What is “Breast Implant Illness,” and What Are the Risks of Breast Implants?

What is Breast Implant Illness?

Breast implant illness (BII) is a complication of silicone breast implants that causes symptoms throughout the entire body [1]. It is unclear how BII happens, as silicone was initially introduced in 1962 and was considered safe [1]. However, over the past 60 years, it has become clear that silicone in the body, whether from breast implants or other prosthetics, can lead to full-body symptoms and even cancer [1].

More needs to be done to protect people against unnecessary harm caused by silicone gel-filled breast implants. Implants have been on the market for more than 60 years, and during that time, they’ve been used by millions of women [2]

The History

Implants were marketed for years before the Food and Drug Administration (FDA) had the legal authority to approve medical devices. It took an investigation by Congress and complaints by the NWHN and other women’s health groups to force the FDA to require manufacturers to study the devices. The Network took this action because we heard from many women that they believed their implants were making them sick. The FDA removed silicone implants from the market in 1992 and required studies to be done to determine the safety of silicone implants [1]. The FDA officially approved silicone breast implants in 2006, but even then, the Network believed that approval was premature because adequate long-term studies of the devices had not been done [1]. In 2019, the FDA held a hearing on the complications of breast implants, and research is continuing for BII and other complications related to breast implants [1].

Risks from Breast Implants

The risks from having breast implant surgery, whether cosmetic or for reconstruction, begin with the surgery and recovery and continue with risks for rupture, allergic reaction, systemic inflammatory symptoms, and cancer [2,3].

Some adverse events from breast implants include [2,3]:

  • Pain
  • Change in nipple and breast sensation
  • Allergy to the implant
  • Silicone migration
  • Surgical complications like rupture, capsular formation, or infection
  • Breast implant associated-anaplastic large cell lymphoma, a type of blood cancer (more common in textured breast implants)
  • Squamous Cell Carcinoma, other lymphomas, mesenchymal tumors, and sarcoma
  • Systemic inflammatory symptoms, including BII

BII symptoms can include [3]:

  • Severe Fatigue
  • Memory loss
  • Rash
  • Brain fog
  • Joint pain
  • Lymphadenopathy
  • Raynaud's phenomenon
  • Stroke-like symptoms
  • Severe dry eyes and mouth
  • Paroxysmal Orthostatic Tachycardia Syndrome (POTS)
  • Sensory neuropathy
  • Severe muscle weakness
  • Itching
  • Hair loss

Testing to confirm BII is not common knowledge for most medical doctors, so many women have to suffer these symptoms while waiting for a diagnosis or receiving an incorrect diagnosis and treatment [2]. Some plastic surgeons may dismiss women's symptoms, stating that they don't believe BII exists. However, it is clear through recent evidence that BII is caused by silicone breast implants [2]. The expert opinion from Tervaert et al. is to use the term autoimmune/autoinflammatory syndrome induced by adjuvants (ASIA) due to silicone incompatibility syndrome rather than BII [2].  For those experiencing severe symptoms that started after their breast implant, removal of the implant is the most effective treatment and resolves the symptoms in most women [2]. It is thought that roughly 25% of women will develop systemic symptoms after breast implants, ranging from mild to severe [2]. Women need to be properly informed of these risks and the treatment through informed consent from their surgeon and from hearing the stories of women who have suffered from breast implants. 

Screening

One thing people with implants can do to protect their health is to get screened regularly for silent ruptures of the implant.  Breast implant rupture is a tear or hole in an implant's shell that releases the implant's contents into the body. When a saline implant breaks, it is usually noticeable because the breast will appear deflated as it leaks out [3]. When a silicone gel-filled implant ruptures, the silicone may be held in by the surrounding scar tissue and leak out gradually. These leaks are much more subtle, and MRI is the most effective way to detect them, although as of 2023, the FDA has announced that ultrasound is an acceptable alternative to MRI [3]. The leaking silicone can migrate to other areas of the body, like the chest wall, lungs, or even the small vessels in your hands and feet, and become difficult or impossible to remove. 

If you have experienced problems with breast implants, you can submit your story to MedWatch, the FDA’s reporting system, and help bring change to the safety of breast implants.   

 

References:

[1] Suh, L. J., Khan, I., Kelley-Patteson, C., Mohan, G., Hassanein, A. H., & Sinha, M. (2022). Breast implant-associated immunological disorders. Journal of Immunology Research. https://doi.org/10.1155/2022/8536149

[2] Tervaert, JW. C., Mohazab, N., Redmond, D., Eden, C. V., & Osman, M. (2021). Breast implant illness: Scientific evidence of its existence. Expert Review of Clinical Immunology 18(1). https://doi.org/10.1080/1744666X.2022.2010546 

[3] U.S. Food & Drug Administration (2023, December 14). Risks and Complications of Breast Implants. Risks and Complications of Breast Implants | FDA


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