PIP implants – from CE marks to ISO accreditation?


The French court ordered TUV Rheinland was ordered to pay compensation to victims of defective PIP breast implants.  The French regulator, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), probably regrets delegating this task to them in the first place.

Insight: In PIP implant scandal, a ragged safety net exposed | Reuters

Here’s one British assessment of the situation from 2013, before the French court ruling.

Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013;106(5):173-7.

The Implant Files reveal that parliamentarians in France aren’t happy with the medical devices market.

The two-person commission, French parliamentarians Julien Borowczyk and Pierre Dharréville, offered particularly scathing criticism of device-approval controls now in place across Europe and the potential conflicts of interest in the device approval process, which relies on so-called Notified Bodies, mostly private firms that are paid by device manufacturers themselves.

“The essential place entrusted to these audit bodies … has led to a complete bankruptcy of the health control system for placing [devices] on the market,” the report said.

The commissioners said that the current regulatory regime has never been robust enough to resist the influence of profit-driven device manufacturers intent on speeding products to market even in cases where testing could have been more robust.

“This balance between the manufacturer’s … impulse and the ability of the regulator to counter it, where it poses health safety risks, is probably at the root of the now well-known failures of the control system,” the report said, adding that the current regime “has not undergone a fundamental change, despite successive reforms.”

As a solution, the Commission produced a range of options, including transferring responsibility for assessing high-risk devices, including implants, to a new department within the European Medicines Agency “on an equal footing” with the EMA’s work regulating drugs.

Such a centralized agency, which echoes the system in the United States in which the Food and Drug Administration is the sole authority over device approval, has been proposed over the years by reform advocates both at the European Commission and the European Parliament. As the International Consortium of Investigative Journalists reported, the idea was strenuously opposed by industry lobbyists, sometimes using misleading claims, and ultimately defeated.

Their solution is likely to involve turning from CE marks to much more demanding ISO accreditation that has also failed in many industries.  What else have they got?

We’re going to have to wait and see how that works out.

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