Hundreds of thousands of women worldwide may have defective and potentially harmful breast-enhancement implants produced by a small French company that went into bust in March 2010 after its silicone gel product was ordered off the market.
Before its assembly lines were halted, Poly Implant Prothese SA (PIP) produced 100,000 silicone implants a year for two decades, with upwards of 80 percent going abroad, primarily to Latin America and to nearby countries in Europe.
At one stage, the factory that employed about 100 workers in a port town on France's southern Mediterranean coast was ranked the world's third-biggest in its line of business, with annual sales hitting 10 million euros in 2009.
Trouble hit when surgeons started reporting abnormally high rupture rates in late 2009.
Public health inspectors visited the factory and discovered it was using industrial grade silicone that was 10 times cheaper than the material approved for medical usage.
A subsequent inquiry showed that a majority of implants made by PIP since 2001 contained the unapproved gel.
All that remains of the business in the town of La Seyne sur Mer is a derelict premises scarred by the tyre-burning protests of desperate staff who had at one stage threatened to burn the plant down over their impending layoff.
Several executives of a company founded in 1991 by one-time butcher Jean-Claude Mas are being sent to trial next year on charges of fraud that carry potential sentences of five years in jail. Names have not thus far been made public.
The public prosecution service in the city of Marseille, which has logged 2,200 legal complaints, opened another judicial inquiry on December 8 after the death from cancer of a woman who had PIP implants.
France's medical safety agency, AFSSAPS, says the silicone used in the PIP implants does not appear to be highly toxic but can cause irritation and inflammation.
While no causal link between the implants and cancer has been publicly declared, the media attention has also renewed interest in a scandal with an international dimension because of the degree to which the French firm exported.
According to French media reports of documents relating to the firm's liquidation, as much as 84 percent of the silicone gel implants were shipped abroad, to some 65 countries in all.
About half of those exports were to Latin American countries including Brazil, Venezuela, Columbia and Argentina, according to those media reports. Another quarter went to nearby Western European neighbours such as Germany, Britain, Spain, Sweden, Belgium, the Netherlands, Portugal and Switzerland.
PIP also had significant exports to eastern Europe and other clients in countries such as China, Australia, Thailand, Singapore and Japan, the media reports say.
(Additional reporting by Elena Berton in Paris and Jean-Francois Rosnoblet in Marseille; Editing by Matthew Jones)