Former NASCAR driver Danica Patrick, 40, told People magazine she had breast implants removed after experiencing breast implant disease . Patrick had decided to undergo breast augmentation surgery in 2014 in hopes of achieving his “ideal body”.
All went well for the first three years; however, she then started experiencing unexplained symptoms. Her hair seemed to be getting very dry, growing more slowly, and starting to fall out. She gained weight and was unable to lose it, and her energy levels plummeted. She also started having gastrointestinal problems, as well as hormonal disturbances, including low sex hormones.
A year later, one of her breast implants hardened and she thought maybe it had ruptured. MRI showed this was not the case. When the other breast also became firm, she began to think that her breast implants might have played a role in her symptoms. She watched more than 100 videos of women with similar symptoms on YouTube and social media. After hearing their stories, she believed she, too, had breast implant disease.
Patrick had her implants removed in April and said she felt some relief within hours of the procedure. Six months later, Patrick is still recovering. Her stomach problems and hormone levels have improved, and she says she looks more like herself again.
A Brief History of Breast Augmentation
Breast Implantation The implant was introduced in 1962 by two surgeons, Thomas Cronin, MD, and Frank Gerow, MD. They are used both to increase breast size and to replace breast tissue that has been removed due to cancer, trauma, or underdevelopment.
In 1976, FDA received medical jurisdiction over the device. Breast implants, however, are “grandfathered,” meaning manufacturers are not required to provide scientific evidence of a product’s efficacy and safety unless something goes wrong.
In the 1980s, consumer concerns about silicone breast implants emerged. These devices are then classified as high-risk devices, and manufacturers must begin providing data on their safety. In 1992, the FDA determined that manufacturers of silicone breast implants had failed to adequately address safety concerns and removed them from the market.
In 1999, the Institute of Medicine (IOM) published a report entitled “Safety of Silicone Breast Implants” which contained three conclusions:
Major safety concerns with silicone implants related to preoperative, local and perioperative complications
The IOM considered at the time that there was insufficient evidence to suggest that breast augmentation was a cause of systemic disease, although they felt well controlled, and large studies over a long period of time were needed to establish this.
In 2006, silicone implants were re-launched on the market. Since then, however, the scientific community has conducted more safety studies, and the FDA ordered both manufacturers to conduct large post-approval studies to look for potential long-term risks.
BREAST IMPLANT DISEASE
With an estimated as many as 3 million women receiving breast implants worldwide, there has recently been renewed concern 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 change, anxiety/depression, rashes, headaches, and inflammation. Women with all types of breast implants report these symptoms, regardless of filling, shape, or surface characteristics, and can occur anywhere from immediately after implantation to years afterward.
Multiple studies have examined whether breast implants are causally associated with systemic and/or autoimmune disease. Results have been mixed, with many studies deemed flawed.
A 2021 review concluded that “there is no specific or evidence-based research to support the development of a new syndrome ‘silicone implant disease’.” However , they point to recent data suggesting that breast implants may be associated with certain connective tissue disorders.
Cited review A cohort study of nearly 100,000 women with breast implants followed for 7 years found that Sjogren’s syndrome, scleroderma and a significantly higher incidence of rheumatoid arthritis.
Some researchers believe that breast implant disease is an autoimmune/inflammatory syndrome induced by adjuvant (ASIA). Known human adjuvants include aluminum hydroxide, squalene, silicon dioxide, or bacteria-derived substances. It is hypothesized that the introduction of adjuvants into susceptible patients causes an enhanced specific immune response leading to nonspecific constitutional symptoms and autoantibody production.
One study concluded, “There appears to be a clear pathogenic relationship between silicone breast implants and breast implant disease/ASIA. Breast Implants Causes characteristic systemic reactions in some women, resulting in symptoms severe enough to warrant device removal. [Implant] removal resolves symptoms in most women, and removal is the most effective treatment.”
While the FDA insists that silicone breast implants are safe to use, they have taken action to strengthen labeling to improve communication between doctors and patients about their risks. In September, the agency issued a safety communication highlighting reports of squamous cell carcinoma and various lymphomas in the scar tissue that forms around breast implants. These lymphomas are different from the lymphomas first reported by the FDA in 2011.
This lymphoma is called breast implant-associated anaplastic large cell lymphoma, a type of non-Hodgkin lymphoma lymphoma often found near implants in scar tissue and fluid. It is considered rare but serious and can be fatal if left untreated. Symptoms include swelling, lumps, or pain in the area of the breast implant. In most cases, it can be successfully treated with surgical resection, but some patients may also require radiation and/or chemotherapy.
Michele R. Berman, MD, is a pediatrician-turned-medical journalist. She has trained at Johns Hopkins University, 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 populations and to summarize the evidence-based medicine behind the headlines.
Correction: This article has been updated to indicate that the FDA first warned in 2011 that breast implants were associated with a rare type of There is a link between lymphoma.