Silimed is one of the largest manufacturers of brest implants world-wide. Silimed has supplied implants to surgeons around the world since 1978, and from its own manufacturing plant since 1980. Read more about the Silimed background here:
Silimed’s manufacturing plant has been inspected by FDA, and in 2012 Sientra (former Silimed US) received FDA approval to sell the implants in the US. This makes Silimed the only non-North American company authorized to sell in the US.
Furthermore, Silimed is the only company with an exclusive manufacturing serial number for each implant, which enables accessing a database and viewing information such as the year of manufacture and the professional who used it. Silimed constantly monitors its sales all over the world.
Silimed’s range of products comprises not only breast implants but also expander prothesis, expanders, facial implants and implants for body contouring. You can download product catalogs beow, under Downloads/Brochures, or on the respective product page.
The whole manufacturing process at Silimed is in strict compliance with national and international standards of quality.
Regularly audited by several agencies, the company always conforms with the certifications which it has won.
- Registration of all the products at the Brazilian Ministry of Health;
- Certificate of Good Manufacturing Practices granted by the National Agency for Sanitary Vigilance (Anvisa);
- ISO 9001 Certificate of Quality (International Organization for Standardization) granted by the German company TÜV Rheinland;
- EN ISO 13485 Certificate of Quality granted by the TÜV Rheinland;
- CE mark approved by the TÜV Rheinland; seal that gives products quality assurance in specific terms of the industry for medical or health products in general for the entire area of the European Community;
- GMP quality system (Good Manufacturing Practices of Medical Products) approved by the FDA (Food and Drug Administration), the North-American agency that controls food, medicine and medical material;
- Raw materials of North-American origin, duly registered at the FDA.