On this page:
- The FDA’s Postmarket Evaluation of Breast Implants
- Warning Letters Issued to Breast Implant Manufacturers
- Ongoing Post-Approval Studies for Breast Implants
- Labeling for Approved Breast Implants
- Registries/Postmarket Surveillance on Breast Implants: Additional Resources
The FDA is continually evaluating the postmarket safety of approved breast implants and the compliance of breast implant manufacturers with the conditions of approval for each breast implant Premarket Approval (PMA).
The FDA’s postmarket review of breast implant safety and effectiveness includes:
- Providing input and guidance to manufacturers as they work to meet post-approval study enrollment, follow-up, and objectives.
- Communicating study status and findings to healthcare providers and patients to help inform them of risks associated with breast implants.
- Evaluating breast implant Medical Device Reports (MDRs), especially those related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Systemic Symptoms in Women with Breast Implants.
- Assessing all postmarket reporting requirements associated with the approved PMA, including manufacturing changes, design changes, and annual reports.
While the points above include overall postmarket evaluations of breast implants, the scope of this page is focused on the breast implant manufacturers’ postmarket expectations related to devices listed below.
When the FDA finds that a manufacturer has significantly violated the FDA’s regulations, the FDA notifies the manufacturer. This notification may be in the form of a Warning Letter. The FDA’s webpage About Warning and Close-Out Letters provides detailed information about the issuance of Warning Letters and the process for responding and closing out the Warning Letter.
|Company||Warning Letter Issued||Relevant Post-Approval Studies by PMA||Initial Response to Warning Letter||Warning Letter Closeout Date|
|Allergan Aesthetics (AbbVie)||05/14/2020||P020056 Natrelle Silicone-Filled Breast Implants P040046 Natrelle Highly Cohesive Silicone-Filled Breast Implants||06/02/2020||n/a|
|Ideal Implant Incorporated||05/14/2020||N/A (warning letter not related to a post-approval study)||06/06/2020||07/15/2020|
|Mentor Worldwide LLC (Johnson & Johnson)||03/18/2019||P030053 MemoryGel Silicone Gel-Filled Breast Implants P060028 MemoryShape Breast Implants||04/05/2019||n/a|
|Sientra, Inc.||03/18/2019||P070004 Sientra OPUS Silicone Gel Breast Implants||03/21/2019||n/a|
This table lists ongoing post-approval studies for breast implants, with links to the study information in the Post-Approval Studies (PAS) Database. For all post-approval studies associated with an implant, go to the PAS Database and search by approval number (application number).
|Breast Implant (Approval Number)||Ongoing Post-Approval Studies|
|Allergan* Natrelle Silicone Gel-Filled Breast Implants (P020056)|
|Allergan* Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046)|
|IDEAL IMPLANT Saline Breast Implants (P120011)|
|Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028)|
|Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053)|
|Sientra OPUS Silicone Gel Breast Implants (P070004)|