Europe wants regulatory reform over PIP implant scandal

pharmafile | January 16, 2012 | News story | Manufacturing and Production, Sales and Marketing EC, MHRA, PIP implants 

The European Commission is seeking regulatory reform for class III medical devices after problems with French-made breast implants.

The French firm Poly Implant Prothese (PIP) developed the PIP silicone gel breast implants, but the company went out of business last year when concerns over the safety of its product came to light.

It has now emerged that its implants were made with industrial grade silicone – rather than medical grade – leading to concerns that they could rupture. 

More than 300,000 PIP implants were sold globally, with around 40,000 patients believed to have the implants in the UK. 

The Commission will set out new proposals later this year that are likely to recommend tougher rules on similar medical devices, but it could take up to three years before they are adopted by member states.

Frederic Vincent, health and consumer policy spokesperson for the European Commission, told the BBC: “[PIP] reinforces our opinion that we have to be tougher on medical devices, particularly class III.”

There are more than 10,000 medical devices ranging from class I devices such as plasters, class IIa and IIb which include X-ray machines and class III, such as breast implants, pacemakers and hip replacements.

In order for a product to be placed on the market in the EU it needs to be given a CE mark to show it has reached health and safety standards. He said the thinking was to keep the CE label, but there could be debate around being “a bit more tough for things like breast implants and pacemakers”.

Vincent said a new directive could ask the member states to be ‘more stringent’ when appointing and monitoring the notified bodies as some were ‘more serious than others’.

He added: “We are dealing with a case of fraud. It means that what happened in France could have happened even with a more stringent pre-market assessment of the products.” 

Once a product is on the market it is the responsibility of national bodies, such as the UK’s MHRA, to monitor the medical devices.

The Commission is also discussing increasing the co-ordination between the national bodies in its new directive.

Government campaign

Over the weekend the government began a new advertising campaign telling those who have had the implants what they can do.

It says there is no need for routine removal, but that women should be able to have the implants taken out by private clinics or the NHS if they are concerned.

But the Harley Medical Group, which fitted more PIP breast implants than any other UK cosmetic surgery firm, says it will not replace them free of charge.

It said replacing the implants would put them out of business. Its chairman Mel Braham said: “We’re only sitting here today because the Medicines and Healthcare products Regulatory Agency (MHRA), their own regulatory authority, has approved these implants and obviously hasn’t done their proper checking.”

He added: “We’re an innocent victim like everyone else, we’re attempting to do our best for our patients.”

The MHRA has not responded directly to Braham’s comments, but in a recent statement it said it is not recommending routine removal.

This is at odds with French, German and Dutch health authorities, which have all recommended that women fitted with banned PIP implants should have them removed as a precaution.

Ben Adams

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