Ten years ago a health bomb exploded

March 29, 2010: Start of the PIP implant scandal. Where are we now?

On March 29, 2010, the French health agency ordered the worldwide withdrawal of the breast implants manufactured by PIP (France). It was the beginning of a worldwide health scandal. More than 300,000 women in 65 countries on 5 continents discovered that they had been fitted with breast implants filled with an unauthorized industrial gel, although these medical devices were CE marked (European conformity).

The consequences for patients are often dramatic (see video):

  • 50% of them suffered a rupture of their implants;
  • 30% will remain with a siliconome until the end of their life (silicone lumps in the body generally causing inflammation of the lymph nodes);
  • 10% of the victims must continue to live with ruptured implants because of the lack of means to have them removed;
  • for nearly 60% of the victims, the permanent anxiety and anguish caused led to a depression;
  • hundreds have respiratory deficiencies, after the silicone has spread into their lungs. Their anxiety has now skyrocketed because of COVID-19. (*)

For the French courts that have ruled, the responsibility for this situation lies largely with the German certifier TÜV Rheinland, which has been condemned four times. We remind that the quality assurance giant acted as a notified body for PIP from 1997 until the discovery of the scandal in 2010.  It was its supposed control that allowed PIP to affix the CE marking on its products thus certified, despite being adulterated.

25,000 victims have joined legal actions in France against TÜV RHEINLAND for its negligence and failure to fulfil its obligations. The amount of compensation is expected to exceed 500 million euros.

What is the outcome?

It is essentially the French taxpayer who covered the consequences of the PIP case via the Solidarity Fund (SARVI), which is financed by French public money, while the French Social Security claims that TÜV RHEINLAND should be ordered to cover the expenses it incurred for the health of the French citizens (17 million euros).

In most other countries, patients were left alone. Those who were able to do so financed the removal of the implants as well as the treatment of complications on their own.

The European Union did not provide any help, even though this medical device bore its mark, a supposed guarantee of the seriousness of European products. When questioned, the Commission services constantly minimised the scale of the scandal without providing the slightest solution. The national health authorities in some countries are in the same position.

There has been very little change in the regulations. A new European directive voted in 2017 had its application delayed. In any case, it only marginally strengthens the regulations. As demonstrated by the global survey “implant files”, the protection of consumers of CE products is still not a priority.

While the complications of affected women are getting worse and their compensation is constantly being delayed, the German regulatory body, TÜV RHEINLAND, shows an incredible wealth. Its turnover has increased by EUR 100 million per year since the scandal broke, to more than EUR 2 billion. This is enough to finance the vast campaign of destabilisation and intimidation that TÜV has implemented in recent months to dissuade the victims from taking them to court.

Even if ALLIANZ, the insurer of  PIP company, has been forced to implement its guarantee, it was for a very limited amount (3 million euros) and only for the benefit of a few thousands women who had surgery in France. This is a real paradox as PIP, once the 3rd largest manufacturer in the world, was selling more than 80% of its production abroad (nearly a million potentially dangerous implants worldwide).

In criminal proceedings, it took 8 years for a final conviction to be pronounced in France and only for the part of the case that concerned deception and fraud. By way of comparison, in the dieselgate case, the VW group was forced to compensate the American victims less than 18 months after the scandal emerged although it concerned only cars. Jean-Claude Mas, the founder of PIP, spent only 6 months in prison before his trial. Regarding the case for “battery and assault”, a criminal investigation has been ongoing for 10 years, without any significant developments. Mr. Mas will not be judged on this aspect. He died in 2019. As for the certifier TUV RHEINLAND, it has not been criminally concerned in spite of suspicious deeds (for example, in 2012, before a search of its premises in France, TUV hastily repatriated its PIP archives to Germany in order to protect themselves from French justice).

As for the German chemical giant Brenntag, which supplied the industrial gel to PIP, it was never investigated. Brenntag was itself certified by TÜV RHEINLAND.

On the judicial level.

Lawyer Olivier Aumaitre and his team, which represent nearly 20,000 victims within PIPA (PIP Implant world victims Association), were the first to initiate in 2010 an action for compensation against TÜV Rheinland, which, ten years later, proves to be the only way to allow full compensation of the victims.

Since 2010, four court decisions have already ordered TÜV Rheinland in France to compensate PIP patients for approximately €65 million, i.e. barely 10% of the expected final compensation, on a provisional basis. The legal actions are still ongoing, while medical expert reports have been ordered to assess the damages, which will take several more years before a final decision is made.

In several decisions dated October 10, 2018, the French Supreme Court of Appeal also ruled in favor of the victims represented by Olivier Aumaître, ruling that the TUV certifier was bound by an “obligation of vigilance” and that in the presence of indications of non-compliance, it had to carry out in-depth controls of raw materials and finished products and in particular unannounced visits. TÜV had not complied with any of these obligations, according to the decisions.

In a decision of 27 February 2020, the highest German court (BGH – Bundesgerichthof) ruled that the guarantee of individual health protection for patients with PIP implants is not only the responsibility of the manufacturer (PIP) “but also of the notified body” certifying these implants. The German Supreme Court also held that it is “necessary that the notified body be exposed to the risk of criminal prosecution by third parties in the event of negligent checks”.

