With the controversies surrounding French-made PIP breast implants, the European Union is seeking tougher tests and inspections for these devices in an effort to protect consumers from substandard products.
Because of the slack system, some experts believe the implants manufactured by PIP have been sold in many parts of the world. (But surprisingly, the devices did not reach the US after the FDA found the company’s failure to adhere in good manufacturing practices).
Investigation shows that since 2000, PIP has developed a simple way to deceive third party auditors from discovering that it was using industrial grade silicone gel intended for making mattresses. With this plan, the company was able to lower the manufacturing costs of its devices—of course at the expense of thousands of women who had the substandard implants.
According to estimates, about 400,000 PIP silicone breast implants were sold in UK, Spain, Australia, Brazil, Argentina, Colombia, and Chile.
To hide the industrial-grade silicone gel, PIP workers placed the barrels containing this substance in a separate warehouse while auditors were making a routine visit. Meanwhile, one employee has admitted that he was asked to erase evidences from the computer system before the audits and add them again afterwards.
And as the company’s way to celebrate its fraudulent act, employees threw huge parties every time the auditors left the premise.
Going back to the EU regulators’ plan to overhaul the rules, the aim is to prevent medical device makers in charge of checking the safety of their own products, and to further beef up transparency.
However, concrete plans to improve the oversight system are yet to be determined later this year. But one possible solution is to carry out unannounced audits particularly when dealing with companies suspected of fraudulent acts.
In January 2012, PIP founder Jean-Claude Mas, 72, has been charged of involuntary injury two years after the French health ministry banned his company’s silicone breast implants which were sold in 65 countries. The devices have been found to be prone to rupture because of their thin shell; in fact about 14 percent of women who have them removed suffered from leak.
Surprisingly, while Mas has admitted deceiving the French authorities for 13 years, he called the victims who filed complaints against him as those “who want to make money.”The PIP founder has also criticized authorities for offering victims to pay for the removal of implants because it can put them to a “surgery risk.”