|Date:||Thursday 21 April 2011|
|Subject:||French regulator confirms non-toxicity of PIP breast implants|
|Contact:||Press Office 020 3080 7651
Out-of-hours 07770 446 189
The French medical device regulator, AFSSAPS, has released the findings of comprehensive testing carried out on Poly Implant Prosthese (PIP) silicone breast implants following health concerns raised in 2010.
These results confirm the UK findings reported in September last year that there was no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material inside the devices.
PIP was one of the major breast implant manufactures for the UK and approximately 40,000 women in the UK have been implanted with PIP silicone breast implants (80,000 implants).
Medicines and Healthcare products Regulatory Agency (MHRA) Clinical Director for Devices, Dr Susanne Ludgate, said: "We wanted to identify any potential toxicity associated with the implant filler as soon as possible, to protect the health of anyone who had used it.
“We are extremely pleased that these further tests have again found no dangerous substances.
“This action is part of the MHRA’s ongoing goal to keep watch over medicines and medical devices, and take any action needed to protect the public as swiftly as possible if there are any health issues.
“We are pleased that women in the UK with these implants can be reassured as a result of these findings.”
Notes to Editor
- The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
- The MHRA was informed in March 2010 by AFSSAPS that they had suspended the company’s marketing, distribution and export of these products. This was due to an inspection of PIP’s manufacturing plant which found that most implants manufactured since 2001 had been filled with an unauthorised silicone gel which differed from the originally approved material.
- In general, a medical device cannot be marketed in the UK without carrying a CE Mark of Conformity. A CE mark is applied by the manufacturer to denote that the device meets the relevant regulatory requirements and performs as intended. For all but the very lowest risk devices, such as unmedicated bandages, an EC Certificate of Conformity must be obtained from an independent certification organisation, called a Notified Body, before the CE marking can be affixed. The MHRA is responsible for designating UK Notified Bodies and regularly audits them to ensure that they continue to perform to the required standards.
- The AFSSAPS's recommendation can be viewed here: Silicone filled breast implants from Poly Implant Prothèse Company - Test results
- The Medical Device Alert can be viewed here: Medical Device Alert: Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP) - All models and lot numbers
- For further information about breast implants, see the MHRA website: Silicone gel breast implants
- Adverse incidents relating to medical devices can be reported via the MHRA website: Reporting adverse incidents involving medical devices
- Information and printed incident report forms are available from: the MHRA Adverse Incident Centre on 020 3080 7080 or email: email@example.com