FDA approves first-ever tissue adhesive for use in surgery

Last Updated: 2015-02-04

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration has approved Cohera Medical Inc's tissue adhesive for internal use during surgery, the first approval of its kind.

The product, TissuGlu, is used to connect flaps of tissue made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles.

Using the synthetic adhesive will help speed up recovery and may eliminate the need for postoperative surgical draining of fluid, the FDA said.

In a news release, the FDA explains that drops of liquid TissuGlu are applied by a surgeon using a hand-held applicator. After applying the drops, the surgeon positions the abdominoplasty flap in place. Water in the patient's tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures.

"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," Dr. William Maisel, deputy director for science at FDA's Center for Devices and Radiological Health, said in the release.

The FDA's review of TissuGlu included data from a clinical study of 130 patients undergoing elective abdominoplasty; half received surgical drains while the other half received TissuGlu and no drains.

The results showed that 73% of patients who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps. Those who did require intervention, however, were more likely to require another operation to insert surgical drains.

Patients who received TissuGlu without surgical drains were generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains. There was no difference between the two groups in reported levels of pain or discomfort due to the surgery.