{"generated":"2026-10-19","source":"U.S. Food and Drug Administration (FDA)","sourceUrl":"https://www.fda.gov/","about":"FDA regulatory, safety and consumer information related to breast enlargement, breast augmentation, breast implants and injectable fillers promoted for breast enlargement.","categories":[{"id":"implants-regulation","name":"Breast implants — regulation and approval","description":"How the FDA regulates saline and silicone gel-filled breast implants, which uses are approved, labeling requirements and restrictions on sale."},{"id":"implants-safety","name":"Breast implants — safety and complications","description":"Known risks, complications, rupture screening, revision surgery, monitoring and long-term follow-up for breast implants."},{"id":"cancers","name":"BIA-ALCL and other cancers","description":"Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), squamous cell carcinoma and other lymphomas reported in the capsule around implants."},{"id":"fillers","name":"Dermal fillers and injectable silicone","description":"Approved and unapproved uses of dermal fillers, the FDA position on fillers for breast enlargement, and warnings about injectable silicone."},{"id":"consumer","name":"Consumer guidance and reporting","description":"Patient-facing advice, decision checklists and how to report adverse events or suspected illegal products."}],"documents":[{"id":"breast-implants-hub","title":"Breast Implants","category":"implants-regulation","kind":"Regulatory hub","url":"https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants","updated":"2023-12-15","summary":"The FDA's central breast implant resource. It explains that implants are medical devices placed under breast tissue or chest muscle to increase breast size (augmentation) or to replace tissue removed by cancer or trauma, and links to approvals, labeling, risks, safety communications and post-approval studies.","keyPoints":["Two implant types are approved for sale in the United States: saline-filled and silicone gel-filled. Both have a silicone outer shell.","Implants vary in size, shell thickness, surface texture and shape.","The FDA provides this information to support, not replace, the discussion between a patient and a physician.","Patients are encouraged to report adverse events through MedWatch."]},{"id":"types-of-implants","title":"Types of Breast Implants","category":"implants-regulation","kind":"Regulatory page","url":"https://www.fda.gov/medical-devices/breast-implants/types-breast-implants","updated":"2019-10-23","summary":"Describes saline-filled and silicone gel-filled implants, their approved age groups, and the role of breast tissue expanders in reconstruction.","keyPoints":["Saline-filled implants are approved for breast augmentation in women aged 18 or older and for reconstruction at any age.","Silicone gel-filled implants are approved for breast augmentation in women aged 22 or older and for reconstruction at any age.","Breast implants are not lifetime devices; the longer they are in place, the more likely removal or replacement becomes.","The most frequent complications are capsular contracture, reoperation and implant removal, with or without replacement.","MRI remains the most effective method for detecting silent rupture; ultrasound is an acceptable alternative for screening asymptomatic patients."]},{"id":"risks-complications","title":"Risks and Complications of Breast Implants","category":"implants-safety","kind":"Regulatory page","url":"https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants","updated":"2023-12-15","summary":"A detailed list of local complications and adverse outcomes reported in at least one percent of breast implant patients, plus sections on reoperation, removal, capsular contracture, rupture, BIA-ALCL, systemic symptoms, breastfeeding and effects on children.","keyPoints":["Listed complications include asymmetry, breast pain, capsular contracture, deflation, delayed wound healing, extrusion, hematoma, infection, malposition, necrosis, sensation changes, rupture, seroma, wrinkling and unsatisfactory size or style.","Capsular contracture is graded I–IV using the Baker scale; grades III and IV are considered severe and may need reoperation.","Silicone gel ruptures are often silent; MRI is the most effective detection method and ultrasound is an acceptable alternative for asymptomatic screening.","The FDA has not detected an association between silicone gel-filled implants and connective tissue disease, breast cancer or reproductive problems, but notes that larger and longer studies would be needed to rule these out.","Some patients report systemic symptoms grouped under the term breast implant illness (BII); causes are poorly understood.","Some women can breastfeed after augmentation and some cannot; implant removal without replacement can leave dimpling, concavity, puckering or sagging."]