SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction

Exclusion Criteria

• •To be eligible for enrollment, the subject must not:
• •1. Have collagen-vascular, connective tissue, or bleeding disorders
• •2. Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
• •3. Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
• •4. Have a BMI that is ≥ 32
• •5. Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
• •6. Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
• •7. Be pregnant, lactating, or expecting to be within the next 24 months
• •8. Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
• •9. Require the use of any additional implant for soft tissue support of the contralateral non-study breast, except in bilateral breast reconstructions, where the use of SERI® Surgical Scaffold is allowed
• •10. Have had a prior soft tissue support implant
• •11. If enrolled into the Pre-Radiated cohort, have had recent radiation (\< 1 year) to the breast/chest wall
• •12. If enrolled into the Post-Radiated cohort, radiation to the breast/chest wall is planned more than 1 year from the time of SERI® Surgical Scaffold placement
• •13. Have clinical evidence of severe radiation tissue damage (e.g. pigmentation, indentation, atrophy, no elasticity to skin of radiated breast) from previous XRT to the breast/chest wall
• •14. Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps