The interim report of the expert group set up by the Government to look into the issue of PIP (Poly Implant Prostheses) implants was published on 6 January 2012. 

The report was commissioned following the discovery that the French manufacturer of PIP implants had been using industrial rather than medical grade silicone.  This information came to light due to concerns about the rate of rupture in these implants.  Initial advice was that there was no medical reason to remove them in the absence of clinical symptoms of rupture.  However, in December 2011, the French regulator raised concerns about the number of ruptures and a possible increased cancer risk.  The interim expert report, commissioned to consider whether advice on removal should be revised, has found no evidence to support this.  The report therefore concludes that there is no need to revise current guidance.

In response to widespread public concern, the UK Government have confirmed it will take the following action in relation to PIP implants:

• The NHS will contact women who have had a PIP implant to notify them of this and will provide information and advice;
• NHS patients seeking information about the make of their implants will be provided this free of charge;
• ŸPeople will be able to consult their GP or the surgical team who fitted the implant for clinical advice and assessment;
• ŸIf following such an assessment, the patient and doctor consider removal is appropriate, the NHS will support this.  Where the original surgery was performed by the NHS, the NHS will replace the implants.

In its report, the expert group commented that it expects private healthcare providers to take the same steps.

The interim report highlights the problem of accurate data in this area which is contributed to by the fact that healthcare providers are not compelled to report incidents of breast implant failure to the healthcare regulator.  At Davies and Partners, we have encountered cases where our contact with the regulator is the first notification they have received of a problem with that particular implant. 

In order to address this problem, the expert group (together with other government agencies such as the National Patient Safety Agency) is to prepare a report on lessons to be learned from the current arrangements for monitoring the safety of implantable devices, and of the regulation and governance of the cosmetic surgery industry.  The need for regulation of this industry has already been identified in a report by the National Confidential Enquiry into Patient Outcomes and Death in September 2010 - see our article “Cosmetic Surgery Providers Could Do Better” click here and at Davies and Partners we hope this recommendation is now acted upon.

If you have any concerns about PIP or other implants, please contact the clinical negligence team at Davies and Partners.  This e-mail address is being protected from spambots. You need JavaScript enabled to view it