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Mark W. Clemens, MD • Houston, Texas

Ventral hernia repair using SERI® Surgical Scaffold for soft tissue support

Before use of SERI® Surgical Scaffold

After use of SERI® Surgical Scaffold at 2 years

Actual patient photos. Individual results may vary.

Postoperative care and follow-up

The patient was discharged from the hospital 7 days after surgery. Both at discharge and postoperatively, there was no palpability of SERI® Surgical Scaffold. The patient was instructed to avoid lifting anything more than 10 pounds for 4 weeks and avoid excessive bending or twisting for 1 to 2 weeks. At 20 days postoperatively, the patient had no complications, and the drains were removed.

After use of SERI® Surgical Scaffold at 2 years

Actual patient photos. Individual results may vary.

Results

This patient has done well. SERI® Surgical Scaffold was not palpable either at discharge or 6 months postoperatively. At 6 months post surgery, there was also no evidence of hernia, bulge, or stretch of the abdominal wall.

Dr. Clemens noted that this postoperative course is typical of the patients he has treated with SERI® Surgical Scaffold. SERI® Surgical Scaffold seems strong enough to withstand the forces of an abdominal wall closure and help support and reinforce weakened tissues.

Summary

Dr. Clemens found SERI® Surgical Scaffold very easy to use. He liked its cloth-like flexibility for easy handling and that the visibility through the scaffold made it very simple to suture. This was especially important when placing big sutures with a large needle, since only a very thin layer of fascia lies over the bowel. The ability to look right through the scaffold and see where the needle is may provide an advantage over any opaque bioprosthetic material. The open weave of the material also aided in the postoperative course and facilitated the egress of fluid and rapid removal of drains.

This Case Review is provided for your information only. As with other surgical and medical decisions, it is the responsibility of surgeons to use sound medical judgment in utilizing the procedures best suited to the needs of each patient and to the skills and experiences of the surgeon. Please refer to the SERI® Surgical Scaffold Instructions for Use for current information.

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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.