Implant Safety

Breast Implant Illness (BII): What the Evidence Says

UNE Plastic Surgery · Dr. Kim Uigeon, board-certified plastic surgeon · Published 2026-09-21 · Updated 2026-09-21

1. The symptoms BII patients report

The U.S. FDA maintains MAUDE, a database for reporting medical-device problems. One study analyzed 751 reports filed as BII between 2010 and 2020 (Taskindoust et al., Plastic and Reconstructive Surgery, 2022).^[2]

By individual symptom, fatigue and weakness (43.7%) were most common, followed by tingling (33.2%), brain fog (32.9%), depression or anxiety (31.2%), joint pain (26.9%), muscle pain (25.6%), headache (25.4%), and hair loss (24.5%). 53.1% of reports mentioned implant removal and 20.4% mentioned rupture. The timing was distinctive: 51.1% of all reports came in 2019 alone — the authors read this as the effect of an FDA hearing that year and a changed reporting channel, closer to a rush of reports once the name and a channel existed than to a sudden rise in symptoms.

Two things are worth noting. One: 39.4% involved saline implants. Silicone was more common at 60.6%, but saline is not a small share — “it is caused by silicone leaking out” does not explain this picture. Two: this is not a causation study. It is only the symptom distribution of voluntarily filed reports; what percentage of people with implants experience these symptoms cannot be known from this data. And one more: 12.4% of reports listed only the word “BII” with no specific symptom — with no diagnostic criteria, patients are classifying themselves under the term. The reported symptom onset even goes back to 1981: the word BII settled recently, but similar complaints existed long before — a new name, not a new phenomenon.

2. A BII symptom checklist

The symptoms associated with BII, ordered by how often they were reported in the 751 MAUDE cases:

• Fatigue and weakness — tiredness that rest does not relieve
• Tingling in the hands and feet, altered sensation
• Brain fog — trouble concentrating, memory feeling hazy
• Depression, anxiety
• Joint pain, muscle pain
• Headache
• Skin changes such as hair loss and rash
• Digestive or urinary changes, cardiovascular symptoms

These same symptoms appear in thyroid disease, anemia, autoimmune disease, and sleep disorders. So matching the list is not read as BII on its own — the order is testing to rule out other causes first, while also looking at whether symptoms began after the implant, how many appear together, and how long they last.

3. Symptom change after explantation

This is usually the biggest question. A 2022 systematic review screened 566 papers over 30 years and distilled 11 (Rohrich et al., Plastic and Reconstructive Surgery, 2022).^[1] The conclusion: some patients improve after removal — that is clear. But the same review also concluded that there is insufficient evidence to support most of the surgical approaches currently practiced. Improvement rates ranged from 17% to 84% across studies, because each recruited patients differently, defined symptoms differently, and followed them for different lengths. The authors closed by saying a properly designed, large prospective study is needed — in other words, even in 2026 there is no firm evidence to promise “removal makes it better.” So when removal is being considered, seeing a rheumatologist first is worthwhile, because fatigue, joint pain, and brain fog appear equally in thyroid disease, anemia, autoimmune disease, and sleep disorders. Ruling out other causes first is the order.

4. When you already have an autoimmune disease

People already diagnosed with rheumatoid arthritis, lupus, or thyroid disease often ask “can I still get implants?” or “I already have them — is this the cause?” Honestly, the studies split, and it cannot be tidied to one side. Two are set side by side:

Why the two came out opposite

Two things. One is timing: Janowsky pooled studies up to 2000 (Janowsky et al., New England Journal of Medicine, 2000),^[6] while Watad analyzed 20 years of a clinical database in 2018 (Watad et al., International Journal of Epidemiology, 2018)^[7] — different kinds of data. The other is diagnostic opportunity: Watad counted disease by diagnostic codes, and people with implants attend follow-up and visit clinics more often, so existing disease is found more readily rather than new disease arising — a possibility the team could not exclude. So OR 1.22 is closer to “22% more likely to be diagnosed” than “22% higher risk,” and it is not a causal number. Nor is there ground to declare it entirely unrelated.

What about the surgical outcome itself

Separate from the association debate, a systematic review examined whether an autoimmune diagnosis or family history worsens surgical outcomes, and found no evidence that it does (Coriddi et al., Annals of Plastic Surgery, 2023).^[4] But read this carefully: of 2,425 records screened, only 2 met criteria and the evidence level was low — closer to “no evidence it is worse” than “proven safe.” A large cohort points the same way: the Nurses’ Health Study followed 87,501 women for 14 years, and the relative risk of connective-tissue disease in women with implants was 0.6, and 0.3 for silicone gel alone — neither statistically significant (Sánchez-Guerrero et al., New England Journal of Medicine, 1995).^[5] In short, a diagnosis by itself is not a reason surgery cannot proceed; the question is not the diagnosis but how active the disease is now.

How it is separated in consultation

• Disease stable: no recent flare and controlled on medication — surgery is not contraindicated, decided after confirming inflammatory markers, how long symptoms have been stable, and any steroid, immunosuppressant, or biologic use with the treating physician.
• Disease active: a lupus flare, active rheumatoid arthritis, vasculitis, high-dose steroids, or a recent biologic change — safer to postpone, as infection, delayed healing, hematoma, and systemic worsening rise together.
• Symptoms without a diagnosis: get a rheumatology work-up before suspecting the implant.
• Symptoms after placement: a time order does not mean causation, but it is not to be dismissed either — it is reviewed alongside testing.

This is discussed at length for a reason: with today’s data, neither “it is entirely unrelated” nor “the implant is to blame” can be stated. Saying the uncertain is uncertain is the right thing.

