Written by: Barbara Hamilton-Bruce
Advice on PIP implants
You might have read reports about ‘dodgy’ breast implants from France. If you have been following the news and have had breast implants manufactured by Poly Implants Prothese (PIP) you might well be anxious, maybe terrified. There is a lot of information, some conflicting, on the risk but whether the risk of rupture is 1%, 5% or 7% the risk of being contaminated with non-surgical silicone is not something that anyone could have consented to.
By way of background the French medical regulators identified that PIP was producing and retailing implants containing non-medical silicone – a fraud with potentially significant medical implications. Amongst the chemicals used in the manufacture were Baysilone, Siopren and Rhodorsil more commonly used as fuel additives or in the manufacture of rubber tubes. The products were distributed widely across Europe at a price significantly lower than other products available in the marketplace. The French authorities shut down the business and banned the products in 2010. British authorities took action to prevent import in response. It is believed that around 45,000 British women may have received PIP implants.
The PIP news is not ‘new’ but it has been pushed further into the area of general interest following action by the French Government in December urging those people with implants to consider urgent and publicly funded removal due to the risk of implant rupture.
Were does this leave UK patients? If you have had breast augmentation and do not know whether the implant was manufactured by PIP you can make the request to the company or surgeon who carried out the surgery. If a simple request for information is not acted upon then a request can be made under Data Protection legislation (known as a Data Subject Access Request) which may attract a small fee.
The breast implant itself is a ‘product’ and you might benefit from general consumer protections: products must be fit for purpose and of suitable quality and safety. If you suffer injury as a result of a defective product you are entitled to compensation for physical and emotional injuries and financial costs in the same way as if you were injured in, say, a road traffic accident.
A number of law firms have already taken action on behalf of clients and have, in many cases, secured free corrective treatment which includes replacement of the defective implants from the clinics and continue to deal with their compensation claims under ‘no win no fee’ arrangements. Public funding (or legal aid) currently remains available for clinical or medical negligence cases (subject to tight income thresholds) but it is possible that cases do not involve any element of negligence on the part of the clinicians or will be more suited to action under the ‘strict liability’ consumer protections.
If the private clinic is no longer trading matters become slightly more complicated but there are generally routes to redress if liability insurers can be identified. However, free corrective treatment stops being an interim option unless the British Government changes its stance on assistance. At the time of writing the Health Secretary, Andrew Lansley has ordered an urgent review – and the advice from British Medical Regulators is that there is no medical need for removal (in the absence of a GP referral due to identified health concerns). If you were to choose to undergo treatment at your own cost this could form part of any compensation claim.
Many of breast implants will have been purchased through surgery conducted outside of the Britain. PIP implants were distributed across Europe (under the PIP and Rofil M names) and possibly, due to their cost, would have been attractive products for ‘cut price’ surgery. The number of British women receiving implants in this way is not known. The right to claim will depend on the laws of the country where the clinic was based and it is probable that specific advice will be required on these points.