Novus Scientific – TERMS OF USE

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  11. Miscellaneous. The provisions of these Terms are severable. Accordingly, if any provision of these Terms is held to be unlawful, void or unenforceable by a court of competent jurisdiction, then such provision shall be modified or eliminated as such court determines severable without affecting the enforceability of all remaining provisions, which shall be enforced to the maximum extent permitted by applicable law.  The failure of Novus Scientific or its affiliates to act with respect to a breach of these Terms by you or others does not constitute a waiver and shall not limit their rights with respect to such breach or any subsequent breaches.
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MEDICAL DISCLAIMER

RX ONLY – Caution: Before using TIGR® Matrix Surgical Mesh read the instructions for use which accompany the product for indications, contraindications, warnings and precautions.

INDICATIONS FOR USE

TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.

CONTRAINDICATIONS

Not suitable for reconstruction of cardiovascular defects.
TIGR® Matrix Surgical Mesh must always be separated from the abdominal cavity by peritoneum.
Not for use following planned intra-operative or accidental opening of the gastrointestinal tract. Use in these cases may result in contamination of the mesh, which may lead to infection.

WARNINGS

  1. Do not use if the package has been opened or damaged or any sterile barrier is not intact.
  2. Do not use after the expiration date – the biodegradable components may not perform adequately.
  3. Do not use on contaminated and/or infected wounds.
  4. For single use only. Do not resterilize. Discard all open and unused portions of the device.
  5. Do not use TIGR® Matrix Surgical Mesh with resorbable fixation devices. The safety and effectiveness of TIGR® Matrix Surgical Mesh when used with such devices like tissue adhesives, surgical glues, or other resorbable fixation devices, including sutures, tacks, and staples, have not been established through in vivo or clinical studies. Surgeons should select the method of non-absorbable fixation based on their professional clinical judgment and currently accepted surgical practices.

PRECAUTIONS

  1. Federal (USA) law restricts this device to sale by or on the order of a physician.
  2. Carefully check that the packaging is undamaged and unopened and that the sterile barrier is intact before use.
  3. The mesh should be large enough to extend beyond the margin of the defect.
  4. Infections should be treated according to acceptable surgical practice to minimize the need for removal of the mesh.