TissuePatch^™ Sealant Film

INDICATIONS: TissuePatch^™ is indicated for use to seal and reinforce against:

• Fluid (including cerebrospinal fluid (CSF)) and/or blood leakage where repair of the dura mater is required;
• Air leakage in thoracic surgery (open and minimally invasive);
• Leakage of low pressure or oozing bleeding or fluid leakage following surgical procedures on soft tissue.
  TissuePatch^™ is intended for use as an adjunct and is not intended to replace sutures or staples, as appropriate, in tissue approximation.

CONTRA-INDICATIONS
Not intended for intravascular use.
Not intended to replace sutures, staples or clips, as appropriate, in tissue approximation.
Not intended to be used as a dura mater substitute/replacement.

WARNINGS AND SAFETY INFORMATION

• TissuePatch^™ should not be used on patients with a known allergy or sensitisation to its constituent components. The use of TissuePatch^™ must be considered on an individual basis.
• TissuePatch^™ should not be used as the primary means of support. The product is to be used as an adjunct, providing temporary support.
• TissuePatch^™ is not a thrombogenic haemostat. It should not be used to control arterial bleeds; it can however be used adjunctively to control low pressure oozing/bleeding.
• TissuePatch^™ should not be wrapped around gastrointestinal anastomoses.
• TissuePatch^™ should not be used on the skin.
• If there is any evidence of damage to TissuePatch^™ the product shall NOT be used.
• TissuePatch^™ should not be used if an active infection is present at the surgical site.
• TissuePatch^™ adhesion can be affected by contact with solutions containing iodine. Such substances should NOT be applied to the site before sealing with TissuePatch^™, though can be used following patch application.
• TissuePatch^™ may swell slightly to a total thickness of <0.5mm. Care should therefore be taken when using the product in confined bony structures where nerves are present.
• TissuePatch^™ may cause a local, mild inflammatory reaction leading to encapsulation by inflammatory cells with some fibrosis.
• TissuePatch^™ is for single patient use only and once opened may not be resterilised. Product should not be re-used as this presents numerous hazards including the risk of cross contamination and lack of sterility.
• DO NOT use TissuePatch^™ if the temperature indicator dot is black; this indicates that the product has been exposed to excessive temperatures and is not suitable for use.