This page can be used as a resource to find FDA information in regards to your specific breast implant including: recalls, Premarket Approval Applications (PMAs), Approval Orders, Summary of Safety and Effectiveness documents, labeling pamphlets, PMA Supplements, post-approval studies, and more. If you would like to understand how to request specific documents from the FDA and do a FOIA request, please click on the link.
- Approval Orders provide details of the approval, including various post-approval requirements (such as the post-approval studies).
- Summaries of Safety and Effectiveness Documents (SSED) provide detailed information regarding the preclinical and clinical studies that were conducted by the manufacturer. These is also a list of all the heavy metals used in the manufacturing process and some of the other chemical constituents.
- PMA Supplements are each approved changes to the manufacturing process.
- We encourage you to read the post-approval studies for your breast implant.
“Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.” – FDA
The FDA classifies medical devices under three categories, of increasing order of risk – Class I, Class II, and Class III. Breast implants are Class III medical devices (as of 1988). They require premarket approval applications (PMA’s) and they require the manufacturer to conduct premarket and postmarket studies. It has been evidenced in the breast implant illness groups that there is a trend in premarket study enrollment of the patients but little to no follow-up. The post market approval studies have very low follow-up rates and bring up a serious concern to the alleged lack of safety.
If you were enrolled in a manufacturer breast implant study, please contact us at [email protected] along with the follow-up received.
Should you wish to read more on FDA medical device regulation and the basic regulatory requirements that manufacturers must comply, click here.
Current manufacturers of approved U.S. breast implants (4):
Allergan (formerly Inamed and McGhan), Mentor, Ideal, Sientra
(If you had McGhan, please note that McGhan changed it’s name to Inamed in 1986. Inamed was then acquired by Allergan in March 2006.)
Silicone Breast Implants:
There was a 14 year FDA ban from April 1992 – Nov. 2006.
The FDA refers to these as “silicone gel-filled breast prosthesis:”
A silicone gel-filled breast prosthesis has a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is filled with a fixed amount of silicone gel. Each implant has a patch that covers the manufacturing port of the implant. Silicone gel-filled implants may vary in shell surface (i.e., smooth vs. textured), shape, profile, volume, shell thickness, and number of shell lumens. Most silicone gel-filled implants are non-inflatable/non- adjustable and have shells made from a single or double lumen. However, a multi-lumen silicone gel-filled implant may be designed with a valve for intraoperative filling and postoperative volume adjustments with saline or with the a lumen filled with a fixed amount of saline.
This description on silicone implants is from the FDA ‘Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Final guidance for Industry’ (1999). Link.
The FDA has a Breast Implants page and a Silicone Breast Implants page with general information. In 2011, the FDA listed an Update on the Safety of Silicone Gel-Filled Breast Implants. Another good resource is **The FDA’s Regulation of Silicone Breast Implants, which covers serious safety, ethical, and other concerns as well as FDA delays and inactions and how implant patients are used as guinea pigs with Dow, McGhan, Mentor, and other silicone breast implants.
Currently approved U.S. silicone breast implant manufactures: Allergan, Mentor, and Sientra
Saline Breast Implants:
The FDA refers to these also as “silicone inflatable (saline-filled) breast prosthesis:”
A silicone inflatable (saline-filled) breast prosthesis has a silicone shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. Most of these are single lumen devices with a valve that is sealable by the surgeon or self-sealing for the purposes of filling the prosthesis. The implants have a patch that covers the manufacturing port of the prosthesis. There are two types of saline-filled implants. One type is a fixed volume implant, which is filled with the entire volume of saline at implantation. Another type is an adjustable volume implant, which is filled intraoperatively and has the potential for further postoperative adjustment. Saline-filled implants vary in shell surface (i.e., smooth vs. textured), shape,profile, volume, and shell thickness.
The sterile saline used as a filler material should conform to United States Pharmacopeia (LISP) standards of Normal Physiological Saline (injection grade) which has a concentration of 0.15M and a pH of 7.2-7.4
This description on saline implants is from the FDA ‘Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Final guidance for Industry’ (1999). Link.
According to the FDA Office of Device Evaluation (ODE), the office responsible for conducting medical device evaluations and clearance for clinical trials and marketing, the following is what is in a saline-filled breast implant shell:
- 80% high molecular weight silicones
- 20% finely powdered silica (aka silicon dioxide)
- Catalyst of a tin or platinum
- Impurities: smaller silicones, volatile (readily evaporating) materials like xylene and other chemicals, and other heavy metals.
Currently approved U.S. saline breast implant manufactures: Allergan, Mentor, and Ideal
The Recall, Market Withdrawals, & Safety Alerts webpage provides a listing of information gathered from press releases and other public notices about certain recalls of FDA regulated products. Not all recalls have press releases or are posted on this page.
Additionally, the Medical Device Recalls webpage provides a means to search for recalls of medical devices. You can conduct a search using various search criteria, including product name, firm, or reason for recall, among others; however, there is not a means to search by product type (or, product code). The easiest way is to just input the manufacturer name in ‘Product Name,’ such as Mentor or Allergan, and press search.
Report Symptoms to FDA MedWatch:
If you have symptoms of breast implant illness, please report them all to the FDA through the MedWatch Online Voluntary Reporting Form. When you click on the link, on the right side under “Begin Report As” click on “Consumer/Patient.”
The reports can be searched in the MAUDE Database. Please note that some information is redacted by the FDA to maintain privacy in the public searches but will be retained in the FDA’s internal database.