FDA approves TissuGlu synthetic adhesive for internal use

The FDA has announced the approval of TissuGlu, a urethane-based adhesive to connect tissue flaps made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles.

The adhesive may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps, according to a press release.

Using a hand-held applicator, the surgeon applies drops of liquid TissuGlu (Cohera Medical) and positions the abdominoplasty flap in place. Water in the patient’s tissue is utilized to create a chemical reaction that bonds the glue and flaps together. A standard closure with sutures finalizes the process, according to the release.

The FDA’s review of the product included data from a clinical study of 130 participants who underwent elective abdominoplasty; half of the patients received surgical drains, whereas the other half received TissuGlu and no drains. Seventy-three percent of the patients who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps. These patients were able to return to the activities of daily living earlier than those who had surgical drains, the release stated. Additionally, no differences in discomfort levels were reported between the two groups.

Reference: www.fda.gov.