Magnetic Resonance Imaging (MRI) Safety Information

The GORE® ENFORM Intraperitoneal Biomaterial is MR Safe.

The GORE® ENFORM Preperitoneal Biomaterial is MR Safe.

 

The information on this page is current as of September 2023. For the most current and complete MR safety information on any product, always refer to the Instructions for Use at eifu.goremedical.com.

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Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

INDICATIONS FOR USE: The GORE® ENFORM Intraperitoneal Biomaterial is indicated for the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where the GORE® ENFORM Intraperitoneal Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement and general tissue reconstructions.

CONTRAINDICATIONS: The GORE® ENFORM Intraperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects. The GORE® ENFORM Intraperitoneal Biomaterial is absorbable and contraindicated for use in patients requiring permanent support from the device.

INDICATIONS FOR USE: The GORE® ENFORM Preperitoneal Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where the GORE® ENFORM Preperitoneal Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement and general tissue reconstructions.

CONTRAINDICATIONS: The GORE® ENFORM Preperitoneal Biomaterial is contraindicated for use in reconstruction of cardiovascular defects. The GORE® ENFORM Preperitoneal Biomaterial is absorbable and contraindicated for use in patients requiring permanent support from the device.

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