Peer-reviewed case reports and studies show that toxic chemicals in the shells and fillers of PIP Implants seep out into surrounding body tissue, migrate into body organs, can cross the placenta and can be found in breast milk. These toxic chemicals make women very sick and many report debilitating symptoms. Women everywhere with TOXIC PIP implants are suffering, they are being poisoned, they are frightened, they are extremely anxious and in pain.
All TOXIC PIP implants are non-compliant, they should be removed, they are dangerous and have a devastating impact on us, our families and our long-term health!
TÜV Rheinland, the Notified Body responsible for issuing the CE Marking to PIP, took more than 10years to identify the shocking human experiments at the PIP factory. They have spent the past five years whining they are also victims of the fraud.
The CE Marking is often mistaken for a symbol of quality or safety, it emerges it is neither. It is a failed system of self-certification which enables manufacturers to place unchecked products onto the European & international markets.
Breast implants, like prosthetic joints, cardiac stents, pacemakers, surgical mesh, are high risk, implantable medical devices which surgeons are implanting under the misapprehension they are reliably safe.
A documentary broadcast in The Netherlands recently showed just how inadequate the regulations are when it obtained a CE Marking for a new medical device which was in fact the orange coloured plastic mesh bags we buy our tangerines & clementines in.
Failed medical devices regulation is of concern to us all.
TÜV Rheinland argue they are victims of the PIP fraud. They say the evidence of the fraud was cleverly concealed. However, a simple check of the original bill of materials would have revealed no medical grade silicone was being delivered to the third largest breast implant manufacturer in the world!
TÜV has substantial Enforcement Powers: it can test product samples, recall & test product batches, bring criminal charges against a manufacturer where there are concerns. TÜV did nothing. They were responsible for conducting systems management & manufacturing checks on PIP for more than a decade and saw nothing of concern.Things would have continued too, but a woman with ruptured PIP implants died in 2011. The first, thorough investigation of PIP, conducted over three days 16-18 March 2010 by the French regulators, exposed the most shocking health fraud imaginable.
However, the scandal only starts here. It emerges that a non-compliant medical device that has been implanted into the body doesn’t have to be recalled! Leaking, ruptured, toxic, non-compliant PIP implants are still in women’s bodies today!
The series of catastrophic failures in the regulation of medical devices such as metal-on-metal hip prosthetics, surgical mesh and PIP implants have revealed dangerous flaws in the regulation of the medical devices, cosmetics, aesthetic surgery, health, silicone & chemical industries. The PIP scandal shows how failures to provide women with a Duty of Care, consumer protection, victim support, best practise guidelines, adequate scientific reviews, government reports or risk assessments are linked to the deeply ingrained negative stereotyping, discrimination and victim blaming at the heart many European and international governments.
Women’s Health Matters!
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