Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

Following mastectomy, women may elect to have breast reconstruction with autologous tissue or
breast implants. Two-stage, tissue expander assisted breast reconstruction is one of the
common surgical methods that could be selected to reconstruct the breast. This method either
begins immediately after mastectomy (known as immediate breast reconstruction) or at some
time afterward (known as delayed breast reconstruction). Historically, surgeons placed a
tissue expander followed by the breast implant either completely or partially under the
pectoralis muscle. However, this method of breast reconstruction has been associated with
less favorable aesthetic outcomes.

Recently, surgeons started adding a surgical mesh derived from human cadaver skin during
breast reconstruction procedures. In summary, during the first stage of the breast
reconstruction, the plastic surgeon releases the pectoralis muscle from the chest wall. The
surgeon then attaches the surgical mesh to the pectoralis muscle and to the chest wall just
below the breast. This is done to create a pocket for the tissue expander. The tissue
expander is implanted in the pocket and partially inflated. The tissue expander is gradually
filled with saline over several weeks or months. Once the desired breast volume has been
achieved, the second stage of the reconstruction takes place. In the second stage, the tissue
expander is removed and replaced with a permanent saline or silicone gel breast implant.

Use of the human cadaver skin surgical mesh during breast reconstruction has been associated
with less pain, fewer tissue expansion visits and improved aesthetic outcomes. However, the
human cadaver skin surgical mesh adds significant cost to the procedure and some surgeons
have reported an increased rate of post-operative complications.

Over the last 10 years, a number of surgical mesh devices have been cleared by the U.S. Food
& Drug Administration (FDA) for the reinforcement and repair weak soft tissue or became
available as tissue grafts from human donors. Some surgeons have published their experience
with a number of these surgical mesh devices for breast reconstruction. However, at present,
no surgical mesh device is approved or cleared by the FDA for use in breast reconstruction.

The Meso BioMatrix device was recently cleared by the FDA for reinforcement and repair of
weak soft tissue. It is a surgical mesh device that is made from pig peritoneum, the tissue
that lines the abdominal cavity. The tissue is thoroughly cleaned and sterilized before use.
When implanted, the Meso BioMatrix device provides structural and mechanical support to weak
soft tissue during the healing process.

This clinical trial is a feasibility trial. A feasibility trial is a clinical trial in which
a device is being studied in a small group of people for a new use. Since the Meso BioMatrix
device is not cleared specifically for use in breast reconstruction, it is considered
investigational and must be studied in a controlled, step-wise series of clinical trials.
Therefore, the results of this trial, if successful, may be used to design a larger clinical
trial in the future.

Inclusion Criteria:

- Non-smoker

- Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast
reconstruction

- Life expectancy greater than 18 months

- Agreement to return for the trial required follow-up visits

Exclusion Criteria:

- Body mass index ≥ 35

- Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction
mammoplasty

- History of chronic corticosteroid use

- Type I Diabetes

- History of radiation therapy to the chest

- Pre-operative treatment with induction chemotherapy for breast cancer

- Pregnancy

- Participating in another investigational drug or device trial that has not completed
the follow-up period