},{"id":"things-to-consider","title":"Things to Consider Before Getting Breast Implants","category":"implants-safety","kind":"Patient decision guide","url":"https://www.fda.gov/medical-devices/breast-implants/things-consider-getting-breast-implants","updated":"2023-03-08","summary":"The FDA's pre-surgery checklist covering informed consent, reoperation, monitoring, BIA-ALCL, BII, surgical mesh and the information patients should discuss with their surgeon.","keyPoints":["Patients should assume additional surgery may be needed because implants are not lifetime devices and complications can occur.","Implant removal or replacement may not be covered by insurance, even when a complication occurs.","The most common local complications are capsular contracture, reoperation and implant removal; others include rupture or deflation, wrinkling, asymmetry, scarring, pain and infection.","BIA-ALCL is a cancer of the immune system, not breast cancer; it is treatable but can be fatal, and treatment usually involves removing the implant and capsule.","Surgical mesh used in breast implant surgery has not been approved by the FDA for that use.","Silicone implants may require regular MRI or ultrasound screening for silent rupture, which may not be covered by insurance."]},{"id":"breast-implant-surgery","title":"Breast Implant Surgery","category":"implants-safety","kind":"Regulatory page","url":"https://www.fda.gov/medical-devices/breast-implants/breast-implant-surgery","updated":"2023-08-03","summary":"Explains where breast implant surgery can be performed, the FDA position on surgical mesh, and questions patients should ask their surgeon.","keyPoints":["Breast implant surgery can be performed in a hospital or a surgery centre.","The FDA has not cleared or approved any surgical mesh for use with breast implants or in breast reconstruction.","Patients are advised to discuss the benefits and risks of mesh with their health care provider."]},{"id":"labeling-guidance","title":"Breast Implants — Certain Labeling Recommendations to Improve Patient Communication","category":"implants-regulation","kind":"FDA guidance (2020)","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breast-implants-certain-labeling-recommendations-improve-patient-communication","updated":"2020-09-29","summary":"Final guidance recommending content and format for breast implant labeling, including a boxed warning, patient decision checklist, device description and rupture screening recommendations.","keyPoints":["Labeling should include a boxed warning and a patient decision checklist.","Materials and device descriptions should list the types and quantities of chemicals and heavy metals found in or released by the implant.","The guidance underpins the new labeling approved on 27 October 2021.","The recommendations supplement the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance."]},{"id":"saline-silicone-guidance","title":"Saline, Silicone Gel, and Alternative Breast Implants","category":"implants-regulation","kind":"FDA guidance (2020)","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants","updated":"2020-09-29","summary":"Guidance covering the information manufacturers should provide for saline, silicone gel and alternative breast implants, superseding the 2006 version.","keyPoints":["Applies to saline, silicone gel and alternative breast implants.","Supersedes the previous version dated 17 November 2006.","Should be read alongside the labeling recommendations guidance."]},{"id":"safety-requirements-2021","title":"FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants","category":"implants-regulation","kind":"Press announcement","url":"https://www.fda.gov/news-events/press-announcements/fda-strengthens-safety-requirements-and-updates-study-results-breast-implants","updated":"2021-10-27","summary":"Announcement of orders restricting the sale and distribution of breast implants and approval of new labeling with a boxed warning, patient decision checklist, rupture screening recommendations and a patient device card.","keyPoints":["Sale and distribution are restricted to providers and facilities that give patients the approved risk information.","The patient decision checklist must be reviewed, initialled and signed by the patient and signed by the implanting physician.","New labeling includes a device description listing specific materials in the device.","The FDA also released updated information on manufacturer post-approval studies."]},{"id":"postmarket-safety","title":"Breast Implant Postmarket Safety Information","category":"implants-safety","kind":"Regulatory page","url":"https://www.fda.gov/medical-devices/breast-implants/breast-implant-postmarket-safety-information","updated":"2025-06-02","summary":"Describes the FDA's ongoing postmarket review of breast implant safety, including medical device reports, BIA-ALCL, systemic symptoms and manufacturer post-approval studies.","keyPoints":["The FDA continually evaluates postmarket safety and manufacturer compliance with approval conditions.","Review includes medical device reports for BIA-ALCL and systemic symptoms in women with breast implants.","Ongoing post-approval studies are listed by manufacturer and application number.","In July 2019 Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders."]