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Monday 24th October 2016

Criticism over faulty implants progress

1st November 2012

MPs have criticised the European Commission over its response to protecting patients from potential harm from medical implants.

houses of parliament

The Parliamentary Science and Technology Select Committee says the EC is not acting quickly enough and that current Europe-wide regulation on medical implants, such as hip replacement joints, is not as effective as it should be.

The EC is revising the regulation, but changes are not expected to take effect until at least 2015, which the MPs say is not soon enough.

Select Committee chairman Andrew Miller said: “I think in the interests of patients we would get a better system in place if the commission speeded up the process to revise current regulations.

“There is an urgent need for more transparency in the regulatory system so that patients and doctors know where their implant is coming from, and crucially whether the product has previously been turned down by other regulatory bodies.”

At present, devices need to have the CE mark of Europe-wide approval.

The committee was also concerned that some patients may be given medical implants that have had limited safety testing and has called for compulsory reporting by doctors of faulty products.

The British Association of Aesthetic Plastic Surgeons welcomed the government’s move to better regulate all CE-marked medical devices.

“In particular,” said consultant plastic surgeon and former BAAPS president Nigel Mercer, “we praise the call for all existing evidence on medical devices to be published immediately.

“Without these changes the public cannot be sure that they can ever be safe from another PIP-like fiasco.”


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