Inclusion Criteria:

A study patient may be included if she:

1. Has planned to undergo a unilateral or bilateral mastectomy and have small to medium
size breasts (<750gm excised tissue anticipated by the surgeon), with none or
moderate (Grade 1 or 2) ptosis, and healthy, sufficiently thick, well-vascularized
skin flaps anticipated by the surgeon.

2. Is a clinically suitable candidate for immediate reconstruction with ADM based single
stage reconstruction technique (as defined for use in the Experimental arm).

3. Is female, ≥18 years of age.

4. Is willing to undergo immediate breast reconstruction with sub-pectoralis muscle
placement of a breast implant by either the Experimental (ADM based single stage) or
the Control (TE/Implant based two stage) techniques.

5. Is in good health other than breast pathology and are suited to general anesthesia
and planned treatments.

6. Understands and is willing to follow all aspects of the study protocol including
randomization and has signed and dated the approved Informed Consent Form prior to
any study-related procedures being performed.

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 mastectomy, breast
biopsy, cyst removal, lumpectomy, mastopexy, reduction and/or augmentation.

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.