Can Chemicals in Breast Implants be the Source of Illness?

Jonathan Vellinga, MD -

There are many known risks to getting breast implants, yet there are still lingering questions about potential side effects. Silicone breast implants have been in the US since the early 1960s. In their early history in the US, both the implants and the breast augmentation industry were largely unregulated. Reports of ruptured implants and other complications began to circulate, and eventually, breast implants came under the regulation of the FDA in 1976, with the "Medical Device Amendments to the Federal Food, Drug and Cosmetic Act." Since then, there have been continual efforts to hold breast implant manufacturers accountable for transparency, improve the safety profile of the implants, and address the health and safety concerns of the public. Many of the known risks of breast implants are now widely disbursed in product literature and online.

Despite FDA requirements for manufacturers of breast implants to list the ingredients and processes of their proprietary products, questions remain about the relationship of breast implants to disease. Of particular concern are the chemicals used in the creation of breast implants and their possible effects on the human body.

What are some chemicals in breast implants that are suspected of being toxic? What impact on the body could those questionable chemicals have?

Breast Implants

Breast implants are medical devices surgically implanted into the chest to increase breast size or to replace tissue that has been removed. In the United States, there are only two approved types of breast implants – those filled with saline and those filled with silicone gel. However, both types are encased in a stiff outer shell composed of silicone, referred to as a “silicone elastomer” or simply a “shell.”

Breast implant products come in different shapes, sizes, and surface textures. Some implants have a smooth exterior, and some have a textured surface. The silicone gel-filled implants come in different levels of firmness that can help uphold surrounding tissue or muscle. Implants can be placed above or below the pectoral muscles, so sometimes extra firmness is needed. If there is not a large enough interior pocket to place the implant, “spacers” can be used to stretch muscle before the implant is placed. The body treats the implant as a foreign object and tends to coat the device with a “capsule” made largely of collagen.

The Silicone Shell

Dr. Pierre Blais highlights the properties of silicone that make it potentially troublesome for use in the human body. The very nature of the process needed to make silicone stiff leaves it with some impurities on the surface. Not only that, some of the molecules on the surface are unsaturated, meaning they attract and will hold other substances to them to complete themselves chemically. He notes that the exterior shell is largely composed of oil, which leaches out into the body slowly over time. To compound issues, the silicone gel filling can “release its components continuously over the service life of the product” (1).

A Note on Shell Texture – A Breast Implant Recall

Hints that there may be health issues where the silicone shell meets the human tissue came into sharp focus in 2019. A maker of breast implants, Allergan (now AbbVie), voluntarily recalled textured “BIOCELL” implants due to an association with Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) (2). BIA-ALCL is a type of immune system cancer, not cancer of the breast. This breast implant recall only affected certain textured models from that particular manufacturer and did not include any of their smooth exterior implants because the smooth exterior was not correlated with the increase in cancer. The recommendation by the FDA was to keep the implants in place if there were no symptoms of BIA-ALCL and to contact Allergan if there were any questions.

Chemical Issues Even Without an Implant Rupture?

Two papers by Dr. Arthur Brawer, a rheumatologist and expert on silicone toxicity, describe how silicone and silicone byproducts can leach out of breast implants long before evidence of a rupture, just as Dr. Blaise has declared (3). Chemicals degrade from the surface of the breast implant shell, and the interior gel can move through the silicone shell and out into the body as well. Once free of the implant, the chemicals interact with the surrounding tissues and the immune system (4).

Our Own Chemical Reactions to Breast Implants

It’s not just the chemicals that breast implants leach that can cause issues; it’s also the body’s reaction to the presence of the implants. Below are some examples of how the body will respond chemically to an implant.

• The body will naturally create tissue to encapsulate the breast implant in an attempt to isolate the foreign material.

• The physical, mechanical friction of the implant in the capsule can create a state of inflammation – the immune system’s healing response.

• Researchers have also noted a cellular response of specialized cells called “fibroblasts” at the surface of the implant. Fibroblasts create collagen and tissue matrices.

• Immune responses are not uncommon, including silicone allergies.

• Collections of microorganisms and cellular material called “biofilms” may form at the surface of the implant.

• The body’s immune system may become confused by the presence of a persistent foreign object in the body and begin to attack itself, creating autoimmunity. For background on the relationship between Breast Implant Illness (BII) and autoimmunity, see our previous article, “The Truth about Breast Implant Illness.”

