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 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, anxiety, and depression. The appearance of such symptoms has been reported with all types of breast implants regardless of filling, shape or surface characteristic, and the symptoms appear anywhere from right after implantation to years later.

Although some patients 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 between these symptoms and 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.

On this page:

• Medical Device Reporting Overview
• Summary of the FDA’s MDR Review
• Search terms relevant to systemic symptoms referred to as BII

Medical Device Reporting Overview

The Medical Device Reporting (MDR) regulation (21 CFR Part 803) describes the FDA’s requirements for medical device manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

MDR is one of the postmarket surveillance tools the FDA uses to monitor the performance of all medical devices, including breast implants, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

It is important to note that although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, duplicate reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can provide critical information that helps improve patient safety.

Summary of the FDA’s MDR Review

The FDA reviewed the MDR database for all reports posted between January 1, 2008 and June 30, 2024 referring to a saline- or silicone-filled breast implants whose text (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

After eliminating duplicate reports, the FDA's review identified a total of 10,318 MDRs between January 1, 2008 and June 30, 2024 meeting the established search criteria. However, many reports do not include enough information to ensure all duplicates are excluded.

Information related to the age of the patient was available in 6,191 of the 10,318 reports or 60.0%. The average age cited in these reports was 42.6 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 75.9% of the reports (7,838/10,318), enough information was provided to determine the time from breast implant implantation to the beginning of the stated systemic symptoms. In these cases, the average time to onset was 5.6 years with a range of 0-42.5 years.

Table 1 provides the top 10 most frequent systemic-related search terms appearing in the 10,318 reports.

Table 1. Most Common Systemic Signs or Symptoms

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 and joint pain.

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

Of the 10,318 reports, 4,210 (or 40.8%) reported the patient undergoing device removal at some time following the beginning of symptoms. Of these, 3,996 reports provided information sufficient to calculate the time from breast implant implantation to removal. The average time to removal was 9.1 years, with a range of 0- 47 years.  Only 785 reports provided information related to the status of a woman's symptoms following breast implant removal. Of these, 687 noted improvement and 98 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