PIP breast implant case: a victory for hundreds of thousands of women around the world

  • The Paris Court of Appeal today confirmed́ the responsibilitý of the certifier TUV Rheinland in the PIP implants case.
  • This decision marks the victory of the PIPA association and paves the way for full compensation for victims.
  • Several tens of thousands of euros per victim are requested by PIPA’s lawyer for their compensation. A first judgment is expected on 16 September 2021.

The companý founded by Jean-Claude Mas marketed breast implants filled with industrial silicone for 10 years. The certification issued by the German group TUV Rheinland allowed PIP to affix the CE mark to the adulterated products and thus market them worldwide.

Olivier Aumaître, lawyer for 20,000 victims and defender of the international PIPA association that initiated this procedure, known as TUV1, said: “We are delighted with this outcome, which puts a definitive end to doubts about TUV’s responsibility. After 10 years of waiting and hard fighting, the German certifier will have to compensate the victims in full. »

For him “it’s the end of the game after extra time and there will be no return match or rematch possible”. Today’s ruling comes after a very long journey: condemnation of TUV by the Toulon Commercial Court in 2013, reversal of this condemnation by the Aix-en-Provence Court of Appeal in 2015, annulment of this reversal by the Court of Cassation in 2018, which had then referred́ the case to the Paris Court of Appeal.

This decision is based on a damning case against the certifier (see our full summary here)

The compensation phase can finally begin

For Mr Aumaître, “With today’s decision, the question is no longer whether TUV will have to compensate the victims, but when and how much. And the bill is going to be particularly heavy, not only because of the number of victims and the damage linked to the PIP implants. The high amount is also due to the wait that TUV made the victims endure, showing constant contempt for these women. The lost time highly aggravated the consequences for their health”. In this new phase, an expert assessment will resume in order to evaluate the damages individually. They are often heavy, especially as they have worsened over time. The medical experts mandated by the Commercial Court of Toulon have thus noted that every PIP patient lives in a state of permanent anxietý. More than half of the victims have suffered a rupture of their implants. Even without rupture, the silicone spreads in the body. It then forms lumps, which very often lead to inflammation. This is called a siliconoma. They are most often located in the lymph nodes but can also reach the lungs or other organs. 30% of victims are affected. This is why the amounts should reach several tens of thousands of euros. The sums requested by Olivier Aumaître for a first group of patients range from 20,000 to 70,000 euros (judgment expected on 16 September). Each victim can evaluate the compensation he or she is likely to obtain thanks to the PIPA calculator. It is based on the principles of evaluation used by legal experts and on the case law of the Dintilhac nomenclature used by most courts for the evaluation of personal injuries.

This calculator is available to all here

In addition, new items of damage could be added. The association representing the victims believes that an epidemiological study should be carried out on PIP patients because consequences that have been minimised until now could be revealed. For example, it is striking to note the high incidence of autistic disorders in children breastfed with TUV-certified silicone.

As the statute of limitations for personal injury is 10 years from the end of the suffering, patients who have not yet applied for compensation may still be entitled to it. They can join the TUV 5 procedure, which is already in progress. To do so, they just need to register on the PIPA website now and before 30 June 2021: https://pipaworld.com/en/pip-implants-compensation/

According to Mr Aumaître, “A last stand of honour is to be expected from TUV on the procedural level, but today’s ruling marks the end of the case on TUV’s liability, and it would be in TUV’s interest, if only for its image, to finally admit defeat and capitulate with dignity.”

PIP Implant: the liability of the certifier TÜV Rheinland confirmed on appeal

French courts open the way to compensation for victims

The Court of Appeal of Aix-en-Provence confirmed today the judgement of the Commercial Court of Toulon which in 2017 had condemned the certifier of fraudulent breast implants to compensate 20,000 patients of all nationalities (procedure TUV2/TUV3).

The company founded by Jean-Claude Mas has marketed breast implants filled with industrial silicone for 10 years. The certification issued by the German group TUV Rheinland allowed PIP to affix the CE mark to the adulterated products and thus market them worldwide.

According to Olivier Aumaître, the lawyer for PIPA, who as early as 2010 had sought TÜV’s liability, and who initiated the proceedings that led to today’s judgment, “this decision definitively opens the way to compensation for victims worldwide who are still eligible to act and can register with PIPA. It is a decisive victory after 10 years of judicial struggle in the service of victims“.  According to him, “This ruling is in line with all the decisions handed down to date, and in particular that of the Court of Cassation [French Supreme Court] “, which in 2018 overturned a decision in favour of the certifier. “It is also consistent with the content of the case, which has become more and more damning for the certifier over the years” (see our full summary here).