Like the European Court of Justice (ECJ), which also issued a favourable opinion in 2017, the German and French supreme courts also reminded that TÜV Rheinland had to maintain its independence from PIP. This independence was undermined by the commercial relationship between TÜV – via its French entity to which it had subcontracted the audits – and the implant manufacturer (TÜV Rheinland  charged PIP for training services and provided consultancy to help PIP penetrate the Asian market).

In addition to the procedures that have already resulted in the first compensation payments for more than 20,000 victims, new legal actions have been initiated.

Women with PIP implants can still join the ongoing procedures.

What conclusions can be drawn from this?

For Olivier Aumaître, lawyer, “waiting for a final judicial decision is not compatible with the health of the victims”, and effective and rapid solutions must now be found in terms of compensation. Failing this, a judicial scandal could succeed the health scandal.

In this respect, he believes that “TÜV’s strategy is a complete failure and its final conviction is now inevitable” and that “it is therefore high time for TÜV to come to the negotiation table in order to end this dispute in honourable conditions for the German group” whose image remains tarnished by this scandal while TÜV and its insurers now risk a very heavy final sentence.

The lawyer adds: “while the world is facing a health crisis caused by a virus whose emergence could hardly have been predicted, the authorities will only regain their credibility if they show a real willingness to prevent crises that are avoidable. As such, they must ensure that medical devices are produced and controlled with a completely different level of safety”. For him: “This also requires compensation and rapid sanctioning of failures, particularly by the control bodies, so that practices change and health scandals such as PIP do not happen again. The credibility of the CE marking, which is supposed to be a guarantee of the quality of European products, is also at stake.

(*) These figures represent estimates based on information provided by some 15,000 patients registered on the PIPA platform.

PIP implants: the German Federal Supreme Court recognizes the responsibility of the certifier TÜV RHEINLAND

By a judgement dated 27/02/2020, the highest German court (BGH – Bundesgerichthof) annulled a decision which had rejected the responsibility of the certifier TÜV Rheinland, holding that the guarantee of individual health protection for patients with PIP implants is not solely the responsibility of the manufacturer (PIP) “but also to the notified body”, certifier of these implants. We remind that the German quality assurance giant acted as a notified body for PIP from 1997 until the discovery of the scandal in 2010 and it was its so-called control that enabled PIP to affix the CE mark on its certified, albeit adulterated products.

The BGH rules that “the notified body, with regard to its rights and obligations, as defined in Directive 93/42/EEC, has a position that is independent of its client and its testing activities serve not only the manufacturer but also, and above all, the final recipients of medical devices…, it is necessary that the notified body is exposed to the risk of criminal proceedings on the part of third parties in the event of negligent checks. The German Supreme Court thus finds that “the conformity assessment procedure… replaces an official approval procedure in the European conception of the law of medical devices” and that “taking into account the health risks linked to the use of defective medical devices, … an individual claim for damages against the notified body is justified“. It adds that “the rejection of a tort responsibility for the notified body in the event of a culpable failure to fulfil its obligations would call into question the meaning and the objective of the conformity assessment procedure”.

This decision, which comes following the prosecution of TÜV Rheinland by the insurance company AOK Bayern, is another decisive victory for the 300,000 victims of the PIP breast implants. It reinforces the proceedings initiated in 2010 by the Parisian lawyer Olivier Aumaître, who first sought responsibility for TÜV Rheinland for this case. According to PIPA’s lawyer, “this decision validates our action once again and reinforce the chances for the final compensation of all women with PIP implants”. Olivier Aumaître further points out that “after the European Court of Justice, the French and German supreme courts are now ruling against TÜV”. For him, “the strategy of TÜV is a complete failure, and it is high time that TÜV come to the negotiating table to end this long-standing dispute”.

Five court decisions have already ordered TÜV Rheinland in France to compensate PIP patients. The Court of Cassation has already brought justice to the victims represented by Olivier Aumaître by its decision from 10 October, 2018. It has indeed confirmed the grounds for the first decision (November 2013) which had sentenced TÜV Rheinland for their negligence, the failure of their controls and their infringement of European regulations. The highest French court had in particular indicated that the certifier was held to an obligation of vigilance and that in the presence of indications of non-conformity it had to carry out in-depth controls of the raw materials and the finished products and to perform unannounced visits. However, TÜV had failed to meet any of these obligations.

The German and French supreme courts also point out that TÜV Rheinland had to keep its independence from PIP. However, this was undermined by the commercial relationship which linked TÜV, via its French entity, to the implant manufacturer (TÜV Rheinland invoiced training services in particular and helped PIP penetrate the Asian market).

Beyond the procedures which have already given rise to the first compensation for more than 20,000 victims, new proceedings have been initiated. French Social Security is claiming 17 million euros from TÜV Rheinland. The Commercial Court of Toulon will examine the claim of nearly 2,000 victims during a hearing on March 4. A new procedure will also be implemented in the coming weeks, in which more than 3,000 new patients from around the world have already mandated PIPA