TephaFLEX® Composite Mesh

TephaFLEX® Mesh backed by TephaFLEX® Film to minimize the potential for tissue attachment

PRODUCT ATTRIBUTES*

The TephaFLEX® composite mesh is comprised of a layer of the TephaFLEX® knitted surgical mesh with a layer of TephaFLEX® film on one of its sides. The mesh was determined substantially equivalent by the Food and Drug Administration for the following indications for use:

“The TephaFLEX® composite mesh is intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapsed repair, colon and rectal prolapsed repair, reconstruction of the pelivic floor and sacral colposuspension.
The film side of the device may help minimize the potential for tissue attachment to the mesh in case of direct contact with the viscera.”

The composite mesh is provided in single sheets of varying widths and lengths ranging from 1x2 inches to 10 x 14 inches and may be cut to the shape or size desired for a specific application.

* "Because the composite mesh is absorbable, it should not be used in repairs where extended or permanent wound or organ support is required."