The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery

Inclusion Criteria:

To be eligible for enrollment, the subject must:

- Be female, greater or equal to 18 years of age

- Be willing to undergo breast reconstruction with sub-pectoralis muscle placement of a
tissue expander, followed by exchange with a sub-pectoral breast implant

- Have previously had or be willing to undergo mastectomy with healthy,
well-vascularized skin flaps anticipated by the surgeon

- Be in good health other than breast pathology and be suited to general anesthesia and
planned treatments.

Exclusion Criteria:

The subject must not:

- Have undergone breast radiation treatment and/or is preoperatively evaluated to
require radiation treatment to the breast area during the course of the study

- Have a known allergy to silk

- Have collagen-vascular, connective disease, or bleeding disorders

- Have a Body Mass Index (BMI) that is greater than or equal to 35

- 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
other than any other current treatment for breast cancer

- Have smoked within the last 12 months

- 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

- Have an abscess or infection at the time of surgery

- Have undergone previous breast surgery with the exception of mastectomy, breast
biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation

- Have had a prior soft tissue support device implanted in the breast

- Have a condition or be in a situation that, in the Investigator's opinion, may put the
subject at significant risk, may confound the study results, or may interfere
significantly with the subject's participation in the study.