Prospective Comparison of Methods to Process Autologous Fat Grafts in Breast Reconstruction

Study Groups:

If participant is found to be eligible to take part in this study, participant will be
randomly assigned (as in the roll of the dice) to 1 of 2 study groups. This is done because
no one knows if one study group is better, the same, or worse than the other group.

- If participant is in Group 1, participant's tissue will be processed by REVOLVE™. In
this method, the tissue is washed with a medical solution and spun at low speed to
filter the tissue and separate the fat tissue from other fluid before it is
transplanted.

- If participant is in Group 2, participant's tissue will be processed by PureGraftTM.
This process uses a system of filters to wash fatty tissue with a medical solution and
separate fat tissue from other fluid before it is transplanted.

Participant has an equal chance (50/50) of being assigned to either group. Both participant
and the study doctor will know to which group participant has been assigned.

Surgery:

After participant has been assigned to a study group, participant will be scheduled for
reconstructive surgery as part of participant's standard care. Participant will sign a
separate consent that explains the surgery in more detail, including its risks.

During participant's surgery, a member of the study staff will watch the surgeon and the
surgical staff as they perform the surgery. They will record the amount of fat that was used
in each step during the surgery.

After the fatty tissue is removed, it will be processed according to the group participant
has been assigned and placed back into participant's body during reconstructive surgery.

During the surgery, participant's surgeon may decide to use a different tissue processing
method than what participant was originally assigned. If this happens, participant will still
be able to take part in this study and participant's surgery will be performed in the
standard way.

Follow-up:

After participant's surgery, participant will have follow-up visits as part of participant's
standard care at about 2-4 weeks, 3 and 6 months, and then 1 time each year for up to 3 years
after participant's surgery. At each visit:

- Photographs will be taken and compared to the pre-operative photographs to learn if the
amount of fat in the reconstruction has changed over time.

- Participant will complete a questionnaire about participant's level of satisfaction with
participant's reconstruction and a survey about participant's level of satisfaction with
participant's appearance and body changes resulting from participant's cancer treatment.
This should take about 10-12 minutes to complete both.

Participant may also have imaging scans, an ultrasound, and/or a mammogram, performed as part
of participant's standard care. If these scans are performed, the results will be collected
from participant's medical record. Any photographs taken throughout participant's
participation may possibly be used for future research.

Length of Participation:

Participation on this study will be over after participant completes 3 years of follow-up
visits.

Inclusion Criteria:

1. Female

2. Previous breast surgery, either mastectomy or partial mastectomy

3. Age equal or greater than 18 years old

4. Patients with available harvest sites for fat grafting

5. Patients with BMI > 20

6. Anticipated harvested fat volume > 100 cc

7. Patients are willing and able to give consent

Exclusion Criteria:

1. Patients with active cancer, including primary cancer, recurrent cancer and locally or
distantly metastatic cancer.

2. Patients who are unable to provide consent.

3. Patients who are suspected or known to be pregnant.