Facilitates Neovascularization (As Early As 2 Days)† and Native Tissue Generation Over Time1,*
Surgeon
Experience
Bioreplaced
Over Time1,*
Product
Training
Indications for Use
SERI® Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where
weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue
in plastic and reconstructive surgery, and general soft tissue reconstruction.
Important Safety Information
Contraindications
- Patients with a known allergy to silk
- Contraindicated for direct contact with bowel or viscera where formation of adhesions may occur
Warnings
- SERI® Surgical Scaffold must be placed in maximum possible contact with healthy well-vascularized tissue to encourage ingrowth and tissue remodeling
- Caution should be used when implanting SERI® Surgical Scaffold in pregnant women. The use of a device that can impede tissue expansion may be hazardous during pregnancy
Adverse Reactions
Adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.
Important
Before using SERI® Surgical Scaffold, read the Instructions for Use which accompany the product for full safety information. This can be found here.
Caution
Rx only.
*Methodology: In an ovine subcutaneous thoracic wall implant study designed to measure the strength and thickness of SERI® Surgical Scaffold and newly generated native tissue at up to 24 months after implantation of SERI®.1
Note: Similar studies in humans have not been performed.
†Methodology: In a study using SERI® Surgical Scaffold in a rat model of abdominal wall defect.1
Note: Similar studies in humans have not been performed.
Instructions for Use
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