THE PIP IMPLANTS TRIAL ,
by Prof.Gaston-François MAILLARD , SWITZERLAND
former Swiss Delegate & Expert of the Swiss & European Breast Implant Commission & "Comité Européen de Normalisation"& ISO
The conclusion of this bad affair was pronounced 10.12.2013 at The High Court of Marseille-FRANCE.
Jean-Claude Mas is sentenced to 4 Years JAIL , 75000.-Euros FINE , and permanent ban to work in medical manufacture.
European Breast Implants manufacture was initiated in 1960 in Toulon -France by the late Dr Henri ARION ,Plastic Surgeon and enginneer in Chemistry. Dr Arion sold his manufacture to Jean-Claude Mas , a commercial in the eightees. At the beginning the implants produced in a sterile atmosphere in a brand new modern Plant in "La Seyne-sur-Mer"near Toulon(Var) showed a very good quality. After the FDA-Silicone-BAN in the USA , the European Authorities decided to assemble a European Commission on Breasts Implant : Members were Manufacturers , Chemists in Silicone , Legal Medical Authorities of the biggest Nations(UK,Germany,France,Italy,NL,Sweden,etc) , Plastic Surgeons, Physicians , Immunologists, Rheumatologists,etc.
All European Countries + Switzerland sent their Delegates .We created the EUROPEAN NORM FOR BREAST IMPLANT (EN) with very severe criterias for the manufacturers in order to maximally protect the patients.
The "CEN" mark(Comité Européen de Normalisation) , was necessary to authorize the selling of the product on the market , an annual inspection by an OFFICIAL NOTIFIED BODY was compulsory. PIP chose the Rheinland-Germany TüV Notified Body .Also a delegation of experts, members of the ad Hoc Commission went regularly to check for the good-manufacture . The Ok was given each year until 2004 .Then the first complaints arrived to the French Medical Authorities . It took nearly 10 years until these findings are officialy published .
End december 2013 , 17411 patients were explanted at the cost of the French national medical Insurance.(Sécurité Publique)
On the total of 30099 PIP-implants ,75 % were correct,
25 % showed a leak of silicone oil through the enveloppe or a tear creating a local inflammation or a capsular contracture.No other pathology was documented .
The explanation was finaly given : Jean-Claude Mas secretely replaced from 2003-2006 , on an unknown percentage of implants , the very expensive compulsory "Medical-Grade-Silicone oil" by crude & cheap industrial silicone oil !
An other prosecussion against TüV is probable.....in the future, because no money can be served now to the plaignants because the PIP society is dead and all money gone.
Finally with this affair we have learnt a lot. A great number of implants from other manufacturers were also explanted during this 5-8 years crisis : the surprise was that many other deep-textured implants had also a very high percentage of capsular contracture even with a good manufacturing and goods factory reputation (good medical grade Si-oil , strong enveloppes,etc)
So the problems of choosing the best implant remains crucial and should be adapted to each individual patient.The deep texturisation of the enveloppe seems to became obsolete.