FDA Restricts Breast Implant Sales and Requires a Boxed Warning and Patient Checklist (2021)

On October 27, 2021, the U.S. Food and Drug Administration (FDA) issued orders restricting the sale and distribution of breast implants to health care providers and facilities that go over the risks and benefits with each patient before surgery. On the same day it approved new labeling for every legally marketed breast implant in the United States, including a boxed warning, a patient decision checklist that the patient may initial and sign and the implanting physician must sign, updated rupture-screening recommendations for silicone gel-filled implants, a list of the materials in the device, and a patient device card. The cancer most closely tied to implants is described on the site’s Lymphoma page.

This page reports what the FDA’s own documents say: what the agency did, how the sales restriction works, what the new labeling contains, the 2020 guidance it came from, the risks the FDA lists, what the action does not do, its status as of October 18, 2026, and how it fits earlier and later FDA breast implant actions. No implant maker or product line is named here.

Table of Contents

  1. What the FDA Did on October 27, 2021
  2. The Restriction on Sale and Distribution
  3. The New Labeling: Boxed Warning, Checklist and Device Card
  4. Rupture Screening and the List of Materials
  5. Post-Approval Studies
  6. Background: The September 2020 Labeling Guidance
  7. The Risks the FDA Lists
  8. What the Action Does Not Do
  9. Dates and Legal Status as of October 18, 2026
  10. How It Fits Earlier and Later FDA Breast Implant Actions
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the FDA Did on October 27, 2021

The FDA’s program page “Things to Consider Before Getting Breast Implants” states that on October 27, 2021, the agency “took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.” The page lists three of them:

  1. Orders restricting sale and distribution. 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.”
  2. New labeling for every implant. The FDA “approved new labeling for all legally marketed breast implants,” with a boxed warning, a patient decision checklist, updated rupture-screening recommendations for silicone gel-filled implants, a device description listing specific materials, and a patient device card.
  3. Updated study information. The FDA “released updated information on the status of breast implant manufacturer post-approval studies.”

The same page adds that “The breast implant manufacturers have posted the updated device labeling to their websites.”

The FDA describes breast implants as medical devices placed under the breast tissue or chest muscle to increase breast size (augmentation), to replace breast tissue removed because of cancer or trauma, or tissue that failed to develop properly (reconstruction), and in revision surgeries that correct or improve the result of an earlier operation. Two types are approved for sale in the United States: saline-filled and silicone gel-filled, both with a silicone outer shell.

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2. The Restriction on Sale and Distribution

The FDA states the restriction in one sentence: “The sale and distribution of breast implants are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in approved labeling provided by each manufacturer.”

The FDA’s consumer update “What to Know About Breast Implants” puts the same rule in plainer terms: the FDA “restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient decision checklist.”

The restriction was not published as a regulation. The FDA’s Breast Implants program page explains that “The restrictions on sale and distribution are included in the Post-Market Approval (PMA) Supplement Approval letter for these implants,” and lists seven approved saline and silicone gel-filled implant lines from several makers. Breast implants reach the U.S. market through premarket approval (PMA), the FDA’s review for higher-risk devices; a PMA supplement is a later request to change an approved device or its labeling, and the approval letter for that supplement sets the conditions the maker must follow. A search of the Federal Register, the U.S. government’s daily publication of rules and official notices, found no rule or notice on the 2021 restrictions.

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3. The New Labeling: Boxed Warning, Checklist and Device Card

The FDA’s documents describe the parts of the labeling approved on October 27, 2021:

The consumer update explains the purpose of the requirement: the FDA “requires that all FDA-approved breast implants include labeling with easy-to-understand information about the benefits and risks associated with the product,” and the requirement “is intended to enhance the discussions patients have with their doctor about the benefits and risks of implants.”

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4. Rupture Screening and the List of Materials

A rupture is, in the FDA’s words, “a tear or hole in the implant’s outer shell.” The FDA’s Risks and Complications page explains why silicone gel-filled implants need screening: when one ruptures, “it is not likely that you or your doctor will immediately notice because most silicone implant ruptures are without symptoms, known as ‘silent ruptures.’” A silent rupture usually does not change how an implant looks or feels and may not be found by a physical examination alone. A saline-filled implant that ruptures deflates, so the change in size or shape is noticeable.