Questionable Chemicals in Breast Implants & Associated Symptoms

Breast implants are proprietary products, and can differ in exact makeup. There are currently 4 makers of breast implants – Allergan, Ideal Implant Incorporated, Mentor World Wide, and Sientra (5). The FDA requires a “Summary of Safety and Effectiveness Data” (SSED) for each implant or group of similar implants that goes through the approval process. Many of these can be found online and provide good lists of device materials and manufacturing processes (6-10 ).

There are many questionable or suspect chemicals in breast implants according to the various SSEDs. Below is a small subset of those chemicals, and what impact they can have on the body. Note that each chemical may or may not be in any one implant, please see product information to determine what chemicals are in a particular implant.

1. Silicone & Silicone by-products of degradation

Siloxanes are chemical compounds that contain silicon. Silicone itself is called polydimethylsiloxane (PDMS). Three types of siloxanes have been found in tissues of breast implant recipients, D4, D5, and D6 (11).

Potential Impacts on the Body:

• The European Union has banned D4 siloxane, labeling it as “persistent, bioaccumulative, and toxic,” while calling D5 a “very bioaccumulative” substance (12). D5 has been associated with uterine tumors in rats and may potentially harm the reproductive system. D4 is also suspected of being harmful to the reproductive system (13).

• Silicone can suppress immune function by suppressing natural killer cell activity (14). Since natural killer cells are known to control the growth of tumor cells, suppression indicates an increased risk of developing cancer.

• Autoimmune / Autoinflammatory Syndrome Induced by Adjuvants (ASIA) is a dysregulated immune system that occurs after exposure to an adjuvant (in this case, silicone) (15). Autoimmune diseases occur when the body mistakenly turns the immune system against itself. There appears to be an increased risk for autoimmune issues in those who have breast implants (16). Symptoms of this syndrome can include fatigue, muscle pains, and impaired thinking (17).

2. Heavy Metals

It is not widely known that heavy metals are used in the production of breast implants. It is beyond the scope of this article to go into each heavy metal, though below is a list of heavy metals in an actual silicone-filled breast implant (9).

• Antimony

• Arsenic

• Barium

• Cadmium

• Chromium

• Cobalt

• Copper

• Lead

• Mercury

• Molybdenum

• Nickel

• Titanium

• Platinum

• Selenium

• Silver

• Tin

• Vanadium

Potential Impacts on the Body:

Each metal can have particular symptoms associated with it. However, in general, heavy metal toxicity could cause the following:

• Damage to the DNA, impaired ability to repair DNA

• Cell damage

• Deactivate enzymes

• Potentially replace minerals and vitamins, inhibiting their effect

• Impair the immune system through overstimulation of inflammatory reactions (18)

• Symptoms that may include fatigue, weight loss, loss of appetite, confusion, chronic infections, and anemia (19)

3. Volatile Organic Compounds (VOCs)

VOCs are a class of chemical compounds that have certain physical properties and are emitted as a gas from a liquid or even a solid. Some paints and solvents contain VOCs, for example, and have strong scents as a result of their gassing (20) and often have highly detrimental effects on human health.

Xylene and Acetone are VOCs typically used as solvents in the manufacturing process of breast implants (21).

Potential Impacts on the Body:

• Both xylene and acetone are known neurotoxins - they are poisonous to the nervous system. Symptoms can be confusion, headache, dizziness, or even losing consciousness.

• Chronic or prolonged exposure to xylene can also lead to anemia, blood clots, and chest pain (21).

• Acetone can negatively affect the blood and kidneys (22).

Testing to Determine if Breast Implants are Causing Harm

Since there are multiple categories of chemicals that can cause symptoms, trying to figure out exactly what is going on can be a challenge. Thankfully, it is easy to test for the presence of heavy metals through urine, blood, or hair samples. Results can indicate if there is a build-up of a heavy metal that could be detoxified.

Testing for gel seepage of silicone breast implants is more complicated. An MRI or ultrasound may pick up a gel bleed, though sometimes there is a rupture that still cannot be seen with that technology. Contrast solutions may be a contraindication for implant recipients due to the potential for adding to toxicity, so tread cautiously in that area. There are tests for silicone hypersensitivity or the presence of silicon (not silicone), but very few labs perform these tests.

