BioCer Receives CE Mark Approval for Mastectomy "Bra" and FDA Approval for Hernia Repair System

BioCer, a German company, has received CE mark approval for the TiO2Mesh “Bra” and FDA approval for the TiO2Mesh hernia repair system. The TiO2Mesh “Bra” is a surgical implant that provides support to breast implants after mastectomy procedures.  The TiO2mesh hernia repair system uses the same surgical mesh implant for repair of soft tissue defects of the abdominal wall and is indicated for common open and laparoscopic techniques of inguinal or incisional hernia repair.

The monofilament polypropylene thread mesh achieves improved biocompatibility through the use of a high-purity and adherent titanium dioxide surface coating. The hydrophilic coating allows for improved handling and placement of the mesh and results in a reduced requirement for additional fixation during certain procedures such as laparoscopic surgery. The edges of the implant are laser cut in order to prevent any micro trauma and the mesh structure weighs only 45 g/m² and has a large pore size of 3.0mm x 2.8mm. The low implant weight of the TiO2mesh coupled with the large-pored structure and minimal material surface promotes optimal fibroblastic ingrowth, reduced shrinkage and reduced foreign body reactions. The self inflating implant is promoted as having optimal strength (55N/cm) versus flexibility, excellent biocompatibility and improved visualization of the surgical site.

The TiO2mesh is available in various shapes and sizes and can also be customized depending on the type of anatomy being addressed through surgery.

Here’s a video of the TiO2mesh being implanted during a minimally invasive procedure:

 

Press release: BioCer Announces CE Approval for Mastectomy “Bra” plus FDA Approval for Hernia repair system TiO2Mesh™…

Product page: TiO2Mesh…