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Medical Device Reports for Systemic Symptoms in Women with Breast Implants

A number of patients and clinicians use the term "breast implant illness" or "BII" to describe a variety of systemic symptoms that have been reported by some women following reconstruction or augmentation with breast implants. These symptoms 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.

The FDA reviewed the medical device report (MDR) database for all reports posted between January 1, 2008 and June 30, 2023 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:

  • BII
  • 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 about causality in individual cases.

After eliminating duplicate reports, the FDA's review identified a total of 9,458 MDRs meeting the established search criteria. However, many reports do not include sufficient information to ensure all duplicated are excluded.

Information related to the age of the patient was available in 5,569 of the 9,458 reports or 58.8%. The average age cited in these reports was 42.4 years of age with a range of 9-99 years. Several reports 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 76% of the reports (7,207/9,458), 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 5.4 years with a range of 0-42.5 years.

Table 1 provides the top 10 most frequent systemic-related search terms appearing in the 9,458 reports.

Table 1. Most Common Systemic Signs or Symptoms

Symptom Percent of MDRs Reporting Symptom*
Fatigue 42.1
Joint pain 30.5
Anxiety 23
Brain fog 22.9
Autoimmune diseases** 21.1
Hair Loss 20.1
Depression 17.3
Rash 16.7
Headache 16.1
Weight (loss, gain, other) 15.5

* Reports sometimes may list more than one symptom.

** Any mention of autoimmune disease which includes symptoms of, or diagnosis of autoimmune diseases

Of the 9,458 reports, 3,861 (or 40.8%) reported the patient undergoing device explant at some time following the onset of symptoms. Of these, 3,664 reports provided information sufficient to calculate the time from implantation to explant. The average time to explant was 8.9 years, with a range of 0- 47 years.  Only 752 reports provided information related to the status of a woman's symptoms following explant. Of these, 658 noted improvement and 94 noted either no improvement or worsening of symptoms.

The FDA will continue to monitor MDRs and provide updates as warranted.

Appendix A. Search terms relevant to systemic symptoms referred to as BII

acid reflux ear ringing illness premature aging
adrenal early menopause inflammation rash
allergy easy bruising insomnia Raynaud
allergies EBV intolerana reflux
anxiety fibromyalgia joint  rheumatoid arthritis
arthritis fog joint pain scleroderma
autoimmune frequent urination kidney shortness of breath
BII gallbladder leaky gut SIBO
Breast implant illness gastritis libido sick
candida Fatigue liver sinus
chest discomfort fever lupus Sjogren
choking     gastrointestinal issues Lyme disease sleep
cold GERD memory loss slow healing
connective tissue GI issues metallic taste slow muscle recovery
cough hair loss migraine throat clearing
dehydration Hashimoto multiple sclerosis thyroid
depression headaches muscle pain tingling
difficulty swallowing heart pain night sweats toxic
dry eyes heart palpitations numbness toxic shock
dry hair heart rate pancreatitis urinary tract
dry skin hormone panic attack vertigo
dying hysterectomy parathyroid weight
  IBS   yeast

a Use of the * wildcard will capture all words that begin with "intoleran", including intolerance and intolerant

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