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FDA approves first internal tissue adhesive for use in abdominoplasty


 

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The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.

The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “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 the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.

To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then 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,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”

The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.

Patients treated with TissuGlu who did not require a surgical drain 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,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.

Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.

TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.

Information on the approval, as well as patient and physician labeling, is available on the FDA website.

emechcatie@frontlinemedcom.com

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