Rebecca Nelson, Elemental by Medium: September 3, 2019.
When Jamee Cook got breast implants at 21, she hoped to feel more confident about her body. Instead, the implants nearly ruined her life.
Just three years after her surgery, Cook, who is now 42, started having a slew of medical problems: fatigue, fevers, sinus infections, memory problems, and trouble concentrating. She felt like she constantly had the flu and could barely muster the energy to take care of her three kids. Because of her health problems, she had to quit her job as a paramedic. Four years ago, she finally saved up enough money to get her implants removed due to the complications and discovered her symptoms subsided. “I felt like I did a turnaround,” she says. She had finally gotten her life back.
Cook is not an outlier among women with breast implants. The safety of breast implants has long been a topic of debate in the medical community. After a safety scare in the 1990s, silicone implants were banned for more than a decade before the U.S. Food and Drug Administration (FDA) allowed them back on the market in 2006. But a growing body of evidence suggests that these newer breast implants aren’t as safe as this generation of women has been led to believe. The FDA requested in July that the implant manufacturer Allergan recall their textured implants, citing a link to a rare cancer called breast implant-associated anaplastic large cell lymphoma. And an online movement of thousands of women who say their implants have made them sick is calling more attention to other long-term complications.
Breast implants first came on the market in the U.S. in the 1960s. They are classified as medical devices by the FDA and an estimated 10 million women around the world have them currently. While the vast majority of those women don’t have issues, there’s increasing evidence that implants are associated with serious risks. But the available data on their safety is of poor quality, and doctors, researchers, and patients disagree about what some of the risks actually are — making it all the more difficult for women to determine them before making a decision.
The medical community has long downplayed the potential complications of implants, says Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., who has studied implants. “There are many, many plastic surgeons whose entire livelihood depends on doing breast augmentation surgery. If they were to tell every patient what all the risks are, they’d have fewer patients.”
Here’s what’s known for sure: Nearly 600 cases of breast implant-related anaplastic large cell lymphoma, a cancer of the immune system, have been reported to the FDA. As of July, 33 people died from it. Textured implants made by Allergan were linked to the cancer, and recalled globally that month. While the FDA says there’s generally a low risk of people with breast implants developing cancer from them, the agency said in a statement at the time that “we believe all individuals who are considering a breast implant of any type be informed of the risk.”
“Of the millions of women with breast implants, we know that complications occur in at least 1% of patients,” says FDA spokeswoman Stephanie Caccomo. “We believe, though, that all women should be aware of the potential risks and complications of breast implants, which are not lifetime devices.”
People who consider implants may be unaware that they are viewed as temporary devices to be removed or replaced at a later date. According to the FDA, the longer people have the implants, the higher their risk for complications. “The life of breast implants varies by person and can’t be predicted,” reads a FAQ about breast implants on the agency’s website. “That means everyone with breast implants will face additional surgeries — but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.”
A handful of recent studies determined that there could be a connection between autoimmune symptoms and breast implants. A survey of FDA data by researchers at Houston’s MD Anderson Cancer Center last September concluded that silicone implants are associated with higher rates of autoimmune diseases like Sjögren syndrome, scleroderma, and rheumatoid arthritis. Meanwhile, an Israeli study from December found that women with silicone implants had a 22% increase in the risk of having an autoimmune or rheumatic disorder.
The FDA pushed back on the MD Anderson study, saying in a statement at the time that agency officials “respectfully disagree” with the authors’ conclusions. But the renewed scrutiny, along with concerns about the link to cancer, prompted the agency to hold a two-day summit on breast implant safety in March. Doctors, researchers, manufacturers, and patient advocates — including Cook — spoke.
In May, the FDA said in a statement that the information gathered at the meeting “makes clear there is an opportunity to do more to protect women considering breast implants.” Officials said they would take better steps to communicate the risks of cancer and other systemic symptoms, and are considering “changes to the labeling of breast implants, which could include a boxed warning and a patient decision checklist to help women consider the benefits and risks of breast implants,” according to Caccomo.
The groundswell of patient advocacy has also started to move the needle in the medical community. “You can’t necessarily prove a link per se, but it’s real,” says Glasberg, the New York City plastic surgeon. “And it’s especially real for those patients.”
Doctors like to say that breast implants are the most studied medical device in history, and they’re not necessarily wrong. But critics have poked holes in the data that exists. The National Center for Health Research’s Zuckerman says that many studies of breast implants used to determine safety had high dropout rates and didn’t track patients for more than a few years, a serious flaw given that most complications crop up later. They were also too small to detect rare complications. Other studies only tracked women who had a diagnosed illness and were hospitalized for it, which would cut out many of the women dealing with the symptoms of breast implant illness. Most of the studies are also paid for by implant manufacturers or plastic surgery associations, who have a stake in data that points to good outcomes.
In 2006, when the FDA reintroduced silicone breast implants, the agency required that manufacturers conduct 10-year studies of 40,000 women. But those studies were never completed. In the breast augmentation section of the Allergan study, 40% of the women dropped out after just two years. Meanwhile, Mentor, another manufacturer, lost 80% of its augmentation participants after three years.
Part of the reason so many women dropped out of the study is because there was no incentive for them to participate. Allergan paid women $20 per year to fill out the survey. For filling out a 27-page long annual survey, Mentor offered no payment. In March, the FDA issued warning letters to Mentor and another implant manufacturer, Sienna, castigating them for failing to comply with the requirements the FDA gave for approval. The agency threatened to rescind its approvals of the products.
The problem with the unreliability of the data on breast implant risks, experts say, is that women do not have the right tools to assess for themselves how safe the procedure is. “I can’t believe that after all these years,” says Zuckerman, “we still don’t know what percentage of women with breast implants are going to have problems, and what percentage are going to have which [kinds of] problems.”
Breast implants have long posed a safety concern. After they were first put on the market in the U.S. in the 1960s, some women reported that their implants were leaking silicone into their bodies. They also complained of chronic illnesses similar to the symptoms of breast implant illness today. In 1992, the FDA banned silicone implants, with the exception of clinical trials.
In 1999, a study from the Institute of Medicine determined that there was no evidence linking silicone implants to more serious complications like autoimmune disorders and cancer. When an FDA panel voted to once again approve silicone devices, the panel’s chairman publicly opposed the decision, writing in a dissent letter that “to approve this device poses threats to women that are clearly unknown.”
The long-term complications posed by breast implants today are rare. “Hundreds of thousands of patients each year opt for breast implants — more than 400,000 just in 2018 in the United States alone,” says Colleen McCarthy, a plastic surgeon at the Memorial Sloan-Kettering Cancer Center in New York City. She is the principal investigator for the PROFILE Registry, which collects data on anaplastic large cell lymphoma and breast implants. “The overwhelming majority of these women report no adverse effects.” For his part, Glasberg says breast implants are safe enough that he would put them in one of his family members.
What is clear is that the medical community can do more to study the risks — and communicate them to people considering the procedure. “If [getting breast implants] is what you choose to do, then so be it,” says Cook. “But you need to be armed with the proper information before you make that decision.”
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