According to the lawyer, this new conviction is “a further disavowal of TUV’s judicial strategy, which is essentially based on denial, concealment of documents and intimidation of victims, and which has proved to be a complete failure“. 

The time for compensation finally seems to have come for the patients. In the first instance, the court had ordered an expertise for the 20,000 women involved in the proceedings. This work should now be accelerated and it is expected that the first final compensations will be awarded during the course of the year. 

The experts have already recognised a permanent damage of anxiety to all PIP patients. They have to cope with heavy complications that worsen over time (rupture of the implant for at least half of them, inflammation of the lymph nodes due to the leak of silicone for a third of them, etc.). The amounts should reach several tens of thousands of euros for each victim.

Thus the sums requested by Olivier Aumaître for a first group of patients range from 20,000 to 70,000 euros, “an objective and realistic indemnity projection because it is based on the work of experts and on our expertise acquired over more than a decade“, the lawyer specifies.

According to Mr Aumaître, “TUV’s strategy, which is dilatory and contemptuous towards the victims, will result in an increase in the amount of compensation given the worsening of damages over time. TUV will have to take responsibility and be accountable for its choices” and “the bill will be heavy” for the German certification giant, which stubbornly refused to implement a negotiated solution.

The PIPA association has also just put a tool on line enabling each victim to assess for herself the compensation she will be able to obtain. The tool has been drawn up taking into account the assessment principles adopted by legal experts and is based on the case law of the Dintilhac nomenclature used by most French courts for the assessment of bodily injury.

This calculator is accessible to everyone here.

It should be noted that new damage items may be added later on. It seems indeed that time has come to conduct an epidemiological study on PIP patients. It could reveal consequences, which have so far been minimised. For example, it is striking to note the high incidence of autistic disorders in children who were breastfed with TUV-certified silicone.

In any case, it is likely that compensation proceedings will continue for several years. 

The limitation periods for personal injury are 10 years from the end of the suffering. Patients who have not yet applied for compensation are therefore still on schedule. For Olivier Aumaître “the time of hesitation and wait-and-see attitude is over, victims must now join the ongoing proceedings without delay before it is too late. Our teams are ready and mobilised; we have remarkable tools at our disposal to help them obtain compensation“.

Those who wish to do so can join the TUV 5 procedure, which is already underway. All they need to do is register on the PIPA website now and before 31 March 2021:

PIP implants – TUV 4 procedure: the decision will be delivered on 11 June 2021.

On Thursday 10 December 2020, the final hearing was held before the Commercial Court of Toulon in the so-called TUV 4 procedure for more than 1,500 new PIP victims of all nationalities.

Represented by Mr. Olivier Aumaître, lawyer, who initiated all the actions against the certifier TÜV RHEINLAND in this case, the patients demand a provision of 6000 euros from the German company that had allowed Jean-Claude Mas to sell his fraudulent implants throughout the world.
Over time, the damage caused by the industrial silicone of the PIP implants is getting worse and the costs are getting higher and higher for the patients, who also have to face long legal procedures.

For example, of the approximately 22,000 patients who have already sought redress in court, more than half have suffered a rupture of their prosthesis. The silicone then spreads throughout the body, causing inflammation of the lymph nodes or breathing difficulties. Legal experts have recognized a permanent anxiety injury to women with PIP.

The current expert reports suggest that final compensation could be between 17,000 and 70,000 euros.

With a case which, according to Maître Aumaître, has become “devastating” for TUV, the principle of the German group’s liability now seems to have been accepted. TUV has understood this and seems to be concentrating its efforts on limiting the quantum of compensation by seeking, against all evidence, to deny the reality of the victims’ suffering and their admissibility to take action, by trying to dissuade them from seeking justice.

By choosing to lock itself into a strategy of delay and denial, TUV Rheinland has allowed toxic silicone to gnaw at the bodies of over 300,000 women. It is a choice that seems to have been taken, since as early as 2011 internal exchanges within the company alerted about its serious failures in the control of PIP.

For Olivier Aumaitre, the German multinational must now pay the price “not only for its negligence, but also for its judicial strategy” which has led to aggravating the personal situation of each victim.

