Medical Examiner

Silicone Breast Implants Were Banned in the ’90s for Making Women Sick. How Did They Make a Comeback?

A blond and brunette woman presented with silicone breast implants.
Bachelorette star Clare Crawley (left) and race car driver Danica Patrick, two celebrities who have experienced breast implant illness. Photo illustration by Slate. Photos by Raymond Hall/GC Images via Getty Images, Ben Gabbe/Getty Images, and Getty Images Plus.

Robyn Towt didn’t want new boobs. But when she was diagnosed with breast cancer and underwent a double mastectomy at 44, friends and doctors told her she needed to “look like a woman” and feel “whole” again. Implants would help put her “back together.”

“I was talked into it,” Towt recently told me over a poolside phone call from her home in Arizona.

She quickly regretted the decision. But it wasn’t the look or feel of her new cleavage that was the problem. Rather, within days of her 2017 implant surgery, she developed strange symptoms, including severe insomnia and crippling fatigue. Nothing her doctor prescribed seemed to help. “She didn’t have any answers for me,” Towt said, adding that the doctor didn’t see a connection to the implants. Prior to the chest enhancement, Towt had walked five or more miles a day and regularly swam, golfed, and wakeboarded. Now, she couldn’t make it to the mailbox.

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Like many desperate patients, Towt turned to the internet, where she trawled cancer recovery forums for insight. Towt found that many women experienced symptoms similar to hers, but most wrote it off as side effects from chemotherapy or radiation—two treatments Towt hadn’t undergone for breast cancer. She tried their recommendations, too, for essential oils and nighttime baths, but they didn’t work, either. Then a woman messaged Towt privately and pointed her in a new direction: “Look into your breast implants,” she said. What Towt found surprised her.

Over the past decade or so, more than 350,000 people in the U.S. have reported adverse events related to silicone gel breast implants to the FDA. Their complaints range from autoimmune symptoms to a rare cancer called breast implant–associated anaplastic large cell lymphoma. Despite the number and severity of the issues described, the experiences of such patients have long been ignored by physicians, manufacturers, and regulators. The famous among them land in the pages of Page Six and People. Bachelorette star Clare Crawley says her implants caused “crazy health problems,” while Danica Patrick reported hair breakage and heavy metal toxicity; both documented their removal surgeries on Instagram. But for many, the confusion around what’s now called “breast implant illness,” or BII, has left them to suffer alone.

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The potential medical downsides of breast implants have made headlines before. In the 1990s, it was the subject of bestselling books and a repeat plotline in made-for-TV movies, from Breast Men starring David Schwimmer to the drama Two Small Voices the same year. Patients won millions of dollars in damages against implant manufacturers, and the Food and Drug Administration even issued a ban on the use of silicone gel–filled breast implants.

But public consensus on the risk posed by breast illness seemed always just out of reach. The lawsuits against implant manufacturers, for example, are still described in some medical and legal literature as ethically dubious, unfair to the targeted corporations, and not based on scientific evidence. And the FDA ban proved both porous and temporary. To date, breast implant illness remains “the most controversial subject in aesthetic and reconstructive breast surgery,” according to one recent paper.

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While sick implant recipients are still written off as crazy, and BII is not a recognized medical condition, researchers are starting to document the reasons and ways that the body might rebel against a silicone implant. The result may share features with long COVID and chronic fatigue syndrome, both illnesses that present with mysterious symptoms and are potentially spurred on by the body’s immune reaction to a virus or other invader. But it is unclear how often these ill effects of implants occur. Among sources that accept that they happen at all, estimates vary between a small percentage (according to peer reviewed research) all the way up to 1 in 5 women (an educated guess by a leading expert). More studies are needed, but a widespread recognition of the illness’s parameters would help get to the bottom of how often it occurs. It would mean patients could make choices around the cosmetic enhancement with robust counseling and treatment. Moreover, it would mean that women like Towt have been right all along.

