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

PIP implants case: TUV is trying to scare patients by sending useless notifications through bailiffs

Further to several articles published in the British press, we strongly contest the fact that TUV would have been forced to send bailiffs to patients who are suing them before French courts.

To fully understand how TUV’s justification is misleading, it is necessary to reframe the judicial history and the procedural context of the PIP lawsuit.

1/ Judicial lawsuits initiated by Olivier Aumaitre, lawyer at Paris bar, in PIP case

Mr. Aumaitre is at the origin of legal proceedings (TUV1, TUV2, TUV3) against the German certifier TUV RHEINLAND. He initialed them in 2011 and they enabled patients from all affected countries to receive a first compensation.

We already represent 17 000 victims and among them a significant number from UK and Ireland. Every day new ones ask us to act on their behalf and seek compensation in partnership with several law firms and consumers associations.

To date, five separate judgements have sentenced TUV to compensate victims: three decisions from the Commercial Court of Toulon (TUV1, TUV2&3) , one decision from the regional court of Nanterre and one decision from the regional Court of Valence.  The French supreme court and the European court of Justice have also ruled in favor of victims.


2/ TUV2 and TUV3 proceedings

On 20 January 2017, TUV was ordered by the Toulon Commercial Court to compensate 20,000 victims of PIP implants,  including 9000 British and Irish ladies. TUV appealed this decision.

Mr Aumaitre and PIPA team defend women in all phases of appeal and expertise in these so-called TUV2 and TUV3 proceedings.

More specifically,

  • We are in charge of the distribution of funds allocated to patients in 2017. We are in daily contacts with relevant authorities for that purpose.
  • We are monitoring the judicial expertise that has been ordered by the Court to assess the whole damages suffered by victims and thus allow each one to receive a full compensation. A meeting attended by Mr Aumaitre recently took place in Toulon on the matter
  • PIPA team is in constant and close contact with judicial courts in Toulon, Aix and Paris.
  • Several procedural meetings were held in Aix-en-Provence and in Paris in which Mr. Aumaitre’s clients were present or duly represented. A meeting attended by Mr Aumaitre recently took place before the Court of Appeal of Paris (TUV1).

Everyone knows that Mr. Aumaitre represents the largest number of victims. He is perfectly identified by the Court as such, as well as by TUV’s lawyer with whom he regularly corresponds, directly or through local correspondant.

We liaise with all victims through our platform PIPA (messages, newsletter…) and thus we could inform them about TUV’s strategy and the fact that they were sending notifications by bailiffs or court officials.


3/ Regarding the case pending before the Court of Appeal of Aix en provence (TUV2/TUV3).

In 2017, it was necessary, before any new judicial step, to secure the payment process of the compensation awarded in 2017. TUV could not expect the trial to continue without first compensating all the victims as it was sentenced in the first instance. Part of these payments were only executed three weeks ago by TUV…

In 2018 all the French courts hearing the PIP case – including the Court of Appeal of Aix-en-Provence – decided to await the decision of the French Supreme Court in the matter in the called TUV1 proceeding. It was agreed that the lawyers would register after this decision, rendered on 10 October 2018 and which marked a decisive victory for the victims.

At no time did the Court of Appeal of Aix en Provence en Provence enjoin TUV to serve its appeal on the clients of Mr Aumaitre or, to our knowledge, on those of other lawyers. TUV has never been forced by any legal  reason to send justice officers to patients. TUV has no obligation to do so and perfectly knows that Mr Aumaitre represent victims. TUV’s local correspondent has been in contact with Mr Aumaitre’s local correspondent for months.

Nevertheless  TUV decided in early 2018 to send various letters to victims to make them believe that they were unrepresented and to force them to register with the Court of Appeal.

This can in no way be justified by the fact that a particular lawyer has officially registered or not with the Court of Appeal of Aix en Provence. Moreover, TUV has issued notices by bailiff to patients whose lawyers had already been registered…

In TUV1, before the Court of Appeal of Paris, in spite of the fact that Mr Aumaitre was the first lawyer who registered few months ago, TUV asked bailiffs to make notification to Mr Aumaitre’s client as if they were not represented and asking them to register within 15 days (whereas registration was already done since months)

The decision to deliver such acts to patients by bailiff is solely the result of TUV’s deliberate strategy to frighten the victims and to cause disorder among them

After TUV Rheinland admitted in April 2019 the competence of French judges and the application of French law (they had been challenging this issue for 9 years), victims’ lawyers including Aumaitre began to register in the Court of Aix-en-Provence.

