Advice for Patients
Breast Implant Associated (BIA) ALCL is a very rare condition. It usually presents with rapid swelling of one breast some years after the implants were inserted. Treatment usually requires complete removal of the implant and the scar tissue (capsule) around it. All patients seeking breast augmentation must be warned of the potential risk by their surgeon and any worried patients who already have implants should seek advice from their surgeon.
All breast enlargement procedures carry the risk of bleeding or infection. These risks are both less than 1%, but if they do occur will result in re-operation. A degree of altered sensation in the breast area is very common after breast enlargement. This usually gradually gets better, but there is a slight risk of losing nipple sensation completely. Hardening, or encapsulation, around the implant is also a potential risk, and up to 10% of women over a ten year period will experience this problem. Where hardening (capsule formation) is found or a lump can be felt patients should seek medical advice.
It is normal for the breast shape to gradually change as time goes by. In the case of most women this will not trouble them, but sometimes the shape is not as good as it was and further surgery might be considered for this reason only. Some patients can feel or see the edges of their breast implants under the skin. Sometimes visible folds and ripples become evident. Implants are made to be very tough, but the envelope can gradually fail and a leak can occur. This is not usually a serious event, but once found will generally mean removal and exchange of the implant.
If you have breast implants and experience any problems with your breasts, in particular swelling, lumps or change in shape, then you should seek medical advice.
If you think your breast implants are causing general health problems you should seek the advice of your original implanting surgeon or the hospital/clinic where the implant operation took place. If you cannot contact either of those, please consult your GP.
The MHRA understand that you may not have much information on your implants but the more information you can provide the better. Ideally this includes:
- Details of the breast implant/tissue expanders you have at present (manufacturer, model, serial and lot number).
- Date they were put in and the dates of any other surgeries for any other removals/re-implantations, which you have had.
- How long each implant has been in you.
- Details of your symptoms or rupture of implants (device failure).
- Details of any medically diagnosed ‘autoimmune’ conditions and the date of onset.
- The reasons for your original surgery (i.e. reconstructive or cosmetic).
If you are reporting issues but you don’t know the details of your implants, it would be very helpful if you could contact your implanting surgeon for details of the manufacturer and model.
However, if that is not possible, please be reassured that your report will still be added to the MHRA database, which will help better understanding of the situation.
For help reporting via yellow card, please watch this video on how to report a problem with a medical device – A Yellow Card guide for patients.
Advice for patients with Allergan (McGhan / Natrelle) implants with a textured Biocell® surface:
Following a ruling by the French regulator over the possible link with Allergan’s textured surface (Biocell®), the CE mark was not re-awarded for this product in December 2018. Allergan subsequently recalled all of their textured implants Worldwide. Their recall was for implants already sent out to distributers and hospitals. It was not a recall of implants in patients and does not change the advice from the MHRA regarding patients currently with implants.
BAPRAS, BAAPS and ABS have been working closely with the Department of Health in setting up of the new national Breast and Cosmetic Implant Registry. Surgeons must make sure their patients are registered on it so that any future issues raised by events, such as PIP and BIA-ALCL, can be quickly investigated and patients contacted as is needed.