Breast Implant Safety
JUNK SCIENCE – by the plastic surgeons and manufacturers
There is a prominent conflict of interest in researchers and plastic surgeons with financial ties to the manufacturers. They can get paid fees in research, consulting, speaker, sponsor, and more. Several scientists who conducted research on silicone breast implants have been found to simultaneously have had financial ties to the industry. The National Center for Health Research also addresses the conflict of interest and evidences how bogus and inaccurate the manufacturers’ junk studies are, in their conclusion, here.
Consumers trusted studies to be done reliably with scientific accuracy and independent opinion – non-biased impartiality to the industry, with no financial conflicts of interest – which are essential elements to account for mass production of a product that impacts health so profoundly.
Instead, public health policy has been influenced by research studies that are bought by corporate interest. The Harvard and Mayo studies done in the 90’s, during the litigations, contradicted the other research in how they found no association between silicone breast implants and connective tissue diseases. Coincidentally these studies were seriously flawed and raised big ethical issues – many of those researchers were paid consultants to the breast implant manufacturers.1,2 See here for a research article from 1995 titled “Will the real junk science stand up? An analysis of the Mayo clinic womens study and Harvard/Brigham nurses study in relation to the silicone gel breast implant controversy.” Buying well respected medical institutions to publish manipulated research is a clever scheme the manufacturers have used to save face and persevere for many years. This manipulation of science by corporate greed is ongoing.
Just recently three U.S. approved breast implant manufacturers (Allergan, Mentor, and Sientra) prematurely terminated their individual silicone breast implant case-control studies to instead collectively fund a study by the American Society of Plastic Surgeons (ASPS), done in 2013. The purpose of the original case-control study was to evaluate the association between silicone breast implants and five rare disease outcomes: rare connective tissue diseases, neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma. The double conflict of interest in the manufacturers sponsoring the studies and in the plastic surgeons handling the study is astounding. Both parties profit from the silicone breast implant industry; plastic surgeons make much of their earnings from breast augmentations. It seems like a deliberate attempt to control the results of a valuable study that perhaps was not going in the direction they liked, a manipulation that unfortunately has repeatedly occurred in the history of breast implants.
Science continues to be bought and bended to peddle old dubious claims that silicone is inert and safe, and that breast implants do not cause illness. It is a multi-billion dollar industry that spends a lot of money in PR, biased research studies, paying plastic surgeons to act as consultants, etc. to protect its cash cow, breast implant revenue. This is despite the decades of evidenced detrimental health effects and the numerous unbiased scientific articles on silicone toxicity and unhealthy effects of breast implants. Trusting doctors and medical institutions to conduct accurate and unbiased research to get a product FDA approved has become a naive concept that many of us were fooled by and suffering the detrimental consequences of.
Websites to check if your doctor has received corporate funding:
- Click here for more information on scientists with conflicts of interest
Where can I find accurate science?
For accurate science on breast implant safety, please see the Scientific Articles page. Over 200+ references to breast implant related scientific articles have been accumulated. They detail the risks and negative health consequences of breast implants including immune dysfunction and endocrine disruption.
Is the new generation of cohesive gel implants safer?
No, the new generation of breast implants is made out of aggressive chemicals and filled with many heavy metals to make the silicone more cohesive. Women in the breast implant illness groups are getting sick fairly quickly – we are noticing an accelerated rate of sickness with this new generation of cohesive gel implants. In addition, textured implants are increasingly causing anaplastic large cell lymphoma (ALCL) cancer of the immune system. Textured implants are some of the most problematic, they tend to have shell debris flake off more readily and also release gel bleed. This may have to do with the toxic concoction of chemicals and heavy metals to bind the silicone and to reduce capsular contracture. Capsular contractures were a frequent problem with the earlier versions of the implants. To reduce the rate of occurence, these new implants are infused with more aggressive chemicals to weaken the immune response and therefore produce thinner capsules. There was a recent patent published in 2016 called “Breast implant comprising a nitric oxide releasing material” which describes using implants coated with nitric oxide and creating a uniform, continuous release of nitric oxide over long periods of time so that capsule formation is reduced.
In January 2017, the scientific article “Destiny Rides Again: the Reappearance of Silicone Gel-Filled Breast Implant Toxicity,” was published by Dr. Brawer and details the symptoms of the new generation of cohesive silicone gel-filled breast implants.
Chemist and biocompatibility expert, Dr. Blais, on these implants:
Through repetitive promotion, the belief has spread that breast implants marketed post-FDA Moratorium are “new and improved”. This belief is illusory. Currently promoted breast implants are basically the same products which were widely sold during the early seventies. They embody minimal design changes and employ substantially identical ingredients. Manufacturing processes are similar albeit more mechanized, reflecting a desire to reduce production costs. Click here for more.
