Breast implant illness: what the FDA says, and what to ask

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What the FDA says

The FDA’s wording is careful: “Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants.” It describes these symptoms as poorly understood, and it notes that some patients report their symptoms eased after their implants were removed.

Notice the words “may be associated.” The FDA does not say implants cause these symptoms, and it does not say they do not. Be wary of anyone, on either side, who speaks with more certainty than that.

How it differs from BIA-ALCL

Breast implant illness is sometimes confused with BIA-ALCL, which is a defined disease. BIA-ALCL is a T-cell lymphoma, a cancer of the immune system and not breast cancer, that “appears more often in patients with textured breast implants.” If it is confirmed, the implant and the scar capsule around it are generally removed.

The FDA’s report data, as of June 30, 2024, list 1,380 unique cases worldwide and 64 deaths. Textured implants made up 73 percent of cases. The median time from implant to diagnosis was 8 years, with a range of 0 to 40, and fluid around the implant (seroma) was the most common sign, in 48 percent. The FDA says report data cannot establish how often BIA-ALCL occurs.

Separately, the FDA has reported squamous cell carcinoma and other lymphomas in the capsule around implants, with both smooth and textured, saline and silicone implants. It believes these may be rare, and their cause, incidence and risk factors are unknown.

If you have implants and symptoms

Start with a doctor who can examine you. Bring a list of your symptoms, when they began and when your implants were placed. Your implant device card, which the FDA has required since 2021, shows what you have. For silicone gel implants, ask whether imaging is due: MRI is the most effective way to find a silent rupture, and ultrasound is an acceptable alternative.

Keep your own record over time: a short note each month of how you feel, any new symptom and anything that seems to make it better or worse. That record helps any doctor you see, and it helps you notice patterns rather than relying on memory. If a symptom is sudden or severe, do not wait for an appointment: call 911 in an emergency.

Where to read more

The FDA keeps its breast implant pages up to date, including the risks and complications page quoted in this article. Read it directly rather than relying on summaries in forums or social media, and bring any questions it raises to your doctor or surgeon. ASPS also publishes plain-language pages on implants and their removal.

What implant removal involves

Some people choose removal, also called explant. Cleveland Clinic describes it as removing the implants and possibly the scar capsule and any leaked silicone. Reasons include painful capsular contracture, which is the most common, BIA-ALCL, leaks, shifting, body changes, or simply wanting them out.

• It is done under IV sedation or general anesthesia, usually as an outpatient.
• Drains may stay for a few days, sometimes 10 or more.
• A support garment is worn for a few weeks.
• Driving and usual activity return after about 1 to 2 weeks, and soreness can last up to 6 weeks.
• It is often combined with a breast lift.

Cleveland Clinic says the most common risk is being unhappy with how the breasts look afterward, so ask the surgeon what to expect. ASPS reports a 2024 national range of $3,650 to $6,500 for the surgeon’s fee alone for implant removal; anesthesia and the facility are extra. The FDA notes that some insurers do not cover removal, even for complications.

If you are thinking about implants

Since October 2021 the FDA has required a boxed warning on all breast implants and a patient decision checklist. Your surgeon goes over it with you before surgery, and you both sign it. The FDA also states: “Breast implants are not considered lifetime devices.” The implant sizes article covers the other choices you will make.

Questions to ask

1. What do you tell patients about the symptoms the FDA describes?
2. Which implant surface and fill do you suggest, and why?
3. What follow-up and imaging do you recommend over the years?
4. If I wanted my implants out, what would removal involve for me?
5. How many removals do you perform, and do you combine them with a lift?

In the Las Vegas Valley, check a surgeon on the American Board of Plastic Surgery lookup and the Nevada State Board of Medical Examiners lookup. The cost guide explains later costs, and the homepage has a short form to reach an independent office. This article is general information, not medical advice. If you have a medical emergency, call 911.

This site gives general information, not medical advice. Only a licensed provider who examines you can say whether a procedure suits you. In an emergency, call 911.