• Phone: +55 (41) 3288-8000
  • 536 José Mendes Sobrinho Street - Zip code: 81350-320 - Curitiba/PR - Brazil

CERTIFICATES

Our products are certified by Anvisa (Brazilian Health Surveillance Agency) and Inmetro (National Institute of Metrology, Standardization and Industrial Quality) manufactured with advanced technology under strict quality control and durability, meeting the standards of good manufacturing practices.

WARRANTY

The exchange of any product of its line is guaranteed, regarding the instruction of use and provided that proven manufacturing defect. This warranty is limited to Lifesil implants and does not include medical, surgical, and hospital costs or reimbursement of the cost of implants.

Lifesil offers all its patients the guarantee of replacement of the breast implant if it has to be explanted (removed) due to rupture or deflation caused by a proven manufacturing defect.

For patient safety, Lifesil has a traceability system that allows detecting all the steps of manufacturing. In case of any manufacturing defect, the previous contact with the manufacturer must be made, stating the serial number written on the packaging or the patient’s card provided by the physician.

QUALITY POLICY

“To produce products for health based on silicone, committing ourselves to the legal requirements of the product, the satisfaction of the customers, and the continuous improvement of the Quality Management System.”

INMETRO

Lifesil was the first manufacturer of silicone implants in the world to receive Inmetro certification.

ANVISA

Lifesil products are certified by Anvisa and manufactured with advanced technology within strict quality control and durability.

Anvisa Register MS 8035982002 / 8035982003 / 8035982001 / 8035982006.

ISO 13.485

Lifesil products are developed and produced in facilities compatible with the ISO 13485 standards for the production of medical devices for class III sterile breast implants.

FDA

Long-lasting medical grade silicone gel with FDA approval.