A FRENCH COURT has ordered German safety certifier TUV to pay €60 million ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.
The German company was ordered to make a provisional payment of €3,000 to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.
In what became a major health scandal, the devices were later found to contain substandard, industrial-grade silicone gel.
“The final amount will be determined after an assessment, but (TUV) is required to make a provisional payment of €3,000″ per person, said lawyer Laurent Gaudon, representing 7,000 women.
TUV said it would appeal the latest ruling, issued by a commercial court in the southern port of Toulon.
Liable
TUV was found liable in 2013 in a first case brought by 1,700 PIP implant recipients and a group of distributors.
But an appeals court later overturned that decision, saying that TUV had fulfilled its obligations as a certifying body and could not be held responsible for failing to detect PIP’s cover-up.
The company maintains it was never its job to check the actual implants, and their task was only to inspect the manufacturing process.
The scandal first erupted in 2010 after doctors noticed abnormally high rupture rates in the implants.
The affair made global headlines in 2011, with some 300,000 women in 65 countries believed to have received the faulty implants.
PIP’s founder, Jean-Claude Mas, was convicted of fraud and sentenced to four years in jail in 2013, confirmed on appeal in 2016.
He always denied the implants posed any health risks.
Thousands of women have had the implants removed, despite health officials in several countries saying they are not toxic and are not thought to increase the risk of breast cancer.
Irish cases
A number of Irish women have taken cases in Ireland against PIP.
Three Irish clinics implant women with the PIP implants: Harley Medical Group, which dealt with 1,100 women; Clane Hospital Cosmetic Surgery which dealt with 250 women; and Shandon St Hospital which dealt with 100 women.
In 2012, the Department of Health said it would cover removal costs for the women that attended the Harley Medical Group. The other two clinics provided “satisfactory packages” after being told to cover the cost of surgery for the affected women.
When the Irish Medical Board heard about the issues with the implants, it contacted all the clinics that used the product and asked them cease using it.
In 2013, MEPs agreed on legislation for stricter monitoring and certification procedures for medical devices such as breast or hip implants, in the wake of the PIP scandal.
The proposed legislation seeks to improve transparency of information for patients and medical staff and to strengthen traceability rules, without creating additional burdens for innovative small manufacturers.
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