Breast Implant Illness (BII): Symptoms, Research & What to Know: Evidence-based guide to breast implant illness symptoms, FDA position, current research, explant outcomes, and doctor discussion points. Includes key tips.
Key Takeaways
- BII is a patient-reported condition â a collection of systemic symptoms that some patients attribute to their breast implants.
- There is currently no diagnostic test for BII, and the medical community has not reached consensus on its cause.
- Commonly reported symptoms include fatigue, brain fog, joint pain, hair loss, and autoimmune-like symptoms.
- The FDA acknowledges patient reports and requires manufacturers to inform patients about BII in labeling.
- Some patients report symptom improvement after explantation (implant removal), though this is not guaranteed.
- Large-scale studies have not established a causal link between silicone implants and autoimmune disease.
If you are experiencing symptoms you believe may be related to your breast implants, consult with your plastic surgeon and primary care physician. A thorough medical evaluation is important to rule out other conditions.
What Is Breast Implant Illness?
Breast Implant Illness (BII) â also referred to colloquially as breast implant sickness â is a term used by patients to describe a wide range of systemic symptoms including fatigue, cognitive problems, joint pain, and immune dysfunction that they attribute to their breast implants, whether saline or silicone.
BII is not an official medical diagnosis â it does not appear in the ICD (International Classification of Diseases) coding system. There is no single breast implant illness test or diagnostic panel that confirms BII. However, it is a real clinical phenomenon that the FDA, professional medical societies, and breast implant manufacturers now formally acknowledge.
The question of whether breast implants can cause systemic illness has been one of the most studied and debated topics in plastic surgery for over three decades.
We present BII information with both clinical rigor and respect for patient experiences. While large-scale studies have not established a causal mechanism, the consistency and volume of patient reports warrant serious consideration and continued research.
BII Symptoms List
The following BII symptoms list represents the most commonly reported complaints from patients. If you recognize multiple symptoms on this list that developed or worsened after augmentation, discuss them with your medical team:
Many of these symptoms overlap with common autoimmune conditions, thyroid disorders, fibromyalgia, chronic fatigue syndrome, and menopause. A thorough medical evaluation to explore all possible causes is essential before attributing symptoms to breast implants.
Most Common BII Symptoms
- Chronic fatigue: Persistent exhaustion not resolved by sleep.
- Cognitive dysfunction ("brain fog"): Difficulty concentrating, memory problems.
- Joint and muscle pain: Widespread pain without clear cause.
- Hair loss: Thinning hair or excessive shedding.
- Dry eyes, dry mouth: Sicca-like symptoms.
- Skin rashes: Various dermatological issues.
- Anxiety and depression: Mood changes not previously experienced.
- Sleep disturbances: Insomnia or unrestorative sleep.
- GI problems: Digestive issues, food sensitivities.
- Temperature dysregulation: Sensitivity to heat and cold.
- Headaches: Frequent or chronic headaches.
- Hormonal imbalances: Changes in menstruation or thyroid function.
What Does the Research Say?
The relationship between breast implants and systemic illness has been extensively studied. Here is what the current evidence shows:
Large-Scale Studies
Multiple large epidemiological studies conducted since the 1990s â including those by the Institute of Medicine (IOM), the National Academy of Sciences, and multiple meta-analyses â have not found a confirmed causal link between silicone breast implants and defined autoimmune diseases.
However, these studies also acknowledged that they could not completely rule out a connection to less-defined symptom clusters, and that some individuals may have heightened sensitivity to implant materials.
Emerging Research
More recent research has explored several potential mechanisms:
- Immune activation: Some studies show measurable immune system changes in symptomatic implant patients.
- Silicone sensitivity: A small percentage of patients may have an inflammatory response to silicone particles.
- Biofilm hypothesis: Chronic low-grade infection around the implant may trigger systemic inflammation.
- Genetic susceptibility: Research suggests some patients may have genetic predispositions that make them more vulnerable.
