all about the French silicone breast implants case: risks, successful compensations and other updated information for the PIP victims
Le scandale des implants mammaires PIP (Poly Implant Prothèses) a éclaté le 29 mars 2010 lorsque l’AFSSAPS (aujourd’hui ANSM) a interdit la vente et l’utilisation de ces prothèses préremplies de gel de silicone. L’agence de sécurité sanitaire a révélé que la société PIP avait utilisé depuis 2001 un gel de silicone industriel pour remplir ces implants. Cette silicone fournie par la société allemande Brenntag n’avait pas de grade médical et n’avait jamais été testée pour une implantation dans le corps humain.
Selon le dossier déposé pour le marquage CE (équivalent d’une autorisation de mise sur le marché) PIP devait remplir ses implants avec du gel de marque NUSIL, dûment testé pour une utilisation médicale et notamment une implantation dans le corps humain.
Pendant près de 10 ans l’entreprise a donc commercialisé dans plus de 65 pays des dispositifs médicaux de classe III frauduleux, non conformes aux exigences de sécurité sanitaire. La classe 3 est pourtant celle la plus élevée et devant faire l’objet de la surveillance la plus stricte. Elle correspond aux dispositifs implantables tels que les stents cardiaques, les pacemakers ou les implants oculaires.
The fraud was discovered by two inspectors of AFSSAPS. They had come to interview PIP officials on a much higher number of incidents than for other brands. Their visit having been announced, they did not discover anything at first, the PIP employees having taken care, as they were used to before any inspection, to conceal the barrels of unauthorized frost.
Intrigued by anonymous photos received a few months ago, they decided to return to inspect the factory unexpectedly. This is how they discovered the Brenntag industrial gel stocks. The leaders of PIP then had no choice but to recognize the fraud.
The company Poly Implant Prothèse was created in 1991 by Jean-Claude Mas and Professor Henri Arion in La Seyne-sur-Mer, near Toulon (southern France)
In the 2000s she became the world’s third largest producer of breast implants. Its turnover reached 13 million euros. She employed up to 120 employees.
Placed in the procedure of safeguard in 2009 following its financial difficulties, it was put into liquidation on March 31, 2010, two days after the revelation of the scandal. The Gemcare investment fund which was to resume the activity finally gave up its plans.
Following the revelation of the scandal, several health safety agencies (France, United Kingdom and Australia in particular) conducted laboratory tests on guinea pigs. They concluded that the Brenntag gel found in the tested products did not present a risk of genotoxicity or cytotoxicity, in other words that it was not a carcinogen.
However, these results should be taken with caution since these studies have only been performed on a few rabbits and for a short time. It also appeared that the composition of the industrial silicone used by PIP varied greatly from one implant to another.
Various components have been found in the analyzed implants including Baysilone (fuel additive), Silopren and Rhodorsil.
Only an epidemiological study could dismiss with certainty the carcinogenic risk.
Laboratory tests have shown the irritating nature of the gel.It is also established that PIP implants have a rupture rate six times higher than other brands. The silicone used being much less cohesive than the medical grade, it spreads much more easily in the body. It is often impossible for surgeons to remove all the gel that has passed.The gel can spread in tissues even in the absence of breakage: the PIP envelopes are indeed often porous, leaving oozing the toxic silicone.
Many cases of inflammation of the lymph nodes have been reported.
In addition, the complications are proving to be increasingly severe. Industrial silicone migrates into the body and to the lymphatic system which can affect different organs. In some cases, the this can lead to pulmonary or intestinal insufficiencies
Patients with PIP implants frequently suffer from the following symptoms and complications:
- inflammation of the lymphatic nodes
- chest and / or abdominal
- pain joint
- pain back pain
- capsular contractures (hull effect around implants with often deformity and associated pains)
- sensations ofnipple burn
- ovarian polycystic(Stein-Leventhal syndrome)
- irritations / rashes
- alopecia (hair loss)
Virtually all PIP patients suffered from acute anxiety related to the wearing of prostheses with unknown effects.
