Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)

Exclusion Criteria

• •A study patient is excluded from participation to the study if she:
• •1. Has undergone breast radiation treatment and/or be preoperatively evaluated to require radiation treatment to the breast area during the course of the study.
• •2. Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI.
• •3. Has a BMI that is ≥ 35.
• •4. Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
• •5. Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs other than any other current treatment for breast cancer.
• •6. Currently has an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit.
• •7. Is pregnant, or lactating.
• •8. Has concomitant unrelated condition of breast/chest wall/skin that, as determined by the PI, could affect the surgical outcome (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum).
• •9. Has an abscess or infection at the time of surgery.
• •10. Has undergone previous breast surgery with the exception of breast biopsy, cyst removal, and lumpectomy.
• •11. Has had a prior soft tissue support device implanted in the breast or is participating in another clinical trial with a breast related device (e.g. drains, expanders, implants).
• •12. Has a known pork allergy or is sensitive to polysorbate.