Editor’s Note: When the U.S. Food and Drug Administration updates certain content on its website, it may replace earlier versions of that content. This information was current as of August 4, 2022, and remained online in this format until December 15, 2023, when it was updated and replaced by a more recent version of the same FDA analysis. The following version of the FDA’s report, from August 4, 2022, may also be viewed on the Internet Archive, here.
U.S. Food and Drug Administration—
A number of patients and clinicians use the term “breast implant illness” or “BII” to describe a variety of systemic symptoms which may be reported by some women following reconstruction or augmentation with breast implants. They include, but are not limited to, fatigue, problems with memory or concentration (“brain fog”), joint and muscle pain, hair loss, weight changes and anxiety/depression. The appearance of such symptoms has been reported with all types of breast implants regardless of filling, shape or surface characteristic, and their onset anywhere from immediately after implantation to years later. Although some women report improvement or resolution of symptoms following removal of the implants, the cause of the symptoms and the degree to which they may be related to the implants are unclear at the current time. Research continues to be performed to better understand any potential association with breast implants. Currently, however, BII is not recognized as a formal medical diagnosis and there are no specific tests or recognized criteria to define or characterize it.
FDA conducted a query of the MDR database for all reports posted between January 1, 2008 and April 1, 2022 referring to a saline- or silicone-filled breast prosthesis whose event narrative included one or more of the terms listed in Appendix A, or one of the following terms or phrases:
- Breast implant illness
- Generalized/unexplained illness
- Unexplained systemic symptoms.
It is important to note that while the MDR system is a valuable source of information, it is a passive surveillance system with significant limitations, including incomplete, inaccurate, untimely, unverified, or biased data in the reports. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants. Furthermore, the receipt of an MDR does not itself establish or confirm that the device caused or contributed to the adverse event or symptom reported. Concurrent medications or devices, habits and known or unrecognized patient comorbidities or conditions may confound the ability to draw a definitive conclusion regarding causality in individual cases.
After eliminating apparent duplicate reports, FDA’s query identified a total of 7,467 MDRs meeting the established search criteria. However, missing information limited our ability to identify all potential duplicate reports. The majority (82.2% ) of the MDRs were received after October 2018.
Information related to the age of the patient was available in 4,196 of the 7,467 reports or 56%. The average age cited in these reports was 42.3 years of age with a range of 9-88 years. Several MDRs were submitted for children born to women with breast implants where the reporter believed the child’s symptoms or events to be attributable to the mother’s implants.
For 78% of the MDRs (5,798/7,467), enough information was provided to determine the time from device implantation to the onset of the stated systemic symptoms. In these cases, the average time to onset was 5.1 years with a range of 0-42.5 years.
Table 1 provides the top 10 most frequent systemic-related search terms appearing in the 7,467 reports.
Table 1. Most Common Systemic Signs or Symptoms
|Percentage of MDRs (N=7,467)
* Any mention of autoimmune disease which can includes symptoms of, or diagnosis of autoimmune diseases
Of the 7,467 MDRs, 2,972 (or 40%) reported the patient undergoing device explant at some time following the onset of symptoms. Of these, 2,869 reports provided information sufficient to calculate the time from implantation to explant. The average time to explant was 8.5 years, with a range of 0- 47 years. Six hundred fifty-seven MDRs provided information related to the status of a woman’s symptoms following explant. Of these, 577 noted improvement and 80 noted either no improvement or worsening of symptoms.
FDA will continue to monitor MDRs and provide updates as warranted.
Appendix A. Search terms relevant to systemic symptoms referred to as BII
|shortness of breath
|slow muscle recovery
- Content current as of: 08/04/2022
- Regulated Product(s): Medical Devices