The global bill could reach a billion euros.

The year 2021 should sound like the year of the end for TUV Rheinland since several court decisions are expected:

  • 11 February 2021: decision of the Aix-en-Provence Court of Appeal in the TUV 2 & 3 proceedings (TUV was sentenced in 2017 in first instance to compensate 20,000 patients as well as 35 clinics and distributors).
  • 20 May 2021: decision of the Paris Court of Appeal (TUV was ordered in 2013 to compensate 1,700 patients and 6 distributors, before this decision was overturned on appeal in 2015, then reinstated by the Court of Cassation in 2018, which asked the Paris Court of Appeal to retry the case in its entirety).
  • 11 June 2021: decision of the Toulon Commercial Court (TUV 4)

Several thousands of patients have already commissioned Olivier Aumaître for a new TUV 5 procedure. The PIPA platform, which registers new claims on a daily basis, expects that these will continue to flow in over the next few years. Indeed, the limitation periods are still far from being reached.

CIVIL LIABILITY IN THE PIP IMPLANT CASE: Synthesis from the victims’ point of view

Several French courts will rule in the coming months on the responsibility of the certifier of the fraudulent breast implants. Its certification enabled their worldwide marketing until 2010. Corollary to the issue of TUV Rheinland’s civil liability, the courts will have to determine the terms of compensation for the 300,000 victims, 25,000 of whom have already claimed compensation from the courts.


see full information here


The PIP case served as a reminder that one could be declared a victim in criminal proceedings while being liable in civil ones. This situation, which TUV pretends to be a paradox, is not exceptional and is perfectly accepted in law. This is the story of a person who rents a car and has it stolen after leaving the keys on the door unattended: in criminal cases, he is indeed the victim of theft; in civil cases, he is liable to the car rental company.

All the courts that have ruled in civil cases, including the Court of Cassation, have rightly considered that the criminal aspect had no impact on the assessment of TUV’s civil liability.

The Criminal Court, which convicted Jean-Claude Mas and his accomplices for deception and admitted TUV Germany as one of the victims (unlike TUV France), made this clear in its decision of 10 December 2013, thus preventing any ambiguity: “It is common ground that any faults or negligence committed [by TÜV] in the performance of the task for which it was responsible have no bearing on the crime of fraud of which it was a victim and which caused it harm…. “and vice versa.

The criminal judge also held that the women with PIP implants had been “put at ease by the guarantees surrounding these products in that they had CE certification requiring serious and in-depth quality controls and tests” and “that they believed they were acquiring an implantable medical device that complied with the standards established by European legislation and therefore subject to all the tests required” by these regulations.

In fact, in the context of the ongoing investigation for homicide and involuntary injuries, TUV RHEINLAND was placed by the investigating judge under the status of assisted witness.


In 2012, TUV had the PIP archives stored at its French subsidiary urgently repatriated to Germany prior to a search of its premises.

The director of TÜV France, Mr LESIEUR thus indicated to the investigators that, at the request of TÜV Germany, “all the documentation concerning PIP” had been repatriated to Germany .

An official from TÜV Germany even came to France personally “to make sure that no documents concerning the company Poly Implant Prothese were kept on the premises of TÜV France“.

Three weeks later, in March 2012, the TUV companies will hand over to the investigators on CD Rom the documents from these archives selected by them, so that the case has been investigated in the light of the information that TUV has agreed to hand over to the French Justice.

More recently, in September 2020, the Court of Nanterre issued an order appointing a bailiff to visit TUV to obtain explanations on the location and existing inventory of these archives, and for the purpose of retrieving them in their entirety.

TUV refused to comply so that the bailiff was unable to fulfil his mission.


Although TUV has repatriated its archives, the investigators were able to capture an exchange of emails dating from 2011 between the head of the medical department at TUV France (Mr DURAND- VIEL) and his German counterpart whom he is interviewing, panicking at the idea of having to answer questions in front of a judge :

What are auditors supposed to check … I may seem strange that, after almost 600 audits, I have to ask you this question!!!! »…

He notes that he is undergoing training with TUV’s lawyers to prepare for the hearings: “I had no difficulty in answering the first set of questions, but after 2 hours and 40 tricky questions, I started giving contradictory (or inconsistent) answers, especially on the above point (…)”.

