The Keogh Final Report

What it says

NHS Medical Director Sir Bruce Keogh has completed his investigations into the PIP breast implant scandal.  A report published by the Department of Health on Monday 18 June 2012 outlines his findings that the non-medical grade silicone gel used in PIP implants is neither toxic nor carcinogenic.  It concludes that PIP implants do not pose any long-tem health risks to those women fitted with them. 

This is of course reassuring news for the 47,000 women in the UK affected. However the report goes on to confirm that PIP implants are “clearly substandard”, and that they are “significantly more likely to rupture or leak silicone than other implants”.  Further, these ruptures may cause physical reactions such as pain, discomfort and lumpiness in an unacceptable number of women.

Lack of Long term health risks    

The gel material used in PIP implants has been found to be neither toxic nor carcinogenic.  Repeated tests have been carried out in the UK, France and Australia and results confirm that the chemical components of the gel do not present a risk to human health.  Professor Keogh concludes, “tests have shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of the women who have PIP implants.”

Although a test carried out by French authorities suggested that PIP implants could cause skin irritation in rabbits – the latest results from tests carried out in Australia show no evidence of a potential to cause skin irritation.  The gel material in PIP implants is therefore not considered to be an irritant.

Substandard & twice as likely to rupture

Despite this welcome news Professor Keogh went on to say, “We have, however, found that these implants are substandard when compared to other implants, and that they are more likely to rupture.”  Analysis of data provides evidence that the rupture rate of PIP implants is in fact double that of other comparable implants.  The report therefore advises women who have symptoms of rupture – for example pain, discomfort or swelling – to seek medical advice from their GP or surgeon.

Symptoms

Although there is no evidence to suggest that the gel filler is intrinsically harmful, the report does concede that ruptures and significant silicone leakage can cause local tissue reactions and affect the lymph nodes.  President of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, said: “the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of patients.”  

Anxiety

Despite the fact that extensive tests have shown that there is no long-term danger to health, the report emphasised that the anxiety associated with having PIP implants is itself a form of health-risk: “anxiety is…a genuine health issue and may well increase the risk of other health problems.” Fazel Fatah agrees and goes on to say that it is therefore “entirely reasonable for women to have the right to opt for removal – regardless of whether there has been a rupture.”  He continues, “It will come as no surprise to the many women affected that PIPs have been officially confirmed as defective – this has also been our long-held view, and that the choice of removal should be offered to them by their provider regardless of rupture or symptoms.”

Advice

In summary Professor Keogh reiterates the earlier advice provided from the expert group in January 2012:-

He recommends that all providers should contact those patients fitted with PIP implants and offer them specialist consultations and investigate whether or not the implants are still intact; if their provider is unable or unwilling to do this he advises women to see their GP and ask for a referral to an appropriate specialist; if the implants are ruptured women should be offered an explantation; and if the implants appear to still be intact then they should be offered the opportunity to discuss the best course of action with their specialist. 

If a woman wishes to have her implants removed she should be supported in this decision by her healthcare provider.  If her original provider cannot or will not help her then the NHS will remove but not normally replace the implants.

If a woman decides not to have her implants removed then she should be offered an annual check up with her specialist; she should consult her doctor if she notices any signs of tenderness or pain, or swollen lymph glands in or around her breasts or armpits, which may indicate a rupture; and if there are signs of a possible rupture she should be offered removal surgery.

Effect on PIP claims

We believe that Professor Keogh’s final report is extremely helpful in terms of supporting women’s cases because it contains clear evidence that the implants are defective: “PIP implants are clearly substandard”. 

We will now be inviting the Defendants to accept this report as definitive evidence that the PIP implants were defective.  We would hope that the defendants will now concede this point and move to compensating the PIP victims.  However, where defendants are uninsured we have to be cautious since a defendant will need to have insurance in place to pay out the hundreds of women affected by the scandal.

Update on Allianz and the situation in France

As you may remember from the news, Allianz was previously thought to be able to avoid compensating the French PIP victims as Allianz was able to argue that the fraud committed by PIP voided the policy of insurance.  A court in France recently found that Allianz could not avoid the policy of insurance which is very good news for the French PIP victims. 

The implications of this ruling on UK PIP claims is now being investigated as it may mean claimants outside of France can benefit from this ruling. However, it is understood that Allianz intend to appeal the judgment but news on this issue is still awaited, plus their appeal, if they decide to pursue it, may well fail.  

This recent development is an interesting one and may help those victims whose defendant clinics are uninsured or are in administration.  We will provide an update about this news as soon as further information is available.

We are now aware which defendants are insured and are dealing with their PIP claims, although the extent of the defendant’s insurance cover in every case is still unknown.  This does enable us to provide clearer advice on how to go about your PIP claim.  Or, if you paid for your original implants by credit card, in part or in full, whether you would be better advised to pursue a credit card claim instead.

If you have been affected by the PIP scandal and want to know if you may be entitled to compensation, please contact Samantha Robson who heads up the PIP team at Slee Blackwell Solicitors via her website, www.cosmeticsurgerylaw.co.uk or on free phone 0808 139 1592.