February 19, 2024
Sodium Valproate (Epilim) Inquiry
In November 2020, the Minister for Health, Mr Stephen Donnelly, announced that an inquiry would take place into the historical licensing and use of the epilepsy drug Sodium Valproate (also...
A court in Marseille has convicted Jean-Claude Mas, the founder of Poly Implant Prothese (PIP), of aggravated fraud and sentenced him to four years in prison. He was also fined €75,000 and banned from ever running a company or working in the medical field again.
Three other company executives were given shorter jail terms and a fourth was given a suspended sentence.
PIP was the third biggest global supplier of breast implants and it is estimated that around 300,000 women in 65 countries received them. Jean-Claude Mas was accused of knowingly substituting an inferior grade of silicon in three quarters of the PIP breast implants.
The PIP implants had been filled with a substandard industrial grade of silicone gel also used in mattresses, instead of the more expensive medical grade. The nature of the irritant gel used within makes removal of ruptured implants a more complex and extensive surgery.
According to a French study, up to a quarter of the PIP implants fitted burst or leaked, with a significant amount of them having adverse affects such as inflammation.
The PIP implant came onto the market after being approved by a Notified Body in Germany (TÜV Rheinland). Having received a CE mark it could be freely placed on any market in the EU, including Ireland.
The court also ruled that TÜV Rheinland, was also a “victim” of fraud by PIP. This judgment could call into question a ruling by a French civil court last month that TÜV had failed to check the quality of PIP products and should therefore pay damages to victims potentially up to €6bn worldwide.
Approximately 1,500 Irish patients were implanted with these products. Lavelle Coleman’s Medical Negligence Group is representing a number of women who have received PIP implants.
According to Avril Scally, Partner “while the news of the conviction of Jean-Claude Mas and the other PIP executives is to be welcomed, many women are still living with ruptured PIP implants and this is totally unacceptable. It is clear that these implants ought not to have been used for any personal use. A large number of women have expressed their concern and worry over the presence of these implants in their bodies. We are advising our clients how to proceed over the presence of these implants in their bodies”.
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