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

Inclusion criteria

To be eligible for enrollment, the subject must:

• Be female, ≥ 18 years of age
• If the subject is a female of childbearing potential, have a pregnancy test evaluated as negative prior to surgery, per the site's standard of care
• Have a nicotine test evaluated as negative prior to surgery and agree not to smoke for the duration of the study
• Be willing to undergo mastectomy with healthy, well-vascularized skin flaps anticipated by the surgeon
• Be eligible to enroll in one of the following three cohorts:

• Subject had radiation therapy (XRT) prior to direct-to-implant (DTI) reconstruction, but will not have XRT following reconstruction;

• Subject did not have XRT prior to DTI reconstruction and will not have XRT following reconstruction;

• Subject did not have XRT prior to DTI reconstruction, but will have XRT following reconstruction.

Exclusion criteria

To be eligible for enrollment, the subject must not:

• Have collagen-vascular, connective tissue, or bleeding disorders
• Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
• Have an autoimmune disease, an immune deficiency, or is on immune-suppression drugs for reasons other than current treatment for breast cancer
• Have a BMI that is ≥ 32
• Have a nicotine test evaluated as positive prior to surgery or unwilling to quit smoking for the duration of the study
• Currently have an alcohol/substance abuse problem or have had a relapse within 1 year prior to screening visit
• Be pregnant, lactating, or expecting to be within the next 24 months
• Have concomitant unrelated condition of breast/chest wall/skin (e.g. significant chest wall abnormalities including pectus excavatum or pectus carinatum)
• 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
• Have had a prior soft tissue support implant
• If enrolled into the Pre-Radiated cohort, have had recent radiation (< 1 year) to the breast/chest wall
• 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
• 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
• Have large or multiple scars on the breast(s) that may interfere with blood supply to the mastectomy flaps