http://www.walesonline.co.uk/news/health-news/2010/09/04/welsh-lawyer-urges-breast-implant-gel-testing-91466-27198084/
Sep 4 2010 by Madeleine Brindley, Western Mail
Preliminary tests by the Medicines and Healthcare Products Regulatory Agency found the material used in the common PIP implants is not a potential cause of cancer.
But more extensive tests on the implants are still being carried out in France.
The results of the tests were revealed as a Welsh solicitor is pursuing claims on behalf of more than 140 UK women who were fitted with the implants.
Mark Harvey, a partner at Welsh law firm Hugh James, called for the testing to be speeded up “as a matter of urgency”.
The Poly Implant Prosthese implants were withdrawn in March amid reports of ruptures and leakage. The French manufacturers went into liquidation shortly afterwards.
The French authorities accused the company of fraudulently using a non-approved silicone gel in the implants for almost 10 years.
The MHRA yesterday said its tests had found no evidence of genotoxicity – the potential to cause cancer – or chemical toxicity in the filler material.
Dr Susanne Ludgate, director of devices clinical at the MHRA, said: “It’s reassuring that our test results have shown no evidence of any associated risks with the filler material.
“We are however waiting for the results of the French tests, which are more extensive and include mechanical testing of the implant shell because there maybe a suggestion of an increased rupture rate compared with other breast implants.
“We will update clinicians and women once these test results are available and provide further advice on patient management as necessary. If women have any concerns, they should speak to their implanting surgeon.”
It is not known how many women in the UK were fitted with PIP implants – one estimate has suggested there are up to 50,000 implants in the UK alone.
Most of the women fitted with PIP implants – one of the cheapest on the market – were told they would not leak.
But scores of women were told their implants had ruptured after they discovered a lump.
Mr Harvey said: “It is obviously of great comfort to us all – and particularly our clients who have suffered ruptured implants – that the initial tests results reveal no serious danger to their health, but they remain anxious for the results of the French authority’s more detailed studies.
“However it remains a significant concern to us all that these implants not only rupture prematurely but leak silicone when they were promised that by their very design they would not and could not.
“For those of our clients whose implants have not yet ruptured this remains a source of considerable worry to them.
“We call on both the French and UK licensing authorities to speed up their testing as a matter of urgency and also for all the clinics who were involved in the implantation of these prostheses to co-operate with us in providing our clients with urgent remedial treatment wherever it is needed.”
Nigel Mercer, president of the British Association of Aesthetic Plastic Surgeons, said: “We would like to praise the MHRA for their proactive response in conducting safety tests and are delighted that there is little risk to patients from the gel.
“Hopefully this will reduce the anxiety of patients while further studies are expected from France.
“Our advice remains that women with suspected rupture contact their surgeon and undergo an ultrasound and removal, as they should with any ruptured implant.”
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