BAPRAS response to recommendation from the Swedish Medical Products Agency

6th June 2013

 

Graeme Perks, President of BAPRAS and a consultant plastic surgeon, said:

"The Swedish Medical Products Agency has newly recommended that PIP implants should be removed for preventative reasons, reporting that one  of the types of PIP implant contains an irritant substance, octamethylcyclotetrasiloxane (D4), resulting in tissue inflammation in about one third of cases, according to their statement.

"BAPRAS would like to reassure women and those reading press reports that whilst we know that PIP implants are significantly more likely to rupture, toxicity analysis conducted by the Department of Health's expert group found that the silicone contained in PIP breast implants does not pose a long-term risk to human health.
"The UK experts looked at siloxanes - silicone derivatives which are widely used in consumer products such as hair and skin products - and were satisfied that, at the very small concentrations found in PIP implants, these compounds pose no significant risk to health.
"BAPRAS is liaising closely with the Department of Health, devolved health services across the UK and MHRA, which is in contact with the Swedish health authorities to explore the basis for their advice. BAPRAS awaits a response from the MHRA following these discussions.

"In the meanwhile it is critical that all the women involved feel fully supported and our advice remains the same; they should return to their implanting clinic for a consultation and that clinic should take full responsibility for supporting them. However, if women are not getting the help they need, then they should talk to their GP and be referred to an appropriately qualified surgeon operating within the NHS."

 

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