PARIS, Feb. 3 (UPI) -- A French breast implant scandal has the European Commission seeking to strengthen oversight by private companies to ensure medical devices are safe.
Breast implants from the now closed French manufacturer Poly Implant Prothese were banned in Europe in 2010 but France caused controversy in December when the country issued a cancer alert and advised French women to have the implants removed, the EUobserver reported.
The European Commission reacted by calling for a study of the implants, made with low-grade silicone meant for use in mattresses, to determine whether they do indeed cause cancer.
Its findings, published Thursday, have been inconclusive.
The report found available data were "insufficient to lead to firm conclusions regarding the health risks for women with PIP silicone breast implants."
The study did find low-grade silicone in the implants can damage the casing, leading to leaks, but toxicity tests performed on the gel were inconclusive.
At least 400,000 women worldwide are believed to have the potentially toxic implants.
With this information, plus the recent revelation the U.S. Food and Drug Administration banned the implants in 2000 without notifying France or the European Commission, the commission is revising European Union-wide legislation on medical devices to strengthen privately run companies that inspect medical products.
There are 70 to 80 such companies in Europe and the commission wants them all to use the same set of standards in certifying and inspecting medical devices.