In fact, involving a doctor in your breast implant health concerns can be very beneficial because they can figure out what to test you for. The reaction of the human body to breast implants does not always fit a diagnosis. This is one of the many confounding problems. The latest attempt to solve this problem is to group the symptoms (diagnosable and undiagnosable) and call them “Breast Implant Illness.” Depending on your symptoms, tests for autoimmunity, thyroid issues, liver function, molds, or parasites may be indicated. Many will test positive for inflammation (C-reactive Protein or high sensitivity C-Reactive Protein), which can be a warning sign that compatibility issues with breast implants are manifesting.

The Question of Safety

The FDA has beefed up its requirements for the implant industry as of 2020 (23).

Current FDA guidelines require much more from implant manufacturers in terms of informed consent – written information given to the implant recipient specifying known risks and disclosing more detailed information about ingredients such as heavy metals, and explaining manufacturing processes. With these newer requirements, the bar for breast implant manufacturers seems higher than it has ever been. Yet, there is an acknowledgment by the FDA and implant manufacturers that there are symptoms associated with breast implants that need more study (24).

The FDA encourages the reporting of symptoms by providing a phone number and a link to MedWatch. Despite the recognition that breast implants are currently causing systemic symptoms called “Breast Implant Illness,” the FDA still allows breast implants with silicone shells to be available to the general public for breast augmentation and reconstruction. Illness in the form of systemic symptoms and the involvement of heavy metals are openly acknowledged but remain below a threshold that would trigger the FDA to ban all breast implants. The FDA continues to state that there is no association between silicone gel-filled implants and Connective Tissue Disease (CTD), reproductive issues, and breast cancer (other than the BIA-ALCL).

Breast Implants Do Not Last a Lifetime

The FDA now repeats across its literature that “Breast Implants are not considered lifetime devices (25)” and to anticipate at least one operation after surgical implantation. Breast implants do not have a long life, but many different factors can extend the time that they remain safe. Genetics, diet, exercise, and personal body chemistry figure into the whole equation. While it is true that the implants themselves are made with some harsh chemicals, it may be a matter of length of exposure or a threshold of chemical strength that must be breached which makes one experience illness. For those who suffer greatly, there is the option to remove breast implants (explantation). Many will find relief upon removing the implants.

Getting breast augmentation or reconstruction is a deeply personal decision, and we know that potential recipients of breast implants often go through a long period of investigation and soul-searching before they come to a decision.

If you haven’t gotten breast implants yet, perhaps the information here and in our previous article can help you make an informed decision.

If you have already gotten breast implants and suspect your implants are a driving factor in serious or unpleasant symptoms, we encourage you to come to us. There are many ways we can support, comfort, and give guidance as we explore options for addressing your symptoms.

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Jonathan Vellinga, MD is an Internal Medicine practitioner with a broad interest in medicine. He graduated Summa cum laude from Weber State University in Clinical Laboratory Sciences and completed his medical degree from the Medical College of Wisconsin.​

Upon graduation from medical school, he completed his Internal Medicine residency at the University of Michigan. Dr. Vellinga is board-certified with the American Board of Internal Medicine and a member of the Institute for Functional Medicine.

info@tcimedicine.com

951-383-4333

www.tcimedicine.com

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Sources:

1. Technology and composition [Internet]. Silicone Breast Implants Organization. [cited 2022Aug18]. Available from: https://sites.google.com/site/siliconebreastimplantsorg/home/Science/researchers/dr-pierre-blais/Technology-and-composition

2. Center for Devices and Radiological Health. Allergan voluntarily recalls BIOCELL® textured breast implants and tissue expanders [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022Aug18]. Available from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders

3. Mechanisms of breast implant toxicity: Will the real ringmaster please ... [Internet]. [cited 2022Aug18]. Available from: https://www.breastimplantillness.com/wp-content/uploads/2017/09/Ringmaster-Dr.-Brawer.pdf

4. Flassbeck D, Pfleiderer B, Klemens P, Heumann KG, Eltze E, Hirner AV. Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants. Anal Bioanal Chem. 2003 Feb;375(3):356-62. doi: 10.1007/s00216-002-1694-z. Epub 2003 Jan 28. PMID: 12589499.

