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Labeling for Approved Breast Implants

FDA Strengthens Breast Implant Safety Requirements and Updates Study Results

On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. 

First, the FDA issued 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. 

Second, the FDA approved new labeling for all legally marketed breast implants that includes:

  • Boxed warning. 
  • Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device.  The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
  • Updated silicone gel-filled breast implant rupture screening recommendations. 
  • Device description with a list of specific materials in the device.  
  • Patient device card.

The FDA expects manufacturers to post the updated device labeling to their websites within the next 30 days.

Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. For more information, see FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. 

Breast implant labeling is provided to ensure a patient receives and understands the benefits and risks of these devices. There is original labeling (at the time the FDA approved the implant) and current labeling that is updated with post approval study information and to adequately communicate the risks. The section below provides information and links to the original labeling and updated labeling for each approved breast implant. 

Updated Labeling to Improve Risk Communication

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.

Labeling to Communicate Long-Term Study Results

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 following section provides links to the approved labeling and the progress of expected labeling supplements.

Saline-Filled Breast Implants

Notes:

  • Updated labeling to communicate long-term study results may not be available for all implants in this table.
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 (P120011) Ideal Patient Labeling Patient Labeling
(2014) (PDF - 3.54MB)		 Physician Labeling 
(2014) (PDF - 683KB)		 SSED (PDF - 346KB) 5-Year Core Study Follow-Up
Mentor Saline Breast Implants (P990075) Mentor  Patient Labeling Patient Labeling
(2009) (PDF – 1.63MB)		 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
(2004) (PDF – 2.73MB)		 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.

Silicone Gel-Filled Breast Implants

  • Updated labeling to communicate long-term study results is pending for all implants in this table.
Breast Implant (Approval Number) Current Patient Labeling Labeling Summary of Safety and Effectiveness Data (SSED) Long-Term Study Data
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
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 (P070004) Sientra Patient Labeling Labeling
(2012)		 SSED (PDF – 1.16MB) 3-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.

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