He admitted that he was carrying out his audits without having the design file: he had to check in the kitchen that the recipe book was being properly applied but did not have it with him:

I didn’t have any copy with me of the design file where the information on the raw material declared by PIP was mentioned, so they [TÜV lawyers] asked me why I really wrote all this information in my handwritten notes (and in the report) if I was unable to check if it was correct? Who was supposed to check whether the correct reference of raw material was used? … »

Mr DURAND VIEL adds in his email of 12 January 2011 that TUV’s lawyers noted that in some years only French auditors performed the audits:

“Furthermore, they [TÜV lawyers] raised the point that 2 French auditors had carried out the 2009 audit, (…) They [TÜV lawyers] said that this situation may have led to a lack of communication [between France and Germany], which may explain why we were unable to check things properly…. »

As his German counterpart did not answer him, Mr DURAND VIEL insisted in a second email dated 14 January 2011:

What are auditors supposed to check when performing an Annex II.3 (followed by an Annex II.4) audit for Class III devices? Do they have the task of checking the consistency of the materials and processes audited on site with the content of the design file that was approved in Cologne?

I see only 2 possibilities:

  1. The auditor is supposed to check the consistency between the design file that has been evaluated and the actual manufacturing process (including raw material references): in this case, I am dead because I was unable to do so, taking into account the fact that I did not have access to the content of the design file in Cologne,
  2. Or the auditor is not supposed to check this consistency: then that’s fine for me, but the following questions come up: who is supposed to check it? ? ? We will not be able to avoid this question. Again, 2 possibilities:

2.1 If it is the Notified Body’s Certification Committee, then this would explain why I have recorded all the information concerning the raw material references, to enable the Certification Committee to compare what I saw with the contents of the design file (but the Notified Body’s Certification Committee has never made such a comparison, being satisfied with the work of the French auditors).

2.2 If not, then WHO? ? Maybe nobody, but then our opponents will easily point out a huge gap in the system, because we check a nice design file, but nobody checks if it is in accordance with the actual practice of the company.

The whole case is practically summed up here: the TUV manager wonders who was supposed to check that the design file was actually applied at the manufacturer’s premises. He admits that TUV France could not do this because it did not know the design file and was not authorised to do so, and that since TUV Rheinland Germany did not carry out this verification either, nothing was seriously audited. PIP’s managers could do whatever they wanted.

As of 2011, this analysis, communicated internally within TUV, actually points out shortcomings in the control of PIP, revealing in particular a complete failure in the verification of raw materials.

Over the past 9 years TUV Rheinland has sought to deny and conceal this major fault in the performance of its mission as a notified body in disregard of the public service delegation conferred by this status. The world number 2 for quality assurance had to be the guarantor of the safety that the CE mark (European conformity) is supposed to provide. This is the essential objective of the regulation: to ensure that no medical device placed on the market compromises the health of users.


TUV France was not authorised to certify medical devices but only low-voltage electrical equipment. The fact that it was this subsidiary that carried outmost of the PIP audits is in itself an infringement of EU regulation.

The intervention of TUV France’s auditors is a key point which explains why TUV did not see anything, even though the elements revealing the non-compliance of the implants were not hidden.

TUV Germany, which was responsible for issuing certificates guaranteeing the quality and conformity of the implants, understood this. This is certainly what motivated it to claim at the beginning of the lawsuit that its French subsidiary had played no role in the control of PIP, other than that of a “point of contact”. It was only after the Commercial Court of Toulon forced it to provide certain documents that TUV acknowledged the intervention of TUV France, in a spectacular reversal of the defence. It then transmitted a sub-contracting agreement between TUV Germany and TUV France dated 1997, which it had previously deliberately concealed.

A flow of invoices was also discovered, which shows that TUV France invoiced PIP for the work of its own employees and not for that of TUV Germany.

Visibly embarrassed, TUV changed its argument again, explaining that TUV France had intervened as a subcontractor as the regulations would have allowed it to do. However, the regulations only provide for this possibility in a very limited framework and for one-off tasks. However, it was pointed out that TUV France’s auditors had carried out the bulk of the audits, which is totally contrary to limited subcontracting.

An examination of the invoicing shows that between 2001 and 2010, PIP was charged at 75% by TUV France and only 25% by TUV Germany, which contradicts TUV’s thesis: a one-off subcontractor cannot invoice 75% of a contract, unless it does most of the work itself.

The judges of the Commercial Court of Toulon analysed the case in 2013 and found that it was in fact TUV Germany which appeared to have been the subcontractor of TUV France.

