Poly implant prosthesis

from Wikipedia, the free encyclopedia
Poly Implant Prosthesis (PIP)
legal form
founding 1991
resolution 2011
Seat La Seyne-sur-Mer , France
management
  • Jean-Claude Mas (Management)
  • Thierry Brinon (Technical Director)
Number of employees ~ 120 (2010)
Branch Medicine (implants)
Website www.pipfrance.fr

Poly Implant Prothèse ( PIP ) was a French company based in La Seyne-sur-Mer near Toulon . It was founded in 1991 by Jean-Claude Mas. It made breast implants and was the third largest manufacturer in the field. PIP was liquidated in 2011 . Both the company and the company's founder are at the center of a global health scandal. It is about a rupture of the implants or a gradual leakage of the silicone gel. A connection with cancer has not been proven.

history

The company produced around 100,000 implants per year for 20 years . Almost 400,000 women worldwide have had silicone implants used to enlarge their breasts or to restore them after cancer surgery. The implants were exported to Great Britain, Germany (around 10,000), Spain and Italy, Latin America, Australia and the People's Republic of China.

Legal proceedings due to complications began as early as 1996. In June 2000, the FDA of the USA objected to the production method with a so-called Warning Letter and in May 2000 stopped the import of the PIP implants into the USA. From 2001 onwards, instead of the officially used silicone inserts, the company filled those made of cheap gel on a large scale. As reports of burst and leaking silicone cushions increased, the French authority Agence française de sécurité sanitaire des produits de santé (Afssaps) banned the marketing, distribution, export and further use of the implants on April 1, 2010. Swissmedic in Switzerland reacted in April 2010. The certification of the implants for the European market is the responsibility of TÜV Rheinland and was only revoked in May 2010, more than a month after the official operating bans.

The French health insurance company Caisse nationale de l'assurance maladie des travailleurs salariés (CNAS) has now filed a complaint with the public prosecutor in Marseille for serious fraud. Argentine and Venezuelan victims' associations want to join the lawsuit.

In the UK , state NHS clinics have to remove implants free of charge, while private clinics refuse; However, implants are widely used in unregulated private clinics, not just in the UK. For Germany, 80 percent of cosmetic surgeries are assumed for which the cost coverage is questionable. So far, at least 1,565 women have had the implant removed again, and half of the implants showed damage, such as cracks.

Jean-Claude Mas

Jean-Claude Mas, born in 1939 and a trained butcher , sold wines, cognac and sausage products in the 1970s before becoming sales manager at the American pharmaceutical company Bristol-Myers Squibb for 15 years . He worked with the French cosmetic surgeon Henri Arion, who first introduced breast implants in France in 1965. When Arion died in an airplane accident in 1991, Mas continued the joint work and founded Poly Implant Prothèse (PIP) in the same year .

With the prohibition of his business in 2010, Jean-Claude Mas went into hiding and has been wanted by Interpol since mid-2011 in order to deliver him to the French judiciary. At the end of January 2012, he was provisionally arrested at his country house in southern France. Among other things, he is accused of filling the cushions with cheap, unacceptable industrial silicone.

On December 10, 2013, Mas was sentenced to four years imprisonment and a fine of 75,000 euros as well as a professional ban for fraud in the criminal trial before the Tribunal Correctionnel in Marseille . In early May 2016, a French appeals court upheld the prison sentence. Mas died on April 4, 2019 at the age of 79.

