Regulatory Focus™ > News Articles > Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

Posted 19 January 2012 | By Alexander Gaffney, RAC 

As the uproar over the faulty breast implants manufactured by French manufacturer Poly Implant Prothese (PIP) continues to unfold, an unwitting casualty may be the US medical device lobby, which has spent the last several years urging the US Food and Drug Administration (FDA) to loosen regulations to be more in line with EU regulatory standards.

The US medical device lobby, led by an association of medical device manufacturers called AdvaMed, has labeled the way the Center for Devices and Radiological Health (CDRH) regulates devices as inconsistent, inefficient and inadequate. A 2011 study conducted for AdvaMed by the Boston Consulting Group concluded that the EU's system of medical device regulation was superior to the US's when graded on the metrics of recalls, approval times and patient safety.

CDRH's Director, Jeffery Shuren, fired back a month later when he suggested that EU regulators were treating their citizens like "guinea pigs", and highlighted that EU regulators do not require proof of effectiveness before allowing a product to be marketed. The comments started a war of words between US and EU regulators, leading the head of the European Commission's Health and Consumers Department to scold Shuren for trying to "publicly discredit the regulatory system in Europe."

Now, that argument may be moot, as FDA successfully avoids a scandal that is causing consternation in the EU.

Breast implants sold by PIP have been reportedly rupturing at an abnormally high rate, and further reports have indicated that the company used unapproved industrial-grade silicone instead of the approved medical-grade silicone. In an interview Reuters, PIP's lawyer, Yves Haddad claimed that PIP's manufacturing plant had done without inspection until 2010, when French regulatory authorities at AFSSAPS received an anonymous tip that the company was not in compliance with regulations.

In response to public outcry, a number of EU regulatory agencies have come out in support of tougher regulation on medical devices. European Medicines Agency (EMA) Executive Director Guido Rasi, French Health Minister Xavier Bertrand, UK National Health Service (NHS) Secretary Andrew Lansley, and European Commission Health and Consumer Policy Spokesperson Frederic Vincent have all called for tougher regulations on medical device manufacturers.

According to Rasi, this could bring the regulation of medical devices more in to line with the way drugs are currently regulated by EMA. "I see an urgent need to regulate devices at the same level of science and attention as with drugs," said Rasi. Bertrand mirrored those sentiments, while Lansley is launching his own investigation in to the matter with an expert review group led by NHS Medical Director Bruce Keough.

The journal The Lancetcame out last week in support of FDA, noting that regulatory vigilance had spared the public in this case, and calling for other countries to learn from the PIP regulatory crisis.

The debate over medical device regulation in the US may be more difficult now for US device manufacturers, notes Bloomberg. With the deadline for the Medical Device User Fee Act fast approaching, Congress may pause to reconsider how forcefully they wish to press the issue in light of the PIP scandal and other recent device failures in the US.



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