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It is intended to use the device: - Advanced intra-abdominal pathology requiring more than one abdominal 1) operation to control the disease. As fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible because abdominal organs protrude due to massive swelling of tissues, e.g. abdominal compartment syndrome and other severe and life threatening abdominal pathology. - 2) To prevent perfusion impairment of abdominal organs from increased intraabdominal pressure. - 3) Advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.

Like the predicate devices the Wittmann Patch is adjustable fascial expander prosthesis for temporary bridging abdominal wall incisions where primary closure is not possible and/or repeat abdominal entries are necessary. The device is used in life threatening conditions such as severe abdominal trauma and intra-abdominal infection with and without abdominal compartment syndrome to enable temporary closure of the incised abdominal cavity when direct fascial closure is not possible and would compromise perfusion of intra-abdominal orqans. After 3-5 days use WP is usually no longer required and removed for final abdominal closure without any mesh in place. The device consists of two adhering sheets of biocompatible polymeric material. One sheet bears small hook like structures and the other a meshwork of loops. The two sheets are sutured to opposing fascial edges of an abdominal incision. The abdomen can be closed by pressing one sheet onto the other expanding the fascia prosthesis) to account for increased intraabdominal volume but at the same time it can be easily opened to inspect, control, and repair intraabdominal pathology. The artificial bur fascia provides a temporary safe fascial closure of the abdominal cavity. Once the intraabdominal pathology improves and swelling diminishes it is possible to re-approximate opposing fascias remove the artificial and close the abdominal wound by final fascia-to-fascia suture. Like the predicate devices the Wittmann Patch consists of two sheets of knitted synthetic fibers with clinging elements on one surface which adhere to each other. The two thin mating meshes are equipped with either loops or hooks respectively. Both sheets are white measuring 20 cm x 40 cm each, and consist of woven polyamide fibers and an additional reinforced backing for the hook sheet. The two sheets adhere to each other when pressed onto the other. High tangential shearing forces are required to separate the two sheets. Testing has demonstrated that separation of the two sheets would occur only with forces greater than those that would disrupt normal, intact fascia [Wittmann, DH, et al Eur J Surg, 159: 75-79, 1993.]. Peeling the top sheet away from the lower sheet opens the two sheets to access the abdominal cavity. No component of the final device can be identified that is potentially toxic, carcinogenic or immunogenic (e.g., organic solvents, heavy metals, cross-linking reagents).