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  1. Breast Implants

Breast Implant Postmarket Safety Information

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The FDA’s Postmarket Evaluation of Breast Implants

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.

Warning Letters Issued to Breast Implant Manufacturers

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

Ongoing Post-Approval Studies for Breast Implants

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  (Now Bimini Health Tech) 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)
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