Marketing History – Breast implant manufacturers have throughout history utilized a PR campaign to falsely promote each new generation as the “new safer implant” than the previous generations.
1. Liquid silicone was first injected, it caused siliconomas and other dangerous health complications including death.
2. Then liquid silicone was encased in a shell that was changed with each generation and continuously sold as the “new and safe” breast implant. According to Dr. Blais, cohesive implants are described in the patents of the fifties and sixties. There were commercialized but surgeons didn’t like how they weren’t “pliable,” they were hard to stuff through an incision.
3. Consequently, they were abandoned in favor of the soft, stretchy thinner shelled implants with more liquid silicone. These were found to heavily leak silicone and shells ruptured, causing more health complications, deaths, and consequently the Dow lawsuits.
4. At one point they even invented the “new” polyurethane coated breast implants that were very toxic, perhaps as a “new” attempt to reduce capsule growth and therefore reduce the high rates of capsular contractures. Those are now banned. Among other things, adverse reaction reports indicated that the foam came off the implant or broke down into fragments, or was “partially digested,” and later there were reports of the foam disappearing.1 Research found the foam to breakdown into 2,4 toluenediamine (TDA), a known animal carcinogen. Silicone and polyurethane are used as sealants in cars and as toxic pesticides, yet they were introduced and toyed with in breast implants as “safe, new and innovative” ideas until the women went through rounds of being free guinea pigs.
5. Then there’s the “new and safe” saline implant which have been found to have faulty valves that cause toxic mold to colonize and produce biotoxins. Mold in saline implants has been recorded as early as 1978 yet is constantly being denied and suppressed by plastic surgeons and the medical community.
6. Many generations of women have gone through human experimentation as manufacturers manipulated research studies, falsified results at times, and then marketed the product.
In essence, all implants are foreign objects made out of silicone shells that are semipermeable, bleed heavy metals, degrade, and cause a foreign body reaction that results in a large flare up of system-wide inflammation. They cause structural and biochemical changes that the immune system responds to. Women continue to be guinea pigs to each new generation of implants, all of which cause harm.
Toxicity – Silicone, Chemicals, Heavy Metals, Biotoxins (saline)
Silicone has the ability to modulate immune, endocrinological, and neurotransmitter functions. It is an adjuvant that internally acts as a strong irritant of the immune system where it can cause inflammation, production of antibodies, and other immune responses. Intact implants have semi-permeable shells that leak gel bleed of silicone and heavy metals, and may also include chemicals from shell degradation. Silicone can migrate outside the capsules and into local axillary lymph nodes where it can then spread via the lymphatic system throughout the body and accumulate in various tissues (see article on silicone dispersion). However, it has a tendency to particularly affect connective tissue, such as the joints. It can also bind to endocrine receptors and cause a disruption in the production and functioning of your hormones – which fundamentally control the processes in the body. One of the mechanisms for silicone to act as an endocrine disruptor is through molecular mimicry. It is very difficult to detox silicone from the body, it is like removing glue. For more information on how the implants’ toxins are processed by the body, see Detoxification.
Both saline and silicone implants have semipermeable silicone shells and these are reactive for the immune system to be in contact with. The FDA refers to saline implants also as “silicone inflatable (saline-filled) breast prosthesis.” According to the FDA Office of Device Evaluation (ODE), the office responsible for conducting medical device evaluations and clearance for clinical trials and marketing, the following is what is in a saline-filled breast implant shell:
- 80% high molecular weight silicones (however there are also low molecular weight silicones, D3-D6, D10, D15, D20)
- 20% finely powdered silica (aka silicon dioxide)
- Catalyst of a tin or platinum
- Impurities: smaller silicones, volatile (readily evaporating) materials like xylene and other chemicals, and other heavy metals.
