Foreign object infections

Introduction

FDA data shows that chronic health problems are reduced in most patients who decide to have their breast implants removed (explantation). Nonetheless, breast implant illness (BII) is a controversial illness as many doctors do not believe that breast implants can lead to the development of chronic health problems. Despite presenting data on health outcomes following explantation, the FDA notes that "BII is not recognized as a formal medical diagnosis".

There is currently no test to detect BII and no test that can help predict the outcome of explantation.

One theory is that the bacterial biofilm colonies growing on breast implants are responsible for chronic health issues. A study by Lee at el. found that culturable bacteria and other microorganisms were 6 times more common in BII patients than non-BII patients with breast implants.

FDA data

Outcomes

https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants

Of the 3,577 MDRs [Medical Device Reporting reports], 1535 (or 43%) reported the patient undergoing device explant at some time following the onset of symptoms. Of these, 1,473 reports provided information sufficient to calculate the time from implantation to explant. The average time to explant was 9 years, with a range of 0- 47 years. Only 290 MDRs provided information related to the status of a woman’s symptoms following explant. Of these, 279 noted improvement and 11 noted either no improvement or worsening of symptoms.

Most common systemic signs or symptoms

Symptom	Percentage of MDRs (N=3,577)
Fatigue	49%
"Brain Fog"	25%
Joint Pain	25%
Anxiety	24%
Hair Loss	21%
Depression	19%
Rash	18%
Autoimmune Diseases (incl. symptoms of autoimmune disease)	18%
Inflammation	18%
Weight Fluctuation	18%

Data on breast implant illness

• FDA data: https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants
• NIH data: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8342259/
  • 23% of patients reported complete resolution of symptoms following explantation, with 74% reporting partial resolution. Only 3% reported no improvement.

Scientific papers

• ‘ASIA’ – Autoimmune/inflammatory syndrome induced by adjuvants https://www.sciencedirect.com/science/article/abs/pii/S0896841110000788 - This review paper (over 800 citations) discusses how autoimmune syndromes are linked to vaccine adjuvants, breast implants, and Gulf war syndrome (GWS).
• Breast Implant Illness: A Biofilm Hypothesis https://dx.doi.org/10.1097%2FGOX.0000000000002755
• Still's disease, lupus-like syndrome, and silicone breast implants. A case of 'ASIA'(Shoenfeld's syndrome) https://www.researchgate.net/profile/Miguel-Saavedra-13/publication/221738376_Still%27s_disease_lupus-like_syndrome_and_silicone_breast_implants_A_case_of_%27ASIA%27_Shoenfeld%27s_syndrome/links/0a85e5325f08a081a5000000/Stills-disease-lupus-like-syndrome-and-silicone-breast-implants-A-case-of-ASIA-Shoenfelds-syndrome.pdf
• Two hundreds cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature https://doi.org/10.1007/s12026-016-8821-y
• Chronic fatigue syndrome with autoantibodies—the result of an augmented adjuvant effect of hepatitis-B vaccine and silicone implant http://www.cfsitalia.it/Documenti/ChronicFatigue_HBV_vaccine_silicone_implants.pdf - This case report suggests that there are safety concerns with giving vaccines (specifically Hepatitis B) to individuals with silicone implants.
• Silicone Gel Breast Implants and Connective Tissue Disease—A Comprehensive Review https://sci-hub.se/https://doi.org/10.1080/08916931000148818 - Discusses the correlation between breast implants and scleroderma, a group of rare diseases that involve the hardening and tightening of the skin. Scleroderma is believed to be an autoimmune disease.

The scientific literature refers to BII as siliconosis, ASIA / autoimmune/inflammatory syndrome induced by adjuvants, and silicone implant incompatibility syndrome. Many articles on this topic can be found by searching Google Scholar.

Support groups

Support groups and communities can be found via Facebook and Youtube (search Youtube for "breast implant illness"). The largest Facebook support group is Breast Implant Illness and Healing by Nicole with 159k members.

Support groups may have certain biases such as the viewpoint that the capsule scar tissue is also a cause of BII. They may be biased towards explanation the capsule along with the implant and biased towards favoring explantation.