We remain in the midst of the Poly Implant Prothèse (PIP) fiasco and its attendant
acquisition of practical experience. Since the formal withdrawal of PIP's devices
in March 2010,
1
and latterly the lymphoma scare, global advice has varied with France, Wales and
others recommending funded implant exchange whereas Britain's National Health Service
(NHS) continues to sanction explantation only. Given that the vast majority of the
estimated 80,000+ UK implants were through the independent sector (a little over 3000
being undertaken by the NHS), patients find themselves in the invidious position of
having to make an informed choice without a strong medical evidence base and clear
advice. News worsened recently
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON076513 issued 31st March 2010.
2
with the MHRA extending their recall retrospective to January 2001 so that now all
of PIP's silicone devices are subject to doubts about their gel composition.http://www.mhra.gov.uk/NewsCentre/CON146714 issued 15th March 2012.
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References
http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON076513 issued 31st March 2010.
http://www.mhra.gov.uk/NewsCentre/CON146714 issued 15th March 2012.
- The PIP mammary prosthesis: a product recall study.J Plast Reconstr Aesthet Surg. 2012; 65: 697-704
AFSSAPS Medical Devices Evaluation Direction. Silicone based filling gel breast implants from Poly Implant Prothèse Company: update of test results, issued 14th April 2011.
- Diagnosis of silicone gel breast implant rupture by ultrasonography.Plast Reconstr Surg. 1996; 97: 104-109
- The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis.Plast Reconstr Surg. 2011; 127: 1029-1044
- High-resolution ultrasound in the detection of silicone gel breast implant shell failure: background, in vitro studies and early clinical results.Aesthet Surg J. 2012; 32: 157-174
Article info
Publication history
Published online: May 28, 2012
Identification
Copyright
© 2012 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Inc. All rights reserved.