The silicone gel bleed that is universally recognized in nearly all manufacturer pamphlets of silicone implants is D4, D5, and D6. Studies have shown that these low molecular weight and lipophilic (fat-loving) siloxanes are extremely toxic. D4 is an endocrine disruptor that interferes with human hormone function and is a reproductive toxicant that may impair human fertility. Exposure to D5 siloxanes has been shown to cause uterine tumors, harm to the reproductive and immune systems, and can also influence neurotransmitters in the nervous system. Structurally similar to D4 and D5, D6 seems to target the liver and has been involved with increased liver weight, periportal lipidosis and thyroid follicular cell hypertrophy in a 4-week rat study.2,3,4,5
Silicone is not inert. Silicone from breast implants “bleeds” through the surrounding envelope and is present in the surrounding capsule or migrates to other distant locations. Silicone and/or the multiple chemical contaminants elicit foreign body reactions associated with granulomatous inflammation and fibrosis. Silicone and its contaminants have the potential for significant toxicity in the implant recipient. – Silicone Toxicology
There are over 40+ toxic chemicals and heavy metals used in the concoction of breast implants. Below is a list of ingredients for silicone breast implants that was released during the Dow trials. Click here for detailed information on each chemical. During degradation of the implant shell, some chemicals are released and have been found to be in high levels of patients with breast implants. Heavy metal analyses also show high levels of the heavy metals listed in the manufacturing process of implants in many women.
Silicone Breast Implant Ingredients (Dow):
- Methyl Ethyl Ketone (neurotoxin)
- Cyclohexanone (neurotoxin)
- Isopropyl Alcohol
- Denatured Alcohol
- Acetone (neurotoxin)
- Polyvinyl Chloride (neurotoxin)
- Toluene (neurotoxin/carcinogen)
- Dichloromethane (carcinogen)
- Ethyl Acetate (neurotoxin)
- Sodium Fluoride
- Lead-based solder
- Talcum Powder
- Oakite (cleaning solvent)
- Methyl 2-cyanoacryltes
- Ethylene Oxide (carcinogen)
- Xylene (neurotoxin)
- Stearic Acid
- Zinc Oxide
- Naptha (rubber solvent)
- Phenol (neurotoxin)
- Benzene (carcinogen/neurotoxin)
- Lacquer Thinner
- Epoxy Resin
- Epoxy Hardener 10 and 11
- Printing Ink
- Metal Cleaning Acid
- Color Pigments as release agents
- Heavy metals such as aluminum, tin, lead, and platinum
The exact composition of the gel has been changed over the years, and it remains confidential proprietary information. However, based on testimony presented at the FDA hearing in 1992, the gel consists of a mixture of 76% low molecular weight (6,000-19,000) and 24% high molecular weight (300,000-400,000) components.
The envelop consists of a polydimethyl-siloxane elastomer, extensively cross-linked to form a network of extremely high molecular weight and contains amorphous silica as a reinforcing agent. Solvent extraction of the envelop and the gel has revealed 30 different linear cyclic components, some of which have adjuvant activity in animals.
Since 1978, it has been recognized that silicone can be expected to “bleed,” by diffusion, from all clinically intact gel implants. Laboratory studies have demonstrated that this phenomenon increases under load, and that primarily low molecular weight (6,000-10,000) components are involved. These compounds would be expected to be capable of diffusing into surrounding tissues. Low molecular weight silicone compounds have been shown to be more soluble in body fluids, and to have greater biological activity than higher molecular weight compounds.
In 1986, “low-bleed” implants were introduced by Dow Corning. The outer elastomer envelop of these implants was made thicker and more uniform than previously. The envelope was also coated on the inner surface with a fluorosilicone polymer, in which liquid silicone is only poorly soluble. These structural changes were reported to reduce the diffusion (“bleed”) rate to about 10% of that formerly encountered. Dow Corning has recently reported “bleed” rates of 60 to 100 mg per year for implants made before 1986 onwards.
Saline implants also have the potential risk of biotoxicity. Many saline implants have defective faulty valves that leak and cause a “backwash” effect in the body. This allows the cultivation of mold in the saline shell where it can thrive for years, causing biotoxicity symptoms. The labels on the saline solution (pyrogen-free Sodium Chloride U.S.P. Solution for Injection) to fill the saline implants, recommends storage at 25°F (77°F) and includes a discard date of about 18 months. With these implants the saline is stored in the body at 98.6°F for many years. This makes the perfect breeding conditions for fungi and other microbes to grow. Mold from faulty valves has been recorded to be found in saline breast implants since as early as 1978. It continues to occur and is regularly suppressed and buried by the medical community. (Sources: here see pg.15, here, and here see pg. 269)
The truths about the extensive lists of heavy metals used in the manufacturing of breast implants, the over 40+ toxic ingredients used that include neurotoxins and carcinogens, and how silicone provokes an immune response is not told by plastic surgeons to us. The implants slowly leach abrasive irritants that provoke inflammation and other systemic health issues. The rupture rate of the current cohesive gels is also much sooner than is being said and it is being witnessed in the breast implant illness groups. Many of them eventually turn from clear to milky to yellow as the gel and shell degrade.