Breast implants, BIA-ALCL lymphoma and “breast implant illness”: what is known today

They are two completely different things and they are confused all the time. One is a lymphoma with a name, diagnostic criteria and an established treatment. The other is a set of symptoms that many women describe, that is being studied and that does not yet have an agreed medical definition.

This page separates them, states what each regulator says today — with dates — and explains what to do with that information.

⚠️ This page does not diagnose. If you have implants and you have symptoms, what is needed is an in-person assessment.

Part one: BIA-ALCL lymphoma

What it actually is

It is not a breast cancer. It is a breast implant-associated anaplastic large cell lymphoma, a type of non-Hodgkin lymphoma — that is, a cancer of the immune system. In 2016 the World Health Organization recognised it as an entity in its own right.

Where it appears. In most reported cases, in the capsule of fibrous tissue that surrounds the implant and in the fluid collected around it (the seroma), not in the breast tissue. In some cases it can spread to the rest of the body.

It is thought to develop from the lymphocytes involved in forming that capsule, as a consequence of the body’s reaction to a foreign object.

How many cases there are in Spain

It is the figure that best sets the scale, and Spain has a register of its own.

The AEMPS — the Spanish Agency for Medicines and Medical Devices — has for years maintained a specific detection protocol and publishes follow-up reports. In the sixth report, published on 3 June 2026:

Up to 2025, the Agency has received 146 notifications of suspected cases, of which 111 have been confirmed.

⚠️ That figure has to be read against the denominator. It is 111 confirmed cases in a country where hundreds of thousands of implants have been placed over decades. It is an uncommon condition — and at the same time it is real, it is registered and there is a national protocol for detecting it, which is precisely what makes it possible to give you this figure.

What the symptoms are

The FDA summarises them as: persistent swelling, the presence of a lump or pain in the area of the breast implant. And it adds the point about timing that matters most:

🔑 “These symptoms may occur well after the surgical incision has healed, often years after implant placement.”

On assessment, a collection of fluid around the implant (seroma) is frequently found. In some cases a lump under the skin or a capsular contracture has also been described.

⚠️ Translated into something you can act on: a breast that swells years after surgery is not normal and it is not “the swelling coming back”. It is a reason to be assessed.

What the prognosis is

The FDA is precise, and it is worth quoting in full because it is usually reported by halves in both directions:

“The risk of developing BIA-ALCL is considered low; however, this cancer is serious and can cause death, especially if it is not treated promptly. In most patients it is treated successfully by surgery to remove the implant and the surrounding scar tissue, and in some patients also with chemotherapy and radiotherapy.”

It is neither a general alarm nor an anecdote. It is an uncommon, serious disease with a very good prognosis when it is diagnosed in time — and that last condition is the reason this page exists.

What increases the risk

• A textured surface. The FDA states it without ambiguity: the risk of BIA-ALCL is higher with textured-surface implants than with smooth-surface implants.
• Not the filling. Based on currently available data, the type of implant filling does not appear to be a risk factor — although the FDA itself warns that this has not been evaluated in a large, well-designed epidemiological study.

🔑 And there is a nuance worth underlining because it changes the reading: not all textures are the same. The greater the texturing, the greater the risk. It is not a gradient the FDA grades in that document — there it only compares textured with smooth — but it is the reading of the data as a whole and it explains what happened next:

⚠️ Macrotextured implants were withdrawn from the market. The FDA asked that the products in its safety communication of 24 July 2019 — Allergan BIOCELL textured implants and their expanders — no longer be implanted, and it also records that France withdrew macrotextured implants as a precaution. The ones implanted today are not those.

⚠️ And the uncomfortable trade-off explained on the risks page remains: textured surfaces give less capsular contracture and more risk of BIA-ALCL. There is no surface that wins on everything.

🔑 What NOT to do

The FDA’s recommendation is explicit and it is the one that should give most reassurance:

“We do not recommend the routine removal of these or other types of breast implants in patients who have no symptoms.”

If you have implants and no symptoms, the right course is not to have surgery out of fear: it is to keep up your check-ups and know which sign to look for.

The newest warnings: squamous cell carcinoma and other tumours

Since December 2023 the FDA has added a new section. There are reports in the scientific literature and in device notifications of squamous cell carcinoma, of lymphomas other than BIA-ALCL and of mesenchymal tumours, including sarcomas, in the scar tissue surrounding implants.

⚠️ They are reports, not an established association. The FDA states that it will continue to gather and review the available data. It is information worth knowing and it does not, today, change any recommendation.

Part two: “breast implant illness”

What it is and what it is not

It is a term used by patients, not an established medical diagnosis. It describes a set of general — not local — symptoms that some women with implants attribute to them.

The FDA records it as follows:

“Symptoms such as fatigue, memory loss, skin rash, ‘brain fog’ and joint pain may be associated with breast implants. Some patients use the term ‘breast implant illness’ (BII) to describe these symptoms. Researchers are studying these symptoms to better understand their origin. These symptoms and their causes are poorly understood. In some cases, removal of the implants without replacement has been reported to reverse the symptoms.”

Four things in one paragraph: that they exist, that they are being studied, that they are poorly understood, and that in some cases they have been reversed by explanting.

And the sentence almost never quoted

In the same document, the FDA states:

“The FDA has not detected any association between silicone gel implants and connective tissue disease, breast cancer or reproductive problems.”

With an honest caveat immediately afterwards: to fully understand these complications, larger and longer studies than those carried out so far would be needed.

🔑 The two sentences together are the real position today: the association with specific, known diseases is ruled out; the question of systemic symptoms remains open.

What has been measured

A 2025 meta-analysis brought together 36 papers and 10,519 patients and compared the frequency of symptoms between women with and without implants. The three most strongly associated:

Symptom	Relative risk
Fatigue or general malaise	3.15 (2.89–3.43)
Myalgia or muscle weakness	2.96 (2.76–3.18)
Cognitive dysfunction	2.87 (2.64–3.12)

And it also found four associations that give some direction:

• Ruptured implants: more likely to have BII-type symptoms (RR 1.12; p = 0.003).
• Silicone implants: more likely than other fillings (RR 2.11; p < 0.0001).
• ⚠️ Explanted patients: fewer symptoms (RR 0.94; p = 0.003).
• ⚠️ Aesthetic indication against reconstructive: fewer symptoms (RR 0.91; p = 0.02).

The authors themselves open the paper by saying that no definitive scientific link has been established and that a symptom-based definition is needed in order to research it properly.

And how little has been published

Another 2025 systematic review puts it as eloquently as possible: it started from 1,204 studies and only 20 met the inclusion criteria, published between 1995 and 2022, with a peak in 2020 and 2022, most from the United States and with widely varying methods, including isolated case reports.

Its findings: arthralgia and fatigue were the most common, and symptoms were frequently relieved by en bloc explant and capsulectomy. Its conclusion is a call for more research, with a multidisciplinary approach.

🔑 Twenty studies in thirty years, on a subject with thousands of posts on social media. That contrast is probably the most useful information on this page.

What to do if you recognise yourself in those symptoms

• Get seen. The symptoms described are non-specific and many have other common, treatable causes — thyroid problems, anaemia, vitamin deficiencies, sleep apnoea, rheumatological disease. Ruling them out is not doubting anyone: it is what has to be done before attributing anything.
• Have the state of the implants assessed, because ruptured implants were associated with more symptoms.
• Take any decision about explanting on an informed basis, knowing that in the literature symptoms frequently improve and that there are also people who do not improve.

⚠️ There is no test that confirms or rules out BII. There is none today. Anyone offering one is selling something that does not exist.

What is done here

Explant surgery is carried out, and anyone consulting about these symptoms has the SECPRE protocol applied — the Spanish Society of Plastic, Reconstructive and Aesthetic Surgery — which is the reference framework in Spain for these cases. It is not a house protocol invented for the occasion, and that is precisely what is worth knowing.

Frequently asked questions

Do breast implants cause breast cancer?

No. The FDA states expressly that it has not detected any association between silicone gel implants and breast cancer. BIA-ALCL, which is associated with implants, is not a breast cancer: it is a lymphoma that arises in the capsule surrounding the implant.

How many BIA-ALCL cases have there been in Spain?

According to the AEMPS’s sixth follow-up report, published on 3 June 2026, up to 2025 the Agency had received 146 notifications of suspected cases, of which 111 were confirmed.

Should I have my implants removed just in case?

No, if you have no symptoms. The FDA is explicit: it does not recommend the routine removal of implants in patients without symptoms. What is appropriate is to keep up your check-ups and know which sign to look for.