The 2021 labeling carried updated rupture-screening recommendations for silicone gel-filled implants. The FDA’s current risks page, updated December 14, 2023, states that magnetic resonance imaging (MRI) “is the most effective method for detecting silent rupture of silicone gel-filled breast implants” and that “An ultrasound is an acceptable alternative imaging for screening for rupture for asymptomatic patients.” The FDA notes that the December 2023 update added the ultrasound option. The consumer update reports that “The FDA recommends that patients with silicone implants get regular screenings to detect silent ruptures,” and the “Things to Consider” page notes that such MRI or ultrasound exams may not be covered by insurance.

The device description lists specific materials in each implant. The FDA’s summary of the 2020 guidance behind it (section 6) says the materials description covers “types and quantities of chemicals and heavy metals found in or released by breast implants.” The FDA also points readers to each implant’s Summary of Safety and Effectiveness Data (SSED), which it describes as “an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative,” behind the approval decision.

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5. Post-Approval Studies

A post-approval study is a study the FDA requires a maker to carry out after a device is approved, to follow patients over time. The third part of the October 27, 2021 actions was updated information on the status of these studies for breast implants. (The 2021 study figures themselves are not given here, because the FDA document that reported them could not be read.)

The FDA’s Breast Implant Postmarket Safety Information page says the agency “is continually evaluating the postmarket safety of approved breast implants and the compliance of breast implant manufacturers with the conditions of approval.” It lists what that review includes: guiding makers on study enrollment, follow-up and objectives; “Communicating study status and findings to healthcare providers and patients”; evaluating medical device reports, especially those on breast implant-associated anaplastic large cell lymphoma and on systemic symptoms; and assessing every postmarket reporting requirement attached to an approval. The page lists the ongoing studies for each approved implant and the warning letters the FDA issued to breast implant makers in March 2019 and May 2020. The FDA’s labeling page adds that makers “may need to update product labeling as the FDA learns new clinical information,” generally at the end of the ten-year follow-up of patients from the original studies and when new post-approval studies are completed.

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6. Background: The September 2020 Labeling Guidance

The 2021 labeling did not come out of nowhere. The FDA’s Breast Implants page states: “The new labeling approved on October 27, 2021 follows from the labeling recommendations described in the FDA’s September 2020 guidance,” titled Breast Implants – Certain Labeling Recommendations to Improve Patient Communication. A guidance document sets out the FDA’s current thinking on a topic; it does not by itself create legal requirements. The 2021 approvals and orders are what made the labeling mandatory for each implant.

The FDA summarizes the guidance as providing recommendations on “the content and format for certain labeling information for saline and silicone gel-filled breast implants,” including:

The FDA adds that these recommendations supplement its separate guidance on Saline, Silicone Gel, and Alternative Breast Implants, “issued September 29, 2020, superseding the prior version dated November 17, 2006.” The public file for the labeling guidance is Federal Register docket FDA-2019-D-4467 on regulations.gov; a docket is the public file where an action’s documents and public comments are kept.

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7. The Risks the FDA Lists

The checklist and boxed warning exist to put the risks in front of patients. The FDA’s own pages list these points, reported here as the FDA states them:

The FDA’s page on medical device reports of BIA-ALCL states that the agency first identified a possible association between breast implants and anaplastic large cell lymphoma in 2011, and that since then it has received 1,380 medical device reports of BIA-ALCL from the United States and other countries; its table counts 64 deaths as of June 30, 2024. The FDA cautions that these reports have limits, including the lack of information about how many patients have breast implants, so they are only one of its sources of safety information. The consumer update also notes that a mammography facility can be told in advance that a patient has implants. These are the FDA’s statements; decisions about any implant belong with a clinician.

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8. What the Action Does Not Do

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9. Dates and Legal Status as of October 18, 2026

Status as of October 18, 2026: in effect. The FDA’s program pages, updated as late as February 2025, still describe the sale and distribution restrictions and the required labeling as current. A check of the Federal Register from 2022 through October 18, 2026 found no FDA document that changes, stays or withdraws the 2021 restrictions or labeling; the later breast implant items found there concern a classification of a different device and advisory panel meetings.

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10. How It Fits Earlier and Later FDA Breast Implant Actions

The FDA’s pages list a sequence of breast implant steps around the 2021 action:

Boxed warnings were also a theme of other 2021 FDA actions: the JAK inhibitor boxed warnings came the same year. Other device and imaging actions on the site include the 2023 breast density notification rule for mammography reports and the 2022 over-the-counter hearing aid rule. Among products used on the body, the 2021 actions on talc cosmetics testing, lead acetate in hair dye and sunscreens have their own pages.