Faced with this umpteenth contradiction, TUV developed a new thesis, arguing that in reality it was TUV Germany that had “hosted” the auditors of TUV France who had intervened under its control. It thus abandoned the thesis of subcontracting to argue that it was in fact TUV Germany which had carried out everything, which is once again contradicted by the facts.

The conduct of the audits by unauthorised French auditors who did not have the design file explains the control failures, particularly with regard to raw materials.


It is known that PIP only used the authorised Nusil silicone for a very small part of its production: less than 15%.

TUV employees indicated in their statements before French judges that the control of raw materials (and thus supply chain) was part of their obligations:

The general terms and conditions and the contract between TUV and PIP provided for this by giving the certifier strong means of control.

But the design file was in the offices of TUV Germany. This reference document detailed the technical characteristics of the authorised Nusil gel as well as its dosages or modes of use. The CE marking, equivalent to a marketing authorisation for medical devices, depended on the conformity of the information contained in this thick file.

It is clearly established that although PIP concealed the use of the Brenntag industrial gel, thanks in particular to a USB memory stick on which Jean-Claude Mas stored false accounting records, it never changed the exact quantities of Nusil gel that it actually purchased. This aspect was not disguised, whereas an elaborate fraud would have consisted in artificially inflating the exact quantities of Nusil.

Hanelore FONT (PIP Quality Director): Yes, regarding my service nothing was concealed and nothing had to be...Everything about Brenntag was not visible at the time of TUV’s visit[but]the figures of NUSIL were not changed”.

Loic Gossard: Only “orders from undesirable suppliers” (i.e. the Brenntag) disappeared.

The French auditors from TUV, who did not have the reference document, could not, however, verify the quantities of gel required or compare their possible findings with the dosages described therein. They found themselves in the role of inspectors in charge of ensuring that a cook prepares a dish correctly, but without knowing neither the recipe nor the ingredients.

A review of PIP’s purchasing history shows that TUV’s auditors did not audit raw materials. PIP did not purchase Nusil gel for periods in excess of 12 months. In 2004 PIP did not order any Nusil and in 2005 only 695 kg (although some 40 tons would have been needed)

However, the audits were supposed to be carried out at least once a year. If a check of the silicone gel components had been made, TUV’s employees would have seen :

  • that the legal period of 6 months for use was exceeded
    • that the same batch numbers appeared from one year to the next.

A simple reading of the supply list would have allowed TUV employees to realise that the quantities purchased did not coincide with those produced.

TUV explained that it was proceeding on a sample and survey basis.

In 2004, there were zero gram of Nusil. When you probe the vacuum, what can you find?

TUV could also question NUSIL and/or go to its European headquarters (located 130 km from PIP’s), which would have enabled it to establish that PIP ordered very little or nothing from Nusil.

This blindness of TUV is to be put in relation with its general laxity towards PIP. It was indeed highlighted that TUV did not respect the audit schedule: it could take a year and a half between two visits, well beyond the maximum period of 12 months.

TUV renewed its certifications several months before carrying out the corresponding audits. In other words, PIP was selling through certificates issued without control. Some documents were neither dated nor signed by TUV


The European directive on medical devices states that notified bodies are subject to an obligation of independence.

The Court of Cassation also reiterated this in its ruling of 10 October 2018: “the body and staff responsible for control must be free of all pressures and incentives, particularly of a financial nature, that could influence their judgment or the results of their control…”.

However, TUV charged PIP for consulting and training services, thereby establishing a business relationship with the manufacturer it was supposed to control. In particular, TUV France supported PIP in penetrating the Asian market.

We may add, more anecdotally, that the invitations to the restaurant accepted by the TUV inspector, who is also a native of Seyne-sur-Mer where PIP had its headquarters, leave one with doubts about TUV’s willing for independence.

PIP employees stressed the closeness that linked them to TUV. Mr Gossart told investigators: “Whether it was AFFSAPS, the FDA or the Australian TGA, they all found significant anomalies. Only TUV never found anything. We didn’t have the same relationship with TUV and the health agencies. We always had lunch with the auditors, but not with the inspectors of the agencies”.


The alerts around PIP products were numerous and necessarily known to TUV.

