Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction

This is a prospective, single-site pilot study in which outcomes associated with the use of
Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in
post-mastectomy breast reconstruction will be obtained. The data collected will include
reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to
ascertain advantages and disadvantages of using this particular HADM in post-mastectomy
breast reconstruction.

Inclusion Criteria:

- Scheduled to undergo a single or two-stage, tissue-assisted, implant breast
reconstruction

- Mastectomy may be unilateral or bilateral, prophylactic or therapeutic

- Skin incision may be skin sparing, or nipple-areolar sparing

- Have signed written, informed consent

- Be at least 18 years of age

Exclusion Criteria:

- Patients undergoing autologous breast reconstruction

- Patients undergoing breast reconstruction following complications of breast
augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)

- Patients undergoing reconstruction after previously failed attempts at reconstruction

- Patients undergoing autologous breast reconstruction in conjunction with a tissue
expander (such as a latissimus dorsi flap, DIEP flap)

- There will be no exclusions based on race or ethnicity

- BMI > 40

- Previous Radiation Treatment. Note: Post-operative radiation treatment does not
exclude subjects from study continuation once enrolled.