SCHEER opinion on the safety of breast implants in relation to anaplastic large cell lymphoma (ALCL)
On March 26th 2021 the final opinion of the SCHEER expert committee (Scientific Committee on Health, Environmental and Emerging Risks), on the safety of breast implants in relation to associated anaplastic large cell lymphoma (ALCL) was published: SCHEER Final Opinion on the safety of breast implants in relation to ALCL | Public Health (europa.eu)
BIA-ALCL is the occurrence of ALCL adjacent to a breast implant. Diagnosis of BIA-ALCL is achieved by analysis of seroma fluid or by biopsy. Treatment by radical surgical resection has a very good prognosis.
BIA-ALCL remains a rare disease. The incidence varies by implant type and it is mainly associated with macro-textured implants. SCHEER advocates an unambiguous, clinically validated classification system for breast implants.
Overall SCHEER considers that there is a moderate weight of evidence for a causal relationship between textured breast implants and ALCL. However, the pathogenic mechanisms of BIA-ALCL are not well understood. Current hypotheses include:
- Genetic predisposition
- Breast implant-associated reactive compounds
- Chronic inflammation as a result of bacterial contamination, separation of particles from the surface of the breast implant, or the surface properties of the breast implant itself which cause inflammation due to friction.
The disease latency varies between a few to 20 or even more years. Depending on the patient’s characteristics, plastic surgery alternatives (i.e. autologous flap tissue or autologous fat transfer) can be taken into consideration. Implant removal, for the single purpose of prophylaxis, is not recommended in non-symptomatic patients.
The expert committee highlights the need for further research to better understand the aetiology and pathogenesis of BIA-ALCL. Reporting of new BIA-ALCL cases by the relevant registries remains of major importance to obtain a better understanding of the risk of BIA-ALCL for patients with breast implants.
As of January 5, 2020, the Food and Drug Administration (FDA) has received a total of 733 US and global medical device reports of BIA-ALCL: Medical Device Reports of BIA-ALCL | FDA
The FDA additionally provides a BIA-ALCL FAQ: Questions and Answers about BIA-ALCL | FDA.
The German health authority (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) has by April 9th 2021 been notified of 35 cases of BIA-ALCL in Germany. Empfehlungen des BfArMs zu Brustimplantaten und ALCL
The BfArM provides a German translation of the above mentioned FAQ issued by the FDA: BfArM/FDA Frage-Antwort-Katalog zu Brustimplantaten und ALCL
The French health authority (Agence nationale de sécurité du médicament et des produits de santé, ANSM) provides a dossier describing its market surveillance activities regarding breast implants: Surveillance de marché des implants mammaires - ANSM
Swissmedic has received seven reports of BIA-ALCL in Switzerland to date. Since public awareness and the number of internationally confirmed cases of BIA-ALCL are continuing to grow, Swissmedic would like to reiterate the importance of a clear risk/benefit assessment. Patients should discuss the risks and benefits of the breast implants being considered and the associated surgery with their doctor in detail.
Note for patients:
If you have health concerns regarding your implants, please consult a healthcare professional.
Note for professional users:
Doctors must discuss all the risks of textured and smooth breast implants with their patients before surgery so that they can then make an informed decision that is appropriate for their individual situation. Patients must be provided with clear information about possible symptoms of BIA-ALCL so that the disease can be detected as quickly as possible. The prognosis in most cases of BIA-ALCL is favourable when discovered and treated at an early stage. Postoperative follow-up investigations play an important role in the early detection of the disease.
Please do not forget to record all breast implants in the breast implant registry managed by Swiss Plastic Surgery.
Reminder: All cases of BIA-ALCL must be reported to Swissmedic as well as in the above-mentioned breast implant registry managed by Swiss Plastic Surgery.
New information and decisions concerning BIA-ALCL and any decisions on the use of certain breast implants or types of breast implants will be communicated here.