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Surgeons have been augmenting breasts since at least the late 19th century, often with disastrous results. The early days involved implants made from ivory, wood chips, and even balled-up plastic tape. Silicone gel implants, which were introduced in 1962, promised a safe alternative in the form of a medical-grade prosthesis. They have since become increasingly commonplace, making up the majority of the 1.8 million breast augmentations (and hundreds of thousands of breast reconstructions) preformed globally in 2018.

But the problems with silicone implants have been apparent to some for decades. Since 1982, patients had been suing implant manufacturers in court, with millions of dollars awarded in damages. In June 1988, cancer patient–turned–consumer advocate Sybil Goldrich wrote about her “Restoration Drama” in an essay for Ms. magazine, helping to bring what would eventually be called BII to national attention. Following two mastectomies, Goodrich’s body rejected multiple implants in increasingly painful ways. “I was no closer to restoration than when I had started,” she wrote. “I simply had several more glaring scars on my disfigured torso.”

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Goldrich’s case piqued the interest of Diana Zuckerman, currently president of the nonprofit National Center for Health Research, and at the time, an investigator of federal health programs and policies for the U.S. Congress. Zuckerman asked the FDA to turn over all of its safety and effectiveness data on breast implants. She was shocked by how little there was. “They had a few studies that had been submitted to them with rabbits or dogs or rats,” she told me. The animals had been injected with silicone directly. Not one study involved actual implants in actual human beings.

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A congressional hearing ensued in December 1990—and the whole world was watching, as evidenced by extensive coverage on TV news and newspaper write-ups over the course of the decade. “The manufacturers are sweating bullets right now,” one anonymous congressional aide told the New York Times in 1992. That year, the FDA instituted what would become a 14-year moratorium on silicone breast implants, during which time they planned to collect and review the evidence. One major manufacturer, Dow Corning, eventually stopped making implants for good after a $3.2 billion product liability settlement (though it continues to produce the silicone used in other companies’ implants). But the industry ultimately came out on top.

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During the moratorium, silicone implants continued to make their way into people’s bodies through numerous loopholes, including for breast cancer patients, people who needed prior implants replaced, and those with anything a surgeon was willing to label a breast deformity. Everyone else was left with saline implants, which can reportedly make for a breast that feels “like a plastic bag filled with water.” Researchers also began publishing papers in major medical journals calling into question the validity of breast implant–related illness, and the results often contradicted patient reports.

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Perhaps the most influential study of the era appeared in the New England Journal of Medicine in 1994. The authors, including a surgeon and a rheumatologist, evaluated 749 women who had received breast implants between 1964 and 1991 in one county in Minnesota, comparing them with their peers who had not received implants. Five women in the implant group had connective tissue diseases, the conditions with which many women in the Dow Corning lawsuits were diagnosed. But 10 women in the nonimplant group reported the illness. On this basis, the authors concluded there was “no association” between implants and diagnosis. The only trouble was showing a doubling of risk in a disease as rare as systemic sclerosis “would require a sample of 62,000 women with implants and 124,000 women without implants, followed for an average of 10 years each,” as the authors wrote in their paper’s conclusion. And, as a team of rheumatologists noted in a contemporaneous rebuttal, the paper had entirely ignored the possibility that implants are linked to even rarer illnesses. Put simply: The study was way, way too small to definitively prove anything.

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Yet the tide had turned against breast implant illness, and policies changed once again. The FDA’s silicone implant ban ended in 2006 with a compromise: Major manufacturers Mentor and Allergan (formerly Inamed; Allergan is the maker of Botox) were allowed to return to market, without restrictions, with the promise that they would eventually complete large-scale, long-term safety studies on their products—a common but troubling FDA compromise called “post-marketing research.” Today, silicone boobs are available to anyone over age 22, while saline implants, which sit inside a silicone shell, are available at 18. Millions of American women have opted in. But more than a decade and a half later, many manufacturer-led studies have still not been completed.

