Former NASCAR driver Danica Patrick, 40, told People magazine that she had her breast implants removed after experiencing breast implant illness. Patrick previously decided to get breast implants in 2014 in a quest to attain “an ideal body.”
Things went well for the first 3 years; however, she then began to experience unexplained symptoms. Her hair seemed to get very dry, grew more slowly, and began to fall out. She gained weight, and was unable to lose it, and her energy levels dropped dramatically. She also began to experience gastrointestinal issues, as well as hormone disruption, including low sex hormones.
A year later, one of her breast implants had become hard, and she thought perhaps it had ruptured. An MRI revealed that this wasn’t the case. When the other breast became hard as well, she started to think that her breast implants may be playing a role in her symptoms. She watched over 100 videos on YouTube and social media by women with similar symptoms. Hearing their stories made her believe that she too was suffering from breast implant illness.
Patrick had her implants removed in April, and said she felt some relief within hours of the surgery. Six months later, Patrick is still on the mend. Her stomach problems and hormone levels have improved, and she said that she looks more like herself again.
Brief History of Breast Implants
Breast implants were introduced in 1962 by two surgeons, Thomas Cronin, MD, and Frank Gerow, MD. They have been used both to augment breast size and to replace breast tissue removed due to cancer, trauma, or failure to develop properly.
In 1976, the FDA was given jurisdiction over medical devices. However, breast implants were “grandfathered” in, meaning manufacturers were not required to provide scientific evidence of product efficacy and safety unless questions arose.
In the 1980s, consumer concerns over silicone breast implants emerged. The devices were subsequently classified as higher-risk and manufacturers had to start providing data on their safety. In 1992, the FDA concluded that silicone breast implant manufacturers had failed to properly address safety concerns and they were removed from the market.
In 1999, the Institute of Medicine (IOM) released a report entitled “Safety of Silicone Breast Implants,” with three conclusions:
- The primary safety concerns with silicone implants were related to preoperative, local, and perioperative complications
- Risks seemed to accumulate over time, but quantitative data were lacking for the most recent devices
- Women needed to be better informed about potential risks of breast implants
The IOM did not feel there was enough evidence at that time to say that breast implants were a cause of systemic disease, although they felt well-controlled, long-term, large studies were needed to determine this.
In 2006, silicone implants were put back on the market. However, since that time, the scientific community has conducted more research to address safety, and the FDA has required two manufacturers to conduct large post-approval studies to look for potential long-term risks.
Breast Implant Illness
As many as 3 million women are estimated to have breast implants worldwide, and there has been a recent resurgence in the concerns around the safety of silicone and silicone-coated saline breast implants.
Breast implant illness describes a variety of symptoms reported by women with breast implants, including fatigue, memory or concentration problems (“brain fog”), joint and muscle pain, hair loss, weight changes, anxiety/depression, rash, headache, and inflammation. These symptoms have been reported by women with all types of breast implants regardless of filling, shape, or surface characteristics, and onset occurs anywhere from immediately after implantation to years later.
Multiple studies have looked at whether breast implants have a causal relationship with systemic illness and/or autoimmune disease. The results have been mixed, and many of the studies were considered flawed.
A 2021 review concluded that “there have not been any concrete or evidence-based studies which support the formation of a new syndrome ‘silicone implant disease.'” However, they pointed out that more recent data have suggested that breast implants may be associated with certain specific connective tissue diseases.
The review cited a cohort study that included nearly 100,000 women with breast implants followed for 7 years, which found significantly higher rates of Sjogren syndrome, scleroderma, and rheumatoid arthritis compared with the general population.
Some researchers consider breast implant illness a form of autoimmune/inflammatory syndrome induced by adjuvants (ASIA). Known adjuvants in humans include aluminum hydroxide, squalene, silica, or bacterially derived substances. Presumably, an adjuvant introduced into a susceptible patient can cause an enhanced specific immune reaction resulting in non-specific constitutional symptoms and autoantibody production.
One study concluded that there “appears to be a clear pathogenic relationship between silicone breast implants and breast implant illness/ASIA. Breast implants cause characteristic systemic reactions in certain women, leading to symptoms of sufficient severity to warrant device removal. [Implant] removal resolves the symptoms in most women, and removal is the most effective treatment.”
Although the FDA maintains that silicone breast implants are safe for use, they have moved to strengthen labeling to improve communications on their risks between physicians and patients. In September, the agency issued a safety communication to highlight reports of squamous cell carcinoma and various lymphomas in the scar tissue that forms around breast implants. These lymphomas are not the same as those first reported by the FDA in 2011.
That lymphoma, known as breast implant-associated anaplastic large cell lymphoma, is a type of non-Hodgkin’s lymphoma usually found in the scar tissue and fluid near the implant. It is considered rare but is serious and can be fatal if not treated promptly. Symptoms include swelling, presence of a mass, or pain in the areas of the breast implant. In most cases, it can be successfully treated by surgical removal, but some patients may also require radiation and/or chemotherapy.
Michele R. Berman, MD, is a pediatrician-turned-medical journalist. She trained at Johns Hopkins, Washington University in St. Louis, and St. Louis Children’s Hospital. Her mission is both journalistic and educational: to report on common diseases affecting uncommon people and summarize the evidence-based medicine behind the headlines.
Correction: This article has been updated to indicate that the FDA first warned of a link between breast implants and a rare type of lymphoma in 2011.