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ALLODERM SELECT™ Regenerative Tissue Matrix
INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS
ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT RESTORE™ RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. ALLODERM SELECT™ RTM is intended for use in post-mastectomy breast reconstruction surgical procedures where the use of the acellular dermal matrix (ADM) is considered homologous, such as managing a potential skin defect created from harvesting tissue for use in autologous tissue reconstruction. Examples of uses in post-mastectomy breast reconstruction not considered homologous include use of an ADM to form an extension of the submuscular pocket for placement of a breast implant or tissue expander, and use to prevent expander or implant extrusion, or to constrain the expander or implant in the correct position. This product is intended for use in one patient, on a single occasion. ALLODERM SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
ALLODERM SELECT™ RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.