Which symptom should I watch for?

Persistent swelling, a lump or pain in the area of the implant, particularly if they appear years after surgery and when the incision has long since healed. It is a reason to be assessed, not an immediate emergency.

Is a smooth implant safer?

As regards BIA-ALCL, the risk is higher with a textured surface. But smooth implants have almost three times as much capsular contracture in the available meta-analyses. There is no surface that wins on everything, and the choice is made weighing both.

Does breast implant illness exist?

The symptoms exist and have been measured: in a meta-analysis of 10,519 patients, fatigue was associated with having implants at a relative risk of 3.15. What does not yet exist is a diagnostic definition, a test that confirms it or a demonstrated mechanism. The authors themselves note that no definitive scientific link has been established.

If I have the implants out, will the symptoms go away?

In the literature, symptoms are frequently relieved after explanting, and explanted patients report fewer symptoms than those who keep their implants. But it is not a guarantee, the quality of the studies is limited and the decision should be taken after an assessment that rules out other causes.

Can I have a test to find out whether I have BII?

No. There is no test that confirms or rules out this entity, precisely because it has no agreed diagnostic criteria.

Sources

• Follow-up of the protocol for the detection in Spain of anaplastic large cell lymphoma (ALCL) associated with breast implants. Sixth report. Spanish Agency for Medicines and Medical Devices (AEMPS), 3 June 2026. aemps.gob.es. — “Up to 2025, the Agency has received 146 notifications of suspected cases, of which 111 have been confirmed”; description of ALCL as a non-Hodgkin lymphoma thought to develop from the lymphocytes involved in forming the fibrous peri-implant capsule.
• Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). U.S. Food and Drug Administration. fda.gov. — BIA-ALCL is not breast cancer but a non-Hodgkin lymphoma; designated by the WHO in 2016; usual location in the fibrous capsule and in the peri-implant seroma; risk considered low but a serious disease that can cause death, particularly if not treated promptly, and treated successfully in most patients by removal of the implant and the capsule, with chemotherapy and radiotherapy in some cases; main symptoms of persistent swelling, a mass or pain in the area of the implant, often years after placement; higher risk with a textured than a smooth surface; the type of filling does not appear to be a risk factor; and an express recommendation not to remove implants routinely in patients without symptoms.
• Risks and Complications of Breast Implants. U.S. Food and Drug Administration, updated 14 December 2023. fda.gov. — “The FDA has not detected any association between silicone gel implants and connective tissue disease, breast cancer or reproductive problems”, with the caveat that larger and longer studies would be needed; description of the systemic symptoms and of the term “breast implant illness”, noting that they are poorly understood and that in some cases removal without replacement reverses the symptoms; reports of squamous cell carcinoma, other lymphomas and mesenchymal tumours including sarcomas in the peri-implant capsule.
• Bouhadana G, et al. Defining Breast Implant Illness: A Systematic Review and Meta-analysis of Patient-reported Symptoms. Plastic and Reconstructive Surgery – Global Open, 2025. PMID 40391348. — 36 papers and 10,519 patients; relative risk of fatigue or malaise 3.15 (2.89–3.43), of myalgia or weakness 2.96 (2.76–3.18) and of cognitive dysfunction 2.87 (2.64–3.12); ruptured implants (RR 1.12; p = 0.003) and silicone fillings (RR 2.11; p < 0.0001) more associated with BII-type symptoms; explanted patients (RR 0.94; p = 0.003) and an aesthetic indication (RR 0.91; p = 0.02) with fewer symptoms; the authors stress that no definitive scientific link has been established.
• Alabdulkarim A, et al. Comprehensive Systematic Review of Breast Implant Illness: Symptoms, Management, and Long-Term Outcomes. Aesthetic Plastic Surgery, 2025. PMID 38992251. — Of 1,204 studies identified, only 20 met the inclusion criteria, published between 1995 and 2022 with a peak in 2020 and 2022 and mostly from the United States; arthralgia and fatigue as common findings; symptoms frequently relieved by en bloc explant and capsulectomy; no diagnostic criteria.

Book your consultation

If you have implants and something has changed — a breast that swells, a lump, new discomfort — the right answer is to be seen, not to search further online. And if you are considering surgery and this page has made you hesitate, that too is a conversation for the consulting room: at our practice in Valencia we explain which implant is being proposed, why, and what follow-up goes with it.

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