Present in over 60 countries and 5 continents, Silimed holds ISO 9001-2008 and EN 13485 certificates, as well as Good Manufacturing Practices from ANVISA and GMP, approved by the FDA. Its products bear the CE Mark and are approved by the principle regulatory agencies worldwide. Since Silimed were established in 1978, they have had a long history of making excellent tissue expanders for breast and many other body areas.