Julia Halpert, HealthCentral: October 25, 2022
With new FDA warnings, troubling research, and a growing online population sharing stories and symptoms, experts and women with implants weigh in.
JENNIFER JOHNSON, 43, of Wilcox, NE, underwent a preventative double-mastectomy—a surgical procedure that removes all tissue from both breasts—in July 2008 at age 29 after learning she carried the BRCA2 genetic mutation.
Research shows that having BRCA2 increases risk of developing breast cancer (BC) by 45%. Johnson’s family history didn’t make her keen to play the odds: Her mother died from the disease at 34, as did her sister Debbie at 39, while another sister, Valerie, was diagnosed with BC in her 40s and, thankfully, is still here. After Johnson’s doctor told her that her own chances of facing a similar fate were exceedingly high, she chose the double-mastectomy as the safer bet.
The surgery didn’t spare her, however. A post-op pathology report found that Johnson already had an aggressive type of breast cancer (“stage 1, triple-negative, grade 3”) in her right breast that required immediate treatment.
Her plastic surgeon was “adamant,” she says, that she get breast implants to return her body to normal, since she was so young. She got silicone implants on her 30th birthday. Within several months, she began experiencing intermittent, aching pain in her muscles and joints, as well as “shooting, stabbing pains” in her chest, she reports. She also battled rashes and severe fatigue. “I basically felt like I was dying a slow death, like my body was just giving out slowly over time,” she recalls.
A team of specialists told her nothing was wrong. But her symptoms continued—leaving her distraught. After four years of this, she had her implants removed (known as explant surgery). To her great relief, “I started feeling better right away,” she says. “Every single symptom disappeared within a year.”
Johnson is among those who have experienced what’s colloquially known as breast implant illness (BII), when significant health issues—fatigue, chest pain, hair loss, headaches, chills, photosensitivity, rash, chronic joint pain, among other symptoms—arise after getting implants.
We asked women who’ve undergone reconstruction or done elective breast implant surgery to share their experiences. We also polled breast health experts on their thoughts about this popular cosmetic surgery being done in the U.S. and around the world—and its potential implications for the chronic community.
Are Breast Implants Safe? Or Not?
In October 2021, the FDA issued new restrictions for breast implants, including a mandated box warning on the product label to inform patients of significant health risks, such as an increased cancer risk; a checklist of items that health care providers should discuss with patients as they consider implants; updated silicone gel-filled breast implant rupture screening recommendations; and a list of specific materials used to create the implant.
Then, this past September, the FDA issued a safety communication following reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas in the scar tissue that had formed around breast implants, noting that “currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.” A spokesperson for the agency added, “The FDA recognizes that many patients’ symptoms may take years to develop, and patients may not be aware of the risk of SCC … We will keep the public informed as significant new information becomes available about SCC and lymphoma variants in the breast implant capsule.”
Implants Remain Popular, Yet Some Patients Suffer
Safety issues haven’t dimmed enthusiasm for breast implants. According to a 2020 report by the American Society of Plastic Surgeons (ASPS), there were 137,808 implants provided for breast reconstruction and 193,073 for cosmetic surgery in this country alone. Silicone implants were used in 84% of breast augmentations, while saline implants were used in 16% of such procedures in 2020.
Mark Clemens, M.D., a professor of plastic surgery at MD Anderson in Houston, TX, who has led several MD Anderson-based safety studies on breast implants, says the recent FDA communication shouldn’t alter the perception of breast implant safety. He believes that it was done out of abundance of caution to inform, not frighten, women. When it comes to breast implants, “the vast majority of women will be completely healthy [after getting them] and won’t have any issues,” he says. However, he urges women who notice any signs of abnormality—asymmetry between breasts, the firming of a breast, or a palpable mass or a fluid collection—to consult a physician to ensure there’s nothing wrong.
Diana Zuckerman, Ph.D., president of the National Center for Health Research, a Washington, D.C.-based nonprofit organization that draws from scientific studies to improve public policy and medical oversight in the U.S., believes more independent research is required before an accurate safety assessment can be made. She says that nearly all the research being done on breast implant safety has been conducted by the very hospitals and plastic surgery organizations that either offer reconstruction and elective implant procedures as a service, or represent the surgeons who are paid to perform them—a big source of revenue and conflict of interest, leaving troubling questions of inherent bias being baked into the results.
“I can’t emphasize enough how much resistance there has been from the plastic surgeons’ medical societies and the implant manufacturers” to doing more and better research on implants, Zuckerman says. While some plastic surgeons have vocalized their concerns over the need for better information for their patients, “the medical societies—the major sources of information that FDA officials rely on—have been vehemently opposed,” she reports. “Their usual mantras are some variation of ‘breast implants are the most studied medical device in history’; hundreds of studies prove they are very safe’; and ‘so-called breast implant illness symptoms are common symptoms caused by aging and other factors, not by the implants.’” Implant manufacturers say the same thing—not coincidentally, Zuckerman adds.
