French regulator ANSM is once again finding itself in position it is all too familiar with: The spotlight. After enduring several scandals over the last two years, most notably those related to pharmaceutical manufacturer Servier and implant manufacturer Poly Implant Prothese (PIP), the regulator is again facing uncomfortable questions after it was revealed that device manufacturer Ceraver had marketed hip implants that did not meet EU standards.
ANSM-Agence nationale de sécurité du médicament et des produits de santé, for those who prefer the full title-is a recent addition to the world regulatory stage, having only been created on 29 April 2012. Prior to its creation as ANSM, it was known as Afssaps. But thanks to the deluge of scandals facing the agency, most of the leadership of that agency was thrown out, leaving French officials to reconstitute the agency with new leadership and a new mission: Keep patients safe.
But the regulators' perceived failings haven't strayed far from the public eye. Just two weeks ago, one of the largest-ever trials in French history got underway, with plaintiffs looking for redress against PIP, whose faulty implants have been associated with revision rates that are higher than necessary. Notably, the implants were reported to have been manufactured with a sub-standard, non-medical grade silicone product that some had believed might cause cancer. Those concerns have not been substantiated.
Déjà vu: Another Device Scandal
Now a similar scandal is brewing, albeit at a much smaller scale. At least 650 patients are alleged to have been fitted with hip implants manufactured by French manufacturer Ceraver that do not meet the EU's CE marking standards.
In a statement, ANSM said it had found "significant irregularities" with how the device, Cerafit, was placed on the market and used by surgeons. "Notably, four experimental rods were implanted in some patients outside the context of a clinical trial authorized in Ambroise Paré Hospital in Paris, which was also inspected," the regulator added.
Other findings included that the design of the device and several of its iterations were not approved by a notified body or subject to CE marking.
The findings were made in April 2013 during what regulators implied was a routine inspection of the company's facilities and activities. At this time, no specific health risks have been identified, but ANSM said it has moved to suspend the device's marketing clearance and recall all remaining devices, of which there are an estimated 1,000.
In a statement, Ceraver, the manufacturer of the device, said it wanted to "reframe the issues raised" by regulators, saying that none of its prosthetic devices presented a risk to human health, and that "no incident has been identified" since 2006. The company also said that the devices had in some cases been subject to CE marking, but that "minor" changes had been made that had taken them out of compliance.
The new scandal comes just as the EU is looking to overhaul the manner in which it regulates medical devices.
At present, the EU system is principally overseen by notified bodies, which conduct much of the work of regulators and test products for compliance. Under the newly-proposed system, the European Medicines Agency (EMA) would act as a central regulator charged with evaluating some medical devices before they would be allowed on the market.
Further difficulties with ANSM could potentially add ammunition to that proposal, put forth by Dagmar Roth-Behrendt.