- 1. What is the PIP implants scandal?
- 2. How was the scandal discovered?
- 3. What is the history of Poly Implant Prothese?
- 4. What are the risks associated with PIP implants? What are the complications?
- 5. Who are PIP implants victims? Colombia, United Kingdom and Venezuela are the most affected countries
- 6. Are all PIP products concerned?
- 7. Should I remove PIP implants? What is the support?
- 8. What are the different judicial procedures? What are the successful pip implants claims?
- 9. What was the role of the TUV Rheinland certifier in PIP implants control??
- 10. What are the charges against the TUV Rheinland certifier?
- 11. How to claim compensation for PIP implants? What damages are taken into account? What are the compensations amounts for the victims?
- 12. How are medical devices controlled?
1. What is the PIP scandal?
The PIP (Poly Implant Protheses) scandal broke out on March 29, 2010 when the AFSSAPS (the French health agency, now named ANSM) banned the sale and use of these silicone breast implants. The health safety agency revealed that since 2001 PIP had been using an industrial silicone gel to fill these implants. This silicone supplied by the German company Brenntag had no medical grade and had never been tested for implantation in the human body.
According to the file submitted for the CE mark (equivalent to a marketing authorization) PIP had to fill its implants with NUSIL brand gel, duly tested for medical use and in particular for an implantation in the human body.
For nearly 10 years the company has marketed fraudulent medical devices in more than 65 countries.
These medical devices which were not compliant with requirements for health security belonged to the highest category (class III) and therefore were supposed to be under the strictest supervision. This class of medical devices is for implantable devices such as cardiac stents, pacemakers or ocular implants.
2. How was the scandal discovered?
The fraud was discovered by two inspectors of AFSSAPS. 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.
3. What is the history of Poly Implant Prothese?
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.
4. What are the risks associated with of PIP prostheses? What are the complications?
Following the revelation of the scandal, several health safety agencies (France, the United Kingdom and Australia in particular) conducted laboratory tests on guinea pigs. They concluded that the Brenntag gel found in the prostheses tested 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 frosted gel.
Many cases of inflammation of the lymph nodes have been reported. They often lead to heavy surgeries, with the removal of lymph nodes usually becoming necessary.
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.
5. Who are PIP implants victims? Colombia, Venezuela and United Kingdom are the most affected.
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: 10000
- Italy : 10000
- Sweden, Norway, Denmark, Finland: 5000
- Australia: 5000
- 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.
6. Are all PIP products concerned?
PIP also manufactured breast prostheses 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.
7. Should I remove PIP implants? What is the support?
ANSM as well as most national health agencies (the Netherlands, Germany, Australia …) recommend preventive removal of PIP implants.
It should be noted that scans, mammograms or magnetic resonance imaging do not always detect a break. 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 have undergone restorative implantation following cancer. For patients who have had cosmetic breast augmentation surgery, only the withdrawal is reimbursed.
In Britain, the NHS supports simple withdrawal.
In almost all other countries, victims must bear the cost of withdrawal and replacement alone.
8. What are the different judicial procedures? What are the successful pip implants claims?
8.1 Criminal proceedings
Three proceedings were instituted 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.
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 are asked 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, assigns TUV Rheinland and TUV France before the Commercial Court of Toulon. Three other distributors (Mexico, Romania and Syria) then join 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 condemns TUV Germany and TUV France to jointly compensate the damages of patients and distributors. In particular, the judgment states that TUV has been fraudulently involved in 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 is allocated to each patient.
In January 2014 the Aix-en-Provence Court of Appeal confirmed the provisional execution of the Toulon judgment. TUV pays 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.
TUV 2 and 3
In 2014 and 2015 Olivier Aumaitre again assigns TUV Rheinland before the Commercial Court in two procedures known as TUV 2 and TUV 3. It represents nearly 15,000 patients and 40 clinics and distributors. More than 5000 other patients join this procedure through other lawyers.
In January 2017 TUV is again condemned to compensate victims and must pay a provision of 3000 euros to each patient. Provisional execution is confirmed by the Aix-en-Provence Court of Appeal TUV pays 60 million to the victims.
TUV 4 and TUV 5
In 2018 Olivier Aumaîitre initiates a new procedure known as TUV 4.
A procedure called TUV 5 is being prepared in 2019.
Proceedings before the Nanterre Regional Court
On 29 November 2018, the Nanterre High Court sentenced TUV Rheinland to compensate 400 Swedish patients. The judgment states that TUV has committed a breach of its duty of vigilance and control.
One patient also obtained TUV’s condamnation before the Valencia Regional Court.
9. What was the role of the TUV Rheinland certifier in PIP implants control?
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 the raw materials used. 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.
10. What are the charges against TUV?
Overall, TUV is criticized for being negligent. Many elements even show that they have acted fraudulently with European regulations.
First, TUV systematically announced its visits to PIP, which had the time to prepare and hide the fraudulent freeze stocks.
The regulation gives the notified body the power to carry out unannounced inspections. In particular, they must be performed when there is doubt. Warning signs were numerous and known to TUV:
- in 2000 the US Food and Drug Administration (FDA) sent a letter to PIP denouncing serious failures in its quality assurance system. This formal notice was public
- complaints had been filed in Britain against PIP, which had been sentenced to compensate patients
In addition silicone breast implants had been subject to a moratorium until 2001 following the scandal Dow Corning. TUV therefore had to be particularly vigilant.
Secondly, the control audits were carried out by the French subsidiary of TUV. The latter was not empowered to certify medical devices. Its accreditation was limited to low voltage electrical appliances.
Third, TUV did not control the raw materials used, which was part of its obligations. PIP has not placed any orders with NUSIL for periods sometimes exceeding 12 months. The NUSIL gel has a shelf life of 6 months. The inconsistency was therefore in the eyes of the TUV auditors. They did not have the design file, which was in Germany. The fact that the controls were carried out by the French subsidiary of TUV therefore had the direct consequence of its inability to effectively check the raw materials and in particular the silicone gel used.
Fourth, TUV did not perform any tests on finished products, nor did it require PIP to do so. The numerous warning signals should have led them to such verifications. TUV was really content to control documents.
Fifth, did not audit suppliers. A simple call to Nusil would have yet allowed them to discover the trickery.
Finally, TUV has been unresponsive to the level of qualification of PIP employees. Thus a pastry chef was in charge of the quality control and a welder was responsible for the production …
11. How to claim compensation for PIP implants? What damages are taken into account? What are the compensations amounts for the victims?
To date, no victim has been fully compensated. The French patients who came forward 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.
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 …)
12. How are medical devices controlled?
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 prostheses in their bodies that present major risks.