dialogue so that sustainable trust in biomedical implant innovations can evolve.

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Section: Discussionmentioning

confidence: 83%

Section: Resultsmentioning

confidence: 99%

Section: Research Objectivementioning

confidence: 99%

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Communication as integral element of biomedical implant innovation

et al. 2016

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“…The demographic and mobility of women that undergo breast augmentation predisposes them to less than the perfect follow-up and leaves room for a more robust implant registry, superior to the current simple system of voluntary reporting which is susceptible to low-data capture rates [11].…”

Section: Discussionmentioning

confidence: 99%

The Effects of Q Inside<sup>TM</sup> Safety Technology Micro Transponder on Routine Breast Implant Imaging

Meisamy¹,

Nelson²

2019

OJMI

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Objectives: A recent entry into the silicone gel-filled breast implant market from Motiva Implants (Establishment Labs Holdings Inc., NY, USA) contains a radio frequency identification device micro-transponder (RFID-M), known as the Q Inside Safety Technology, as an added safety feature embedded in the shell of its breast implant. This RFID-M device allows for the rapid unique identification of the implant. Concern for imaging voids due to the presence of the RFID device during MRI screening scans have arisen given its metallic components. Our investigation aims to determine whether the Q Inside Safety Technology RFID-M device in the Motiva Implants Limits the visualization of breast tissue in conventional breast imaging modalities. Methods: Seven patients with Motiva Implants were referred to dedicated diagnostic breast imaging centers for evaluation of their prostheses and surrounding breast parenchyma between January and May 2018. Imaging indications included routine evaluation of implant integrity, evaluation of significant breast symptoms, oncologic follow-up, and breast cancer screenings. Results: Under mammography, the Motiva Implants have a similar contour and mobility to other commonly used implants. The RFID-M is not visible and produces no artifact, allowing for proper visualization and screening of all visualized parenchymal tissues. Under ultrasound, the Motiva Implants are well-visualized in all patients. The RFID-M was not visible in vivo. No related ultrasound artifact was apparent within the lumen or behind the implant as shown in Figure 2(a). Five patients received MRI. The breast parenchyma and axillae were well-visualized in all 5 patients. The RFID-M was found to produce a "butterfly-shaped" susceptibility artifact that projects into the lumen of the breast implant and causes image distortion in some of the surrounding soft tissues and chest wall posterior to the implant. Conclusion:

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“…In this case, however, the manufacturer obtained their CE mark in 1991, but changed the grade of silicone gel in 2001 without notifying the certificate issuer. It is estimated that defective PIP breast implants caused significant harm to over 47,000 women in the UK alone .…”

Section: Clinical Studiesmentioning

confidence: 99%

Medical device regulation: the need for clinical vigilance and oversight

Charlesworth

Zundert

2019

Anaesthesia

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The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

Cited by 29 publications

References 10 publications

Communication as integral element of biomedical implant innovation

Communication as integral element of biomedical implant innovation

The Effects of Q Inside<sup>TM</sup> Safety Technology Micro Transponder on Routine Breast Implant Imaging

Medical device regulation: the need for clinical vigilance and oversight

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The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

Cited by 29 publications

References 10 publications

Communication as integral element of biomedical implant innovation

Communication as integral element of biomedical implant innovation

The Effects of Q Inside&lt;sup&gt;TM&lt;/sup&gt; Safety Technology Micro Transponder on Routine Breast Implant Imaging

Medical device regulation: the need for clinical vigilance and oversight

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The Effects of Q Inside<sup>TM</sup> Safety Technology Micro Transponder on Routine Breast Implant Imaging