FDA. US: The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use. TissuGlu
is a urethane-based adhesive that a surgeon can use to connect tissue
flaps made during surgery to remove excess fat and skin or to restore
weakened or separated abdominal muscles (abdominoplasty surgery).
Connecting the tissue flaps with an internal adhesive may reduce or
eliminate the need for postoperative surgical draining of fluid between
the abdominoplasty tissue flaps.
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,” said William Maisel, M.D., M.P.H., deputy director
for science at FDA’s Center for Devices and Radiological Health.
The
FDA’s review of TissuGlu included data from a clinical study of 130
participants undergoing elective abdominoplasty. Half of the
participants received surgical drains while the other half received
TissuGlu and no drains. The study results showed that 73 percent of
participants who received TissuGlu required no postoperative
interventions to drain fluid that had accumulated between the
abdominoplasty tissue flaps.
In the 27% of patients who did
require invasive treatments, 21% received needle aspirations alone. Six
percent of the TissuGlu group received both needle aspirations and
drains for persistent seroma formation.
Participants 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.
TissuGlu is manufactured by Cohera Medical, Inc., located in Pittsburgh, Pennsylvania.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.