BRUSSELS (Reuters) - European Union governments should strengthen safety controls on high-risk medical devices by using spot checks on products and manufacturing facilities after the scare over faulty silicone breast implants, the EU’s health chief said Thursday.
Europe’s weak regulations on medical devices have been partly blamed for allowing French company Poly Implant Prothese (PIP) to manufacture substandard silicone breast implants for up to a decade, and be used by hundreds of thousands of women around the world.
“I am deeply concerned about the potential health impact for the many women, in Europe and in other parts of the world, who received faulty silicone breast implants manufactured by the French company PIP,” EU health and consumer affairs chief John Dalli told a news briefing in Brussels.
“The consequences for their health are still uncertain.”
Dalli said he had written to the bloc’s 27 health ministers and urged them to make full use existing EU rules.
He called for an urgent review of the 70 to 80 regulatory agencies responsible for approving high-risk medical devices in Europe, most of which are private companies.
Within months, EU governments should ensure the agencies, known as notified bodies, are only authorized to assess and approve devices and technologies for which they have a proven expertise and competence, Dalli said.
“I have asked my colleagues in the member states for their personal commitment to implementing these actions as a matter of priority,” he said.
“I know that we all subscribe to the need to put patients first and to restore trust in our regulatory system.”
Responding to Dalli’s statement, the industry body Eucomed, which represents about 22,500 medical technology companies in Europe, said it would support the Commission in strengthening medical devices legislation.
“After analyzing the Commission’s proposal, Eucomed believes the measures are balanced and appropriate and will have a positive effect on patient safety,” it said in a statement.
The Commission said the measures would boost surveillance of a European market for medical devices and diagnostics - worth an estimated 78 billion euros ($103 billion) in sales in 2007 - while it drafted a full overhaul of existing EU legislation in the coming months.
The EU executive has also ordered its scientific experts to carry out a further study into the potential health impacts of the PIP implants, after an initial report found insufficient evidence women using the implants were at a greater risk than others. ($1 = 0.7545 euros)
Additional reporting by Kate Kelland in London,; Editing by Rex Merrifield and Andrew Heavens