|Date:||31 March 2010|
|Contact:||Press Office 020 3080 7651//3564
Out-of-hours 07770 446 189
The MHRA is today advising breast implant surgeons not to use silicone gel-filled breast implants manufactured by the French company Poly Implant Prothese (PIP).
The MHRA was informed by the French medical device regulatory authority (AFSSAPS) that it has suspended the company’s marketing, distribution and export of these products.
AFSSAPS recently carried out an inspection of PIP’s manufacturing plant and found that most implants manufactured since 2001 have been filled with an unauthorised silicone gel which differs from the originally approved material.
The MHRA is investigating, in collaboration with AFSSAPS, whether the unapproved gel affects the safety of these implants. AFSSAPS is carrying out tests to establish the level of risk.
The MHRA has today issued a Medical Device Alert to breast implant surgeons and healthcare professionals.
Director of Devices Clinical, Dr Susanne Ludgate said, “Clinicians should not implant these devices and they should quarantine any stock.
“Patients who have concerns about their PIP silicone gel filled breast implants should contact their breast implant surgeon.
“Once we receive further information about the safety of these products, we will provide further advice on patient management, as necessary, when more information is available.”
Notes to Editor
- 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 Medical Device Alert can be viewed on the MHRA website.
- For further information about breast implants, see link to MHRA website section on breast implants.
- Adverse incidents relating to medical devices can be reported using the MHRA website. Information and printed incident report forms are available from: the MHRA Adverse Incident Centre on 020 7084 3080 or email: firstname.lastname@example.org
- To report a counterfeit device or medicine contact the MHRA dedicated 24-hour hotline on 020 7084 2701, or email email@example.com, or write to: Counterfeits, The Intelligence Unit, MHRA, Market Towers, 1 Nine Elms Lane, London, SW8 5NQ.
- 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 judgments 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.