Nicole Daruda, age 58 and living in Vancouver Island in Canada, openly doubts the industry’s safety claims. “Breast implants are linked to autoimmune symptoms and diseases and many other health problems,” she maintains. Daruda got cohesive gel implants in 2005 and saw her once excellent health “decimated by breast implants.” Within the first few years of having them she says she experienced fatigue, brain fog, various infections, food allergies, and hypothyroidism, with more symptoms appearing each year.
Daruda had her implants removed in 2013, and within four years she says all of her symptoms resolved. She started the Facebook group, Breast Implant Illness and Healing by Nicole, in April 2015 to provide a forum for women experiencing health issues after having implants to support and talk to each other. The group now has more than 170,000 members. Daruda says that she’s heard from thousands of women on her social media platform who report their health has improved after getting their implants removed.
IMPLANTS AND LYMPHOMA
What You Need to Know About Lymphoma
According to the FDA, as of September 2020, more than 700 people worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma, an uncommon cancer. The agency found that the women with textured breast implants have a small but increased risk of developing this disease. The working theory, Dr. Glasberg explains, is that the texturing on the implant drives inflammation, which causes a change in the capsule around the implant that then develops into lymphoma.
Despite his belief that breast implants are safe for the vast majority of women, Dr. Clemens authored a 2021 study that examined eight cases of Epstein–Barr virus-positive large B-cell lymphoma associated with breast implants “and we’ve been trying to understand these better,” he says. (The eight women in the study were all patients at MD Anderson, a medical center that offers breast reconstruction and elective breast implant surgery, who were among the 30 known cases in the world of this type of lymphoma, per the FDA tally.) Increased awareness, combined with more pathology testing of scar tissue, plus physicians and patients being aware of breast implant-associated issues has “drawn our attention to looking for these other diseases,” he says.
IMPLANTS AND AUTOIMMUNE DISEASE
Breast Implants and Autoimmune Disease
Autoimmune issues arise when the body mistakenly attacks its own healthy tissue, causing damaging inflammation and often chronic pain and fatigue, among other symptoms, some of them disabling and/or permanent.
In 2018, MD Anderson conducted the largest study to date to explore long-term safety outcomes of breast implants, finding an association, though not a causation, with some rare diseases, including the autoimmune disorders Sjögren’s syndrome, rheumatoid arthritis (RA), and scleroderma. What’s more, researchers in the Netherlands found that more than two-thirds of women with autoimmune symptoms who had their breast implants removed experienced a reduction in symptoms.
That same year an Israeli study—research that Zuckerman says is both independent and well-designed—compared more than 24,000 breast implant patients to more than 98,000 women without breast implants but who shared similar demographic traits and reported a 22% increase in several autoimmune and rheumatic disorders, as diagnosed by their physicians and reported in their medical records. In addition, the same study reported a 60% increased risk of Sjögren’s syndrome, multiple sclerosis (MS), and sarcoidosis among those with implants, as well.
Dr. Clemens, the principal investigator of the large MD Anderson study, points out that some of those diseases in his study were self-reported by study participants, and not necessarily diagnosed by a physician—a limitation of the research. He doesn’t believe the findings are cause for concern. “The vast majority of patients with implants do not experience these symptoms or diseases,” he says. “However, it is important that they are aware of these conditions so that if they note any changes or have concerns, they can discuss with their treating physician.”
Then again, a 2021 study on breast implants and respiratory health found that 74% of participants who had their breast implants removed showed significant improvements on at least three of the six pulmonary function tests performed—an objective, not self-reported, medical tool.
For her part, Zuckerman notes that research is often funded by implant manufacturers and used to argue that breast implant illness is not real. A major weakness of most BII studies, a report by her organization found, is that they evaluate only diagnosed diseases. The reason why women decide to have their implants surgically removed and not replaced, she explains, is often due to symptoms of autoimmune and connective tissue diseases, rather than official diagnoses.
“The women and their doctors often report a constellation of symptoms that do not fit the exact criteria of known diseases,” she explains, adding that most people aren’t hospitalized for the autoimmune issues most associated with BII. Without symptoms that perfectly fit a specific diagnosis, many women will not have a diagnosis logged into medical records.
REMOVING YOUR IMPLANTS
Can Implant Removal Mean a Return to Health?
Some women, who can find no other explanation for their symptoms, like Johnson, are having their implants removed. In 2020, 22,676 explants were performed on reconstruction patients in the U.S., per the ASPS. Johnson says she was forced to find a different plastic surgeon to perform the procedure, since the one who put them in didn’t believe they caused health issues.
“He stood back looking at my chest and said, ‘I did an amazing job on those and really don’t want to take them out,’” she recalls.
Zuckerman believes the health rebound after explant surgery may be higher than the plastic surgery industry acknowledges. Since 2015, her organization has been contacted by more than 4,500 women who had breast implants they wanted removed due to rupture, breast pain, or medical symptoms caused, they believed, by their implants. NCHR was asked to advocate with health insurance companies, Medicare, and Medicaid to cover the costs of implant removal, she adds, since many of the women could not afford explant surgery.
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