Poly Implant Prothèse

History

PIP was founded in 1991 by the Frenchman Jean-Claude Mas, born in 1939, a former butcher and later medical sales representative for the Bristol Myers company for 15 years. Mas had previously teamed up with plastic surgeon Henri Arion, who had introduced breast implants to France in 1965. After Arion died in a plane crash, Mas went on alone and launched PIP in 1991.

Timeline

2000: Implant sales in the United States halted by an FDA launched moratorium on silicone implants.

2001: PIP began to use unapproved in-house manufactured industrial-grade instead of medical grade silicone in the majority of its implants.

2003: PIP is acquired by Heritage Worldwide Inc. Regulatory filings show the first signs of legal problems and financial losses.

2009: Concerns surfaced in France first in 2009 when surgeons started reporting an abnormally high rupture rates, resulting in a flood of legal complaints and the company's bankruptcy.

2010: TÜV Rheinland, headquartered in Germany, gave a quality certificate to the production process used by the company until March 2010. However, this didn't apply to the type of silicone used. A former PIP worker and union chief, Eric Mariaccia said, "You had to have been a chemist to have noticed anything". He also said that "The responsible ones aren't the workers but the heads of the company, notably the four who were linked to production and thus responsible for their quality".

2010: In March 2010 PIP was placed into liquidation with losses of 9 million EUR after the French medical safety agency recalled its implants. In a subsequent inspection of the manufacturing site, the company was found to use unapproved industrial-grade, silicone, with a cost of only 10% of an approved gel.

2011: On 20 December French officials say that an action plan is underway following the death of a woman from ALCL. The French government recommended on 23 December 2011 that 30,000 women in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm.

The bad silicone has been used to make male chest, testicle and buttock implants as well. "Three people were specially trained to work with a machine that made silicon testicles'" said a former PIP worker.

Most of the male chest, buttock and testicle implants were exported to Latin America.

Scandal

Starting in 1991, the company produced approximately 2 million sets of silicone breast implants over a 20-year period. The implants were exported to Latin American countries such as Brazil, Venezuela and Argentina, Western European markets including Britain (25,000), Germany, Spain and Italy, as well as Australia (8900).

Following the FDA ruling in 2000 which banned silicone breast implants in the US market (leading to a slump in sales worldwide), Mas sought to "tighten PIP's belt" and recoup some of its lost market share by severely cutting costs. In particular, Mas was credited with the idea that by switching PIP's silicone from externally purchased medical-grade to in-house produced industrial-grade, huge savings (on the order of 90%) could be generated that would ensure profits remained high no matter the market. As one PIP engineer later noted, this decision involved a relatively small change in the formula for the silicone, enough so that only superficial differences in the end product were noted. However, none of the relevant regulations were followed for manufacturing medical implants, and no pre-launch tests were conducted.

Legal process

The lawyer Yves Haddad represented Mas. Legal complaints have been filed by 2,500 women in France and 250 women in Britain. Mas was wanted in Costa Rica for "life and health" offenses, a warrant issued by Interpol.

By February 2011, TÜV Rheinland sued PIP, claiming it had been "thoroughly and continuously misled" regarding the silicone used. Many executives are expected to face charges of aggravated fraud in an ongoing court case in France, expected to be scheduled for October 2012, which carries the possibility of prison terms of up to five years.

The death of a cancer victim who had such implants may result in more serious charges of involuntary manslaughter.

Frédéric Van Roekeghem, general director for La Caisse Nationale d'Assurance Maladie (French state social insurance agency, CNAM), will go to court regarding the complaints of bad implants. A criminal charge will be made within a few days he said to TF1 on 25 December 2011. The decision has been made in consultation with minister of health, Xavier Bertrand.