Poly Implant Prothèse (PIP), the now defunct manufacturer of fraudulent silicone breast implants, was producing some 160,000 implants per year in early 2007, and was set to increase production to 600,000 units by the end of 2008, Clinica has learned.

The figure is important in seeking to gauge the global scale of the crisis affecting these devices. In addition to concerns about the filler itself, which is currently under investigation, there is virtually no information in the public domain about the number of women affected in each of the vast majority of the countries where the implant was distributed, and their traceability. Data available on the PIP website immediately before it was shut down, on or around 1 April, suggested that the devices were being sold in 66 countries.

PIP's efforts to expand production capacity are described in statements issued by its parent company, Heritage Worldwide, to investors in March 2007. Signed by CEO Jean-Claude Mas, they note that Heritage/PIP had "made substantial headway into Brazil and Argentina" and that "[while] we continue to do well in Europe, we have made significant inroads into Australia and Asia".

More on the PIP case
	Australian PIP implant surgery promises new insight into failures (11 May 2010) An Australian recipient of the controversial Poly Implant Prothèse (PIP) implants has undergone replacement surgery for the second time on the same breast in less than two months.
	Nagor in plans to relieve PIP crisis with UK implant replacement scheme – UPDATE (26 April 2010) IUK aesthetic surgery implant manufacturer Nagor is collaborating with the British Association of Aesthetic Plastic Surgeons (BAAPS) to set up a scheme to help replace silicone breast implants made by Poly Implant Prothèse (PIP), Clinica has learned.
	Disparities emerge in reactions to PIP breast implants ban (14 April 2010) Disparities have emerged in how healthcare authorities, clinicians and patients are reacting to the situation surrounding the banned Poly Implant Prothèse (PIP) silicone breast implants.
	PIP breast implants "untraceable", registry now urgent – Italian govt (9 April 2010) The country's under-secretary of state for health called on the "professionalism and conscience" of the country's surgeons in order to help the government "verify whether the defective implants have been implanted in Italy".
	Spectre of widespread breast explantations returns with PIP recall (1 April 2010) The PIP case is reminiscent of the Trilucent soya-oil breast implants case that erupted in June 2000.
	French company replaces product material and sees product banned (31 March 2010) The French medtech regulator, AFSSAPS, has suspended the sale, use, distribution and export of breast implants pre-filled with silicone gel manufactured by Poly Implant Prosthèse.
	The homepage: Poly Implant Prothèse (Clover Leaf Medical) The website of the UK distributor of the PIP implant, Clover Leaf Medical, was taken down recently. Clinica has a copy of the HTML document of the homepage.
	$100 million liability? Twist in the tale of Trilucent implant case (September 2002) In the case of Trilucent (as summarised before its conclusion, in Clinica's sister publication European Regulatory Affairs News), around 10,500 women worldwide were implanted with around 17,000 implants.
Clinica - Policy & Regulation

The statement, dated 27 March 2007, goes on to say that the focus of Heritage/PIP at the time was to expand into Asia and Latin America. These markets were described as "growing very rapidly". It states that the expansion programme would result in a 275% increase in production. At the time, it had national distributors in 63 countries, in addition to a Spain-based subsidiary.

All PIP silicone implants produced as far back as 2001 are affected by the concerns raised on 30 March 2010 by French regulatory agency Afssaps, in view of the fact that the La Seyne-sur-Mer firm is not able to demonstrate at what point it began to use an illegal silicone filler after the device's CE marking.

"Implant collapse" in Aus case

Australian patient Marlene Fabris, who underwent a second PIP implant replacement on 11 May in Melbourne, has told Clinica that the failure was found to have been due to the implant collapsing on itself, and not a rupture.

This second PIP failure occurred only five weeks after the first, which occurred 14 weeks after implantation (www.clinica.co.uk, 11 May 2010), and the implant is understood to be under investigation.

The national regulatory body, the Therapeutic Goods Administration (TGA), gave PIP approval to market its silicone breast implants in Australia in November 2004. The implants were distributed solely, Clinica understands, by Medical Vision Australia, based in Hackney, South Australia.

"Australia, with more than 20 million people and a higher GDP than France, provides a healthy platform for our products, and a springboard to enter into other Asia-Pacific countries," said PIP's CEO Mr Mas at the time.