Two years after Nicole Daruda of Vancouver Island received silicone breast implants, she found herself beset by health issues: recurring infections, G.I. problems, jumbled thinking. By the five-year mark, she had food allergies and other maladies and had been diagnosed with two autoimmune diseases. A year later, at 47, she noticed swelling around her left armpit and breast, and it came to her: Could her ailments have something to do with her implants?
In 2013, Daruda had the implants removed, and her panic attacks and anxiety went away. Within two years, she no longer needed thyroid medication and her allergies disappeared. She started a Facebook group called Breast Implant Illness and Healing by Nicole. Today it has more than 125,000 members. “A tsunami of women came together to say the jig is up,” Daruda says.
Breast implant illness (BII) is the term coined by people with implants to describe postsurgical symptoms that include fatigue, joint pain, muscle weakness, dry eyes
and mouth, and brain fog. BII isn’t an official diagnosis, which can present challenges for women seeking treatment or insurance coverage. But evidence is mounting that patients like Daruda are right to be suspicious.
Since the first silicone-gel breast implant surgery in 1962, tens of thousands of patient anecdotes and dozens of scientific studies have pointed to a possible link between the implants and conditions like autoimmune diseases. “It’s been known for 25 years that silicone implants can leak,” says Jan Willem Cohen Tervaert, MD, PhD, professor of medicine and director of the Division of Rheumatology at the University of Alberta, who has spent 25 years studying how the body reacts to implants, authored ten studies on the topic, and treated more than 500 patients reporting BII.
SILICONE VS. SALINE: All breast implants have silicone shells, but the filling can be silicone gel or saline. Ninety percent of women choose silicone because it feels more like breast tissue.Early studies suggest this option is more likely to be associated with BII, but more research is necessary.
Cohen Tervaert hypothesizes that when silicone leaks, it can be absorbed by surrounding tissue and nearby lymph nodes, further activating the immune system. “Over time, some people’s systems may be unable to recover from the chronic stimulation, and autoimmune disease may set in.”
In 1984, a federal jury in San Francisco ordered Dow Corning, then the largest maker of silicone implants, to pay a patient $1.5 million in punitive damages after she alleged that the implants triggered an autoimmune disease. Hundreds of other lawsuits followed, and in 1990, public outcry led Congress to hold hearings on implant safety. In 1992, FDA commissioner David Kessler, MD, requested a voluntary moratorium on silicone implants until the FDA could assess the safety data.
“We know more about the life-span of automobile tires than we do about the longevity of breast implants,” he later said. But despite years of investigation, “the signals between silicone breast implants and autoimmune diseases were never strong enough to claim certainty,” says S. Lori Brown, PhD, who conducted research for the FDA. In the absence of direct causal evidence, the FDA lifted the ban on silicone gel implants in 2006.
The issue resurfaced 12 years later, when researchers at the University of Texas MD Anderson Cancer Center published the largest-ever long-term safety study of implants. They reviewed health data from nearly 100,000 patients with silicone and saline implants and saw associations between implants and three autoimmune diseases: Sjögren’s syndrome, scleroderma, and rheumatoid arthritis.
(The FDA disputed the findings in part because of what it called shortcomings in the study’s design, including that some of the diseases were self-reported by patients and not confirmed by doctors.) Then, in December 2018, a study comparing the long-term health of 24,000 women with silicone breast implants against that of 98,000 women of similar age without them found that those with implants had a 45 percent increased risk of autoimmune disease.
There is still no conclusive evidence that proves implants cause autoimmune illness. Yet a 2017 review of medical literature found that after silicone implants are removed, about 75 percent of patients experience a significant reduction in symptoms.
Meanwhile, in January 2018, the Journal of the American Medical Association Oncology had published evidence showing silicone breast implants are associated with increased risk of a rare cancer called breast implant–associated anaplastic large-cell lymphoma. That October, the Plastic Surgery Foundation, in collaboration with implant makers and the FDA, launched a National Breast Implant Registry to collect information on implant safety.
“Patient requests for better safety data were heard loud and clear,” says Andrea Pusic, MD, former head of the American Society of Plastic Surgeons’ research arm and chief of plastic and reconstructive surgery at Brigham and Women’s Hospital in Boston. To date, 815 surgeons have joined, and 17,200 patients have been entered into the registry.
The FDA held a two-day hearing on the risks and benefits of implants in March 2019. “I’ve been calling attention to these issues for 25 years, but what’s different now is the number of patients speaking out,” says Diana Zuckerman, president of the National Center for Health Research. (Nicole Daruda approves more than 200 requests every day to join her Facebook group and frequently travels to Washington to meet with other advocates.)
Last October, the FDA released proposed language for new breast implant labeling, including a black box warning on implants and a patient decision checklist to ensure that women considering implants are fully informed of the risks. The warning “is the most visible thing we can do to bring attention to the issue,” says Binita Ashar, MD, director of the FDA’s Office of Surgical and Infection Control Devices.
“We want patients to know that we believe their reports of symptoms. And we’re working to learn more so we can better predict which patients may experience problems and who may need to avoid breast implants.” In the Netherlands, doctors are encouraged to advise women with a genetic predisposition to autoimmune diseases against silicone implants.
Right now the best thing women with implants can do is monitor them (reporting unusual signs or symptoms to a doctor)—and keep perspective. “In the right patient, with the right care team, breast implants can be a very positive thing,” says Pusic. “It’s just that they are not free of risk.”
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