Trials / Completed
CompletedNCT00756652
Mentor MemoryGel Post-Approval Study
MemoryGel Silicone Gel-Filled Breast Implant Post-Approval Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 42,491 (actual)
- Sponsor
- Mentor Worldwide, LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional breast reconstruction surgery. This postapproval study is intended to satisfy one element of FDA's postapproval monitoring requirements. In January 2015, the FDA approved a protocol amendment that limits the scope of data collection for the study to the collection of only secondary procedure/reoperation data for MemoryGel participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mentor Silicone Gel-Filled Breast Implants | |
| DEVICE | Saline Breast Implants |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
- First posted
- 2008-09-22
- Last updated
- 2020-06-04
- Results posted
- 2020-06-04
Source: ClinicalTrials.gov record NCT00756652. Inclusion in this directory is not an endorsement.