Saturday 8 May 2010

Surgeons Advised To Prepare For Global Breast Implant Removal

On March 31st, French authorities banned the manufacture, use and export of PIP breast implants after complaints of high rupture rates and finding that the filler was unauthorised and illegal for human use. Now, it has emerged that surgeons around the world were instructed to prepare for removal of the implants just three days into the crisis.

LONDON Friday, 23 April 2010 – Plastic surgeons worldwide have been advised to prepare all women implanted with silicone breast implants made by Poly Implant Prothèse (PIP) for the likely need to remove them, Clinica has learned.

The advice appears in correspondence sent in the early days of the PIP crisis by the International Confederation for Plastic Reconstructive and Aesthetic Surgery (IPRAS) to member organisations. Clinica has not been able to obtain confirmation of its exact recipients, but IPRAS' membership spans around 100 countries.

Referring to the ongoing tests on the illegal filler gel used in PIP implants, a letter signed by IPRAS general secretary Dr Marita Eisenmann-Klein says: "Although the investigation of the French health authorities [Afssaps] is still ongoing, I suggest that you prepare the patient that the recommendation will be most likely implant removal."

The letter, among other correspondence seen by Clinica, is dated 2 April, three days after Afssaps distributed its alert, on 31 March, explains Bernard Murphy, Investigations Editor at Clinica.

It cannot, therefore, be seen as reflecting any developments in Afssaps' ongoing investigations or in official safety policy related to the implant, but provides further insight into the degree of concern that the PIP devices' high failure rates have raised already.

The letter also warns that PIP had filed for bankruptcy, and suggests that patients be advised to approach their insurance companies in terms of recovering the medical costs of replacing their implant (though generally not for the cost of the new implant itself).

Afssaps' investigations of the implant were triggered initially by PIP rupture rates that were found to be double those of other brands (www.clinica.co.uk, 1 April 2010). The filler gel was found to be illegal, in that it was different to that registered in the product's technical dossier, and has not been tested on humans. Pending the outcome of ongoing biocompatibility tests, Afssaps imposed a precautionary ban on the manufacture, national distribution, export and use of the implant, among other measures.

 

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