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In perPIPtuity

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More news in the long-running PIP breast implant saga this week from Sweden (http://www.lakemedelsverket.se/english/All-news/NYHETER-2013/PIP-implant...). Their Medical Products Agency has examined PIP implants and concluded there to be 2 types, one of which has higher than normal levels of a compound known as D4 (octamethylcyclotetrasiloxane). This has been found to produce tissue irritation in about a third of women from whom PIP implants have been removed. Whilst they can see ‘no immediate health risk associated with these implants’, preventative removal has been recommended for the 4000 women implanted in Sweden as it is not known which women have these implants.

This follows last month’s paper in the Journal of the Royal Society of Medicine (http://www.rsm.ac.uk/media/pr318.php), which reported that D4 has been identified as an endocrine-disrupting chemical (EDC): EDCs have been shown to affect the developing foetus. Furthermore, the article drew attention to the reliance of June 2012’s UK Keogh report (https://www.gov.uk/government/publications/final-expert-report-on-pip-br...) on animal-based data.

As BAAPS pointed out recently (http://www.baaps.org.uk/about-us/press-releases/1653-analyse-this-surgeo...), analysis of implants taken from actual patients rather than off-the-shelf would given more of an understanding of what is actually happening when these implants come into contact with human tissues. Somewhat ominously, mention of an earlier ‘scandal’ involving Trilucent (soyabean) implants reminds all that the unexpected biological reaction was what prompted their removal. For the last couple of years we surgeons have been diligently recording our findings at operation (some devices have become unusually yellowed, others have significant apparent leak, or ‘gel bleed’ and yet others appear entirely intact) and reporting to the MHRA – we await with interest their analysis.

Finally, two clinical studies of PIP-implanted women are just about to be published in the Journal of Plastic Reconstructive & Aesthetic Surgery (http://www.jprasurg.com/article/S1748-6815(13)00257-X/abstract; http://www.jprasurg.com/article/S1748-6815(13)00278-7/abstract). Both have confirmed the rupture rate to be of the order 30%. Both have demonstrated ultrasound scan to be highly accurate for rupture and one suggested that 30% have ruptured implants of which they were otherwise completely unaware (http://www.jprasurg.com/article/S1748-6815(13)00257-X/abstract). It will be interesting to see how the UK government responds to their patients’ concerns.