15 April 2010
French Breast implant manufacturer Poly Implant Prothese (PIP) has recalled devices and suspended marketing, distribution, export and use of its silicone gel-filled implants. This decision was made by French medical device regulatory authority (AFSSAPS) on March 29th , following reports that this product has abnormally high rupture rates, causing women to require surgery to remove them. It was found that the gel used and manufactured was different to that which had originally been approved. The UK MHRA issued a medical device alert and suspended use of the product on the 31st March
It is thought that the recall could effect up to 45,000 women in the UK and abroad. Women who may have had these implants should seek medical advice and arrange to see their surgeons for examinations and annual ultrasounds
The product liability team at Leigh Day & Co has considerable experience in handling claims relating to defective medical devices. If you would like to speak to one of our lawyers please contact Bozena Michalowska on 020 7650 1311.
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