03 January 2012

To whom it may concern

Nagor is the largest manufacturer of Breast Implants in the UK and has been in business for over 33 years.

We are aware through the media of the reports associated with PIP and have no relationship of any kind with that organization.

Women with Nagor products do not need to take any action at this time but may wish to consult their implanting surgeon for information about their implants.

Nagor manufacture over 80,000 sterile medical devices annually at their facilities in England and Scotland. The breast implant products that we manufacture at the facility are CE marked, Class III, medical device products which is the highest classification according to the Medical Device Directive and therefore subject to the highest level of examination and quality. Our breast implants are manufactured with long-term implantable medical grade silicone supplied from an ISO 9001 certified source.

Our facility is regularly inspected by the authorities responsible for the certification of these products and we have continued to meet the quality and performance standards expected for all breast implant products.

We are in regular communication with the health authorities concerning our product vigilance and post marketing surveillance reporting requirements and continue to meet all of the commitments associated with marketing these products worldwide.

We are conducting on-going clinical trials on this product range in the UK and data to date shows a 5 year rupture rate of 0.0% which is amongst the lowest of the currently marketed breast implant products. We therefore believe that our products are among the safest in the market and the patients can be confident in choosing Nagor that they will perform as intended and meet their expectations and requirements.

We would recommend that concerned patients consult the current guidance of the UK health authority (MHRA): http://www.mhra.gov.uk/NewsCentre/CON137888

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