Repliform^® Tissue Regeneration Matrix

Prescriptive Information

The Repliform Tissue Regeneration Matrix is intended for the repair or replacement of damaged or inadequate integumental tissue such to repair enteroceles, rectoceles and/or cystoceles and for pelvic floor reinforcement.

Contraindications

The Repliform Tissue Regeneration Matrix is contraindicated for use in any patient in whom soft tissue implants are contraindicated. These patients include those with preexisting local or systemic infection, pathology of the soft tissue where the implant is to be placed, any pathology that would limit the blood supply and compromise healing, patients diagnosed with autoimmune connective tissue disease, and patients sensitive to specific antibiotics listed on the Repliform graft package.

Warnings

Processing of the tissue, laboratory testing and careful donor screening minimize the risks of the donor graft transmitting disease to the patient. As with any processed donor tissue, the graft cannot be guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential of reproductive impact of the clinical application of Repliform grafts.

Potential Adverse Effects

Potential adverse effects which may result from placement of an implant graft include, but are not limited to: dehiscence due to poor vascularization, loss of support, which may cause dehiscence at the implant wound site, hypersensitive, allergic, or other immune response to the Repliform graft, which is composed of proteins, proteglycans, and other components of human dermis.

Cautions

The Repliform Tissue Regeneration Matrix is packaged aseptically into a PEEL POUCH and sealed within a FOIL BAG. The FOIL BAG and PEEL POUCH are NOT STERILE, and therefore, should not be placed inside sterile field. If packaging is damaged, DO NOT USE. Immediately return the package and product to Boston Scientific.

Trademark

Repliform Tissue Regeneration Matrix is regulated by the FDA and complies with US regulations in 21 CFR part 1270 and 1271 - Human Tissue Intended for Transplantation.

Repliform is a trademark of LifeCell Corporation.

Repliform Matrix is exclusively distributed in the USA by Boston Scientific Corporation.