Preliminary testing of the silicone filler used in banned breast implants made by Poly Implant Prothèse (PIP) has revealed “no evidence of genotoxicity or chemical toxicity”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced today.

The results will bring relief to patients, plastic surgeons and health authorities around the world. But, in the words of the MHRA, they must be seen as only “encouraging”, since a definitive assessment of the fraudulent silicone and implant shell will only be supplied by the completion of more comprehensive testing by French regulatory agency Afssaps.

“The tests found no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants,” said the agency. While recognising that the tests were “not as extensive as those being carried out in France”, they nevertheless provide “initial information as to whether there is a safety issue with the filler material”, it said.

More on the PIP case
	Initial PIP silicone filler tests “encouraging” – MHRA (3 September 2010) Preliminary testing of the silicone filler used in banned breast implants made by Poly Implant Prothèse (PIP) has revealed “no evidence of genotoxicity or chemical toxicity”, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced.
	Europe on alert as banned “Rofil-branded PIP” breast implants surface in Portugal (18 August 2010) Portuguese doctors have been warned against using breast implants marketed by Dutch firm Rofil Medical Nederland, marking a further twist in the crisis involving the fraudulent implants made by Poly Implant Prothèse (PIP) of France.
	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 Products) The website of the UK distributor of the PIP implant, Clover Leaf Products, 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

“It’s reassuring that our test results have shown no evidence of any associated risks with the filler material,” said Dr Susanne Ludgate, clinical director at the MHRA. “We are however waiting for the results of the French tests which are more extensive and include mechanical testing of the implant shell because there maybe a suggestion of an increased rupture rate compared with other breast implants,” she added.

“Proactive response”

The British Association of Aesthetic Plastic Surgeons (BAAPS) welcomed the MHRA’s findings, citing the reassurance they offer to patients, subject to the French testing. “We are delighted that there is little risk to patients from the gel,” said consultant plastic surgeon and BAAPS president Nigel Mercer.

He also praised the MHRA for its “proactive response in conducting safety tests”.

The association reiterated its advice that, in the meantime, women with a suspected rupture contact their surgeon and undergo ultrasound and removal “as with any ruptured implant”.

“Various filling gels”

The MHRA told Clinica that it has no plans to test the filler further. The MHRA launched its biocompatibility tests after Afssaps said it had been delayed by the ongoing criminal investigations into PIP (www.clinica.co.uk, 12 July 2010).

Afssaps told Clinica today that its “final evaluation of the test results” is now expected by mid-September.

A spokesperson also said that the agency’s investigations are centred around “different filling gels, seized for analysis from PIP premises”.

The scale of the problem: known unknowns

The investigations into the safety of the filler used in PIP devices – produced since 2001 and marketed in at least 64 countries – were launched over five months ago.

Afssaps recalled all non-implanted devices at the end of March 2010, after discovering that the La Seyne-sur-Mer firm had been using a non-CE-marked and untested silicone filler for an unknown period of time. Since then, it also emerged that PIP had stopped using a “protective barrier” in the shell since 2005 (www.clinica.co.uk, 18 July 2010).

The global scale of the problem is difficult to estimate. It must be of significant concern that, at its peak, PIP claimed to be producing 160,000 breast implants per year and was aiming to increase output to 600,000 per year to meet demand (www.clinica.co.uk, 13 May 2010). The UK and France alone have an estimated 50,000 and 30,000 PIP implantees respectively.

In addition, PIP implants rebranded by Dutch manufacturer Rofil Medical have appeared on the Portuguese market, the Infarmed agency has warned (www.clinica.co.uk, 18 August 2010).