TÜV Rheinland

In connection with the health scandal, TÜV Rheinland AG has come under fire as the notified body responsible for the certification of PIP implants as implantable medical products in connection with the CE mark . TÜV Rheinland was responsible for checking the quality management and compliance with the European guidelines for medical devices. The company claims that it was itself a victim of the criminal activities of PIP and that it has been taking legal action against the implant manufacturer since the irregularities became known in March 2010. On February 2, 2012, TÜV Rheinland was invited to a hearing at the Commercial Court in Toulon. As a consequence of the scandal, the chairman of TÜV Rheinland is calling for changes to the test regulations in order to prevent extreme criminal acts in the future. For this purpose, according to his ideas, a 4-point program is to be introduced which prescribes type tests, taking samples from production and testing products that have already been delivered. In addition, supervisory authorities should be obliged to include the testing organizations in their flow of information. In January 2013, an affected 62-year-old woman from Ludwigshafen also sued TÜV Rheinland for damages; The complaint was (also) dismissed in the appeal proceedings by the higher regional court in Zweibrücken with judgment of January 30, 2014 (Az. 4 U 66/13), as was another lawsuit, pending at the Regional Court of Munich I with judgment of December 11, 2013 (Az. 9 O 10603/12). On September 12, 2013, the health insurance AOK Bayern filed a lawsuit against TÜV Rheinland with the Nuremberg-Fürth regional court and demanded that the costs of the operations to remove breast implants from 27 insured persons be taken over as compensation. In March 2014, the regional court dismissed this action with reference to the judgment of the Zweibrücken Higher Regional Court. On November 14, 2013, the French Tribunal de Commerce ( commercial court ) ruled in the case and assigned TÜV Rheinland joint liability. Six dealers had sued and more than 1,600 affected women had demanded damages totaling more than 50 million euros from TÜV Rheinland. After the verdict had been announced, TÜV Rheinland announced that it would appeal. In May 2017, the appellate court in Aix-en-Provence upheld the judgment of the commercial court.

In Germany the case came before the Federal Court of Justice (BGH). The latter postponed its decision to await a decision by the ECJ . The ECJ ruled on February 16, 2017 that the notified body is not subject to a general obligation to carry out unannounced inspections, to check products and / or to view the manufacturer's business documents. Only when there are indications that all requirements may not have been met does the notified body have to take all necessary measures to meet its obligations. Based on this decision, the BGH ruled in favor of TÜV Rheinland and rejected the appeal. In February 2020, the BGH ruled on the action brought by an insurance company against TÜV Rheinland, saw liability in tort and referred the proceedings back to the Nuremberg Higher Regional Court .

In June 2020, the ECJ decided a lawsuit from Germany: The French insurer of PIP cannot be prosecuted by a German plaintiff.

Consequences of the scandal in Germany

In June 2014, the Advisory Council on the Assessment of Developments in the Health Care System proposed that Europe-wide, independent approval be prescribed for all medical devices.

