French Implant Manufacturer Warned by US 10 Years Before the Scandal Broke

It has been estimated that 300,000 women have the defective breast implants manufactured by the now bankrupt French company Poly Implant Prothese (PIP).  According to reports, the devices are extremely prone to rupture as they lack a protective coating that prevents silicone gel from migrating to other parts of the body.

Fortunately, the defective silicone implants were not approved and sold in the United States.  In fact, the US Food and Drug Administration has warned PIP in 2000—10 years before the scandal broke—about its failure to follow “good manufacturing practices.”

However, reports show that 80 percent of PIP breast implants were exported to other countries including UK, Chile, Germany, Venezuela, Spain, Argentina, Colombia, and Brazil.

According to the FDA warning sent to PIP founder Jean-Claude Mas, the company’s plant in La Seyne-sur-Mer in the south France has 11 deviations from “good manufacturing practices.” 

The organization also warned him about the “adulterated” saline breast implants, and cited his company’s failure to investigate the deflation of its products in addition to failure to report 120 complaints in France and other countries.  Currently, there is global manhunt for the 72-year-old company founder who is a former butcher.

With the FDA warnings, consumer groups in France ask why their authorities did not conduct an investigation on the safety of PIP’s breast implants.

The US is one of the countries that require very strict guidelines when it comes to implants and devices used in cosmetic plastic surgery.  In fact, Mentor and Allergan Natrelle are the only two companies allowed to manufacture and sell breast implants in the country.

To allay the concern of patients in the US who had breast augmentation surgery, the American Society of Plastic Surgeons (ASPS) has released a statement saying that the defective implants did not reach the country.  The organization added that only those who had the procedure outside the US should be concerned with the defective product.

Because of the fiasco, the French government has promised it will pay for the implant removal surgery of women affected by the defective products.  It has been estimated that 30,000 patients in the country had the PIP silicone-filled implants.

Reports show that PIP’s cheap silicone implants were filled with an industrial silicone gel designed for mattress rather than for human.

On the other hand, the British government still insists that there is no need to require all women with PIP’s silicone implants to undergo implant removal surgery although they are advised to immediately consult their doctor to determine if there is a leak.