Looking to get tough after a breast implant scandal caused an international sensation, a committee of the European Parliament has made several proposals to increase device safety. These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system--among other items--to prevent future such episodes involving implantable devices.
The Environment and Public Health Committee passed the resolution unanimously yesterday making these recommendations as health regulators attempt to coordinate with each other to communicate about adverse events involving medical devices.
The Poly Implant Prothèse (PIP) scandal rocked Europe earlier this year, after it was revealed that the now-defunct implant maker had made substandard products. Although it is unknown how many women received them, an estimated 400,000 were sold worldwide. In fact, earlier this month, a study published online in the Journal of Plastic, Reconstructive and Aesthetic Surgery determined the company's implants had a rupture rate that could surpass 33%. Initial studies set the failure rate at between 2% and 5%.
Those numbers are shocking, and it seems as if politicians are starting to get serious. The resolution doesn't mince words when taking the member states to task over the lack of communication. Indeed, the scandal "has shown a malfunctioning at European and national levels, notably a lack of cooperation (…), and a lack of traceability of raw material used for medical devices," the resolution states. And this situation just isn't sustainable.
"It is essential to learn from this [PIP] fraud and to strengthen surveillance and safety controls and placing on the market requirements" for medical devices, states the resolution. The EU is revising legislation on this front this year. In addition, healthcare professionals need to be able to report adverse events and other device-related problems "without being hampered by a great deal of red tape," the resolution continues. In addition, the committee members called for a shift to a pre-market authorization system, and patients must be made aware of breast implant risks.
The members also pushed the introduction of a breast implant register in each member state. The members emphasize the registers should be interconnected between states to facilitate the exchange of information, for example, when device defects are detected.
Also, there should be a single European database that readily provides information about medical devices on the market, clinical investigations, EC certificates issued, as well as other relevant information, the members state.
How far these proposals go remains to be seen. But they come soon after the FDA touted the superiority of the device regulatory process in the U.S. versus Europe. Sure, industry may claim the EU system is quicker and better, but it often allows the introduction of unsafe products to the market. That said, the FDA faces its own criticisms about device approvals and oversight, particularly after recalls involving vaginal meshes and hip implants.
- check out the release