FDA approves the first internal tissue adhesive

TissuGlu, the first tissue adhesive permitted for internal use, was approved Wednesday by the U.S. Food and Drug Administration.

“The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” said William Maisel, deputy director for science at FDA’s Center for Devices and Radiological Health.

Surgeons can use the urethane-based adhesive to connect tissue flaps created during surgery to restore weak or separated abdominal muscles or eliminate extra fat and skin. Postoperative surgical fluid drain between the abdominal tissue flaps can be reduced, or even eradicated, by rejoining the tissue with an internal adhesive.

A surgeon using a hand-held applicator applies the TissuGlu and then situates the skin in place. A chemical reaction is initiated by water in the skin’s tissue and attaches the two separate flaps of skin. Following the TissuGlu application, the surgeon also uses sutures to close the tissue.

The FDA examined data from a clinical study of 130 patients who underwent optional abdominoplasty. Half of the patients received TissuGlu while the other half received surgical drains. Results showed that 73 percent TissuGlu of patients did not need postoperative procedures to drain accumulated fluid, while 27 percent of patients needed invasive treatments.

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