'Inconclusive' data about breast implant risks
By Dave Keating
Commission report says more information needed on health risks from
implants made by French firm.
There is not enough data available to fully assess the health risks of breast implants made by French firm Poly
Implant Prothèse (PIP), according to a report published today by the European Commission.
The report into PIP implants was drawn up by the
EU's Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The committee will now carry out a more in-depth study into the
issue. Five EU member states – Belgium, the Czech Republic, France, Germany and the Netherlands – have recommended that women have PIP
implants removed after it was revealed that the company had illegally been using industrial-grade silicone instead of medical silicone in its
implants.
Yesterday, French health authorities published a report that said there were systematic lapses in the oversight of PIP. The report
called for tighter EU safety controls on medical devices that go into the body.
A Commission spokesman said today's report did not mean the
committee had determined that the implants are safe, only that there was not yet enough evidence available.
He said that the revision of the
Medical Services Directive, which is scheduled for proposal this spring, would allow the EU to incorporate the lessons learned from this health
scare.
“Another avenue to be explored is the creation of a so-called UDI – Unique Device Identifier. That would apply per device,
it could be a little microchip or something on the box,” the spokesman said. He pointed to the fact that Denmark was able to quickly determine
how many Danish patients had PIP implants because it has a national register. But many member states do not have such a register.
[European
Voice]
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