Memory Gel and Shape Combined Cohort

The post-approval study will include 2518 women undergoing breast augmentation or
reconstruction with MemoryShape or MemoryGel Breast Implants. Four cohorts will be included:
primary augmentation, revision-augmentation, primary reconstruction, and
revision-reconstruction. For the purpose of assessing rheumatological and neurological signs
and symptoms, a control group of 300 women will be selected from the participating
investigators' practices, who are undergoing an aesthetic surgery other than breast implant
surgery. Breast implant patients and the concurrent control group patients will be followed
for 10 years. Baseline and operative data will be collected at the beginning of the study,
and follow-up data will be collected annually for 10 years through online questionnaires.

Inclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

1. Is a candidate for breast augmentation with MemoryShape or MemoryGel Breast Implants
and is at least 22 years old (primary or revision) OR is a candidate for breast
reconstruction (primary or revision) with MemoryShape or MemoryGel Breast Implants and
is at least 18 years old;

2. Signs an Acknowledgement of Informed Decision from the patient brochure;

3. Signs an Informed Consent Form, including an Authorization to Disclose Health
Information and Release Medical Records;

4. Agrees to answer baseline questions;

5. Agrees to authorize return of the device(s) to Mentor if the device is explanted;

6. Agrees via Informed Consent to comply with study follow-up, including following the
surgeon's standard of care for office visits and responding to questionnaires in their
entirety; and

7. Has a valid e-mail address and access to the internet to complete online
questionnaires.

Exclusion Criteria MemoryShape and MemoryGel Breast Implant Patients:

1. Has active infection anywhere in her body;

2. For augmentation patients, has a history of cancer of any kind, except non-melanoma
skin cancer; for reconstruction patients, has a history of cancer of any kind, except
non melanoma skin cancer or adequately treated breast cancer;

3. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is
currently being evaluated for symptoms suggestive of connective tissue disease or
neurological disease;

4. Is currently pregnant or nursing;

5. Is planning on undergoing or has undergone bariatric surgery; or

6. Is planning on undergoing experimental procedures or procedures with investigational
products/devices during the study period that in the opinion of the investigator could
compromise the results of this study.

Inclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

1. Is a candidate for aesthetic surgery (for example, liposuction, rhinoplasty, brow
lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty;
may not include silicone implants) and is at least 22 years of age;

2. Signs an Informed Consent Form, including an Authorization to Disclose Health
Information and Release Medical Records;

3. Agrees to answer baseline questions;

4. Agrees via Informed Consent to comply with study follow-up, including responding to
questionnaires in their entirety; and

5. Has a valid e-mail address and access to the internet to complete online
questionnaires.

Exclusion Criteria Concurrent Control Group (Other Aesthetic Surgery) Patients:

1. Has ever had unilateral or bilateral breast implants (including breast tissue
expanders);

2. Expects to undergo breast implant surgery during the study period;

3. Has ever had silicone implants anywhere in her body;

4. Has active infection anywhere in her body;

5. Has a history of cancer of any kind, except non-melanoma skin cancer;

6. Has a confirmed diagnosis of connective tissue disease or neurological disease OR is
currently being evaluated for symptoms suggestive of connective tissue disease or
neurological disease;

7. Is currently pregnant or nursing;

8. Is planning on undergoing or has undergone bariatric surgery; or

9. Is planning on undergoing experimental procedures or procedures with investigational
products/devices during the study period that in the opinion of the investigator could
compromise the results of this study.