BIA-ALCL Update
BIA-ALCL is a rare type of T-cell Lymphoma (cancer of the immune system) that can develop in the scar tissue capsule or fluid that surrounds breast implants.
In the UK the MHRA has issued advice that breast implants do not need to be removed, unless there are symptoms of BIA-ALCL. The current data from MHRA is that as of August 2020 there have been 78 reports of patients diagnosed with BIA-ALCL that have met the WHO diagnostic criteria. From the 78 patients diagnosed with BIA-ALCL, 3 have died and 1 death met the WHO diagnostic criteria for BIA-ALCL. The MHRA continue to monitor new cases of BIA-ALCL diagnosis and deaths related to BIA-ALCL and are part of an EU taskforce.
In Australia the TGA advice is the same as the MHRA and the FDA, the TGA state that ‘medical experts do not recommend removing your breast implants if you do not have symptoms of BIA ALCL.’ The TGA report that 4 patients in Australia, have died from BIA-ALCL. In the USA the FDA has also issued advice that breast implants do not need to be removed, unless there are symptoms of BIA-ALCL
Medical Device Reports of BIA-ALCL
The FDA updated the table on the agency’s BIA-ALCL webpage which reports an increase of 160 new cases and 3 deaths since the July, 2019 update. The global medical device reports (MDRs) of BIA-ALCL is based on data of global deaths reported in MDRs and literature reported as MDRs. To date a total of 733 unique cases and 36 patient deaths have been reported, globally.
620 cases of BIA-ALCL have been linked to Allergan implants, 496 cases of BIA-ALCL diagnosis were linked to textured breast implants. Out of the 36 deaths, 16 had been reported with a textured breast implants. 15 of the 16 patients which were reported with the name of the manufacturer were manufactured by Allergan.
My advice
The number of women with a BIA-ALCL diagnosis is extremely low, however anyone with breast implants should monitor for symptoms of BIA-ALCL which include:
Swelling caused by fluid developing around one or both breast implants
- Swelling caused by fluid developing around one or both breast implants
- Tenderness and pain
- Lump(s) in the breasts or armpit.
It is important to note that the above symptoms do not always resulting a BIA-ALCL diagnosis and can be caused by other reasons. It is essential to immediately contact your plastic surgeon or plastic surgery company for tests to rule out BIA-ALCL if you experience any symptoms. If BIA-ALCL is diagnosed a complete, prophylactic capsulectomy, also referred to as an En Bloc resection with breast implant removal will in most cases, be all that is needed. When the cancer has spread beyond the breast implant scar capsule and local area additional treatments, such as chemotherapy and radiotherapy may be necessary.
Smooth shelled breast implants have a significantly lower risk of BIA-ALCL developing. Alternatively if you do not want breast implants, you could opt for a breast uplift and, or autologous fat transfer to replace the volume that will be missing, when your breast implants are removed.
More information about BIA-ALCL symptoms, diagnosis criteria and treatment :
UK
British Association of Aesthetic Plastic Surgeons (BAAPS)
British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS)
Association of Breast Surgery (ABS)
Germany
German regulator (BfArM)
France
Australia
The Australian Therapeutic Goods Administration (TGA)
USA
The United States Food and Drug Administration (FDA)
Canada
