PIP CASE

• ORIGIN

Poly Implant Prothese (PIP) was founded in 1991 by Jean-Claude Mas and Professor Henri Arion in La Seyne-sur-Mer in the Var department, near Toulon, in the south of France. In the 2000s, it became the world's third largest manufacturer of breast implants. It employed 120 people.

 

Until 2001, the use of silicone was prohibited in France. PIP marketed its implants filled with saline solution or hydrogel, while silicone implants were dedicated to export markets. From 2001 onwards, the use of silicone was authorised and PIP declared that it filled its breast implants with Nusil medical silicone gel, one of the two authorised silicone brands, which had undergone clinical tests establishing its safety.

 

In accordance with the regulations (European Directive 93/42/EEC of 14 June 1993 on medical devices), applied in France in the Public Health Code, PIP, as a manufacturer of a medical device, was required to obtain certification from one of the bodies authorised by the European Commission, freely chosen by the manufacturer, enabling it to obtain the CE marking. This CE marking certifies that the product complies with the essential requirements in terms of quality, safety and consumer protection and is equivalent to a marketing authorisation, in this case on a global level.

 

In 1997, PIP chose TÜV RHEINLAND LGA Products GmbH (TRLP), part of the German TÜV RHEINLAND group.

 

TÜV RHEINLAND, which has been monitoring German industry since the 19th century, is an institution synonymous with high quality standards and reliability in its certifications. Employing 15,000 people, it has a turnover of €2 billion.

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• THE DISCOVERY OF THE SCANDAL

 

The PIP breast implant scandal broke in March 2010 when the French health authority AFSSAPS (now ANSM) discovered that, although certified by TÜV RHEINLAND, PIP silicone implants had been pre-filled with an undeclared silicone gel, in this case a harmful industrial gel that had never been tested for implantation in the human body.

 

On 29th March 2010, the AFSSAPS decided to withdraw PIP implants from the market, marking the end of their commercialisation worldwide.

 

The revelation of the scandal had widespread global repercussions and developments in the PIP case have since been widely reported in the media.

 

• THE FIGURES

 

In the absence of traceability controls, the exact number of victims with PIP silicone-filled implants is unknown.

 

It is estimated that PIP produced 1 million implants between 2001 and 2010 and that the number of recipients is probably between 300,000 and 400,000.

 

PIP exported 90% of its production outside France to 65 countries around the world.

 

Women with PIP implants spread across Europe (particularly France, Great Britain, Sweden and Spain) for around 30%, Latin America (particularly Colombia, Venezuela, Mexico, Argentina and Brazil) for about 50%, and the rest of the world, particularly Asia and Australia, for about 20%.

 

PIP implants were used for both reconstruction following cancer-related mastectomies and cosmetic breast augmentation.

 

 

• LEGAL ACTION

 

The AFSSAPS decision in March 2010 marked the start of a series of legal actions:

 

Criminal proceedings

 

The French authorities brought criminal proceedings against the directors of PIP, in particular for fraud.

 

In this first case, decisions were handed down by the French criminal courts in 2013 (Marseille Criminal Court), 2016 (Criminal Appeals Chamber of the Aix-en-Provence Court of Appeal) and 2018 (Court of Cassation). Mr Jean-Claude Mas (who died in 2019) and other PIP employees were sentenced to prison terms and fines.

 

Under certain conditions, the criminal aspects of the PIP case may enable victims to obtain assistance from SARVI (Service d'Aide au Recouvrement des Victimes d'Infraction - Assistance Service for the Recovery of Victims of Crime).

 

Insurance

 

In 2010, the Toulon Commercial Court heard a civil case involving Allianz, PIP's insurer, which, in view of the fraud, sought to have its insurance contracts declared null and void. Olivier Aumaitre Avocats intervened in this litigation to represent victims and seek the conviction of the insurer. Several decisions were handed down in 2012 (Toulon Commercial Court), 2015 (Aix-en-Provence Court of Appeal) and 2018 (Court of Cassation).

 

It was ruled that the insurer Allianz was only liable for a limited amount (€3 million) and only to victims who had received PIP implants in France. A ruling by the European Court of Justice (ECJ) on 11th June 2020 found that this was not contrary to the principle of non-discrimination.