  •  In 2001, the FDA (Food & Drug Administration) sent a letter to PIP in which it listed an impressive series of shortcomings in the application of PIP’s quality system. As a result, PIP implants were banned from the American market while TUV certified them.
  •  The Australian TGA has also alerted PIP to multiple non-compliances.
  •  TUV has been informed of complaints and class actions in England concerning PIP implants.
  •  Finally, the MHRA – the British health agency – sent a warning letter in 2007 to PIP and ZLG, the TUV regulatory body in Germany, specifically about non-compliance. ZLG itself sent a letter on the subject to TUV. This complaint followed a first report in 2002. The British MDA had also intervened in 2000.

Despite repeated requests from the victims, TUV stubbornly refused to include these letters in the proceedings, to the point of opposing the execution of a judge’s order by a bailiff.

It can be added that TUV was responsible for ensuring the effective implementation of a system for monitoring material vigilance alerts. In view of the number of cases recorded, it should have been alerted about the quality of the products.

For the victims, these indications of non-compliance make the conviction of TUV inevitable.

In its 2018 ruling, the Court of Cassation stated that in the presence of such indications, TUV, as a notified body, should have

  •  carried out checks on raw materials (an obligation which was incumbent upon it even in the absence of such indications, see above);
  •  controlled the final products;
  •  organised unannounced visits.

As TUV has not fulfilled any of these requirements, it is difficult to see how judges could not hold it liable.


It would seem incomprehensible in these conditions that the civil courts seized of the case should rule in the sense of the Aix-en-Provence decision of 2015 which had surprisingly cleared TUV from responsibility, a decision that the Court of Cassation entirely annulled after having pointed out its insufficiencies and contradictions.

  • It would be incomprehensible as to the reliability of the CE marking on which European industry relies.
  • This would be incomprehensible in view of the responsibilities entrusted by the European Union to the certification players and their insurers, who would then have no motivation to change their practices in the direction of strict and real control.
  • This would be incomprehensible from the point of view of the French taxpayer:

If victims were to be deprived of civil compensation, they would have no choice but to bring civil proceedings in the criminal case under investigation for unintentional injuries, with the costs of the expert’s report being borne by the public purse. This would give them the possibility of benefiting from the guarantee of the SARVI public fund, which is responsible for compensating the victims of crimes whose perpetrators are insolvent. While this body has already paid out several million euros to patients in connection with fraud, the amount could reach 750 million euros given the total number of victims. This would be in addition to the €18 million spent by the social security to enable French patients to have fraudulent implants removed.

The PIP victims consider the case to be damning against the certifier TUV Rheinland. It has to bear the consequences of the scandal that the fulfilment of its obligations should have led to avoid and prevent

PIP BREAST IMPLANTS: The first final compensation expected up to 70,000 euros per patient

On July 1, 2020, the first “post expertise” hearing is held before the Commercial Court of Toulon on behalf of victims of the PIP breast implant scandal.

We remind that the Toulon court has already condemned the certifier TUV Rheinland three times. A provision of 3000 euros had been granted and the judges had mandated two medical experts (Professor Dominique Casanova and Dr. Antoine Alliez) to evaluate the damages suffered by each of the victims and allow the court to decide on the final amounts.

In March 2020, the experts decided on the principles for assessing the damages and issued their first final reports for a first group of patients. Olivier Aumaître, the victims’ lawyer, was thus able to formulate individually quantified compensation claims. This is the first time in this part of the case.

The medical experts used the “Dintilhac” nomenclature. This is the reference for the assessment of personal injury and has generated a rich jurisprudence. Using a logarithmic scale (from 1/7 to 7/7) it is possible to estimate with a certain degree of accuracy the amounts that will be awarded to each patient according to the complications suffered.

The Experts retained that any patient with a PIP implant had suffered a moral prejudice of permanent anxiety, ranging from 2 to 3.5 on the Dintilhac scale, corresponding to amounts ranging from 6,000 to 25,000 euros.

For Olivier Aumaître: “this is an important victory that we have won, and a major fact that ensures each woman victim a minimum compensation for a moral prejudice of anxiety qualified as permanent, excluding the risk of statute of limitation”.

Added to this are the suffering endured (multiple operations, complications such as siliconomes, respiratory insufficiencies after migration of the silicone into the lungs, various pains, etc), aesthetic damage that is often permanent; past or future health expenses.

The experts note that patients will have to be medically monitored for life.

For the first group of patients, the compensation varies, depending on the situation of each victim, from 17,000 to 70,000 euros, bearing in mind that some victims have very serious cases. Olivier Aumaître underlines that “with time, the dangerousness of the PIP gel appears more and more probable”.