- Heavy metal concerns: Some studies have examined trace metals in implant shells and their potential systemic effects.
FDA Position on BII
The FDA has taken increasingly responsive steps regarding BII:
Since 2021, the FDA requires that every patient considering breast implants receive and sign a Patient Decision Checklist that includes information about BII. This ensures patients are informed about the possibility of systemic symptoms before surgery.
Key FDA Actions
- 2019: FDA acknowledges "breast implant illness" in public communications and requests manufacturers study systemic symptoms.
- 2020: FDA recommends enhanced labeling with "boxed warning" about known risks, including systemic symptoms.
- 2021: Patient Decision Checklist required â includes information about BII symptoms so patients can make informed decisions.
- Ongoing: FDA requires post-approval studies tracking systemic symptoms in breast implant patients.
Explantation and Symptom Resolution
Many patients who believe they have BII choose to have their implants removed (explantation). Here's what the data shows about outcomes:
What Studies Show
- Multiple patient-reported surveys show 60â90% of BII patients report symptom improvement after explantation.
- Improvement is often reported within weeks to months after removal.
- Some patients report complete resolution of symptoms; others report partial improvement.
- A subset of patients do not improve after explantation, suggesting other factors may be at play.
- The placebo effect and natural symptom fluctuation make it difficult to draw causal conclusions from self-reported data.
- Controlled studies comparing explantation to sham surgery have not been conducted (and would be ethically challenging).
Explantation Considerations
- En bloc capsulectomy: Many BII patients and surgeons prefer removing the implant and capsule intact (as one piece).
- Total capsulectomy: Complete removal of the scar tissue capsule, even if not in one piece.
- Cost: Explantation surgery typically costs $4,000â$10,000 depending on complexity.
- Insurance: Some insurers cover explantation if there is a documented medical reason (e.g., rupture, contracture). Coverage for BII-related explantation varies.
- Breast appearance: Breasts will look different after implant removal. Some patients choose a breast lift (mastopexy) at the time of explantation.
Breast Implant Illness Treatment Options
While there is no FDA-approved breast implant illness treatment protocol, several approaches are used by patients and their care teams:
Current Treatment Approaches
- Explantation: Implant removal (with or without capsulectomy) is the primary intervention. Many patients report symptom relief.
- Anti-inflammatory protocols: Some physicians prescribe dietary changes, supplements, and anti-inflammatory medications to manage symptoms.
- Autoimmune specialist referral: Rheumatology evaluation to rule out or co-manage overlapping autoimmune conditions.
- Detoxification support: Some functional medicine practitioners recommend toxin clearance protocols, though clinical evidence is limited.
What to Do If You Suspect BII
If you're experiencing symptoms you believe may be related to your breast implants:
Recommended Steps
- 1. See your primary care physician: Get a thorough medical evaluation to rule out thyroid disorders, autoimmune conditions, fibromyalgia, and other potential causes.
- 2. Consult your plastic surgeon: Discuss your symptoms and whether explantation may be appropriate.
- 3. Get blood work: ANA, thyroid panel, inflammatory markers, and other relevant tests.
- 4. Check your implants: MRI or ultrasound to evaluate implant integrity (silent rupture can cause local symptoms).
- 5. Research surgeons: If considering explantation, find a board-certified plastic surgeon experienced in explant procedures and en bloc capsulectomy.
- 6. Document symptoms: Keep a symptom diary to track patterns, triggers, and changes over time.
Frequently Asked Questions
References & Sources
- US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Annals of Surgery (2019) . View source â
- Breast Implants â Certain Labeling Recommendations. FDA Guidance (2020) . View source â
- Silicone Implant Illness: Science versus Myth?. Plastic and Reconstructive Surgery (2019) . View source â
- Safety of Silicone Breast Implants. National Academy Press (1999) . View source â
This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult with a board-certified plastic surgeon or qualified healthcare provider before making any medical decisions.