Ban on the marketing, distribution, advertising and use, as well as the recall, of macro-textured and polyurethane-coated breast implants by the ANSM (French health authority: Agence nationale de sécurité du médicament et des produits de santé)
Macro-textured and polyurethane-coated breast implants from the manufacturers listed below – the detailed list can be found in the decision published by the ANSM.
Allergan, Arion, Sebbin, Nagor, Eurosilicone, Polytech
On 4 April 2019, the French health authority stated that it has now banned the marketing, distribution, advertising and use of certain breast implants from certain manufacturers and ordered their recall in France. The ANSM has published the decision on its website (in French): Decision of the ANSM; Communiqué of the ANSM on the decision
Please note that, in its communiqué on this decision, the ANSM stated that it still does not recommend the preventive removal of macro-textured or polyurethane-coated breast implants.
In collaboration with the European Task Force on BIA-ALCL, Swissmedic is currently evaluating the available information and deciding on any necessary evidence-based measures. Furthermore, the EU Commission has been asked to issue a new mandate to SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) to further evaluate the disease BIA-ALCL. The latest SCHEER report on BIA-ALCL can be found here: SCHEER Final Advice 19.10.2017
At this time Swissmedic will not implement the French measures on the Swiss market. This is due to the lack of evidence on the cause and underlying mechanism of BIA-ALCL (breast implant-associated anaplastic large cell lymphoma), as well as the lack of scientific evidence showing a causal connection between the use of a particular breast implant and the development of BIA-ALCL.
Swissmedic has received four reports on BIA-ALCL in Switzerland to date. Since the public awareness and the number of internationally confirmed cases of BIA-ALCL continue to grow, Swissmedic would like at this point to stress the importance for patients of discussing in detail the risks and benefits of any envisaged breast implant operation with their doctor. This is particularly relevant in light of the latest hearings conducted by the ANSM on 7 and 8 February 2019 (Link) and the FDA (US Food and Drug Administration) on 25 and 26 March 2019 (Link), in which the explanation of the possible risks to individuals considering a breast implant, or who had received an implant in the past, was considered to be inadequate by various BIA-ALCL interest groups.
The EU taskforce, represented by the German Authority BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), presented a joint oral statement at the FDA meeting:
Note for patients:
If you have health concerns connected with 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. Possible symptoms of BIA-ALCL must also be investigated so that the disease can be detected as quickly as possible. The prognosis in most cases of BIA-ALCL is favourable if it is discovered and treated at an early stage. Postoperative follow-up investigations play an important role in the early detection of the disease.
All cases of ALCL must be reported to Swissmedic.
We also recommend that all breast implants fitted in Switzerland, as well as any corresponding serious incidents including BIA-ALCL, be entered in a registry that should contain internationally comparable data.
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.