Since that time, whereas a judicial timetable has been scheduled by Court in accordance with all lawyers involved (including Mr Aumaitre and TUV’s lawyer), and despite the fact that patient’s registration are in progress, TUV took again the decision to notify writ of summons through bailiff to victims…

The sending of bailiffs by TUV was obviously completely unnecessary. It has only served to deter new victims from pursuing them in French courts.

The German group also probably hopes, by doing this to weaken the victims defence.

It’s important to underline that victims who received notification don’t have to do anything (of course they don’t have to respond neither to attend any hearing in France). We represent them.


4/ TUV’s strategy is a failure

It’s not the first time that TUV uses bailiff for tactical reason in order to intimidate the victims. TUV always proceed like this when it knows that the situation is critical for itself.

It is  regrettable that TUV continues such a strategy which has proven to be a complete failure after so many courts found them liable.

TUV would be better advised to spend these millions of euros to help victims to repair the consequences of its breaches.

We find it unacceptable and ridiculous that TUV, which was found liable in this scandal, dares to sue the victims as if they were guilty.

TUV’s reputation is not enhanced by such provocative behaviour, which many patients consider malicious.

Surprisingly, the German quality assurance giant has difficulties with the notion of obligation. TUV had no obligation to issue documents by bailiff to patients. On the other hand, in its decision ruled in 2018, the French Supreme Court reminded TUV that as part of its mission as a notified body, it had an obligation of vigilance. Therefore, it was required, to check final products, purchases of raw materials and to carry out unannounced visits to PIP. TUV having failed to comply with all these obligations, its final conviction is no longer in doubt.

We understand that TUV is in panic, especially since it has been involved in the past in other scandals related to its certifications (Rana Plaza building whose collapsing in Bangladesh killed 1000 workers, lead mine La Oroya in Peru which poisoned thousands people).

This should not allow TUV to take victims in hostage and to have  them undergo new stress.

TUV’s strategy of intimidation will have no effect. We will carry on representing patients, in order to obtain complete compensation on their behalf.

Whatever TUV could expect, we will carry out our fight for justice and complete our task on behalf of all women we represent.

We therefore suggest all victims to demand full compensation by joining our legal action. They can do so very easily by registering on our PIPA website


The main protagonist in the criminal case of the PIP implant scandal died without having served the four-year prison sentence ruled against him for fraud.

He will also not be tried for assault and battery. This second criminal trial, in which other people are involved, will therefore take place, but without Jean-Claude Mas. PIPA lawyer, Olivier Aumaitre stated “We can only deplore the lack of progress in this criminal procedure, which began nine years ago, and which sees its main protagonist disappear before a trial has even begun“.

All the responsibilities have still not been established in this health scandal, where a French company has poisoned the entire planet with adulterated breast implants which were CE marked (European conformity), and certified by the German multinational TUV Rheinland.

The fight for the compensation of victims started in 2010 by Olivier Aumaître continues on the civil level. The death of the founder of PIP has no impact on the compensation proceedings against the certifier that are ongoing before the French courts.

The case recently underwent a procedural turnaround with the announcement by TUV that they agreed to be tried by the French courts and waived their right to request that the case be referred to the German courts.

Five duly reasoned court decisions have already ordered TUV Rheinland to compensate the victims (three judgments of the Toulon Commercial Court, one decision of the Nanterre Regional Court and one decision of the Spanish Court of Valencia).

The only isolated decision (rendered by the court of appeal of Aix en Provence in 2015) which, after an initial conviction, had incomprehensibly cleared TUV was annulled on 10th October 2018 by the Court of Cassation. The French Supreme court recalled that TUV was subject to an obligation of vigilance and that in the presence of indications of non compliance, TUV had to control the breast implants, purchases of raw materials and carry out unexpected visits. All these essential points had been ignored despite a devastating case.

It is now up to the Paris Court of Appeal to retry this case by setting guidelines for the compensation of patients.

The question is no longer that of identifying the liable body since the conviction of the certifier no longer seems to be in doubt, but that of the modalities of compensation and the time it will take.

