Saturday 6 April 2013

PIP Victims Robbed of their Health


Ruptured PIP implants begin leaking as soon as they are implanted in the body.  On removal ruptured PIP implants are accompanied by an emulsion called "milky fluid' shown here.


Thousands of perfectly healthy women and women recovering from reconstructive breast surgery after breast cancer mastectomies have become victims of Jean-Claude Mas, his family and associates greed.  

Mas was employed as a Medical Sales Representative for many years before realising the European and Australian regulations for implantable medical devices were so inadequate that his commercial plan to exploit women would go undetected for many years, earning him millions.

Mas relied on obtaining safety certification of the CE Mark.  Which was taken as a sign of safety by Medical experts before it was clear the CE mark was simply a passport to trade.

No single device was ever tested by TÜV, their audit visits were always announced weeks in advance, giving Mas and his criminal gang time to manage the evidence.

The FDA in the USA weren't so easily fooled.  They visited the PIP plant in France and reported unacceptable non-comformities, they crucially, refused to license PIP implants in the USA.  Effective, responsible regulatory systems do work and the American public were protected from a scandal that began with a company formed by three convicted felons.  Australian and European Regulators failed to take act on this extraordinary warning. 

According to British government ' handful of' senior British surgeons drew concerns to the British Regulator MHRA, higher numbers of Adverse Incident Reports were submitted by patients. The MHRA took the view, after discussion with PIP and the CE certifier: TÜV Rheinland, it was the senior surgeons' surgical techniques that were questioned for PIP ruptures and nothing at all do the with implant manufacturers. Mas and his associated surely had a good laugh while Senior British Surgeons were vilified by the MHRA.

    

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