MSP demands answers from MHRA over inaction on PIP implant warning

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By a Newsnet reporter

SNP MSP Fiona McLeod has written to the UK Government’s Medical and Healthcare Products Regulatory Agency (MHRA) asking what officials did with a letter warning about the risks of PIP breast implants.

Globally-respected Scots surgeon Awf Quaba revealed in a Sunday Mail news report that he had written to the agency in 2006 about his concerns at the high rupture rate of the French-made implants.

Mr Quaba is a plastic surgeon at the private Spire Murrayfield Hospital in Edinburgh.  Mr Quaba ensured that the Edinburgh hospital stopped using the implants due to his concerns about their reliability and safety.

It has since come to light that Poly Implant Prothese, the French company responsible for manufacturing the implants, used cheaper industrial grade silicon instead of the more expensive and higher quality medical grade silicon.  The silicon in the PIP implants was intended for use in products such as mattresses and industrial tubing and had not been approved for use within the human body.  

Jean-Claude Mas, owner of PIP, was arrested in October last year after the French authorities issued an international arrest warrant through Interpol.  After his arrest Mr Mas accused women who were concerned about the implants of “psychological instability”, and insisted that they were “only doing it for the money”.  Mr Mas is currently in hiding, and is facing two separate French police investigations for manslaughter and fraud.

The French health authorities claim that 5% of PIP implants have ruptured since surgery, and the French and other European governments recently announced that they would pay the surgical costs of all women who wanted the implants removed.

In contrast, the UK authorities have refused to pay for removal of implants which were inserted in private medical procedures.  The UK authorities insist that only 1% of the implants have ruptured.  Women who are concerned about their implants have been advised to have a scan to detect whether there is any problem with their implants.  Some 45,000 women across the UK have the implants, of which around 4,000 are in Scotland.

The great majority of implantations in the UK were carried out privately as cosmetic breast augmentation.  Some 5% of PIP implants were carried out on the NHS, usually as reconstructive surgery for women who had a mastectomy due to breast cancer.  On Friday it was announced that the NHS will pay for the removal and replacement of implants carried out on the NHS.  

However the great majority of women with the implants will have to rely upon their private health provider.  Many women have claimed that they are unable to afford additional surgery, or that the private clinic which carried out the operation is no longer in business.

Speaking to the Sunday Mail, Mr Quaba cast doubt on the findings of the MHRA and said:  “A five per cent rupture rate was more in line with our experience in Edinburgh.

“It was also apparent that silicone used in the PIP implant was causing irritation.

“We did everything we could to raise the issue. In 2006, we reported our findings to the regulator as well as the maker and UK distributor.

“The maker and distributor blamed implanting surgeons.  We were unhappy with their explanation, and took the decision in early 2007 to stop using PIP at Murrayfield Hospital.

“This was more than three years before the implants were banned by French authorities.”

Now Fiona McLeod, SNP MSP for Strathkelvin and Bearsden and member of the Scottish Parliament’s Health Committee, wants to know why the MHRA took no action despite receiving Mr Quaba’s warning letter over five years ago.  

Ms McLeod said:

“While there is no evidence for routine removal of PIP implants, it is of the upmost importance that the UK regulatory agency tells us what action was taken when it received the letter from Awf Quaba.

“We need to know if, when these concerns were raised five years ago, did they look into the doubts raised and if so what was the outcome?

“I have written to the UK agency asking for this information to be revealed.

“We know that more than 4,000 Scottish women have been given these implants and they deserve to know what action was taken when Mr Quaba raised his concerns at their high-rupture rate.

“The Scottish Parliament has considered concerns on implants and whilst there is no evidence we should know if Mr Quaba’s concerns were properly looked into.

“The NHS is continuing to offer advice and support to women who have had PIP implants who are, understandably, extremely worried. More evidence is being gathered but at the moment the advice is there is no need for routine removal.

“Patient safety must be our priority and it should always be the priority of the UK regulatory agency.”