Poly Implant Prothèse (PIP) was a French company founded in 1991 that produced silicone gel breast implants. The company was preemptively liquidated in 2010 following the revelation that they had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone since 2001 (instead of the mandated medical-grade silicone they had previously used). The hundreds of thousands of unapproved implants sold globally by PIP from 2001 to 2010 were found to have a 500% higher risk of rupturing or leaking than approved models, as well as being implicated in several deaths due to systemic toxicity and several cases of induced breast cancer. The scandal, which produced fears of a massive health disaster, prompted a full recall of the company's implants by the French health ministry in 2010, by which time the company was already defunct.
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.
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.
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. 2013: Criminal trial is held in France, and Jean-Claude Mas was sent to prison for four years. 2021: French court found TUV Rheinland negligent and partially liable for damages.
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