Health regulator told of PIP implant dangers six years ago
The UK’s healthcare regulator first knew about the potential dangers of the PIP breast implants five years ago, and yet allowed thousands more women to have industrial-grade silicone inserted into their bodies.
Even as late as last December – when the French regulators urged women to have their PIP implants removed – the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) was still in denial, calling for further evidence.
Yet surgeons had first told the MHRA of their concerns about the PIP implants as early as 2006, and were also writing in the medical journals. One surgeon noted that silicone from a PIP implant had migrated to a lymph node.
The PIP implants had been approved in 2000 on the understanding that they use medical-grade silicone – something that the manufacturer never observed.
Holland’s health regulator has not been so relaxed, and has called on all women to have their PIP implants removed immediately. It has said that the implants have a high risk of rupturing – something that the UK authorities have continued to deny.
Overall, hundreds of thousands of women throughout the EU and Latin America have had PIP implants.
The extent of the problem came to light only last December when the French authorities reported the death from cancer of a woman who had PIP implants, and estimated the rupture rate could as high as 7 per cent.
(Sources: Lancet, January 11, 2012; ABC News, January 11, 2012).