Du har säkert följt utvecklingen den senaste veckan och det gör även vi. Läkemedelsverket avser inte att agera just nu utan avvaktar utfall från EU-arbetsgruppen och SCHEER. Det som EU arbetsgruppen (task force) förmedlade på FDA Panel meeting i mars 2019 kvarstår, dvs;
Conclusion
BIA-ALCL is a topic of significant concern and the data is continuing to emerge. The taskforce’s evaluation of BIA-ALCL is ongoing and, as with all issues, we take an evidence-based approach. The Taskforce will continue to evaluate this data.
There are no preventive explantation recommendations in relation to the BIA-ALCL.
It is imperative that the risks of having either textured or smooth-surfaced implants are fully discussed with all individuals before surgery, so that they can make fully informed choices.