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PIP Recall News

In March 2010 the Medicines and Healthcare products Regulatory Agency (MHRA) recalled all silicone gel breast implants in the UK manufactured by the French company Poly-Implant-Prothése (PIP). The recall was in response to similar action taken in France by the French regulatory authority AFSSAPS, who had identified a higher than normal incidence of breast implant rupture and other complications with the PIP breast implants.

An inspection of the manufacturing plant by AFSSAPS revealed that Poly-Implant-Prothése had dispensed with using a protective barrier in the manufacture of the implants – increasing the chances of a breast implant rupture – and that the implants were being filled with an unapproved, cheaper gel, most commonly used in the manufacture of mattresses. The company was subsequently closed down, with owner Jean-Claude Mas being convicted of aggravated fraud and sentenced to four years in jail.

In 2012, the government agreed to fund the removal and replacement of PIP breast implants for NHS patients that had undergone reconstructive surgery; but this did not apply to women who had undergone private cosmetic surgery. Private patients could only have the faulty breast implants removed by the NHS if their doctor agreed that there was a medical need to do so. Only in Wales (where no PIP breast implants were used in private clinics) is it possible to have breast implants replaced on the NHS.

Subsequent to the PIP recall in France, a French court found that insurance company Allianz had failed to prove that it was a victim of PIP´s fraudulent activities, and was ordered to pay compensation to women in France who had suffered an injury due to the faulty implants. However, the limit of Allianz´s liability was 3 million €uros, and the compensation was only distributed among French claimants.

A subsequent case against German safety company TUV Rheinland (the company which certified the implants as being safe) produced a more favourable outcome for PIP claimants from the rest of the world – awarding 17,000 claimants €3,000 immediately for the removal of their faulty breast implants, with a further €13,000 compensation for replacement PIP breast implants to be received at a later date.

In the UK, the High Court endorsed a Group Litigation Order allowing claimants to claim compensation for PIP breast implants on the grounds of alleged breaches of the implied quality and fitness of PIP implants. The PIP Group Litigation Order was made on the basis of legislation contained within the Sale of Goods Act 1979 and Sale of Goods and Services Act 1982.

Of interest was the opinion given by Sir Bruce Keogh – chairman of a government commission investigating the PIP breast implant scandal that “anxiety over possible health risks is a form of health risk in itself” – allowing claimants to participate in the Group Litigation Order, even if they had suffered no physical symptoms of an injury.

It is now too late for women who wish to claim compensation for faulty breast implants to be involved in the Group Litigation Order in the UK, but not too late to join the French action against TUV Rheinland, make a claim against the UK distributor of PIP breast implants, a private clinic (or their former insurance company if the clinic has gone out of business), an individual surgeon or your credit card company if the breast implant procedure was funded by your credit card.

Therefore, if you have any questions about the PIP recall – and whether or not you may still be entitled to claim PIP breast implant compensation – you are invited to contact our free claims advice department for an individual assessment of your case, confidentially and with no obligation on you to proceed with a PIP recall claim for compensation.

Medical Note: If you believe that you are experiencing problems with any breast implant you have received in the past, please do not hesitate to seek professional medical advice as soon as possible.

Judge Disqualifies Seventeen Claimants from PIP Group Litigation Order

August 29, 2014

A High Court judge has refused permission for seventeen potential claimants to join the PIP Group Litigation Order scheduled to be heard in October.

The PIP Group Litigation Order is similar to a class action and allows a number of similar compensation claims for faulty breast implants to be managed collectively against a number of defendants – in the case of the PIP Group Litigation Order, against the Transform Medical Group and four other cosmetic surgery clinics.

In March 2012, the High Court endorsed the PIP Group Litigation Order allowing claimants to take legal action against the five companies on alleged breaches on the Sale of Goods Act 1979 and Sale of Goods and Services Act 1982. The first hearing is scheduled to take place in October; however the Order came with the proviso that claimants should register to participate in the collective legal action prior to April 2013.

Just before the cut-off date, seventeen potential claims for PIP breast implant compensation were being managed by Tandem Law – a Manchester law firm specialising in Group Litigation Orders. Tandem Law suddenly went out of business due to its overseas investors withdrawing their support, and the company was acquired by AHV Legal.

In the changeover period, the 17 applications to participate in the PIP Group Litigation Order were overlooked, and not completed until February 2014. The Transform Medical Group, Alexander Healthcare, Spire Healthcare and Aspen Healthcare objected to the new applications being added to the register of claimants; along with Cloverleaf Products Ltd – the UK supplier of the faulty breast implants against whom the cosmetic surgery companies are seeking indemnity.

