Breast Implant Illness, often referred to as “BII,” is a term used by some patients and healthcare providers to describe a range of systemic symptoms reported by individuals who have undergone breast reconstruction or augmentation with breast implants. These symptoms, while varied, are a cause of concern for many.
Patients reporting BII experience a spectrum of health issues that can significantly impact their quality of life. These are not limited to, but commonly include:
- Persistent fatigue
- Cognitive difficulties, such as memory problems and lack of concentration, often described as “brain fog”
- Aches and pains in joints and muscles
- Unexplained hair loss
- Fluctuations in weight
- Feelings of anxiety and depression
It’s important to note that these symptoms have been reported across all types of breast implants, regardless of the material used for filling (saline or silicone), shape, or surface texture. The onset of these symptoms can vary greatly, appearing shortly after implantation or many years later.
While some individuals have reported improvement or even complete resolution of these symptoms following the removal of their breast implants, the underlying cause of BII and the direct link to implants remain unclear. Ongoing research is dedicated to better understanding any potential connection between these symptoms and breast implants. Currently, it is critical to understand that BII is not recognized as a formal medical diagnosis. There are no established diagnostic tests or universally accepted criteria to define or characterize this condition.
To monitor and understand potential issues related to medical devices like breast implants, the U.S. Food and Drug Administration (FDA) utilizes a system called Medical Device Reporting (MDR).
The Role of Medical Device Reporting (MDR)
The Medical Device Reporting (MDR) regulation, as outlined in 21 CFR Part 803, is a crucial tool used by the FDA to oversee the safety and performance of medical devices, including breast implants, after they are on the market. This regulation mandates that medical device manufacturers, importers, and user facilities report certain adverse events and product issues to the FDA.
MDR serves as a postmarket surveillance system, enabling the FDA to:
- Monitor the ongoing performance of all medical devices.
- Identify potential safety concerns related to devices.
- Contribute to benefit-risk assessments of these medical products.
It is vital to understand the limitations of the MDR system. As a passive surveillance system, MDR data alone cannot determine the incidence, prevalence, or cause of an event. This is due to factors such as:
- Under-reporting of adverse events.
- Duplicate reporting of the same event.
- Inaccuracies within reports.
- Lack of definitive proof that the device caused the reported event.
- Absence of data on the frequency of device use.
Therefore, MDR reports represent just one piece of the FDA’s comprehensive postmarket surveillance strategy. These reports, when analyzed alongside data from other sources, provide essential information that aids in enhancing patient safety.
Key Findings from the FDA’s MDR Review on BII Symptoms
The FDA conducted a thorough review of the MDR database, examining reports submitted between January 1, 2008, and June 30, 2024. This review focused on reports related to saline-filled or silicone-filled breast implants where the report text included terms associated with systemic symptoms or “breast implant illness,” including the term “BII” itself.
After removing duplicate reports, the FDA’s analysis identified a total of 10,318 MDRs that met the search criteria. It’s important to acknowledge that some duplicates may still be present due to incomplete information in some reports.
Age information was available in approximately 60% of these reports (6,191 out of 10,318). Among these, the average age of patients reporting symptoms was 42.6 years, with a wide range from 9 to 99 years. Notably, some reports involved children of women with breast implants, where the reporter believed the child’s symptoms were linked to the mother’s implants.
For about 76% of reports (7,838 out of 10,318), there was sufficient data to determine the time between breast implant surgery and the onset of systemic symptoms. In these cases, the average time to symptom onset was 5.6 years, ranging from immediately after implantation to 42.5 years later.
The following table outlines the ten most frequently reported systemic symptoms found within the 10,318 MDR reports:
| Symptom | Percentage of MDRs |
|---|---|
| Fatigue | 41.1% |
| Joint Issues* | 30.9% |
| Anxiety | 22.9% |
| Autoimmune diseases** | 22.6% |
| Fog | 22.5% |
| Hair Loss | 19.6% |
| Illness | 18.7% |
| Depression | 16.9% |
| Rash | 16.7% |
| Weight (loss, gain, other) | 16.5% |
* Includes joint pain.
** Includes symptoms or diagnosis of autoimmune diseases.
Of the total reports, 4,210 (approximately 41%) indicated that the patient underwent breast implant removal after the onset of symptoms. Among these, 3,996 reports provided enough detail to calculate the time from implantation to removal. The average time to implant removal was 9.1 years, with a range of up to 47 years. Information on symptom status after implant removal was available in only 785 reports. Of these, 687 reported improvement in symptoms, while 98 reported no improvement or worsening of symptoms.
The FDA has stated it will continue to actively monitor MDRs related to breast implants and will provide updates as more information becomes available.
In Conclusion
Breast Implant Illness (BII) remains a topic of ongoing discussion and research. While not currently a formally recognized medical diagnosis, the FDA is actively monitoring reported systemic symptoms associated with breast implants through its Medical Device Reporting system. The data gathered provides valuable insights into the experiences of patients and helps guide further investigation. It is crucial for patients and healthcare providers to have open conversations and to rely on credible sources like the FDA for the most up-to-date information as research continues in this area.
