On February 9 European Health and Consumer Policy Commissioner John Dalli called for immediate action from the EU to ensure stringent implementation of the current legislation on medical devices. This was in response to the fraudulent use of non-medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company inFrance. The European Commission is now scrambling to tighten controls on the approval of medical devices and restore patient confidence.
Actions proposed by Commissioner Dalli include:
- Verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence
- Ensure that all notified bodies in the context of the conformity assessment make full use of their powers, including conducting unannounced inspections
- Reinforce market surveillance by national authorities, in particular, spot checks in respect of certain types of devices
- Improve the functioning of the vigilance system for medical devices – for example, giving systematic access for notified bodies to reports of adverse events and enhancing coordination in analyzing reported incidents
- Support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers
In addition, the European medical device industry trade association Eucomed has suggested using “only the best” notified bodies, developing a single approach to vigilance and market surveillance, and strengthening harmonized standards.
There is no doubt this will have impact to those U.S. companies working in European markets
“Some doctors, regulators, and even the medical devices industry itself say this affair exposes Europe’s weak regulation system, one that allowed PIP to operate for longer than it could have under a more rigorous regime,” says Kate Kelland in the February 3, 2012 issue of Insurance Journal.
In fact, she points out that the FDA rejected PIP’s application to sell its breast implants in 2000, over a decade ago, for failure to investigate deflation problems and not disclosing the many complains the company had already received from women around the world.
Medical devices are regulated under the Conformité Européenne (CE mark) system in Europe; however, gaining this designation is relatively easy
“Because Europe has no centralized process for approving medical devices, manufacturers don’t go directly to a national or Europe-wide regulator,” states Kelland. “Instead, they seek a CE mark through any one of 70-80 organizations known as Notified Bodies, which largely are private companies. Scientists who published a review of the system in the European Heart Journal in May 2011 found that the fragmentary setup encourages manufacturers to shop around for countries or Notified Bodies most likely to offer hassle-free certification.”
A 2010 Stanford University survey of medical device manufacturers showed that high-risk devices took an average of 54 months to get through the FDA to market, compared to just 11 months inEurope. The European system is often used as an example of a faster system that works better than the FDA’s. Congress is still considering an overhaul of the device review process and wants to make a decision by the fall. But what sort of impact will the PIP scandal have on the decision-making process?
“Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts,” says Alex Nussbaum in a recent article on www.bloomberg.com. He adds that experts like Carl Heneghan, an Oxford University professor, believe the PIP problem, along with other EU device failures, should give lawmakers pause. “All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” says Heneghan, who is an expert in device recalls. “The flip side is the European people are being used as guinea pigs.”
Rottenstein Law Group in Hewlett, New York hopes the breast implant recall will help convince U.S. regulators that the FDA’s medical device approval process should not be accelerated. In a press release they cite a similar problem where thousands of U.S. women have suffered injuries as a result of vaginal mesh implants that, in their opinion, were not properly reviewed.
“Categorized by the FDA as medical devices that the agency can clear for sale based on similarity to medical devices already on the market, and without the benefit of human testing, the implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having the mesh products implanted,” states the law firm.