Drain-free tummy tuck FAQs

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+ How long has TissuGlu® been available? Is it safe?

TissuGlu was approved for use in Europe in 2011 and in the United States since February 2015. To date, TissuGlu has been used in thousands of procedures around the world. TissuGlu is nontoxic and breaks down into harmless components that get eliminated by the body naturally.

+ What is TissuGlu made of?

TissuGlu is a synthetic, lysine-based urethane adhesive. It creates strong bonds with tissue. Once it sets, each drop of TissuGlu can hold about 10 pounds of shear force (the type of force that happens when you bend or twist).1

+ What are the benefits of TissuGlu?

TissuGlu may help eliminate the need for drains after surgery. By choosing TissuGlu instead of drains, you may be able to

+ What are the risks of using TissuGlu?

Extensive clinical studies were performed using TissuGlu. There were no increased safety risks with the use of TissuGlu. Potential complications associated with the use of TissuGlu and the tummy tuck procedures include seroma (fluid) formation. These complications may require treatments such as drain placement and/or fluid removal by needle, which may be performed in the operating room. Additional potential complications include wound healing issues, rash/redness, surgical site or incision infection, scarring, hematoma (bruise or swelling), incision separation, and immunological reaction. Ask your doctor to explain the risks and potential complications associated with the use of TissuGlu Surgical Adhesive and an abdominoplasty procedure.

+ How does TissuGlu work?

Your doctor applies TissuGlu in a grid pattern with a special applicator, so it’s very precise. The many points of contact created by the multiple drops of adhesive help ensure that the tissue bond holds very tightly. This keeps the tissue layers together and helps prevent gaps between the tissue layers where fluid can accumulate.
See TissuGlu in action.

+ How long does TissuGlu stay in my body?

The bonds between the TissuGlu and tissue start breaking down within the first few weeks of the healing process and the TissuGlu is gone in a matter of months.

+ Is there a scientific study I can read?

Yes. The safety and efficacy of TissuGlu were studied in clinical trials in the United States. The studies showed that TissuGlu was a viable alternative to drains. Study results showed that participants who used TissuGlu had fewer invasive procedures, shorter recovery times, and a better quality of life during recovery compared with those who used drains.

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Reference: 1. Data on file, Cohera Medical, Inc.

Important TissuGlu® Surgical Adhesive Safety Information

INDICATION

TissuGlu® Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue plane in abdominoplasty.

IMPORTANT SAFETY INFORMATION

Contraindications
Do not use in patients with known or suspected allergies to urethane-based or isocyanate-containing products.

Warnings

  • Do not use TissuGlu® Surgical Adhesive in patients who have had prior exposure to TissuGlu®. Immunological response associated with repeat TissuGlu® exposure has not been studied.
  • The effectiveness for the treatment of patients with BMI > 28 has not been established. Higher BMI patients have a propensity for fluid accumulation and may have an increased risk of seroma formation.
  • Effectiveness was not observed in weight loss patients undergoing abdominoplasty. Weight loss patients have a propensity for fluid accumulation and may have an increased risk of seroma formation and aspiration.

Benefits
TissuGlu® may reduce the need for drains after surgery. By using TissuGlu® instead of drains, you may:

  • Return to normal activities more quickly
  • Experience less discomfort and pain than when drains are used
  • Have fewer invasive treatments for fluid management. The results showed that 73% of TissuGlu® patients had no treatments after surgery. However, some patients did require additional invasive treatments including reinsertion of drains.

Risks
Clinical studies were performed using TissuGlu®. There were no increased safety risks with the use of TissuGlu® than when drains were used. Potential complications associated with the use of the device and the tummy tuck procedures include seroma (fluid) formation. These complications may require treatments such as drain placement and/or fluid removal by needle, which may be performed in the operating room. Additional potential complications include wound healing issues, rash/redness, surgical site or incision infection, scarring, hematoma (bruise or swelling), incision separation, and immunological reaction.

Safety Information:
For full safety information please visit http://tissuglu.com, contact your doctor, or call Cohera Customer Support at 1-800-641-7458.

Disclaimer:
TissuGlu® Surgical Adhesive is currently approved for sale in the United States for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty. TissuGlu® Surgical Adhesive received European CE Mark in 2011, where it is approved for large flap surgical procedures such as abdominoplasty. TissuGlu® Surgical Adhesive is not approved for sale in any other region. Any questions related to the indication for use should be directed to your Cohera Medical Account Manager or to Cohera Medical Corporate Clinical Affairs. Refer to the complete TissuGlu® Surgical Adhesive Directions for Use for prescribing and usage information.