},{"id":"bia-alcl-qa","title":"Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)","category":"cancers","kind":"Patient and clinician Q&A","url":"https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl","updated":"2019-10-23","summary":"FDA answers on BIA-ALCL: what it is, who is at risk, symptoms, diagnosis, treatment and what patients and clinicians should do.","keyPoints":["BIA-ALCL is a T-cell lymphoma of the immune system, not breast cancer.","It is usually found in the fluid or scar tissue near the implant and may spread in some cases.","Risk is higher with textured-surface implants than with smooth-surface implants.","Main symptoms are persistent swelling, a mass or pain around the implant, often years after surgery.","Most patients are treated successfully with surgery to remove the implant and surrounding capsule; some also need chemotherapy or radiation.","The FDA does not recommend routine removal of implants in patients without symptoms."]},{"id":"scc-safety-communication","title":"UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants","category":"cancers","kind":"Safety communication","url":"https://www.fda.gov/medical-devices/safety-communications/update-reports-squamous-cell-carcinoma-scc-capsule-around-breast-implants-fda-safety-communication","updated":"2023-03-08","summary":"Updated safety communication on reports of squamous cell carcinoma and various lymphomas in the scar capsule around breast implants.","keyPoints":["The communication updates a September 2022 safety communication.","The lymphomas described are not the same as BIA-ALCL.","The FDA believes cases of SCC and lymphomas in the capsule may be rare.","Health care providers should discuss these risks with women who have or are considering breast implants.","Patients and providers are asked to report cancers around breast implants to the FDA."]},{"id":"dermal-fillers","title":"Dermal Fillers (Soft Tissue Fillers)","category":"fillers","kind":"Regulatory page","url":"https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers","updated":"2023-07-06","summary":"Describes approved facial and hand uses of dermal fillers, the risks, and the FDA's position on unapproved body uses including breast enlargement.","keyPoints":["Dermal fillers are approved for specific facial uses, lip and cheek augmentation, back-of-hand augmentation, HIV lipoatrophy and contour deficiencies.","The FDA recommends against using dermal fillers or any injectable filler to increase breast size (breast augmentation) or for other body contouring.","These uses are not approved by the FDA, and the risks of unapproved uses or unapproved products are not known.","Injectable silicone is not approved for any aesthetic procedure and can cause long-term pain, infection, scarring, embolism, stroke and death.","Needle-free devices are not approved for injecting dermal fillers, and no dermal filler is approved for over-the-counter use.","Removal of filler may require injections, surgery or other interventions, and it may be difficult or impossible to remove permanent fillers."]},{"id":"approved-fillers","title":"FDA-Approved Dermal Fillers","category":"fillers","kind":"Regulatory list","url":"https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/fda-approved-dermal-fillers","updated":"","summary":"The FDA's list of approved dermal fillers and their approved indications, limited to facial tissue and the hands.","keyPoints":["The list covers approved facial and hand products.","The FDA has not approved liquid silicone or silicone gel for injection.","Approved indications vary by product; not every product is reviewed for every body site."]},{"id":"injectable-silicone-warning","title":"FDA Warns About Illegal Use of Injectable Silicone for Body Contouring and Associated Health Risks","category":"fillers","kind":"Press announcement and safety communication","url":"https://www.fda.gov/news-events/press-announcements/fda-warns-about-illegal-use-injectable-silicone-body-contouring-and-associated-health-risks","updated":"2017-11-13","summary":"Warning about injectable silicone and products falsely marketed as FDA-approved fillers to enlarge the buttocks, breasts and other body parts.","keyPoints":["Injectable silicone used for body contouring is not FDA-approved.","Serious side effects include ongoing pain, scarring, tissue death, permanent disfigurement, embolism, stroke, infection and death.","Complications may occur immediately or weeks, months or years later.","Silicone injections for body contouring are often performed by unlicensed providers in non-clinical settings.","Injectable silicone differs from the silicone contained inside approved breast implants, because the implant shell keeps the gel from migrating."]},{"id":"consumer-breast-implants","title":"What to Know About Breast Implants","category":"consumer","kind":"Consumer update","url":"https://www.fda.gov/consumers/consumer-updates/what-know-about-breast-implants","updated":"2025-01-31","summary":"Patient-facing overview of implant types, risks, labeling, long-term monitoring, BIA-ALCL and communication with a surgeon.","keyPoints":["The FDA has approved implants for augmentation, reconstruction after cancer or trauma, correction of developmental defects, and revision of previous surgery.","Risks include additional surgery, BIA-ALCL, systemic symptoms (BII), capsular contracture, breast pain, rupture, deflation, silent rupture and infection.","Breast implants are not lifetime devices and their lifespan cannot be predicted.","Mandatory labeling includes a patient decision checklist, boxed warning and patient device card.","Patients with silicone implants are advised to have regular screening for silent rupture and to tell mammography facilities that they have implants.","Injectable silicone is not approved for breast augmentation, reconstruction or body contouring."]},{"id":"medwatch","title":"MedWatch: FDA Safety Information and Adverse Event Reporting Program","category":"consumer","kind":"Reporting program","url":"https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program","updated":"","summary":"How patients and clinicians report injuries, adverse events or product problems related to breast implants, fillers and other FDA-regulated products.","keyPoints":["Voluntary reports can be filed online or by phone at 1-800-FDA-1088.","Reports help the FDA monitor approved products after they are sold.","Useful details include device name, manufacturer and a description of the event and any interventions."]}],"facts":[{"topic":"Implants are devices, not procedures","statement":"The FDA regulates breast implants as medical devices and reviews their safety and effectiveness; it does not approve breast enlargement procedures or clinics.","source":"breast-implants-hub"},{"topic":"Approved implant types","statement":"Only saline-filled and silicone gel-filled breast implants are approved for sale in the United States. Both have a silicone outer shell.","source":"breast-implants-hub"},{"topic":"Age indications for augmentation","statement":"Saline-filled implants are approved for breast augmentation from age 18; silicone gel-filled implants are approved for augmentation from age 22. Both are approved for reconstruction at any age.","source":"types-of-implants"},{"topic":"Implants are not lifetime devices","statement":"The longer implants remain in place, the more likely it is that they will need to be removed or replaced, and patients should assume further surgery may be needed.","source":"things-to-consider"},{"topic":"Most frequent complications","statement":"The most common local complications are capsular contracture, reoperation and implant removal; others include rupture or deflation, wrinkling, asymmetry, scarring, pain and infection.","source":"things-to-consider"},{"topic":"Silent rupture","statement":"Most silicone gel implant ruptures have no symptoms. MRI is the most effective detection method, and ultrasound is acceptable for screening asymptomatic patients.","source":"risks-complications"},{"topic":"BIA-ALCL","statement":"BIA-ALCL is a T-cell lymphoma of the immune system, not breast cancer. It is more common with textured implants, often presents as persistent swelling, a mass or pain, and is usually treated by removing the implant and capsule.","source":"bia-alcl-qa"},{"topic":"SCC and other lymphomas","statement":"The FDA has received reports of squamous cell carcinoma and various lymphomas in the scar capsule around breast implants. These are not the same as BIA-ALCL and are believed to be rare.","source":"scc-safety-communication"},{"topic":"Breast implant illness","statement":"Some patients report systemic symptoms such as fatigue, memory loss, rash, brain fog and joint pain, collectively called breast implant illness. The causes are poorly understood and research is ongoing.","source":"risks-complications"},{"topic":"Fillers are not approved for breast enlargement","statement":"The FDA recommends against using dermal fillers or any injectable filler to increase breast size. The use is not approved, and the risks of unapproved uses and products are not known.","source":"dermal-fillers"},{"topic":"Injectable silicone","statement":"Injectable silicone is not approved for any aesthetic procedure. It can cause chronic pain, infection, scarring, permanent disfigurement, embolism, stroke and death.","source":"dermal-fillers"},{"topic":"Filler removal","statement":"Removing or reducing filler may require injections, surgery or other interventions, and permanent or non-hyaluronic-acid fillers may be difficult or impossible to remove.","source":"dermal-fillers"},{"topic":"Labeling and consent","statement":"Since 2021, FDA-approved breast implants carry a boxed warning, a patient decision checklist and a patient device card, and their sale is restricted to providers who give patients this information.","source":"safety-requirements-2021"},{"topic":"Surgical mesh","statement":"The FDA has not cleared or approved any surgical mesh for use with breast implants or in breast reconstruction.","source":"breast-implant-surgery"},{"topic":"Reporting problems","statement":"Patients and clinicians can report adverse events or product problems to the FDA through MedWatch online or by phone at 1-800-FDA-1088.","source":"medwatch"}]}