Breast Implant Safety

Breast Implants Linked to
Systemic Symptoms, Autoimmune and Cancers

After nine years of our activism, on October 27, 2021 the FDA issued orders restricting the sales and distribution of breast implants to ensure patients are provided risk information including a black box warning and checklist for breast implants (already categorized as a Class III medical device which are known to have a high risk to users) to warn women of the negative health problems which hundreds of thousands of women are reporting. Here is the FDA’s statement acknowledging systemic symptoms from breast implants which this website listed and coined as “breast implant illness” in 2013. Over the years, several kinds of breast implants have been removed from the market for failure or for being associated with BIA-ALCL which is a cancer of the immune system.  Recently the the FDA issued another statement that various cancers are found in the capsule tissue that surrounds implants. Check for breast implant recalls here: FDA Medical Device Recalls. 

On September 2018 the largest study ever published of silicone breast implants shows silicone breast implants are associated with an increased risk of autoimmune diseases such as Sjogren’s syndrome, Scleroderma, Rheumatoid Arthritis, stillbirths and melanoma cancers.  Additionally, another study published October 2018 found an association between silicone breast implants and a higher likelihood of being diagnosed with various autoimmune/rheumatic disorders such as sarcoidosis, systemic sclerosis and Sjogren’s syndrome. Contrary to plastic surgeons telling women that breast implants are completely safe, the science and evidence of the negative health consequences of breast implants continues to come to light.

350,000 Breast Implant Incidents Hidden

Why has breast implant illness been hidden from the public for so long?  In November 2018, the International Consortium of Investigative Journalists (ICIJ) broke out its global examination of medical device failures in Implant Files and specifically their investigative story Breast Implants Injuries Kept Hidden As New Health Threats Surface by Sasha Chavkin which details how adverse event reports regarding breast implant injuries were hidden from the public.  After ICIJ’s Implant Files were released, the FDA, Health Canada and other international regulatory bodies came under scrutiny regarding medical devices including breast implants and consequently the FDA announced safety discussions regarding breast implants.  On the eve of the safety discussions, the FDA revealed that they Kept  Hundreds of  Thousands of Breast Implant Incidents Hidden From Public.  

What Doctors and the FDA
Aren’t Telling You About Breast Implants

Cohesive Gel Implants are not Safer

Many women ask us, are there any safe breast implants?  The answer is no, there are no safe breast implants, all kinds of breast implants (saline, silicone and cohesive gel/gummy bear) cause symptoms and breast implant illness.  Manufacturers and plastic surgeons have a long, erroneous history of insisting each new generation of breast implants are safer than previous generations.  In the beginning of breast augmentation history,  doctors were injecting silicone which caused death to women.  Then came the runny silicone breast implants which leaked,  ruptured and caused broad illness resulting in lawsuits and the bankruptcy of Dow Corning. Then plastic surgeons promoted saline as the new safe breast implant but now we know saline cause symptoms too and can mold.  Since 2005, plastic surgeons have been promoting cohesive gel/gummy bear breast implants as the new safe breast implant however, again, this is not true and cohesive gel seem to be the most chemically aggressive implants laden with heavy metals which are used to make the silicone cohesive and these aggressive chemicals and heavy metals are causing profound illness much earlier than previous implants.  In addition, we have several photos of ruptured and leaking cohesive gel implants which shows they are not exactly cohesive in the human body.

Silicone Toxicity and Silicone Gel Bleed

Instead of being told the lie that silicone is an inert and biologically inactive substance, we wish we had been told the truth which is silicone is made up of approximately 40 toxic chemicals and an array of heavy metals which will damage your health, and that silicone bleeds through the shell microscopically from early on. The ingredients of silicone were revealed in the Dow Breast Implant Trial and although they tried to cover it up after the fact, it has become public knowledge and both the ingredients of silicone and the coverup are described in the book Breast Implants and the D.I.R.T. Committee by Gail Hamilton. Plastic surgeons don’t talk about the ingredients in silicone because nobody would buy implants if they knew the toxic chemicals and heavy metals in them. If you research each of the chemicals of silicone online you will read that they are defined as as cytotoxic, neurotoxic, endocrine disruptors, carcinogenic and harsh irritants to live tissues causing inflammation and damaging organs and glands. Here are some of the known ingredients in breast implants:

  • Methyl ethyl ketone (neurotoxin)
  • Cyclohexanone (neurotoxin)
  • Isopropyl Alcohol
  • Denatured Alcohol
  • Acetone (used in nail polish remover and is a neurotoxin)
  • Urethane
  • Polyvinyl chloride (neurotoxin)
  • Amine
  • Toulene
  • Dicholormethane (carcinogen)
  • Chloromethane
  • Ethyl acetate (neurotoxin)
  • Silicone
  • Sodium fluoride
  • Lead Based Solder
  • Formaldehyde
  • Talcum powder
  • Oakite (cleaning solvent)
  • Methyl 2- Cynanoacrylates
  • Ethylene Oxide (Carcinogen)
  • Xylene (neurotoxin)
  • Hexon
  • 2-Hedanone
  • Thixon-OSN-2
  • Stearic Acid
  • Zinc Oxide
  • Naptha (rubber solvent)
  • Phenol (neurotoxin)
  • Benzene (carcinogen/neurotoxin)
  • Lacquer thinner
  • Epoxy resin
  • Epoxy hardener
  • Printing Ink
  • Metal cleaning acid
  • Colour pigments as release agents
  • Heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
  • Platinium
  • Silica

How Silicone Bleeds Through
the Shell of the Breast Implant

How Silicone Bleeds Through the Shell of the Breast Implant

Here is a video demonstrating how silicone bleeds through the shell of the breast implant and can be felt as a slick coating on the implant and thus poisons us even though the implants are still intact and do not appear ruptured.

