Former NASCAR driver Danica Patrick, 40, said People magazine that she had her breast implants removed after experiencing breast implant disease. Patrick previously decided to get breast implants in 2014 in a quest to achieve “an ideal body.”
Things went well for the first 3 years; however, she then began to experience unexplained symptoms. Her hair seemed to dry out a lot, grew more slowly and began to fall out. She gained weight and couldn’t lose it, and her energy levels dropped dramatically. She also began experiencing gastrointestinal problems, as well as hormonal disturbances, including low sex hormones.
A year later, one of her breast implants had hardened and she thought it might have ruptured. An MRI revealed that this was not the case. When the other breast also hardened, she began to think that his breast implants might be playing a role in his symptoms. She watched more than 100 videos on YouTube and social media of women with similar symptoms. Hearing her stories made him believe that she, too, was suffering from breast implant disease.
Patrick had the implants removed in April and said he 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 increase 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, the breast implants were “exempt,” meaning that the manufacturers were not required to provide scientific evidence of the product’s efficacy and safety unless doubts arose.
In the 1980s, consumer concerns about silicone breast implants arose. Devices were later classified as higher risk and manufacturers had to start providing data on their safety. In 1992, the FDA concluded that manufacturers of silicone breast implants had not adequately addressed safety issues and they were withdrawn from the market.
In 1999, the Institute of Medicine (IOM) published a report entitled “Safety of silicone breast implantswith three conclusions:
- The main safety concerns with silicone implants were related to preoperative, local, and perioperative complications.
- Risks seemed to accumulate over time, but quantitative data was lacking for newer devices
- Women needed to be better informed about the potential risks of breast implants
The IOM did not feel that there was sufficient evidence at the time to say that breast implants were a cause of systemic disease, although they felt that large, long-term, well-controlled studies were needed to determine this.
In 2006, silicone implants were put back on the market. Since then, however, the scientific community has conducted more research to address safety, and the FDA has asked two manufacturers to conduct large post-approval studies to look for possible long-term risks.
breast implant disease
It is estimated that up to 3 million women have breast implants worldwide, and there has been a recent resurgence of concerns about the safety of silicone and silicone-coated saline breast implants.
Breast implant disease 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 swelling. These symptoms have been reported by women with all types of breast implants, regardless of filler, shape, or surface characteristics, with onset occurring from immediately after implantation to years later.
Multiple studies have looked at whether breast implants have a causal relationship with systemic and/or autoimmune diseases. Results have been mixed, and many of the studies were considered flawed.
A revision 2021 concluded that “there have been no concrete or evidence-based studies to support the formation of a new syndrome ‘silicone implant disease'”. However, they noted that more recent data has suggested that breast implants may be associated with tissue disease.
The review cited a cohort study which included almost 100,000 women with breast implants followed for 7 years, which found significantly higher rates of Sjogren’s syndrome, scleroderma, and rheumatoid arthritis compared to the general population.
Breast implant disease is considered by some researchers to be a form of adjuvant-induced autoimmune/inflammatory syndrome (ASIA). Known adjuvants in humans include aluminum hydroxide, squalene, silica, or bacteria-derived substances. Presumably, an adjuvant introduced into a susceptible patient can cause an enhanced specific immune reaction resulting in nonspecific constitutional symptoms and autoantibody production.
A study concluded that “there appears to be a clear pathogenic relationship between silicone breast implants and breast implant disease/ASIA. Breast implants cause characteristic systemic reactions in certain women, leading to symptoms of sufficient severity to warrant removal of the implant.” device”. [Implant] extraction resolves symptoms in most women, and extraction 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 communication about their risks between doctors 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 reported by the FDA in April.
That lymphoma, known as Anaplastic large cell lymphoma associated with breast implants, is a type of non-Hodgkin’s lymphoma that is usually found in scar tissue and fluid near the implant. It is considered rare but it is serious and can be fatal if not treated in time. Symptoms include swelling, a lump, 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 rare people and to summarize the evidence-based medicine behind the headlines.