, PARIS, Feb 1 – France vowed 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, industrial-grade 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 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 non-standard 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.
A number of countries, including Germany and the Czech Republic, followed France in recommending that the implants be removed as a precaution, but Britain has said it will not follow suit.
At least 13 countries in Europe and Latin America have also urged women to have a checkup.
French officials have said that cancer, including 16 cases of breast cancer, had been detected in 20 French women with the implants, but have insisted there is no proven link.
Following the discovery of PIP’s faulty implants, AFSSAPS conducted inspections of the nine implant makers and distributors active in France and found no further problems.
Mas, a former travelling salesman who got his start in the medical business by selling pharmaceuticals, founded PIP in 1991 to take advantage of the booming market for cosmetic implants.
He reportedly told investigators that he used fake business data to fool health inspectors.
The substandard gel was in 75 percent of PIP breast implants, saving the company about one million euros ($1.3 million) annually, according to an ex-company executive.