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Advice for patients with breast Implants

What has happened?

Breast implants are generally safe – they are regarded as ‘Medical Devices’  and in Europe these are covered by the CE  mark. This is a legal requirement for all manufacturers and is renewed every 5 years. Recently you may have come across the news released on Bloomberg that one of the largest breast implant manufacturers (Allergan) has halted sales and has recalled some of its breast implants. In the UK the MHRA has also released some information on this situation and has informed medical practitioners that Allergan has stopped selling Microcell® and Biocell® breast implants and tissue expanders as their CE mark expired on 16th December 2018.

So why has this happened?

We have become aware of a link between textured breast implants and a clinical condition described as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).  In the UK this is a rare incidence  of around 1 in 24,000 – compared to the incidence of breast cancer of 1 in 9. Textured implants have a proven benefit in reducing capsular contracture rates when placed in front of the pectoralis muscle. This texturing is different on implants produced by different companies  and some data indicates different rates of BIA-ALCL ranging from Mentor Siltex® incidence 1:86,000 and Allergan Biocell® 1: 4,000. The French regulatory body,  Agence Nationale de Securite du Medicament (ANSM) has requested that Allergan provide further information on their products and requested that they be pulled off the market after their clearance lapsed and the CE mark was not renewed for these textured breast implants.

What is the current advice for patients?

The main advice is that patients who already have Allergan breast implants or expanders do not need to have them removed or replaced. The steps taken  by the regulatory body in France and Europe is a pre-cautionary one  while the link between breast implant surface texture and BIA-ALCL is investigated. Patients should continue with their scheduled follow-ups as arranged.

If  any patients develop any new symptoms such as swelling or pain you should contact your surgeon and seek further advice.

If you are due to have a breast implant or tissue expander discuss your concerns with the surgeon. The main point at present is that textured  Microcell® and Biocell® breast implants and tissue expanders should not be used until the CE mark is renewed.  Currently there are other textured implants and polyurethane implants with a valid CE mark that may be used and your surgeon can discuss this with you.

Advice for patients under the care of PDS

 Those patients under the care of Mr M D  Humzah Consultant Plastic Reconstructive & Aesthetic Surgeon (PDS) are advised to contact us if they have any specific concerns -  you will not have had Allergan implants  and we will be able to discuss any concerns you have. We can be contacted  by e mail :  or Telephone : 0800 084 2321.

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