The consequences also affect their children since many of them had to give up breastfeeding because of the potential risks for their baby.
Silicone breast implants can cause a rare cancer:anaplastic large cell lymphoma or BI-ACL (Breast Implant-Associated Anaplastic Large Cell Lymphoma).
It should be noted that to date, no epidemiological studies on women with PIP implants have been conducted. The list of complications could therefore be lengthened.
Thus there is now a strong presumption that silicone is to be related to the emergence of diseases developed by the victims’ children. A survey of a group of 600 patients revealed that 50 of them who breastfed and/or became pregnant while they were PIP carriers, had children with autism or autoimmune diseases. Knowing that only a minority of these 600 women had had a concomitant pregnancy, the rate of women concerned seems particularly high.
It is estimated that PIP produced 1 million implants between 2001 and 2010. Given the unsold stocks, the number of carriers is probably between 300000 and 400000. PIP exported 90% of its production in 65 countries.
The number of patients per country is not known with certainty but we can establish an estimate:
- Colombia: 60000
- Great Britain: 50000
- Venezuela: 40000
- France: 30000
- Spain: 18000
- Brazil: 12000
- Mexico: 10000
- Argentina: 12000
- Italy : 10000
- Sweden, Norway, Denmark, Finland: 5000
- Australia: 6000
- Ecuador: 2000
- Thailand: 2000
- Bulgaria: 2000
- Hungary: 2000
- China: 1500
- Iran: 1500
Other patients are distributed in various countries: Austria, Germany, Czech Republic, Turkey, Poland, Greece, Czech Republic, Romania , Tunisia, Panama, Costa Rica …
PIP implants were as well intended for reconstruction after a mastectomy as a breast augmentation for aesthetic purposes.
PIP also manufactured breast implants filled with saline or hydrogel. It has not been established that these implants are affected by the fraud.
Some employees told investigators or ANSM that the micro-textured (MX) silicone implants were filled with the NUSIL gel. Given the widespread lie within the company, we can doubt the veracity of this information. Since the quality system has been largely falsified, it is impossible to establish with certainty which implants were made with the correct gel.
We can therefore say that all PIP prostheses pre-filled with silicone gel are affected by fraud.
The French health agency (ANSM) as well as most national health agencies (the Netherlands, Germany, Australia …) recommend removal of PIP implants.
It should be noted that scans, mammograms or magnetic resonance imaging do not always detect a rupture. In addition, the envelopes of the PIP prostheses have proved to be porous. The toxic gel can therefore spread in the body even in the absence of rupture. The withdrawal is therefore recommended regardless of the patient’s situation.
In some countries (France, Italy) social security provides replacement for patients who had undergone reconstruction surgery after cancer. For patients who have had cosmetic breast augmentation surgery, only the withdrawal is reimbursed.
In Britain, the NHS supports only withdrawal.
In almost all other countries, victims must bear the cost of withdrawal and replacement alone.
8.1 Criminal proceedings
Three proceedings were implemented against PIP managers on different grounds:
- aggravated deception and fraud
- injury and manslaughter
- misuse of social property, concealment of misuse of corporate assets and fraudulent bankruptcy
The first part has come to an end: on September 11, 2018 the Court of Cassation has confirmed the conviction of Jean-Claude Mas to four years in prison and those of other leaders (18 months suspended at 2 years firm).
The other two criminal proceedings are still under investigation. They are expected to continue despite the death of Jean-Claude Mas, founder of PIP.
8.2 Civil procedures
8.2.1 The insurer Allianz
The insurer of PIP Allianz initiated in May 2010 a procedure before the commercial court of Toulon requesting the cancellation of the civil liability policy. Three distributors represented by Olivier Aumaitre, a lawyer at the Paris Bar, opposed it.
In July 2015 the Court of Cassation confirmed the decisions rendered in first and second instance: the insurance only applied to patients operated in France, with an overall limit of 3 million euros.