For Olivier Aumaître “It will be important after several years of developments, and since the Court of Cassation has established principles, that a harmonised case-law be drawn up for the compensation of existing and future victims”.

It is recalled that thousands of new victims continue to join the action that Olivier Aumaître was the first to bring against TUV.

For Mr Aumaître, “The death of Jean-Claude Mas, and time that elapses, remind us of the urgent need to find a compensation solution for patients with PIP implants, either on a legal level or as part of the implementation of a compensation fund”.

PIPA will continue to help women around the world to obtain redress.

10th October 2018: a great victory for PIPA and PIP patients: the French Supreme Court (“Cour de cassation”) rules in favour of the victims and against the certificator TÜV RHEINLAND


Wednesday, October 10, 2018, Paris

PIP breast implants case: the decision of the French Supreme court confirms the responsibility of the certifier TUV Rheinland and gives hope to thousands of victims around the world

By an expected decision today, the French Supreme court (“Cour de cassation”) overturned the decision of the Court of Appeal which, incomprehensibly, had cleared the German certifier TUV Rheinland in 2015.

According to the Supreme Court, the Court of Appeal neglected essential elements, and made a mistake in not holding TUV liable, despite the proof provided of the failure of its controls. The highest French court ruled in the same way as the judges of the Toulon Commercial Court who, on three occasions, ordered the German group to compensate PIP victims.

With this scathing disavowal of TUV’s strategy, the French Supreme Court is paving the way for the world’s largest collective trial.

This is a decisive step in the search for liability that three distributors had began eight years ago through their French lawyer Olivier Aumaitre. The latter has since founded an association bringing together more than 15,000 patients and a collective of international lawyers at the service of victims (PIPA – PIP Implant World Victims Association : www.pipaworld.com).

Several thousand new victims have already mandated PIPA to conduct new proceedings before the Commercial Court, the first hearing of which is scheduled for 17 December 2018.  PIP victims can join this legal action until that date.

For Olivier Aumaitre, at the origin of the proceedings against TUV, “the Court of Cassation renders a decision in accordance with the law, fair and consistent with the objective elements of the case which are devastating for TUV. It validates all the actions we have taken since 2010 and which we have pursued against all odds for the past 8 years in the interests of the victims”.

This is a victory not only for the victims but also for the European Union. This historic decision will force certifiers and their insurers to be particularly vigilant in their controls of medical devices. This self-regulation will have a virtuous effect by strengthening the safety of CE-marked products.

For Olivier Aumaitre, this is “a good decision for the consumer whose interests and health are protected by the European system and for the European economies, which are partly based on the reputation of CE marking“.

“This is a complete failure of the arrogant and threatening strategy of the German certifier, who showed a deep contempt for the victims, and who preferred to spend millions of euros unnecessarily on lawyers’ fees and on communication and denigration operations, rather than assume its responsibilities by repairing what was reparable,” said Mr. Aumaître, who is considering criminal action against TUV for attempting intimidation and blackmail of his clients.

We call on TUV to change its attitude and to grasp the hand offered from the beginning by the distributors. TUV must now immediately compensate the victims. Indeed, the pathologies developed by PIP patients are often heavy (inflammation of the lymph nodes, contamination of different organs by the blood, etc.). The longer we wait, the worse the situations get. If TUV has shown no empathy for these victims, it is to be hoped that the financial risk will make them see reason, as the final bill may increase over time,” adds Cedric Joachimsmann, a former distributor of PIP implants, who first held TUV Rheinland liable.

As the average compensation should be between €10,000 and €20,000 per patient, according to initial indications from the courts, the total bill should amount to €6 billion for TUV Rheinland.

We invite TUV to contribute the first billion to the European compensation fund that we are calling for in a petition. The majority of patients around the world still have to claim compensation. We intend to continue the fight, through the PIPA organization for the 400,000 victims around the world,” says Cedric Joachimsmann.

 Petition on Change.org:


About PIPA :

PIPA is a digital platform designed to facilitate the handling of victims’ compensation claims and is supported by an international network of partner lawyers specializing in litigation. Tehy are the first to have initiated compensation proceedings in France for PIP implant victims.

Since 2010, this task force has represented and defended more than 15,000 PIP implant patients on all 5 continents and in 2017 obtained an order for TUV RHEINLAND to pay their clients a record provisional compensation of nearly 60 million euros.

In 2018, more than ever, the fight continues.