With an average compensation estimated at 40,000 euros, the bill could exceed one billion euros for the German quality assurance giant. This total remains relatively low since less than 10% of the victims (estimated at 300,000 worldwide) have so far made a claim for compensation. It should be noted that legal proceedings are still ongoing and victims can still join them by registering on the PIPA platform (www.pipaworld.com).

Moreover, these compensations remain low in view of the ordeal endured by the patients:

  • 50% of them have suffered a rupture of their prostheses;
  • 30% will remain with a siliconome until the end of their life (silicone “balls” 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 depressive episode;
  • hundreds have respiratory deficiencies after the silicone reached their lungs.

According to PIPA’s lawyer, who calls for the German giant and its insurers to come to the negotiating table “10 years after the scandal broke, the time has undoubtedly come to turn the page on this affair by mutual agreement, as the giant Bayer/Mosanto has done in another area”.

After the Court of Justice of the European Union (CJEU) ruled on June 11, 2020 that patients could not turn against the PIP insurer (Allianz), the path opened by Olivier Aumaître and the PIPA association 10 years ago probably represents the only possibility of compensation now still open to victims.

It is, moreover, the one followed in France by the Social Security which is claiming nearly 20 million euros in expenses from TÜV Rheinland, and by a German insurer (AOK), whose admissibility of the claim against TÜV Rheinland was recognized on February 7, 2020 by the German Supreme Court (Bundesgerichhof).

PIP BREAST IMPLANTS European Court of Justice acknowledges lack of patient protection

The European Court of Justice today dismissed the claim of German patients with PIP breast implants who considered that the implementation of the PIP company’s insurance to French patients only was discriminatory.

Allianz, PIP’s insurer, had initially requested the cancellation of its liability insurance policy. Following the intervention of the French lawyer Olivier Aumaître before the Commercial Court of Toulon, the French courts had confirmed the validity of the insurance contract. However, it had restricted its benefit to patients operated on in France, as one of the clauses provided for. This principle had been validated in 2015 by the Court of Cassation.

The overall amount was also capped at 3 million euros. Allianz was able to manage the compensation of French patients alone and in total opacity.

The ECJ’s decision acknowledges one of the main shortcomings of European regulations concerning medical devices. No European directive requires manufacturers to take out insurance. They are therefore subject only to national laws, which vary widely.

This legal vacuum is a flagrant paradox. While the CE mark (European conformity) allows pacemakers, breast implants or hip prostheses to be freely marketed throughout the European Union and beyond, obtaining it does not oblige the manufacturer to take out insurance. Thus, 90% of PIP patients located outside France are not covered by PIP’s liability insurance.

For Olivier Aumaître, lawyer for PIP victims united within PIPA, “the regulation favours international exchanges of products, which is a good thing, but consumer protection stops at the border”.

More than 10 years after the revelation of the scandal, the European authorities have still not deemed it necessary to remedy this major deficiency.

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

The European Union has refused any support, even though PIP implants carry its mark, a supposed guarantee of the seriousness of European products. When questioned, the Commission’s services have constantly downplayed the scale of the affair.

A new health scandal is therefore likely to occur at any time. The victims could then benefit from the PIP case law by turning against the certifier as the PIP patients did against TUV RHEINLAND and its insurers, of which ALLIANZ is also a member,

For Olivier Aumaître, “the decision of the CJE confirms that the system of protection for breast implant patients relies essentially on the certifier and its insurers, who are responsible and solvent”.

The path opened in 2010 by the lawyer against TUV Rheinland thus represents the only viable recourse for the 300,000 PIP patients worldwide.

Four court rulings have already ordered TÜV Rheinland in France to compensate PIP patients to the tune of approximately 65 million euros, i.e. barely 10% of the expected final compensation. The legal actions are still ongoing, while medical expertises have been ordered to assess the damages, which will take several more years before a final decision is taken.

In several decisions dated October 10, 2018, the French Supreme Court 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, he 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 for the notified body to be exposed to the risk of criminal prosecution by third parties in the event of negligent checks”.

The German and French Supreme Courts also reminded that TÜV Rheinland had to maintain its independence from PIP. However, 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 for training services and helped PIP to penetrate the Asian market, among other things).

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

Women with PIP implants can still join ongoing procedures.

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.