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11. Primary Documents

  1. U.S. Food and Drug Administration. Things to Consider Before Getting Breast Implants (section “FDA Strengthens Breast Implant Safety Requirements and Updates Study Results”). Program page, content current as of March 8, 2023 — fda.gov Things to Consider page
  2. U.S. Food and Drug Administration. Breast Implants (sections on the October 27, 2021 actions, guidances, and restrictions on sale and distribution). Program page, content current as of December 15, 2023 — fda.gov Breast Implants page
  3. U.S. Food and Drug Administration. Labeling for Approved Breast Implants. Program page, content current as of February 6, 2025 — fda.gov labeling page
  4. U.S. Food and Drug Administration. What to Know About Breast Implants. Consumer Update, content current as of January 31, 2025 — fda.gov consumer update
  5. U.S. Food and Drug Administration. Risks and Complications of Breast Implants. Program page, updated December 14, 2023 — fda.gov risks page
  6. U.S. Food and Drug Administration. Breast Implant Postmarket Safety Information. Program page, content current as of February 6, 2025 — fda.gov postmarket page
  7. U.S. Food and Drug Administration. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma. Content current as of February 6, 2025 — fda.gov BIA-ALCL reports page
  8. U.S. Food and Drug Administration. Breast Implants – Certain Labeling Recommendations to Improve Patient Communication. Guidance for Industry and FDA Staff, September 2020 (listed on the FDA guidance-documents site; the address is not linked here). Public docket FDA-2019-D-4467 — regulations.gov FDA-2019-D-4467
  9. U.S. Food and Drug Administration. FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants. News release, October 27, 2021 (retired to the FDA’s archive; not read for this page).

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Key Research Papers

  1. Hyland CJ, Gadiraju G, Parikh N, Dey T, Broyles JM (2022). Public Perceptions of Breast Implant Complications and the FDA Boxed Warning on Implants. Plastic and Reconstructive Surgery Global Open 10(11):e4439 — PubMed PMID: 36381489
  2. Villanueva K, Gupta N, Alnaseri T, Da Lio AL, Roostaeian J, DeLong M (2024). Plastic Surgeons’ Perspective on the FDA Breast Implant Regulatory Mandates. Aesthetic Surgery Journal 44(10):NP676-NP683 — PubMed PMID: 38696656
  3. Le-Petross HT, Scoggins ME, Clemens MW (2023). Assessment, Complications, and Surveillance of Breast Implants: Making Sense of 2022 FDA Breast Implant Guidance. Journal of Breast Imaging 5(3):360-372 — PubMed PMID: 38416893
  4. Coroneos CJ, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW (2019). US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Annals of Surgery 269(1):30-36 — PubMed PMID: 30222598
  5. Nelson JA, Dabic S, Mehrara BJ, Cordeiro PG, Disa JJ, Pusic AL, Matros E, Dayan JH, Allen RJ Jr, Coriddi M, Polanco TO, Shamsunder MG, Wiser I, Morrow M, Dogan A, Cavalli MR, Encarnacion E, Lee ME, McCarthy CM (2020). Breast Implant-associated Anaplastic Large Cell Lymphoma Incidence: Determining an Accurate Risk. Annals of Surgery 272(3):403-409 — PubMed PMID: 32694446
  6. Santanelli di Pompeo F, Clemens MW, Paolini G, Firmani G, Panagiotakos D, Sorotos M (2023). Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in the United States: A Systematic Review. Aesthetic Surgery Journal 44(1):NP32-NP40 — PubMed PMID: 37616552
  7. Cohen Tervaert JW, Mohazab N, Redmond D, van Eeden C, Osman M (2022). Breast implant illness: scientific evidence of its existence. Expert Review of Clinical Immunology 18(1):15-29 — PubMed PMID: 34882509

The first two papers study how the public and plastic surgeons view the FDA’s boxed warning and the 2021 regulatory requirements. The third reviews implant assessment and surveillance in light of the FDA’s guidance. The fourth reports long-term outcomes from the FDA-required post-approval studies. The fifth and sixth estimate how often BIA-ALCL occurs, and the seventh is a review of the evidence on breast implant illness.

PubMed Topic Searches

  1. PubMed: breast implant boxed warning
  2. PubMed: breast implant-associated anaplastic large cell lymphoma
  3. PubMed: breast implant illness
  4. PubMed: silicone breast implant rupture screening

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Connections

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