FDA
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. Specific requests for documents from the FDA can made through FOIA.
- Approval Orders provide details of the approval, including various post-approval requirements (such as 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 also include a list of 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.
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, Mentor, Ideal, and Sientra. Allergan was formerly Inamed and McGhan. History: McGhan changed it’s name to Inamed in 1986 and was acquired by Allergan in March 2006.
Updates:
1. FDA has issued warning letters to all four breast implant manufacturers:
“The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable. … Allergan’s failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s premarket approval order.” – FDA
2. October 2019, FDA released a statement on enhancing breast implant labeling recommendations including: a black box warning, patient-decision checklist, product ingredient information including types and quantities of chemicals and heavy metals, silicone gel-filled breast implant rupture screening recommendations, and updated patient device card. A draft guidance was issued and was open to public comment until December 23, 2019.
3. FDA requests Allergan to recall its textured breast implants from the US market. Allergan responds with a global recall of silicone and saline textured breast implants and tissue expanders. This comes after more cases of BIA-ALCL have been reported. See FDA News Release. FDA Medical Device Reports of BIA-ALCL, and NCHR. (July 2019)
Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
4. FDA issues a safety statement in response to the FDA Meeting held in March 2019: Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants (May 2019)
While the FDA doesn’t have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed, referred to by some patients and health care professionals as breast implant illness.
We believe women considering a breast implant should be aware of these risks. As we describe below, we are taking steps to better characterize the condition and its risk factors, and are considering ways to help to ensure women have all of the information they need to make informed decisions about whether to obtain breast implants or to remove existing breast implants in an effort to reverse systemic symptoms.
5. FDA Issues Warnings to Mentor and Sientra (March 2019)
“We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies.” – FDA Commissioner Scott Gottlieb, M.D.
“Mentor [and Sientra’s] failure to address these concerns and comply with its post-approval study requirements is a violation of the firm’s pre-market approval order.”
6. The FDA officially added “Systemic Symptoms (Breast Implant Illness (BII))” to their Risks of Breast Implants (March 2019)
7. FDA 2019 BIA-ALCL Updated Information:
- BIA-ALCL Letter to Healthcare Providers (2/6/19)
- FDA Summary of Raw MDR Data Received as of September 30, 2018 (2/6/19)
- Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants (2/6/19)
8. FDA launched the National Breast Implant Registry (NBIR) (September 2018)
FDA Breast Implant Meetings:
Growing numbers in the Facebook breast implant illness groups (70,000+ women) and a Petition to Request a FDA Hearing led to a new beginning of FDA meetings on breast implant concerns being reviewed. In September 2018, a closed meeting was held between the FDA and breast implant illness advocates. On March 25-26th, 2019, an open FDA Public Advisory Committee Meeting was held.
FDA Meeting March 25-26, 2019:
Agenda: On March 25 and 26, 2019, the [Medical Devices Advisory] committee discussed and made recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction concerning the following topics:
(1) breast implant associated anaplastic large cell lymphoma (BIA-ALCL);
(2) systemic symptoms reported in patients receiving breast implants;
(3) the use of registries for breast implant surveillance;
(4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants;
(5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy;
(6) the use of real-world data and patient perspectives in regulatory decision making, and
(7) best practices for informed consent discussions between patients and clinicians.
Links:
Meeting Materials, Schedule, and Roster
FDA Public Advisory Committee Meeting Information for the Public
Docket Folder ID: FDA-2019-N-0426 with open comments from the public that closed on April 26th, 2019
Webcasting:
March 25th, 2019 (DAY 1) | March 26th 2019 (DAY 2)
See “FDA Breast Implant hearing – A Consumer Representative Perspective” a blog written by Rachel Brummert.
Silicone Breast Implants:
There was a 14 year FDA ban from April 1992 – November 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).
See FDA Breast Implants and FDA Silicone Breast Implants for 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.
On March 19th, 2019, the FDA released ‘FDA issues warning letters to two breast implant manufacturers [Mentor and Sientra] for failure to comply with post-approval study requirements.’
Currently approved U.S. silicone breast implant manufactures: Allergan, Mentor, and Sientra
Allergan:
1. Allergan Natrelle Silicone & Allergan Silicone Timeline
2. Allergan Natrelle 410 Cohesive Anatomical Silicone & Allergan Silicone Timeline
Mentor:
FDA’s warning letter to Mentor Worldwide LLC (Mentor) (3/18/19)
1. Mentor MemoryGel Silicone & Mentor Silicone Timeline
2. Mentor MemoryShape Silicone & Mentor Silicone Timeline
Sientra:
FDA’s warning letter to Sientra (3/18/19)
1. Sientra Silicone & FDA Timeline
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).
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.
See FDA Breast Implants and FDA Saline Breast Implants for general information.
Currently approved U.S. saline breast implant manufactures: Allergan, Mentor, and Ideal
Allergan Natrelle Saline & Saline Timeline
Mentor Saline & Saline Timeline
Ideal Saline & Saline Timeline
BIA-ALCL:
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a cancer of the immune system caused by breast implants and predominately linked with textured implants.
In 2011 the FDA “identified the possible association between breast implants and the development of anapestic large cell lymphoma (ALCL).”
In March 2017, the FDA issued an update confirming that breast implants cause ALCL cancer and that data suggested a higher risk of it occurring with textured breast implants. For more information see the FDA’s Questions and Answers about Breast Implant-Assoicated Anapestic Large Cell Lymphoma (BIA-ALCL) and this website’s BIA-ALCL page.
As of February 8, 2019, the FDA “estimates that BIA-ALCL may develop in 1 in between 3,817 to 30,000 women with textured breast implants.” See Updates above for more FDA BIA-ALCL news.
Recalls:
Recall, Market Withdrawals, & Safety Alerts 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.
As of September 2018, the FDA has newly launched the National Breast Implant Registry (NBIR), where data is entered by plastic surgeons.
BIA-ALCL cases can be reported by patients to MedWatch and by physicians to PROFILE (BIA-ALCL Registry).