In response to news that an independent group of experts led by Sir Bruce Keogh has published their final report following the PiP implant investigations, the President of the Royal College of Surgeons has called for a mandatory database for all surgical implants “as a minimum”.
The Final Report of the Expert Group concludes that the breast implants, despite containing non-medical grade silicone, do not show any evidence of potential harm to human health but may cause local reactions in a small proportion of women if it the implant ruptures. Unfortunately, the report also confirms evidence that the rate of rupture for PiP breast implants is higher than other brands – 15 to 30 per cent after ten years compared with 10 to 14 percent for other brands of implant.
The President of the Royal College of Surgeons, Professor Norman Williams, said that the report highlights the need for better regulation and monitoring of all surgical implants:
“The PIP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants.
With the publication of the final report by the expert group, it is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.
It is the view of the College that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques which would provide ongoing patient safety data.
New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long term.”
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