France urges Europe-wide controls after implant scandal
PARIS FRANCE vowed on Wednesday to strengthen the regulation and monitoring of prosthetics and called for Europe-wide controls after a defective breast implant case sparked a global health scare.
More than 400,000 women around the world are thought to have received implants made by Poly Implant Prothese (PIP), which shut in 2010 after it was found to have used substandard, industrialgrade silicone gel.
French Health Minister Xavier Bertrand said inspections of manufacturers of medical devices will be reinforced following the incident, with the number of inspectors increased and the inspections “more numerous and unannounced”.
In a statement, he said a report released by French health authorities on Wednesday had “shown the massive deception organised by PIP ... which took advantage of public health authorities and health professionals.” Bertrand also said that European Union rules on regulating and monitoring medical devices “must be radically overhauled”.
In the report, French health authorities urged stronger national and European regulation and monitoring of medical devices.
“This strengthening must be done at two levels, national and European,” said the report by France’s Directorate General for Health (DGS) and the consumer safety body AFSSAPS.
The report also called for AFSSAPS to increase its inspections, with both regular and surprise visits. Inspections for some devices should be carried out annually and include taking samples for analysis, it said.
There also had to be easier ways to report defective devices, the report added.
Bertrand said the health ministry had called on the DGS and AFSSAPS to prepare proposals for further reforms of the inspection system and to provide a list of at-risk prosthetics by the beginning of March.
An AFSSAPS inspector discovered PIP’s use of the nonstandard silicone in March 2010 and ordered its products banned, but only after the company had already used the gel in hundreds of thousands of implants.
A French court last week charged the company’s founder, 72-year-old Jean- Claude Mas, with causing “involuntary injuries” and the courts are also pursuing a mass fraud investigation.
Fears over PIP implants spread across the world late last year after French health authorities advised 30,000 women to have them removed because of an increased risk of rupture.
Between 400,000 and 500,000 women in 65 countries are believed to have implants from PIP, once the world’s third-largest silicone implant producer.