Issues such as the 1,000s of faulty breast implants provided to women in France and the U.K. are indicative of a weak foundation for medical device approval, said challengers of the European Union’s CE Mark med-tech approval process.
Under the CE Mark system, regulatory authorities have no control over the how devices are actually made, relying on "design specifications" to render approval decisions, patient safety expert Brian Toft said in a meeting with U.K. health minister Simon Burns in September 2011.
Toft has been a vocal advocate for change in the CE Mark pathway, calling it "a smokescreen for faulty and dangerous devices that place patients at risk."
Late last year, news broke that France was considering a recall of 30,000 sets of breast implants supplied by Poly Implant Prosthese over concerns that they might contain a non-authorized silicone gel known for high rupture rates.
"We have to remove all these implants," Dr. Laurent Lantieri, a plastic surgeon on a special committee investigating the issue told reporters at the time. "We’re facing a health crisis, linked to a fraud."
By then, 523 women had already had the implants removed and 2,000 had filed complaints, spurring French authorities to launch a criminal investigation into PIP. British officials launched their own investigation a couple of weeks later.
Toft, who is a professor of patient safety at Coventry University in the U.K., highlighted ineffective regulatory checks for allowing the sub-par products on the market.
The PIP implants evaded notice despite inspections at manufacturing facilities because the company was given 10 days notice prior to the check and workers concealed the problem silicone, according to the Independent. There were more than 100 product alerts issued by the Medicines & Healthcare Products Agency last year, according to the news source, but the agency can’t act unless a failure is reported.
Toft isn’t the only one calling for change in the CE Mark system.
During the European Society of Cardiology meeting in Paris last August, physicians called the regulatory pathway too lax in review of potentially dangerous products.
The European system is often cited as an example of how the FDA’s med-tech review process might be faster and more efficient, but doctors at the ESC conference had harsh words for the CE Mark pathway, saying it uses the same structure to review pacemakers and electric toasters.
"Where there have been isolated instances of devices that were associated with complications, those have disproportionately occurred in countries that have earlier approval – and that tends to be Europe," Cardiff University cardiologist Dr. Alan Fraser, who led a E.U. regulatory review panel at the ESC meeting, told reporters at the time.