Poly Implant Prothèse

[2] PIP was founded in 1991[2] by the Frenchman[3] Jean-Claude Mas, born in 1939, a former butcher and later medical sales representative for the Bristol Myers company[4] for 15 years.

[citation needed] 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,[2] Venezuela[6] and Argentina, Western European markets including Britain (25,000), Germany, Spain and Italy, as well as Australia (8900).

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.

[2] 2003: PIP is acquired by Heritage Worldwide Inc.[8] Regulatory filings show the first signs of legal problems and financial losses.

[9] 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.

[11] The French government recommended on 23 December 2011[12] that 30,000 women[2] in France seek removal of breast implants made of a suspect silicone gel by the worldwide exporting PIP firm.

[2] By the end of 2011, eight cases of breast tumours had been uncovered in women after removing the implants, yet, while of concern,[13] according to the French government, there is no evidence of any increased cancer risk.

[2] Patients are used as "guinea pigs", said Nigel Mercer, a former president of the British Association of Aesthetic and Plastic Surgeons (BAAPS), because medical implants lack the requirement of an independent clinical trial.

[16] This tissue developed anaplastic large-cell lymphoma (ALCL), a rare form of cancer that affects the immune system cells.

"[21] Investigators interviewed Mas on 18 and 19 November 2010 after the French health authority AFSSAPS discovered the PIP breast implants did not conform to regulations.

[23] The French government recommended per 23 December 2011[12] that 30,000 women[2] in France seek removal of breast implants made by PIP.

[14] French public health care funds will be used to finance the recommended implant removals, at a cost estimated at 60 million EUR.

[17] Shadow Health Secretary Andy Burnham said private clinics in Britain that fitted PIP implants must be forced to pick up the cost of removing them.

[24] On 8 January 2012, The Sunday Times reported that leading cosmetic surgeon Jan Stanek had conducted a study with colleague Mike Berry into PIP implants.

[26] Germany's medical safety board and Brazil's health watchdog called for users of PIP implants to visit their doctor for checks.

[2] On 6 January 2012 Germany's Federal Institute for Drugs and Medical Devices recommended the removal of PIP breast implants as a precaution.

Nine clinics in Sweden has sold them says Gert Bruse of the Swedish Medical Products Agency (Läkemedelsverket) told the Dagens Nyheter (DN) newspaper this week.

At the time, the US market accounted for 40% of Heritage Worldwide's revenues, or 3 million EUR, according to corporate documents filed in 2009 with the U.S. Securities and Exchange Commission (SEC).

Between 1996 and 2009, PIP was targeted by several dozen lawsuits in the United States, filed by users and business partners, claiming breach of contract or unmet payments.

[7] On 29 December 2011, Health Minister Renato Balduzzi said that hospitals and clinics are required to compile a list of women who has received breast implants from PIP.

The Ministry of Welfare have stated that health insured women will be offered counsel and ultrasound examination, free of charge.

[6] The local paper Nice-Matin obtained the business plan in which Mas is named as a "technical-commercial consultant" to the company and described as "a creative genius".

An investment of 2 million EUR was planned to put the former PIP plant back into operation, aiming to manufacture 400 implants a day with about 20 workers.

[2] 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.

[5] A fraud case was filed against PIP on 30 December 2011 by France's state-run health insurance fund (CNAM) officials in Marseille announced.

Mas told police that "... employees would remove evidence of the industrial silicone gel before TUV Rheinland made its annual inspections."

[45] British Association of Aesthetic Plastic Surgeons (BAAPS) says that poor postmarketing surveillance is the root of the crisis, and proposes significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping.

Professor Sir Bruce Keogh, the NHS Medical Director, will look into whether the cosmetic surgery industry needs to be more effectively regulated.

Breast implant