 

Proceedings against the certifier TÜV Rheinland

 

Olivier Aumaitre Avocats initiated the legal proceedings in France against the TÜV RHEINLAND group, seeking to hold it liable for failing to carry out proper checks.

 

The actions were initially brought on behalf of foreign distributors of PIP implants, which were subsequently joined by numerous victims.

 

Olivier Aumaitre Avocats took action against TÜV RHEINLAND LGA Products GmbH (TRLP), as well as against a French entity, TÜV RHEINLAND France (TRF), which occurred to have been involved in the inspections, even though it was not authorised to do so.

 

An initial ruling (TUV1 proceedings) was handed down in 2013 by the Toulon Commercial Court, which (i) declared itself competent (TUV contested the jurisdiction of the French court and wanted to be tried in Germany) (ii) recognised the liability of TRLP and TRF for breaches of their obligations and negligence in their inspections, and (iii) ordered them jointly and severally to compensate the victims (iv) who were awarded an interim payment of €3,000 (v) to be deducted from their final compensation, the assessment of which was entrusted to legal experts.

 

Since then, the Toulon Commercial Court has handed down similar rulings on behalf of other victims from around the world who have joined the original actions brought by Olivier Aumaitre Avocats, grouped together in new proceedings known as TUV2 and TUV3 (2017), TUV4 (2022), TUV5 (2023) and TUV6 (2025).

 

Olivier Aumaitre Avocats represents nearly 20,000 victims from around the world in these various lawsuits.

 

The European Court of Justice, which heard the PIP case, issued a ruling in 2017 establishing the principle of the certifier's duty of care.

 

The decisions of the Toulon Commercial Court were essentially upheld by the Courts of Appeal of Aix-en-Provence in 2021 (TUV2 and TUV3) and Paris in 2021 (TUV1).

 

Several confirmatory judgments were handed down by the Court of Cassation in 2018 (TUV1) and in 2023 (TUV1, TUV2 and TUV3).

 

The courts unanimously held that TÜV "failed in its obligations of control, prudence and vigilance in the performance of its duties and that its professional liability is proven".

 

The Lyon Court of Appeal must rule solely on whether or not TUV's liability should be limited in time.

 

The Aix-en-Provence Court of Appeal handed down the first decision ruling on the final compensation for victims represented by Olivier Aumaitre (2023), which was upheld by the Court of Cassation (2024).

 

Other decisions unfavourable to TUV have been handed down, notably by the Nanterre Judicial Court (2018; 2024).

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In January 2026, Olivier Aumaître obtained the first ruling from the Toulon Commercial Court on final compensation following an expert assessment of an initial group of 371 TUV2 victims.

Compensation ranges from €6,000 to €47,000. 

 

• THE RISKS OF PIP IMPLANTS

 

Since the scandal came to light, health safety agencies have recommended the preventive removal of PIP implants certified by TÜV RHEINLAND.

 

It has been established that PIP silicone implants have a rupture rate six times higher than normal, thus increasing the risk of contact between the industrial silicone gel used (less cohesive than medical gel) and the human body. It is often impossible for surgeons to remove all of the gel that has leaked out. Silicone can also spread into the tissue even if there is no rupture: PIP shells are often porous, allowing the adulterated gel to leak.

 

Various components have been found in the implants analysed, including Baysilone (a fuel additive), Silopren and Rhodorsil, all of which are toxic products.

 

Numerous cases of lymph node inflammation have been reported. These often lead to surgery, as removal of the lymph nodes is usually necessary.

 

In addition, increasingly severe complications are being observed. Industrial silicone migrates through the body, particularly via the lymphatic system, and can affect various organs. In some cases, this can lead to pulmonary or intestinal failure.

 

Patients with PIP implants frequently suffer from a multitude of symptoms and complications. Almost all PIP patients have suffered from acute anxiety related to wearing implants with unknown effects. The consequences also affect their children, as many of them have had to give up breastfeeding due to the potential risks to their babies.

 

Silicone breast implants can cause a rare form of cancer: breast implant-associated anaplastic large cell lymphoma (BI-ACL).

 

It should be noted that to date, no epidemiological studies have been conducted on women with PIP implants. The list of complications could therefore grow longer.

 

Many victims have replaced their PIP implants with implants from Allergan, which has since been the subject of a new health scandal.