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 ).