Studies & Medical Case Reports

Studies & Medical Case Reports

  1. Understanding Breast Implant Illness
  2. Low Molecular Weight Silicone Induce Cell Death
  3. Sclerodermalike esophageal disease in children breast-fed by mothers with silicone breast implants
  4. Immune functional impairment in patients with clinical abnormalities and silicone breast implants
  5. Suppressed natural killer cell activity in patients with silicone breast implants: reversal upon explantation
  6. Silicone-induced modulation of natural killer cell activity
  7. An association of silicone-gel breast implant rupture and fibromyalgia
  8. Antibody to silicone and native macromolecules in women with silicone breast implants
  9. Cellular immune reactivities in women with silicone breast implants
  10. Breast implant-associated anaplastic large cell lymphoma: a systematic review
  11. Silicone breast implant rupture presenting as bilateral leg nodules
  12. Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure
  13. Silicon granuloma mimicking lung cancer:  
  14. Neck lymphadenitis due to silicone granuloma
  15. Silicone Toxicology
  16. Locoregional silicone spread after high cohesive gel silicone implant rupture
  17. Silicon granulomas and dermatomyositis like changes associated with chronic eyelid edema
  18. Demonstration of silicon in the sites of connective-tissue disease in patients with silicone gel breast implant
  19. Systemic sclerosis after augmentation with silicone breast implants
  20. Human adjuvant disease following augmentation mammoplasty
  21. Increase urinary NO3(-) + NO2- and neopterin excretion in children breast fed by mothers with silicone breast implants: evidence for macrophage activation
  22. Espophageal dysmotility in children breast-fed by mother with silicone breast implants. Long term followup and response to treatment
  23. Silicone gel breast implant rupture, extracapsular silicone, and health status
  24. Microscopic Polyangiitis following silicone exposure from breast implants
  25. Left unilateral breast autoinflation
  26. The semi-permeability of silicone: a saline-filled breast implant with Aspergillus flavus (fungus)
  27. Paecilomyces variotii contamination in the lumen of a saline filled breast implant
  28. Microbial growth inside saline filled breast implants
  29. Detection of subclinical infection in significant breast implant capsules
  30. Infections in breast implants
  31. Capsules Left Cause Systemic Inflammatory Disorder
  32. Importance of histological analysis of seroma fluid
  33. Promotion of variant human mammary epithelial cell outgrowth by ionizing radiation: an agent-based model supported by in vitro studies
  34. Implant infection after augmentation mammaplasty: a review of the literature and report of a multidrug-resistant Candida albicans infection
  35. Stimulation of T lymphocytes by silica after use of silicone mammary implants
  36. Severe Asia Syndrome associated with lymph node, thoracic and pulmonary penetration by silicone
  37. Rupture and intrapleural migration of Cohesive Silicone Gel Implant
  38. Siloxanes (silicone) of breast implants produces fatal liver and lung damage in mice
  39. The spectrum of ASIA: ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants
  40. Intrapulmonary and cutaneous siliconomas after silent silicone breast implant failure
  41. Silicone breast implant rupture presenting as bilateral leg nodules
  42. Microbial Growth Inside Saline Implants
  43. Endocrine activity of persistent organic pollutants accumulated in human silicone implants–Dosing in vitro assays by partitioning from silicone
  44. Residual silicone detection using mri following previous breast implant removal: Case reports
  45. Complications related to retained breast implant capsules
  46. Silicone breast implants and autoimmunity: causation, association, or myth
  47. Adjuvant Breast Disease: An Evaluation of 100 Symptomatic Women with Breast Implants Or Silicone Injections and a picture of silicone in breast milk ducts from a ruptured silicone breast implant
  48. Anti-collagen autoantibodies are found in women with silicone breast implants
  49. Silicone Review
  50. Silicone breast implant associated musculoskeletal manifestations
  51. Silicone breast prosthesis and rheumatoid arthritis: a new systemic disease: siliconosis. A case report and critical review of the literature
  52. Breast implant associated anaplastic large cell lymphoma: a case report and reconstructive option
  53. Radiological trap and oncological precautions in a patient who has undergone a permanent withdrawal of PIP breast implants
  54. Late massive breast implant seroma in postpartum
  55. Late seroma during pregnancy, a rare complication in prosthetic breast augmentation a case report
  56. Talc deposition in skin and tissues surrounding silicone gel-containing prosthetic devices
  57. Silicone breast implants, Autoimmunity and the gut
  58. Silicone breast implant-induced lymphadenopathy: 18 Cases
  59. Is explantation of silicone breast implants useful in patients with complaints
  60. Seroma in Prosthetic Breast Reconstruction
  61. Severe manifestation of autoimmune syndrome induced by adjuvants (Shoenfeld’s Syndrome)
  62. Hypercalcemia as a consequence of modern cosmetic treatment with liquid silicone
  63. The Dark Side of Breast Implants by Frank Vasey

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