French justice has therefore noted that a company manufacturing implantable medical devices exported to 65 countries, had no obligation of insurance for its customers located abroad, including in the European Union.
This legal vacuum was validated by the European Court of Justice which, in a decision of 11 June 2020, confirmed that PIP’s insurance only covered patients who were fitted with the implants in France.
8.2.2 Procedures against the TUV Rheinland certifier
2010, three distributors (J & D Medicals, Bulgaria, EMI, Brazil, GF Electromedics, Italy) gave notice to the German company TUV Rheinland Germany and its French subsidiary. They requested TUV to take care of the financial losses suffered by these companies but also to guarantee the compensation of the patients of their respective countries. In the absence of any desire for dialogue from TUV their lawyer, Olivier Aumaitre, subpoenaed TUV Rheinland and TUV France before the Commercial Court of Toulon. Three other distributors (Mexico, Romania and Syria) then joined the procedure.
After the disclosure of this first civil action in the press, 1600 patients, mainly from Latin America joined the procedure in February 2012.
In May 2013 the execution judge in Nanterre authorizes Olivier Aumaitre to seize 900,000 euros on TUV France accounts. The seizure is however unsuccessful, the bank balance being insufficient.
On November 14, 2013 the Commercial Court of Toulon condemned TUV Germany and TUV France to jointly compensate the damages of patients and distributors. In particular, the judgment states that TUV acted in fraud of the European Medical Devices Directive and that TUV has breached its obligations of control, prudence and vigilance in carrying out its duties.
A provision of 3000 euros was allocated to each patient.
In January 2014 the Aix-en-Provence Court of Appeal confirmed the provisional execution of the Toulon judgment. TUV paid 4.8 million euros to the victims.
This decision was overturned by the Aix-en-Provence Court of Appeal on 2 July 2015 after an instruction conducted in record time (18 months against an average of more than 3 years for much simpler cases).
On October 10, 2018, the French Supreme Court (Cour de Cassation) reversed the judgment of the Court of Appeal of Aix-en-Provence in all its provisions, thus consolidating the first instance decision of the Commercial Court of Toulon, which was then restored.
The judgment of the highest French court is particularly explicit. It specifies that a notified body such as TUV Rheinland is bound by a duty of vigilance. The Court states that if there are indications of non-compliance, the certifier must carry out unannounced inspections and verify the raw materials and the products themselves.
As French Supreme Court does not judge on the substance, it could not sentence TUV directly and therefor, referred the proceedings to the Paris Court of Appeal, which will take into account its indications.
The decision from the Court of Appeal of Paris is expected on 20 May 2021
TUV 2 and 3
In 2014 and 2015 Olivier Aumaitre subpoenaed again TUV Rheinland before the Commercial Court in two procedures known as TUV 2 and TUV 3. He defends the interests of 15,000 patients and 40 clinics and distributors. More than 5000 other patients joined this procedure through other lawyers.
In January 2017 TUV was again sentenced to compensate victims and to pay a provision of 3000 euros to each patient. Provisional execution was confirmed by the Aix-en-Provence Court of Appeal TUV pays 60 million to the victims.
On 11 February 2021, the Court of Appeal of Aix-en-Provence confirmed the liability of TUV Rheinland and order to compensate the victims.
The Court held that TUV had failed in its obligations, in particular in the control of raw materials, and that it had failed in its duty of independence. The Court also held that there had been numerous alerts and indications since 2001 which should have led TUV to carry out in-depth checks, including unannounced inspections.
TUV 4 and TUV 5
In 2018 Olivier Aumaîitre initiated a new procedure known as TUV 4 for 1800 new victims.
The judgement from the commercial Court of Toulon is expected on 11 June 2021.
A procedure called TUV 5 is pending.
One patient also obtained TUV’s condemnation before the Valencia Regional Court.
The European regulation provides that any manufacturer of medical devices must use a notified body which certifies that the products comply with the essential requirements in terms of quality and safety and protection for consumers.
On the basis of the certificate issued by the notified body, the manufacturer may affix the CE marking to his products and thus sell them freely throughout the European Union. This equates to a marketing authorization, which is often enough to access non-European markets.
