Foreign object infections

Breast Implant Illness

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". BII occurs across all implant types, textured and untextured, as well as damaged and undamaged.

There is currently no test to detect BII and no test that can help predict the outcome of explantation. However, medical tests can find other reasons to explant such as a damaged implant.

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.

Overlap between BII and post-vax long haul

Both BII and vaccine injury show a significant overlap in symptoms. Whereas many vaccine injury and long COVID patients see a significant improvement in symptoms after several months, BII does not seem to exhibit a similar pattern. It is unclear if BII and long haul are two different facets of a similar process, or if they are distinct illnesses.

Because there is currently no test to differentiate between BII and long haul (aside from time), both patients and their doctors should consider the possibility of BII.

Symptom data from:

• https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-systemic-symptoms-women-breast-implants
• https://www.react19.org/post/persistent-neurological-symptoms-patient-survey

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).
• Autoimmune dysautonomia in women with silicone breast implants https://doi.org/10.1016/j.jaut.2021.102631 - The authors discuss a correlation between auto-antibodies and symptom severity, suggesting that autoimmunity is the cause of symptoms. It is unclear if auto-antibody tests may be useful in diagnosing BII or predicting explantation outcomes.
• 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.

Parallels between BII and replacement joint infections

The scientific literature strongly suggests that both conditions are caused by similar processes. With breast implants, the study by Lee and colleagues (https://dx.doi.org/10.1097%2FGOX.0000000000002755) found that Propionibacterium acnes, Staphylococcus epidermidis, and fungal Candida species all grow on implants. All of those species have also been found growing on prosthetic/replacement joints.

• A joint infection study by Achermann and colleagues (https://dx.doi.org/10.1128%2FJCM.00006-10) have found Staphylococcus aureus, Coagulase-negative staphylococci, Streptococcus species (mitis, agalactiae, dysgalactiae, gallolyticus, pneumoniae), Propionibacterium acnes, and Candida albicans.
• Koskela and colleagues (https://doi.org/10.1007/s10096-008-0664-6) as well as Hischebeth and colleagues (https://doi.org/10.1016/j.diagmicrobio.2018.08.012) discuss the role of Staphylococcus epidermidis in replacement joint infections.

Despite the parallels, a BII diagnosis is not mainstream while a joint infection diagnosis is mainstream. Both sets of literature rarely reference one another.

In terms of detecting infections growing on foreign objects, the replacement joint literature rarely recognizes the difficulties associated with detecting microorganisms. There is a presumption that their medical tests have very few false positives and false negatives. There is very little discussion about patients who may be suffering because they have an infection that is difficult to detect. The microbiology literature has plenty of information on microorganisms that are difficult to detect. Many microorganisms have a "viable but non-culturable" state where they are living but not dividing; usually microorganisms enter this state to survive harsh environments until more favourable conditions arrive that would allow them to reproduce and flourish (see https://doi.org/10.1016/j.mimet.2011.04.018). For many species, scientists do not know how to get these microorganisms to replicate. Some areas of medicine wrongly assume that there is no infection because the lab is unable to culture the microorganisms and get them to reproduce. This may potentially cause many chronic conditions to be underdiagnosed. In the BII study by Lee and colleagues (https://dx.doi.org/10.1097%2FGOX.0000000000002755), only 36% of the breast implants were associated with a positive culture test while 84% of the explantation surgeries led to improvements in symptoms. This suggests that culture tests (even with better methodology such as sonication) would miss most patients who would benefit from explantation.

With breast implant illness, many doctors do not believe that such a condition exists so their denial may be the leading cause of underdiagnosis.

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.

They may share information on how to find doctors who are knowledgeable about BII.

Support groups may have certain biases such:

• The viewpoint that the capsule scar tissue is also a cause of BII and should be removed during explantation.
• Favoring explantation.

More resources

Breast Implant Illness .com has a wealth of information on symptoms, tests, surgeons, etc.

Infections related to joint replacements and other medical devices

Introduction

The dominant narrative in the literature for joint replacements and biofilms is that bacterial and fungal biofilms are responsible for chronic infections that lead to health problems.

Diagnostic testing

The flowchart below shows one algorithm for diagnosing a periprosthetic joint infection (periprosthetic = close to prosthetic). Testing includes:

• May include symptoms such as:
  • Pain/redness/warmth/drainage at the incision site
  • Swelling of the joint/limb
  • Pain or stiffness in the joint after a pain-free period
  • Fever
  • Chills or night sweats
  • Fatigue
  • General malaise (a general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify)
• Blood tests to measure ESR (Erythrocyte sedimentation rate) and CRP (C-Reactive Protein). Both are associated with inflammation generated by infections.
• Fluid samples from the joint. These samples can be cultured to look for bacteria and fungus/yeast. However, many potentially pathogenic microorganisms are difficult to culture so these tests may yield false negatives. Culture-negative PJI (Periprosthetic joint infection) has been reported in 7% of PJI episodes treated at Mayo Clinic Rochester from 1990-1999 (see https://doi.org/10.1086/522184).
• Biopsy

Source: Figure 1 from https://dx.doi.org/10.5371%2Fhp.2021.33.1.11

Other tests include:

• Elevated white blood cell count in synovial fluid (the fluid that lubricates joints).
• Elevated neutrophil percentage in synovial fluid.
• Purulence (pus) in the affected joint.
• Nuclear imaging

References:

• Current Guideline for Diagnosis of Periprosthetic Joint Infection: A Review Article https://dx.doi.org/10.5371%2Fhp.2021.33.1.11
• Periprosthetic joint infection: Current concept https://dx.doi.org/10.4103%2F0019-5413.106884

Treatment

Unfortunately, pathogens growing in biofilms are extremely difficult to eradicate with antibiotics/antifungals and are resistant to eradication by the immune system.

Removal of the medical device or prosthetic can eliminate the environment that helps biofilms thrive. However, certain types of explantation surgeries (e.g. pacemakers, heart valves) are very risky.

The chronic Lyme / PTLDS literature may offer some hope for non-surgical treatments. Animal model experiments by Monica Embers and colleagues provide strong evidence that Borrelia bacteria biofilms can cause chronic illness (see https://youtu.be/kZyI46hRIrk and https://doi.org/10.3389/fmed.2021.666554). Anna Goc and colleagues have found that chemicals produced by plants are effective in dismantling biofilms in lab environments as well as in human beings. A non-controlled trial on humans (https://doi.org/10.1177/2040622320922005) found that 3/17 participants became symptom free and an additional 8/17 participants demonstrated significant improvement.

Essure (permanent birth control for females)

Essure injuries were featured in the Netflix documentary The Cutting Edge.

Symptom prevalence reported in a paper by Maassen and colleagues (https://sci-hub.se/https://doi.org/10.1016/j.jmig.2018.10.009) are as follows:

Common Essure symptoms

Symptom	Prevalence (%)
Abdominal pain	69.9%
Back pain	31.2%
Fatigue	31.2%
Pain in legs and hips	29.0%
Dysmenorrhea (severe and frequent menstrual cramps and pain during a woman's period)	18.3%
Heavy menstrual bleeding	17.2%
Skin rash	16.1%
Cycle changes	15.1%
Pain in joints	11.8%
Intermenstrual bleeding	9.7%
Dyspareunia (persistent or recurrent genital pain that occurs just before, during or after intercourse)	9.7%
Itching	8.6%

Some symptom frequencies are similar to long haul while others are not (e.g. intercourse-related pain, rash, pain in legs and hips, back pain, abdominal pain).