PIP IMPLANTS – THE LEGAL POSITION

It is estimated that some 40,000 women in the UK have received the potentially faulty PIP (Poly Implant Prostheses) breast implants.  PIP, a French company now in liquidation, manufactured the implants (which may also have included chest and testicle implants for men) using an industrial grade silicone gel, which reportedly is also used as a mattress filler, rather than the more expensive medical grade silicone.  

About PIP implants

PIP implants are believed to have a higher rupture rate than other silicone implants. Transform believe the figure to be approximately 7% (one in fourteen), but an 18 month study conducted by plastic surgeons Jan J. Stanek FRCS and Miles Berry MS FRCS (Plast) puts the failure rate much higher, about one in every four (25%).  Mr Stanek believes his study to be accurate, because he gave all his patients who took part in the study an ultrasound scan which revealed the ruptures.  The Government’s recent review has been unable to confirm whether the PIP implants have a higher rupture rate than other silicone implants (average 1%).

Symptoms after a rupture include swelling, pain, burning, lumps and hardness.  The implants have also been reported to leak without causing noticeable symptoms.  Disturbingly, it has been suggested that the PIP silicone could cause cancer.  The Department of Health has issued a statement saying its expert group have not reported a link with the disease.  However, in France the family of a woman who died from a rare form of cancer are pursuing a manslaughter case against PIP, as they believe her cancer to have been linked to the implants.   The French Health Ministry deny there is a link to the disease.

What can be done?

Women who have the PIP implants will have to decide whether to have surgery to remove the implants, which will involve putting themselves through the trauma of an operation, or whether to do nothing.  The NHS says it only advises women to have their implants removed if they are experiencing symptoms of pain or tenderness.

The Department of Health has said that the NHS will remove and replace implants for those women who originally had the surgery done by the NHS.  If the implants were done by private organisations, women are advised to speak to the organisation who carried out their surgery and Holly House, Highgate Hospitals, Make Yourself Amazing, Ramsay Health Care, Spire Healthcare, BMI Healthcare, Nuffield Healthcare and HCA International have said they will replace implants for free where clinically necessary.  For those whose private clinics no longer exist or refuse to remove their implants, women are advised to speak to their GP to see if the NHS will remove them (but not replace, unless clinically necessary).  Otherwise women will have to fund the cost of removal (and replacement) themselves.

Is there a claim for compensation?

In respect of private clinics, a contractual claim can be brought against the clinic (or their public liability insurers) for personal injuries suffered.  Women will be able to rely on consumer protection legislation (section 14 of the Sale of Goods Act 1979) to assert that the implants are not of satisfactory quality.  

Against both private clinics and the NHS, a claim is more difficult but argument can be made that there are claims:

* In negligence – ‘Alarm bells do have to ring when a product is 5 times cheaper, let’s say, than the next available product’ – John Pereira, Consultant Plastic Surgeon at McIndoe Surgical Centre.  This argument would be that surgeons should have been suspicious as to the quality of the product because of its consequences particularly in view of the reports questioning the safety of PIP implants which appeared in the British Journal of Plastic Surgery in 2005. However, a likely defence would be point to the Medicines and Healthcare products Regulatory Agency (MHRA) approval of the implants and the apparent legitimacy of PIP.

* Possibly a claim direct to the MHRA itself for approving the use of the PIP implants and not taking investigatory action and banning the implants quickly when problems and concerns were first identified.  Such a claim would not be easy.

* Under the Consumer Protection Act 1987, although such a claim would need to be brought against PIP (as the manufacturer of the product) or more appropriately, their public liability insurers (although the extent of the cover is as yet unknown).

What could be claimed for?

In a personal injury claim, a claim can be made for general damages (for an injury) and special damages, which are all of the claimant’s out of pocket costs associated with the injury (for example, lost earnings during recovery time, or the cost of the operation to remove and/or replace the implants).  In these circumstances the injury would include any damage caused by the implant leaking or rupturing and for the pain and suffering associated with the additional surgery.  Some women may develop a psychiatric injury due to the stress and anxiety of discovering the suspected dangers associated with their implants and damages can be recovered for that injury too.  It is further arguable that damages for mental trauma (which in itself is not a recognised psychiatric injury) could be sought.

Legal advice is now available in Newmarket and Edmondson Hall injury lawyer Deborah Hargreaves is a member of the Association of Personal Injury Lawyers and has been specially trained in cosmetic surgery litigation.  Edmondson Hall offer a ‘no win no fee’ agreement, where you would retain 100% of your damages and the initial consultation is free.  Hopefully this will be reassuring to the many thousands of patients who are now in a dilemma as to what they should be doing.

To contact Deborah Hargreaves by email click here