Western Europeans' concerns over the safety of silicone breast implants made by French company Poly Implant Prothese (PIP) continue to grow as more women are made aware of the potential health risks associated with the devices.

PIP began manufacturing breast implants in 1991; they shut operations down in 2010 when European regulators pulled their silicone breast implants off the market because they contained non-medical-grade silicone filler. During that time, an estimated 300,000 PIP silicone implants were sold, mostly in Western Europe and Latin America.

The implants have since been found to have high rupture rates. However, French and British authorities do not think they pose an increased risk of cancer.

Still, the French government recommends that the 30,000 French women that have the silicone implants undergo surgery to have them removed. The French government will cover the cost of surgery.

The British government has taken the position that the 40,000 British women that have the silicone implants do not need to have them removed at this time. The government is continuing to review the potential risks associated with PIP implants.

It was revealed that the U.S. Food and Drug Administration notified PIP's manufacturers of 11 breaches from standard 'good manufacturing practices' at PIP's plant in southern France in 2000 when the company submitted an application for approval of its saline implant products (at the time silicone implants were not approved for use in the United States). According to a warning letter from the FDA, PIP did not have a quality assurance process that would ensure the manufactured products matched design specifications, did not investigate deflation problems with the product, and failed to report 120 complaints in France and other countries. The FDA ended up rejecting PIP's application for saline breast implant approval in the United States.

Disclosure of the FDA's complaints raises questions about the safety of PIP's saline implants, in addition to their silicone implants.