Breast Implant Illness (BII) is a patient-reported syndrome characterized by a range of systemic symptoms experienced by individuals with breast implants. This condition is a subject of ongoing medical discussion, raising questions about the long-term safety of medical devices used for both cosmetic augmentation and reconstructive surgery. The complexity surrounding BII stems from the difficulty in establishing a clear medical definition and determining how frequently it occurs in the population of people with implants.
Defining Breast Implant Illness and Its Symptoms
Breast Implant Illness is currently recognized as a syndrome—a collection of varied signs and symptoms—rather than a single, universally accepted disease with a specific diagnostic code or biomarker. The symptoms often affect multiple body systems, contributing to the challenge of diagnosis.
The most frequently reported symptoms include chronic fatigue and cognitive problems known as “brain fog,” which involves difficulty with memory and concentration. Physical manifestations commonly involve widespread joint pain, muscle aches, and generalized muscle weakness. Other recurring symptoms may include hair loss, skin rashes, sleep disturbances, dry eyes, and symptoms resembling autoimmune or connective tissue disorders. These systemic complaints can develop any time after surgery, sometimes immediately and sometimes many years later.
The Challenge of Measuring Prevalence
Directly quantifying how common BII is presents a significant scientific hurdle because there is no standardized, formal case definition. Without agreed-upon diagnostic criteria, researchers cannot easily conduct large-scale epidemiological studies to establish a clear incidence rate. The reliance on patient self-reporting is another complicating factor, as BII symptoms are non-specific and overlap considerably with many other conditions, such as fibromyalgia and chronic fatigue syndrome.
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), track data through passive surveillance systems like the Manufacturer and User Facility Device Experience (MAUDE) database. This system collects adverse event reports submitted by patients, doctors, and manufacturers. However, these spontaneous reports are limited by underreporting and are not clinically verified diagnoses, meaning they suggest a pattern but do not confirm a causal relationship.
The difficulty in obtaining concrete statistics is further compounded by the variety of implants used, including differences in shell material, surface texture, and filling (saline versus silicone). Until a specific biomarker or a universally accepted set of criteria is established, the true prevalence of BII will remain elusive and subject to a wide range of estimates.
Current Estimates on How Common BII Is
Despite the challenges in measurement, various studies have produced a broad range of estimates regarding the frequency of BII. Published studies suggest that between 1% and 10% of women with breast implants may experience symptoms consistent with the syndrome. This wide range reflects the different methodologies and definitions used across research groups.
Patient advocacy groups and self-reported surveys often suggest a higher frequency, driven by increased awareness through social media and patient networks. Some large epidemiological studies comparing symptom rates in women with and without implants have yielded varied results. For instance, one study found that approximately 20% of both the implant group and the non-implant control group reported four or more severe BII-like complaints, suggesting the symptoms occur at equal rates in both populations.
Women with breast implants, particularly silicone implants, have also been shown in some studies to have an increased risk for a formal diagnosis of an autoimmune or rheumatic disorder. One large-scale study indicated that women with silicone implants had a 45% increased risk of being diagnosed with at least one such disorder compared to those without implants. While this does not equate to a BII diagnosis, it suggests an increased susceptibility to immune system dysregulation in some recipients.
Diagnosis and The Role of Explantation
Given the lack of a definitive diagnostic test, the current clinical approach to BII involves a diagnosis of exclusion. This process requires a thorough medical investigation to rule out other established conditions that share similar symptoms, such as thyroid disorders, lupus, rheumatoid arthritis, or other connective tissue diseases.
The primary treatment option for individuals diagnosed with BII is explantation, which is the surgical removal of the breast implants and often the surrounding scar capsule. Patient-reported outcomes following explantation are a cornerstone of the evidence supporting the syndrome. A systematic review found that a majority of patients, around 81.9%, reported an improvement in their systemic symptoms after having their implants removed. While this outcome is not guaranteed for every patient, the resolution of symptoms following explant surgery is widely cited as the most compelling evidence that the implants were the source of the illness.