Producers are free to choose from the approximately 80 notified bodies throughout the Union. Each Member State has the power to issue an authorization to organizations in its territory.
PIP chose the German company TUV Rheinland, the second largest quality assurance company in the world (behind the Swiss SGS).
PIP had opted for the EC declaration of conformity procedure (complete quality assurance system). This meant that TUV was responsible for evaluating the design records of medical devices as well as the entire quality assurance system and its application. This includes, among other things, strict control of raw materials. The notified body is the only one to control the manufacturer. It is a real delegation of public service. Health control services such as ANSM intervene only in the event of an alert on a health risk.
TUV Rheinland’s responsibility is based on 4 key points
- TUV France carried out most of the audits of PIP. However, this subsidiary was not authorised to certify medical devices. Its employees did not know what they were supposed to check because the reference document (the design file) was located at TUV’s German headquarters. TUV lied for the first few years, trying to hide the involvement of the French entity
- TUV did not control the raw materials although it was its obligation. PIP never concealed its purchases of authorised silicone (Nusil). The auditors would have easily found the absence of authorised silicone… if only they had checked and if they knew what to check
- There were multiple alerts about PIP implants (US FDA, UK MHRA, Australian TGA, etc). TUV was aware of these indications of non-compliance. Consequently, TUV should have controlled the products and organised unannounced visits, as the Court of Cassation reminded it.
- TUV had established a commercial relationship with PIP. It was therefore not independent of the manufacturer it was supposed to control.
A summary regarding the civil liability of TUV Rheinland is available here
To date, no victim has been fully compensated. The French patients who applied within the deadlines set by Allianz were able to share the three million euros that the insurer had allocated following court decisions. This way of compensation is now extinct. Patients who paid for their initial PIP transaction by credit card could request a refund via their credit card insurance.
So far the only procedure that opens the way to full compensation is the civil action against TUV Rheinland led by Olivier Aumaitre.
22000 victims received a preliminary compensation of 3000 euros. This provision was intended to cover the cost of removal of implants as well as the cost of expertise. This must allow the court to decide on the final amounts for each victim individually.
The criminal trial against TUV leaders gave an indication of the amounts that victims can hope to obtain. The court had sentenced Jean-Claude Mas and the other defendants to compensate the 7000 civil parties. The amounts allocated have not been paid, however, the convicted persons being insolvent.
Victims who have no particular complications can expect 6,000 euros in respect of non-pecuniary damage and the reimbursement of withdrawal and replacement costs.
Patients who have suffered additional complications or damages should be compensated for several tens of thousands of euros. Indeed all the damages must be taken into account for the calculation of the amounts of compensation: moral, physical, aesthetic, psychological, sexual harm … All medical expenses and loss of income must also be deducted.
The first experts’ reports allow an initial assessment of the final compensation that may be granted. On the basis of the assessments of the medical experts having examined a first batch of fifty cases, the amounts requested from the court by Olivier Aumaitre range from 17,000 to 70,000 euros. The Court is expected to render a decision on this matter by the summer of 2021.
In addition, other ways of compensation are possible.
First of all, the SARVI (Assistance Service for the Recovery of Victims of Offenses) can compensate up to a limit of 3000 euros for all victims admitted as civil parties in criminal proceedings.
Then other civil actions are possible against public and / or private organizations involved in the scandal (ANSM, European Union, Brenntag …)
The PIP implant case has been a revealing example of breaches in the control of devices in the European Union, which have recently been highlighted by the journalistic investigation known as the #implants files.
Apart from the failures of notified bodies, which are private companies remunerated by the customers they are supposed to control, the scandal revealed the total lack of monitoring of the medical devices.. Thus no traceability is organised.
The authorities are therefore unable to know the number of patients implanted with any medical device whatsoever, and even less to contact the persons concerned in the event of a failure…
It is therefore likely that many women with PIP implants are still unaware that they have implants in their bodies that present major risks.