Labeling for Approved Breast Implants
Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. Labeling may include patient brochures, instructions intended for physicians, and other written or printed materials accompanying the breast implant. There is both the original labeling at the time the FDA approved the breast implant and the current labeling, that is updated with post approval study information and to adequately communicate the risks.
The information below provides updates on the latest breast implant labeling. The tables include links to the original labeling and updated labeling for each approved breast implant.
On this page:
- FDA’s Guidance with Recommendations to Improve Risk Communication and Other Actions
- Approved Breast Implants Labeling, and Long-Term Study Results
FDA’s Guidance with Recommendations to Improve Risk Communication and Other Actions
The FDA issued final guidance, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication in September 2020. This final guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants. The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDA’s September 2020 guidance.
On October 27, 2021, the FDA took several actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. These actions include orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. These FDA requirements are described in detail at FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. In addition, the FDA regularly updates information on the status of breast implant manufacturers’ post-approval studies, at Post-Approval Studies (PAS) Database.
Approved Breast Implants, Labeling, and Long-Term Study Results
The tables below list all approved breast implants, the current patient labeling, original patient and physician labeling, and the Summary of Safety and Effectiveness Data (SSED). The SSED is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the Premarket Approval (PMA).
Breast implant manufacturers may need to update product labeling as the FDA learns new clinical information. This generally occurs at the end of the ten-year post approval follow-up period for patients that received the implant during investigational studies and when new post-approval studies are completed. The updated product labeling can be found under the “Current Patient Labeling” column.
Table 1: Approved Labeling for Saline-Filled Breast Implants
| Breast Implant (Approval Number) | Current Patient Labeling | Patient Labeling | Physician Labeling | Summary of Safety and Effectiveness Data (SSED) | Long-Term Study Data |
|---|---|---|---|---|---|
| IDEAL IMPLANT Saline Breast Implants (Now Puregraft Serene Breast Implant) (P120011) | Serene Saline Breast Implant | Patient Labeling (2014) (PDF - 3.54MB) | Physician Labeling (2014) (PDF - 683KB) | SSED (PDF - 346KB) | 10-Year Core Study Follow-Up |
| Mentor Saline Breast Implants (P990075) | Mentor Patient Labeling | Patient Labeling (2021) | Physician Labeling (2009) (PDF - 842KB) | SSED (PDF – 1.1MB) | 10-Year Core Study Follow-Up |
| Inamed (now Allergan*) Saline Breast Implants (P990074) | Allergan Patient Labeling | Patient Labeling (2021) (PDF – 1.54MB) | Physician Labeling (2005) (PDF – 1.88MB) | SSED (PDF – 263KB) | 10-Year Core Study Follow-Up |
* In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Smooth surfaced implants are not affected by this recall.
Table 2: Approved Labeling for Silicone Gel-Filled Breast Implants
| Breast Implant (Approval Number) | Current Patient Labeling | Labeling | Summary of Safety and Effectiveness Data (SSED) | Long-Term Study Data |
|---|---|---|---|---|
Motiva SmoothSilk Round Silicone Gel-Filled Breast Implants Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants (P230005) | Motiva Patient Labeling | Labeling (2024) | SSED (PDF 961KB) | 3-Year Core Study Follow-up |
| Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028) | Mentor Patient Labeling | Labeling (2013) | SSED (PDF - 522KB) | 10-Year Core Study Follow-Up |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053) | Mentor Patient Labeling | Labeling (2006) | SSED (PDF – 363KB) | 10-Year Core Study Follow-Up |
| Mentor MemoryGel Enhance Silicone Gel Breast Implants† (P030053/S069) | Coming soon | Coming soon | SSED‡ (PDF – 363KB) | 3-Year Core Study Follow-up |
| Allergan* Natrelle Silicone Gel-Filled Breast Implants (P020056) | Allergan Patient Labeling | Labeling (2006) | SSED (PDF – 263KB) | 10-Year Core Study Follow-Up |
| Allergan* Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046) | Allergan Patient Labeling | Labeling (2013) | SSED (PDF – 1.1MB) | 10-Year Core Study Follow-Up |
| Sientra OPUS Silicone Gel Breast Implants (Now owned by Tiger Aesthetics Medical) (P070004) | Sientra Patient Labeling | Labeling (2012) | SSED (PDF – 1.16MB) | 10-Year Core Study Follow-Up |
Notes:
- †The Mentor MemoryGel Enhance Silicone Gel-Filled Breast Implant was approved with the tradename MemoryGel Ultra High Profile - Extended Range (UH-R) Breast Implants.
- ‡For Mentor MemoryGel Enhance Silicone Gel-Filled Breast Implant, the FDA does not publish an SSED for this type of PMA Supplement (180 day Supplement). See Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process for more information.
- *In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Smooth surfaced implants are not affected by this recall.