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FDA Approves First Tissue Adhesive for Internal Use

By: Azia Tariq, Section Editor

The U.S. Food and Drug Administration (FDA) has approved TissuGlu®, the first tissue adhesive approved for internal use. William Maisel, M.D., M.P.H., Deputy Director of Science at FDA’s Center for Devices and Radiological Health states, “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.” 1

The intended use for TissuGlu®, a lysine-derived, urethane-based (LDU) adhesive, is to connect tissue flaps made during surgery in order to remove excess skin and fat. In addition, it is intended to restore weakened or separated abdominal muscles in procedures such as an abdominoplasty surgery. During such procedures, drops of liquid adhesive are applied using a hand-held applicator. After applying the drops, the surgeon positions the abdominoplasty flap in place. Water in the patient’s tissues starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures. Connecting the tissue flaps with an internal adhesive can help reduce or even eliminate the need for postoperative surgical draining of fluid.1

Data from a clinical study of 130 participants undergoing elective abdominoplasty suggests that participants who received TissuGlu® without surgical drains were able to return to most daily activities such as showering and climbing stairs, and resume their usual routines sooner than those who had surgical drains. Half of the participants received surgical drains while the other half received LDU adhesive and no drains. The study results showed that 73% of participants who received the adhesive required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps. Of the 27% of patients who required invasive treatments, 21% received needle aspirations alone and 6% received both needle aspirations and drains for persistent seroma formation. There was no significant difference between the groups in reported levels of pain or discomfort due to surgery.1

Additional studies determined that usage of TissuGlu® lowered both drainage time and volume. In a prospective, multicenter, randomized trial assessing the use of the lysine-derived urethane adhesive in patients undergoing abdominoplasty, 20 patients were randomized to a control or to a treatment group in which the adhesive was applied to the abdominal wall prior to closure of the abdominoplasty. Control patients underwent an identical procedure but without application of TissuGlu®. Results indicated decreased drain removal time (2.9±1.4 vs. 3.7±1.5 days; p=0.13) and lower total drain volume (208.7±138.2 vs. 303.5±240.8 ml; p=0.14) in the treatment group.2

In the Journal of Plastic, Reconstructive, and Aesthetic Surgery, a canine model of abdominoplasty was used to examine seroma formation and efficacy of the LDU adhesive. More fluid accumulation was observed in the control group than the treatment group (mean, 690 vs. 44; median volume 348.5 vs. 15 ml; p < 0.01) (n = 8) at Week 3 necropsy. The study demonstrated that the adhesive is capable of preventing seroma formation in the canine abdominoplasty model and that its usage may be clinically beneficial in the prevention of seroma formation in patients undergoing abdominoplasty.3

The use of LDU adhesives was also analyzed in mastectomy patients. In the study, 32 patients received a mastectomy using a gold standard mastectomy technique as well as TissuGlu®. A control group of 173 patients who received a gold standard mastectomy only was evaluated retrospectively. Similar results were shown regarding drain removal time (17% decrease) and hematoma formation (14% decrease). Though the primary endpoint results showed no significant difference in the development of a postoperative seroma (p>0.05), it was found that 7% of the control group patients required revision surgeries or re-hospitalization due to infection, whereas none of the LDU adhesive patients required re-hospitalization. Secondary endpoints revealed that superficial postoperative hematoma was present in 17% of the control group vs. 3% in the treatment group (p<0.05). Drain removal times also favored the LDU adhesive group (4.2 vs. 3.5 days, p<0.05).4
      Although still early, the decrease in formation of hematoma, which are reflected by decreasing rates of re-hospitalization and revision surgeries, render LDU adhesive a promising agent in abdominoplasty and reconstructive surgery.



  1. FDA approves first tissue adhesive for internal use. Fda.gov. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432906.htm Published 02/4/2015.
  2. Walgenbach KJ, Bannasch H, Kalthoff S, Rubin JP. Randomized, prospective study of TissuGlu® surgical adhesive in the management of wound drainage following abdominoplasty. Aesthetic Plast Surg. 2012;36(3):491-6.
  3. Gilbert TW, Badylak SF, Beckman EJ, Clower DM, Rubin JP. Prevention of seroma formation with TissuGlu® surgical adhesive in a canine abdominoplasty model: long term clinical and histologic studies. J Plast Reconstr Aesthet Surg. 2013;66(3):414-22.
  4. Eichler C, Fischer P, Sauerwald A, Dahdouh F, Warm M. Flap adhesion and effect on postoperative complication rates using Tissuglu(®) in mastectomy patients. Breast Cancer. 2015. doi: 10.1007/s12282-015-0591-1.


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