5. Why explantation alone is not a satisfying choice

Many places do not mention this, so it deserves stating. A study followed 100 women who wanted silicone implants removed from 1992, for a mean of 2.7 years, and reported the impressions of those who had removal without re-insertion (Peters et al., Annals of Plastic Surgery, 1997).^[8]

• Felt their appearance improved: 15%
• Satisfied: 36%
• Disappointed: 33%
• Felt “mutilated”: 13%

Nearly half were not satisfied with the result. Removing a long-standing implant leaves skin where it was, and with thinned tissue it often looks drooped or hollow — it is not a return to before. Other numbers from the same study are worth noting: of 186 removed implants, 57% were already ruptured or leaking, and 25% of capsules were calcified, in patients who had them a mean of 12 years. And at 2.7 years after removal, 56% said they had not been adequately informed at their first surgery — the most painful figure. In short, removal is a decision for symptoms, not for appearance; deciding while knowing this, versus not, gives entirely different satisfaction.

6. Whether to remove the capsule too

Capsulectomy removes the membrane that naturally forms around the implant. On social media, en bloc is discussed as if essential. A 2022 poll asked 736 plastic surgeons worldwide (Scheflan et al., Plastic and Reconstructive Surgery, 2022).^[3] Removal itself was accepted by most regardless of symptoms — 95.2% agreed “removal is the patient’s legitimate request” — but only 77.2% agreed with removing the capsule as well. For symptomatic patients it was removal 98% and capsulectomy 89.9%; for those without symptoms, removal 94.3% and capsulectomy 82.9%. It also split by placement: 52.5% agreed with removing capsule and implant as one block for subglandular implants, dropping to 31.4% under the muscle.

Why the split on the capsule? Because the risk of removing it is definite, while the benefit of doing so is not yet proven. This is especially so under the muscle: the capsule adheres firmly to the ribs and intercostal muscles, so removing it whole raises the risk of nerve injury, pneumothorax, chronic pain, and bleeding — which is why the rate of choosing en bloc is markedly lower there. The term itself is worth noting: en bloc is originally a cancer-surgery term — excising a tumor whole to a margin of normal tissue — a method used to treat the rare cancer BIA-ALCL that was extended to BII, not a proven standard for BII. A thin, normal capsule is generally reabsorbed after the implant is removed; a thick or calcified capsule is right to remove. It is not decided uniformly but by the state of the capsule.

7. The order followed in consultation

When removal is discussed at UNE, the order is this. First, rule out other causes — a rheumatology or endocrinology work-up is advised; if thyroid disease, anemia, or autoimmune disease is found, symptoms may persist even after removal. Second, look at the implant state — rupture or contracture is a reason to remove or exchange independent of BII, confirmed by ultrasound or MRI. Third, show the post-removal look in advance — the 33% and 13% figures above are discussed here, and fat grafting or a lift is planned alongside if needed. Fourth, decide the capsule by opening and looking — no promise of “en bloc” in advance; thin and normal is left, thick or calcified is removed. Fifth, follow for 12 months — whether an improvement at 1–3 months holds is only known with time, so short-term results are not the judgment.

8. Summary

• BII is a real complaint but not yet a diagnosis. There is no need to deny the symptoms, nor to treat them as a confirmed disease. Ruling out other causes first is the order.
• Some improve after removal, but the evidence is limited. Improvement rates ranged 17–84%, and a systematic review concluded there is insufficient evidence to support current surgical approaches.
• Removal is not a cosmetic decision. 33% of those who had removal alone were disappointed with the appearance. Deciding while knowing this changes satisfaction.

Whether to remove is ultimately yours to decide. The aim is only to set expectations accurately before deciding.

References

1. Rohrich RJ, Bellamy JL, Alleyne B. Assessing long-term outcomes in breast implant illness: the missing link? A systematic review. Plast Reconstr Surg. 2022;149(4):638e–645e. doi:10.1097/PRS.0000000000008874. (566 papers screened to 11; improvement 17–84%; insufficient evidence.)
2. Taskindoust M, Bowman T, Thomas SM, et al. The patient narrative for breast implant illness: a 10-year review of the U.S. FDA MAUDE database. Plast Reconstr Surg. 2022;150(6):1181–1187. doi:10.1097/PRS.0000000000009724. (751 voluntary reports; not a causation study.)
3. Scheflan M, Gronovich Y, Maisel Lotan A, Winder G. What 736 plastic surgeons think about explantation and capsulectomy: a global opinion poll. Plast Reconstr Surg. 2022;149(6):1071e–1079e. doi:10.1097/PRS.0000000000009076. (Surgeon opinion, not procedure outcomes.)
4. Coriddi M, Burke EA, Myers P, Soudant C, McCarthy CM. Autoimmune disease and breast implants: systematic review of outcomes. Ann Plast Surg. 2023;90(4):385–388. doi:10.1097/SAP.0000000000003466. (2 included studies; limited evidence.)
5. Sánchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast implants and the risk of connective-tissue diseases and symptoms. N Engl J Med. 1995;332(25):1666–1670. doi:10.1056/NEJM199506223322502. (Nurses’ Health Study, 87,501 cohort.)
6. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342(11):781–790. doi:10.1056/NEJM200003163421105.
7. Watad A, Rosenberg V, Tiosano S, et al. Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis. Int J Epidemiol. 2018;47(6):1846–1854. doi:10.1093/ije/dyy217. (Cross-sectional, diagnostic-code based.)
8. Peters W, Smith D, Fornasier V, Lugowski S, Ibanez D. An outcome analysis of 100 women after explantation of silicone gel breast implants. Ann Plast Surg. 1997;39(1):9–19. doi:10.1097/00000637-199707000-00002. (100 patients; mean 2.7-year follow-up.)