5. Center for Devices and Radiological Health. Breast implants: Additional resources [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022Aug18]. Available from: https://www.fda.gov/medical-devices/breast-implants/breast-implants-additional-resources

6. Food and Drug Administration [Internet]. Summary of Safety and Effectiveness Data. Allergan. [cited 2022Aug18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf2/P020056b.pdf

7. Food and Drug Administration [Internet]. Summary of Safety and Effectiveness Data. Allergan 410. [Internet]. [cited 2022Aug18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040046b.pdf

8. Food and Drug Administration [Internet]. Summary of Safety and Effectiveness Data. Mentor MemoryGel™. [cited 2022Aug18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030053b.pdf

9. Food and Drug Administration [Internet]. Summary of Safety and Effectiveness Data. Mentor MemoryShape™ [Internet]. [cited 2022Aug18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf6/P060028b.pdf

10. Food and Drug Administration [Internet]. Summary of Safety and Effectiveness Data. Sientra. [cited 2022Aug18]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf7/p070004b.pdf

11. Flassbeck D, Pfleiderer B, Klemens P, Heumann KG, Eltze E, Hirner AV. Determination of siloxanes, silicon, and platinum in tissues of women with silicone gel-filled implants - analytical and bioanalytical chemistry [Internet]. SpringerLink. Springer-Verlag; 2003 [cited 2022Aug18]. Available from: https://link.springer.com/article/10.1007/s00216-002-1694-z

12. Feregotto T. D4 and D5 effectively banned [Internet]. CE.way. Tadej Feregotto https://ceway.eu/wp-content/uploads/2015/05/ce-way-logo.png; 2018 [cited 2022Aug18]. Available from: https://ceway.eu/d4-d5-effectively-banned/

13. Brief profile. Octamethylcyclotetrasiloxane.

14. [Internet]. ECHA. [cited 2022Aug18]. Available from: https://www.echa.europa.eu/web/guest/brief-profile/-/briefprofile/100.008.307

15. Campbell A, Brautbar N, Vojdani A. Suppressed natural killer cell activity in patients with silicone breast implants: reversal upon explantation. Toxicol Ind Health. 1994 May-Jun;10(3):149-54. doi: 10.1177/074823379401000304. PMID: 7855864.

16. Ribeiro PDC, Sato EI. Autoimmune/autoinflammatory syndrome induced by adjuvants: a focus on silicone. Clin Rheumatol. 2022 Jul 7. doi: 10.1007/s10067-022-06274-0. Epub ahead of print. PMID: 35798923.

17. Watad A, Quaresma M, Bragazzi NL, Cervera R, Tervaert JWC, Amital H, Shoenfeld Y. The autoimmune/inflammatory syndrome induced by adjuvants (ASIA)/Shoenfeld's syndrome: descriptive analysis of 300 patients from the international ASIA syndrome registry. Clin Rheumatol. 2018 Feb;37(2):483-493. doi: 10.1007/s10067-017-3748-9. Epub 2017 Jul 25. PMID: 28741088.

18. Cohen Tervaert JW. Autoinflammatory/autoimmunity syndrome induced by adjuvants (ASIA; Shoenfeld's syndrome): A new flame. Autoimmun Rev. 2018 Dec;17(12):1259-1264. doi: 10.1016/j.autrev.2018.07.003. Epub 2018 Oct 12. PMID: 30316995.

19. Lehmann I, Sack U, Lehmann J. Metal ions affecting the immune system. Met Ions Life Sci. 2011;8:157-85. PMID: 21473381.

20. Rajkumar V, Gupta V. Heavy Metal Toxicity. [Updated 2022 Jan 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-.

21. EPA. Environmental Protection Agency; [cited 2022Aug18]. Available from: https://www.epa.gov/indoor-air-quality-iaq/what-are-volatile-organic-compounds-vocs

22. Langman JM. Xylene: its toxicity, measurement of exposure levels, absorption, metabolism and clearance. Pathology. 1994 Jul;26(3):301-9. doi: 10.1080/00313029400169711. PMID: 7991289.

23. 22) Toxicological profile for acetone - agency for toxic substances and ... [Internet]. [cited 2022Aug18]. Available from: https://www.atsdr.cdc.gov/toxprofiles/tp21.pdf

24. Center for Devices and Radiological Health. Saline, silicone gel, and alternative breast implants guidance [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022Aug18]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants

25. Center for Devices and Radiological Health. Risks of breast implants [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022Aug18]. Available from: https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants#Connective_Tissue_Disease

26. Center for Devices and Radiological Health. Risks of breast implants [Internet]. U.S. Food and Drug Administration. FDA; [cited 2022Aug18]. Available from: https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants