Are breast implants safe? What the FDA says in 2026

Kent V. Hasen, MD Board-certified plastic surgeon (American Board of Plastic Surgery). Last reviewed: October 2026

As of October 2026, these remain the current FDA requirements.

Key takeaways

• Breast implants are FDA-regulated medical devices with a well-characterized risk profile. The FDA is clear that they are not lifetime devices and that they carry known risks.
• Under FDA rules issued in 2021, breast implants can only be sold to providers who review the boxed warning and a patient decision checklist with you before surgery, and you have the opportunity to sign it. This review is required for every patient.
• BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a rare immune-system cancer linked mainly to textured implants. The FDA's reports include only 1 case with a known history of a smooth implant and no known textured implant.
• In 2019, the FDA requested a voluntary recall of specific Allergan BIOCELL macrotextured implants. The recall covered those Allergan products only, other textured implants remain on the US market, and smooth implants were not affected.
• Silicone implant rupture is often "silent," so the FDA recommends a first ultrasound or MRI 5 to 6 years after surgery, then every 2 to 3 years.
• Replacement on a fixed 10-year schedule is a myth. The FDA does not recommend removing or replacing implants in the absence of symptoms or complications.
• Patients with implants can and should continue recommended mammography screening. Tell your imaging provider you have implants so they can take additional views.

Breast implant safety is one of the most common topics patients bring to a consultation with Dr. Hasen. The information online ranges from genuinely useful to seriously misleading. This page is for two groups of readers. The first is someone researching breast augmentation for the first time and wanting to understand the current FDA guidance before making any decisions. The second is someone who has had implants for years and wants to know whether recent FDA actions, updated warnings, or news coverage about textured implants or breast implant illness apply to them.

The safety profile of breast implants is real and well-documented. Every implant also carries known risks, and this page sets them out plainly. The questions and answers below are built around what the FDA actually says, what the evidence actually shows, and what you should realistically expect.

Are breast implants safe according to the FDA in 2026?

Breast implants are FDA-regulated medical devices with a well-studied safety profile. The FDA is clear that they are not lifetime devices and that they carry known risks, including rupture, capsular contracture, and the rare textured-implant-associated lymphoma BIA-ALCL. Under FDA rules issued in 2021, breast implants can only be sold to providers who review the boxed warning and a patient decision checklist with you before surgery.

Frequently Asked Questions

What does the FDA require surgeons to tell patients about breast implants?

Under FDA rules issued in 2021, breast implants can only be sold to providers who review the boxed warning and a patient decision checklist with you before surgery, and you have the opportunity to sign it. That checklist covers the most clinically significant risks: the likelihood of at least one reoperation during your lifetime, rupture (both silent and symptomatic), capsular contracture, BIA-ALCL, and the broader category of systemic symptoms some patients report after implantation. The FDA also sets minimum ages for cosmetic augmentation. Saline implants are FDA-approved for cosmetic augmentation in patients 18 and older. Silicone gel implants are FDA-approved for cosmetic augmentation in patients 22 and older. These minimums apply to cosmetic augmentation only, and breast reconstruction has no minimum age.

What is BIA-ALCL and which implants are linked to it?

BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) is a rare cancer of the immune system that develops in the fluid or scar tissue capsule surrounding a breast implant. It is not breast cancer. Nearly every confirmed case where the patient's full implant history is known has involved a patient with a history of textured implant exposure. Of the cases reported to the FDA through June 30, 2024, 1 involved a known history of a smooth implant and no known textured implant. The FDA estimates the risk for patients with textured implants at roughly 1 in 3,817 to 1 in 30,000. BIA-ALCL is often curable when caught early through complete surgical removal of the implant and the surrounding capsule. Symptoms to watch for include a sudden, persistent swelling or fluid accumulation around the implant, typically occurring years after placement.

Are there other cancers linked to the implant capsule?

In September 2022, the FDA issued a safety communication, updated in March 2023, about reports of squamous cell carcinoma (SCC) and various lymphomas found in the scar tissue capsule around breast implants. These cancers are separate from BIA-ALCL. Cases have been reported with both smooth and textured implants, and with both saline and silicone implants. The FDA says these cancers may be rare, and their cause, incidence, and risk factors are not yet known. In the reported cases, diagnosis came 7 to 42 years after placement, and the most common symptoms were swelling and pain. If you notice new swelling, a lump, or pain in either breast, report it to your surgeon. The FDA does not recommend removing implants solely because of these reports if you have no symptoms.

Are textured breast implants banned in the US?

No. Textured implants remain on the US market. In 2019, the FDA requested a voluntary recall of specific Allergan BIOCELL macrotextured implants and tissue expanders after data showed they were associated with a disproportionate share of BIA-ALCL cases globally. That recall was limited to Allergan's BIOCELL products, and other textured implant surfaces were not included. Smooth implants were not affected at all. If you have existing implants and are unsure of the brand or surface type, your surgeon can help you locate your implant device card. The device card has been part of FDA labeling requirements since 2021, so patients who had surgery from then on should have received one. Removal is not automatically required. Monitoring and open communication with your surgeon are important.

What is breast implant illness and is it real?

Breast implant illness (BII) describes a patient-reported cluster of systemic symptoms, most commonly fatigue, joint pain, cognitive difficulties often called brain fog, and skin changes, that some patients attribute to their implants. BII is not a formally recognized medical diagnosis. Plastic surgeons and researchers take it seriously, and the FDA's boxed warning itself lists systemic symptoms that some patients report after implantation. Some studies report symptom improvement after implant removal, though results vary and the reasons are not yet understood. Research is ongoing. If you are experiencing systemic symptoms and have implants, a conversation with your surgeon is the appropriate starting point.

How do I know if my silicone implant has ruptured?

Silicone implant rupture is often called "silent rupture" because modern cohesive silicone gel holds its shape even when the shell is compromised, so the breast may look and feel unchanged. This is why the FDA recommends that patients with silicone implants have a first ultrasound or MRI 5 to 6 years after surgery, then every 2 to 3 years, to detect ruptures that would otherwise go unnoticed. The FDA accepts ultrasound for screening patients without symptoms and recommends MRI when there are symptoms or when ultrasound results are unclear. Saline rupture behaves very differently: the implant deflates noticeably within days because the saline is absorbed by the body.

Do breast implants need to be replaced every 10 years?

The 10-year replacement rule is a myth. Implants are not lifetime devices, and failure rates do increase over time. The FDA does not recommend removing or replacing implants in the absence of symptoms or complications. Replacement is clinically indicated when there is a confirmed or suspected rupture, when capsular contracture is causing distortion or discomfort, when there is malposition or implant displacement, or when a patient chooses to change size. Your regular follow-up appointments are where your implants are monitored over time.

What is capsular contracture and how common is it?

Capsular contracture occurs when the scar tissue that naturally forms around any breast implant tightens and hardens, potentially distorting the shape of the breast or causing discomfort. It is graded on the Baker scale from I (normal, soft) to IV (hard, painful, distorted). Manufacturer core studies of primary augmentation report rates ranging from roughly 1 in 10 to 1 in 5 at 10 years. Rates vary by implant surface, plane of placement, and surgical technique. Capsular contracture is treatable. Correction typically requires surgery to remove or release the capsule and may involve implant exchange.

Can I still get a mammogram if I have breast implants?

Yes, and you should. Breast implants do not eliminate your need for recommended breast cancer screening. What changes is the technique: implants can obscure portions of breast tissue on a standard mammogram, so you must tell your imaging provider that you have implants before the exam. They will use additional displacement views (the Eklund technique) to move the implant back and image as much native breast tissue as possible. If your imaging center is not experienced with implant patients, ask to be referred to one that is. Implants have not been shown to increase breast cancer risk, and routine screening remains important.

A note on long-term implant care

The practical steps are straightforward: keep your implant device card in a safe place, attend your recommended follow-up appointments, arrange periodic imaging for silicone implants on the schedule your surgeon recommends, and report any new or changing symptoms promptly. Your implant information can also be entered in the National Breast Implant Registry, which supports long-term tracking of implant safety. Monitoring is an ongoing part of your breast health and a reason to stay connected with your care team. At each follow-up, Dr. Hasen will review your imaging schedule and any changes you have noticed.

Plan your consultation with Dr. Hasen

If this page raised questions about your anatomy, your existing implants, or what to expect from surgery, a conversation with Dr. Hasen is the right next step. Learn more about breast augmentation at Naples Aesthetics. At consultation, Dr. Hasen will review your anatomy or your existing implants, explain the risks that apply to you, and recommend a clear plan for surgery or long-term monitoring. You decide whether and when to proceed.

Schedule your consultation with Dr. Hasen.

Sources

• FDA: Risks and Complications of Breast Implants
• FDA: Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
• FDA: UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants, FDA Safety Communication
• FDA: What to Know About Breast Implants
• FDA: Breast Implants, Certain Labeling Recommendations to Improve Patient Communication

Information on this page is for educational purposes and is not medical advice.