By Miriam Christie
In Europe, all medical devices are regulated and must have a stamp of safety or licence, known as a CE mark. Due to safety concerns over Microcell and Biocell implants, manufactured by global pharmaceutical company Allergan, the CE mark has not been re-awarded for the products.The CE mark for Allergan’s smooth surfaced implants has been renewed and their smooth implants are not affected. The failure to renew the CE mark for their textured implants does not at this stage affect any other manufacturer.BIA-ALCL is rare and usually eminently treatable. Current research suggests the risk of developing this condition in the UK is approximately one in 24,000 breast implants sold. In comparison, the general incidence of breast cancer in the UK is one in nine and affects women with and without breast implants equally.
Paul Harris, president of the British Association of Aesthetic Plastic Surgeons (BAAPS) said: “The news that Allergan’s CE mark for their Biocell textured surface implants has not been renewed will be a cause for understandable concern for many patients, particularly those who have implants currently in place. It is important however to recognise that this is a pre-cautionary step taken by the regulators whilst the link between breast implant surface and BIA-ALCL becomes clear.
“We advise any patients with new symptoms such as swelling or pain to contact their implant surgeon for specific advice, otherwise they should make a routine appointment when available to discuss their concerns.”
Not all textured surfaces are manufactured in the same way and they appear to convey different levels of risk, making it is difficult to draw definite conclusions. Texturing of an implant surface also offers advantages, particularly with more anatomically shaped implants. Many surgeons in the UK still advocate the use of textured implants for their patients. It is vital, however, that the risks of using textured or smooth surfaced implants are fully discussed with all patients prior to surgery so that patients are able to make informed choices.
Marc Pacifico, BAAPS Council Member and Consultant Plastic Surgeon said: “The majority of patients in the UK with breast implants will have textured surface implants in their breasts. According to all the latest scientific data these remain safe devices and there is no indication for any woman to consider removing or replacing their implants. Patients should continue with any planned follow-up they have arranged.”