See also

Web links

Individual evidence

  1. ↑ sfluxe.com ( Memento from July 18, 2012 in the web archive archive.today )
  2. ^ Report on focus.de from January 13, 2012 , accessed on January 13, 2012
  3. ^ Report on an investigation by the British National Health Service on spiegel.de from June 18, 2012, accessed on June 18, 2012.
  4. ↑ nydailynews.com - Men received banned silicone in chest, testicle implants, French PIP scandal grows , Daily News January 5, 2012
  5. ↑ Nicola Kuhrt: Up to ten thousand German women received cheap implants. spiegel.de from January 12, 2012 , accessed on January 13, 2012
  6. ↑ message on xinhuanet.com from January 6, 2012 , accessed 13 January 2012
  7. ↑ Article on thelocal.fr of December 27, 2011 , accessed on January 13, 2012.
  8. ^ Letter from the FDA to the company (PDF; 347 kB), accessed on January 13, 2012.
  9. ^ Thiemo Steinücken: BMG for changes within the system. In: Medizinprodukte J. , Volume 19, No. 1, 2012, pp. 42–43
  10. ↑ Press release ( Memento of July 5, 2011 in the Internet Archive ), accessed on January 13, 2012.
  11. ↑ Michaela Wiegel: First blood, then breasts. , faz.net January 6, 2012 , accessed January 13, 2012.
  12. ↑ Report on berliner-kurier.de of January 13, 2012 , accessed on January 13, 2012.
  13. ↑ Report on diestandard.at of January 11, 2012 , accessed on January 13, 2012.
  14. ↑ Editorial in the Observer of January 8, 2012 , accessed January 13, 2012.
  15. ↑ Silicone gel-filled breast implants from the manufacturers Poly Implant Prothese (PIP) and Rofil Medical Nederland BV ( Memento from February 21, 2014 in the Internet Archive ).
  16. ↑ sfluxe.com ( Memento from July 18, 2012 in the web archive archive.today )
  17. ↑ Steve Bird: The terrifying story of how a former French butcher earned millions from selling faulty breast implants made from mattress filling . In: Daily Mail , December 31, 2011. Retrieved December 31, 2011. 
  18. ↑ Police arrest manufacturers of cheap implants , accessed on January 26, 2012
  19. ↑ http://www.tageblatt.lu/nachrichten/story/24796444
  20. ^ Archived copy ( Memento of January 28, 2012 in the Internet Archive ).
  21. ↑ Archived copy ( Memento of February 2, 2012 in the Internet Archive )
  22. ↑ http://www.varmatin.com/article/faits-divers/les-montages-financiers-en-cascade-de-pip.761431.html .
  23. ↑ zeit.de : Four years imprisonment for manufacturers of cheap breast implants. December 10, 2013, accessed December 10, 2013 .
  24. ↑ http://www.sueddeutsche.de/panorama/prozess-um-billig-silikon-chef-des-brustimplantate-herstellers-muss-ins-gefaengnis-1.1839788 .
  25. ^ Ärzteblatt : Four years imprisonment for company founders. December 10, 2013, accessed July 30, 2014 .
  26. ↑ Breast implants process: prison sentence against PIP founder confirmed at tagesschau.de, May 2, 2016 (accessed on May 2, 2016).
  27. ↑ Founder of scandal-ridden breast implant company PIP dies. Report on dtoday.de, April 4, 2019. Accessed April 5, 2019.
  28. ↑ TÜV Rheinland: Press release from January 13, 2012
  29. ↑ TÜV Rheinland: TÜV Rheinland: Statement on implants from Poly Implant Prothèse
  30. ↑ Markus Becker: Breast implants scandal: Cheating with cheap silicone was a top priority. In: Spiegel Online . January 6, 2012, accessed January 14, 2012.
  31. ↑ Interview with Manfred Bayerlein: "Outrageous Fraud" in Focus 10/2012 , page 122.
  32. ↑ Benjamin Schulz: Defective breast implants: woman sued TÜV Rheinland. In: Spiegel Online . January 8, 2013, accessed January 8, 2013.
  33. ↑ Benjamin Schulz: Faulty breast implants: health insurance company sued TÜV Rheinland. In: Spiegel Online . September 12th, 2013.
  34. ↑ Scandal over dangerous silicone cushions: TÜV does not have to pay for implant removal. sueddeutsche.de, March 20, 2014, accessed on March 21, 2014 .
  35. ↑ Dangerous silicone breasts: TÜV should pay millions. In: Focus.de . 15th November 2013.
  36. ↑ "Follow for further proceedings." , Frankfurter Allgemeine Zeitung, May 16, 2017, p. 9.
  37. ↑ Responsibility of the TÜV: Dispute about inferior breast implants comes before the Federal Court of Justice. spiegel.de, February 18, 2014, accessed on February 18, 2014.
  38. ↑ The ECJ has to decide on damages for breast implants. zeit.de, April 9, 2015, accessed January 4, 2016
  39. ^ Judgment of the Court of Justice (First Chamber) of February 16, 2017 (C-219- / 5 - Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH), available at http://curia.europa.eu .
  40. ↑ BGH, judgment of June 22, 2017 (Az .: VII ZR 36/14), available at www.bundesgerichtshof.de.
  41. ^ The Federal Court of Justice - Press: Press releases from 2020 - Federal Court of Justice on the liability of the "Notified Body" towards patients in connection with the exchange of silicone breast implants from the French manufacturer PIP. Retrieved March 7, 2020 .
  42. ↑ Andreas Mihm: 100,000 euros surcharge for the country doctor. faz.net, June 24, 2014, accessed July 2, 2014.

Coordinates: 43 ° 6 '48.2 "  N , 5 ° 51' 0.7"  E