Regulatory Focus™ > News Articles > UK Disagrees with Sweden on PIP Breast Implant Removal

UK Disagrees with Sweden on PIP Breast Implant Removal

Posted 06 June 2013 | By Louise Zornoza

A new report by Sweden's Medical Products Agency and the National Board of Health and Welfare recommends that breast implants manufactured by now-defunct French manufacturer Poly Implant Prothèse (PIP) should be removed from patients for preventative reasons, except in individual cases where there are medical reasons for not doing so. 

However, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a public statement reiterating its position that the silicone contained in implants manufactured by PIP does not pose a long-term risk to human health and that the siloxanes-silicone derivatives which are widely used in consumer products such as hair and skin products-in PIP implants also pose no significant risk to health. 

As a result, MHRA did not recommend removal of the implants but noted that it would "speak to the Swedish health authorities to explore the basis for their advice."

The Medical Products Agency decided to ban PIP silicone gel-filled breast implants in March 2010. The French governmental agency Afssaps had found that the silicone gel which was used in the product differed from that which was listed in the technical documentation. Approximately 4,000 women had, by then, received PIP implants in Sweden. The global figure is estimated at about 400,000.


MHRA Statement on PIP Implants

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