The case proceeded to the High Court, where it was heard before Mrs Justice Thirwall DBE. The cosmetic surgery clinics argued that the seventeen claimants should not be allowed to join the PIP Group Litigation order on the grounds of recommendations made in the Jackson Report – the 2014 review of the rules and principles governing the costs of civil litigation, in which Lord Jackson had criticised delays and non-compliance with Group Litigation Orders. The clinics´ barristers supplied several examples of cases in which Lord Jackson´s recommendations had been applied.

Barristers on behalf of the seventeen applicants argued that, should they not be allowed to participate in the PIP Group Litigation Order, their prospects of recovering compensation for faulty breast implants would be compromised. They contended that, should the PIP Group Litigation Order find in favour of the other claimants, there may be insufficient funds remaining to compensate the seventeen late applicants.

Mrs Justice Thirwall DBE found this argument speculative, and commented that if this scenario was to be realised, the seventeen claimants would have reason to claim compensation from AVH Legal. She allowed the objection by the cosmetic surgery clinics on the basis of the Jackson Report, and disqualified the late applicants from the PIP Group Litigation Order.

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TUV Ordered to Pay Compensation for PIP Breast Implants

November 13, 2013

A court in France has ordered German safety company TUV Rheinland to pay 17,000 women compensation for PIP breast implants which were manufactured by the bankrupt company Poly-Implant-Prothese.

The class action against the German company – which certified the safety of the PIP implants – was brought on the basis that TUV Rheinland had a responsibility to check the quality of the implants before issuing Poly-Implant-Prothese with a guarantee that they conformed to European standards. However, it was alleged, no such checks were made, and Poly-Implant-Prothese substituted a low grade of industrial silicone in place of the approved type in order to reduce costs.

According to a French study last year, up to a quarter of the PIP breast implants burst or leaked; some causing medical complications when the silicone gel secreted into the victims´ lymph nodes, and one woman in France is known to have died due to anaplastic large cell lymphoma. No long-term side effects have yet been confirmed, and experts believe that it may be many years before the full effect of the faulty PIP breast implants is known.

Solicitors on behalf of TUV Rheinland argued in court that the company was a victim of fraud, and that they were only expected to audit Poly-Implant-Prothese´s paperwork – not the implants themselves. However, solicitors representing the claimants said that TUV Rheinland failed to do its job properly and gave “global credibility” to a product which did not deserve it. It also emerged in court that the employee in charge of quality control had only a cookery diploma, while another in charge of the laboratory had previously trained as a pastry chef.

After hearing evidence on behalf of TUV Rheinland and the 17,000 claimants from Britain, France and South America, judges at the Commercial Court in Toulon found TUV Rheinland had “neglected its duties of vigilance” and awarded each claimant €3,000 (£2,500) immediately for the removal of their faulty breast implants, and a further €13,000 (£10,900) compensation for PIP breast implants to be received at a later date subject to an appeal by TUV Rheinland.

The verdict provides an opportunity for up to 400,000 women worldwide to claim compensation for PIP breast implants, and Jan Spivey – spokeswoman for the British plaintiffs and the PIP Action Campaign group – said “I am delighted. It is a first important victory for PIP victims worldwide and especially those British victims who have received no help from the health service or the Government. It means that they can start to get the surgical help [to replace defective implants] that they urgently need.”

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Poly Implant Prothese (PIP) Recall in the UK

December 23, 2011

Thousands of breast implant recall compensation claims could emerge from women worried about the Poly Implant Prothese (PIP) recall in the UK.

When the recall was first announced in March 2010, the advice provided at the time by the French medical device regulatory authority AFSSAPS was for women who were concerned over their PIP breast implants to undergo an ultrasound scan to check for suspected ruptures of the implant sac.

Subsequently it emerged that the recalled breast implants, which have a higher incidence of rupturing than is usual, also contained an unauthorised silicone gel which could cause an inflammatory reactions in certain women. Now health officials in France are advising for all women who have received PIP recalled breast implants to have them removed.

Although the UK´s medicines watch dog – the Medicines and Healthcare products Regulatory Agency – insists there is no risk of cancer from this lower grade silicone gel, one woman in France is known to have died due to anaplastic large cell lymphoma and many women in the UK have suffered unusual and painful symptoms once the silicone gel has secreted into their lymph nodes.

With the manufacturer of the recalled breast implants having gone out of business since the recall, breast implant recall compensation claims are being directed against the clinics and surgeries which originally performed the breast implant operation – not only for the physical ailments caused by the ruptured implants, but for the emotional distress of suffered by the affected women who may not yet be aware of how badly their health has been affected.

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