The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) occasionally requires post-approval studies to help monitor the safety, effectiveness, and reliability of the approved device for its intended use. These studies are conducted under an FDA-approved protocol with the intended purpose of gathering specific additional information about the marketed device.

As a condition of gaining access to the approved silicone gel filled breast implants, the first 41,900 women will participate in the 10 year study. In addition, there will be a concurrent control group of 1000 women with saline filled breast implants to serve as concurrent controls for assessing rheumatologic and neurologic signs and symptoms. The study methods include a baseline questionnaire, a device tracking form, a visit at one year post-op, a visit at four to six years post-op, a visit nine to ten years post-op, and the questionnaire at the time of any participants discontinuation (when possible).

• Postoperative Complications
• Mammaplasty

MemoryGel Breast Implant Participants

Inclusion Criteria:

Must be a woman who

1. Is a candidate for breast augmentation with Mentor MemoryGel breast implants and is at least 22 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with Mentor MemoryGel breast implants.
2. Signs an Acknowledgement of Informed Decision from the patient brochure.
3. Signs an Informed Consent Form and an Authorization to Disclose Health Information and Release Medical Records.
4. Completes the baseline questionnaire (as evidenced by the participant's signature on the last page of the questionnaire).
5. Agrees to authorize return of the device(s) to Mentor if the device is explanted.
6. Agrees via Informed Consent to comply with the study follow-up, including full participation in all follow-up questionnaires and responding to questionnaires in their entirety.
7. Is a U.S. resident.

Exclusion Criteria:

1. Has active infection anywhere in her body
2. Has existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
3. Is currently pregnant or nursing

Saline Breast Implant Control Participants

Inclusion Criteria:

1. Is triggered as part of the selection process for concurrent controls
2. Is a candidate for breast augmentation and is at least 18 years old (primary or revision) OR is a candidate for breast reconstruction (primary or revision) with saline breast implants.
3. Signs an Informed Consent Form and an Authorization to Disclose Health Information and Release Medical Records.
4. Completes the baseline questionnaire (as evidenced by the participant's signature on the last page of the questionnaire).
5. Agrees to authorize return of the device(s) to Mentor if they are Mentor devices
6. Agrees via Informed Consent to comply with the study follow-up, including full participation in all follow-up questionnaires and responding to questionnaires in their entirety.
7. Is a U.S. resident.

Exclusion criteria:

1. Has current or past, unilateral or bilateral, silicone breast implants
2. Has active infection anywhere in her body
3. Has existing breast cancer or pre-cancer of the breast without adequate treatment for those conditions
4. Is currently pregnant or nursing