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PIP breast implant update from MHRA

The Hospital Group - cosmetic surgery

PIP breast implants – UK test results

The Medicines and Healthcare products Regulatory Agency (MHRA) has received encouraging results of UK testing on the silicone gel breast implants manufactured by the French company Poly Implant Prosthese (PIP). The tests found no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants. The tests are not as extensive as those being carried out in France, but they have provided initial information as to whether there is a safety issue with the filler material.

 

MHRA Director of Devices Clinical, Dr Susanne Ludgate said, “It’s reassuring that our test results have shown no evidence of any associated risks with the filler material. 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. We will update clinicians and women once these test results are available and provide further advice on patient management as necessary. If women have any concerns, they should speak to their implanting surgeon. Implanting surgeons should report any clinical and radiological problems associated with these implants to the MHRA Adverse Incident Centre.”

 

Policy for patients of The Hospital Group

If you think you were a PIP implant patient with The Hospital Group and have any concerns about them, they are offering a free consultation with a clinic nurse for initial discussion/assessment (this can be via telephone or in clinic). Please contact your local clinic, or call the central appointment line on 0121 445 0213. Where necessary or appropriate, the nurse will then refer you to see a surgeon for assessment – again, this is provided free of charge. Each case would be assessed individually, but the priority is to ensure the patients’ welfare at all times. If a clear case of rupture was diagnosed and implant removal were advised, The Hospital Group's intention would be to replace the implants at no cost to the patient. 

 

Further Information

For further information or the background on this story, you can view previous PIP Updates or the MHRA press release dated 3rd September on their website.

Cosmetic surgery news : 8 September 2010