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While Americans may have brought breast implants—and attention to breast implant illness—to the world, international researchers are the ones advancing much of the study on the side effects of silicone. “We really think it is a specific disease,” says the Dutch autoimmune disease researcher Jan Willem Cohen Tervaert, director of the division of rheumatology at the University of Alberta. “Patients do develop these symptoms.” What exactly those symptoms are remains fuzzy, but the most common side effects of implant illness include fatigue, brain fog, joint and muscle pain, hair loss and skin changes, and breathing difficulties. This suite of symptoms fits the patterns of similar conditions that have gotten short shrift by the establishment but affect the lives of millions: long COVID, chronic fatigue, and fibromyalgia.

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And like those other illnesses, the body’s natural defense system may be a key culprit. The leading theory is that BII symptoms are the result of the body’s immune response gone haywire. “When you place any implant in a body, the immune system is going to be triggered,” Cohen Tervaert says, whether it’s a cosmetic implant, Essure sterilization, or a joint replacement. For some people, the body’s curiosity about the foreign object resolves shortly after surgery. For others, likely due to a genetic predisposition, the inflammation never stops. In a real-world analysis of almost 25,000 silicone breast implant recipients published in the International Journal of Epidemiology in 2018, researchers in Israel reported that the odds of developing any autoimmune or rheumatic disorder increased by about 20 percent in women with breast implants. (Put another way: In the sample of patients, more than 26 percent of people with implants developed an autoimmune or rheumatic disorder, compared with about 23 percent of those without implants.) The risk of developing Sjögren’s syndrome, systemic sclerosis, and sarcoidosis were especially elevated in those with implants.

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That alone might not be enough to suggest a causal relationship between breast implants and autoimmune dysfunction, but it’s just one piece of the puzzle. Silicone itself may be a part of the problem; implants are known to leak, both as the result of rupture and a phenomenon called “gel bleed.” That’s why implants require periodic monitoring with MRIs and, in many cases, replacement every decade or so. And autoimmune reactions to medical devices are hardly limited to a single material. Similar symptoms to BII have been reported by people with polypropylene mesh implants. Mesh is used most commonly for hernia repair and in pelvic prolapse surgery. Notably, these immune response can take years to develop.

That’s why Cohen Tervaert thinks the problem is much bigger than BII, which he suspects afflicts as many as 1 in 5 people with silicone implants (of which already-established autoimmune disorders, like those described by the 2018 report from Israel researchers, make up some smaller percentage). Instead, he calls it autoimmune/inflammatory syndrome induced by adjuvants, or ASIA. Unlike BII, ASIA has a clear diagnostic protocol (including patient histories, extensive physical examination, and specific lab tests), which Cohen Tervaert helped to develop more than a decade ago. But few physicians are trained in the method; to date, it is available only in Dutch.

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In his practice, Cohen Tervaert has found that many women self-reporting BII have six or seven symptoms of ASIA, including changes in their tear production, heart rate changes, nerve damage, swollen lymph nodes, and fatigue. At a biological level, they appear to have abnormalities in their B cells and the formation of autoantibodies, both of which are major players in the immune system. Cohen Tervaert thinks ASIA could even help to explain the formation of breast implant–associated lymphoma—a cancer of the immune system that appears in the scar tissue or fluid around the implant. “An individual’s risk of developing [it] is considered to be low,” according to the FDA, “however, this cancer is serious and can lead to death.”

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When it comes to diagnosing ASIA due to “silicone incompatibility,” Cohen Tervaert’s goal is to make sure other diagnoses are ruled out before physicians recommend treatment: explanting the device and, in some cases, medications to suppress autoimmune dysfunction. In studies to date, Cohen Tervaert reports that somewhere between 60 and 80 percent of people with ASIA feel better after explanting. Even so, Cohen Tervaert suspects that the longer an implant is in place in a patient susceptible to ASIA, the harder it will be for them to recover.

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Towt is one of the lucky ones. After the fellow cancer survivor messaged her about her breast implants, she moved quickly to get them removed. Within 48 hours of explanting, Towt says she felt back to her old self. She was golfing within a week, and wakeboarding within a month. “If I didn’t experience it myself, I probably wouldn’t believe it,” she tells me. Looking back, she feels she was the victim of “predatory behavior” on the part of her surgeons. She’s only grateful to have explanted so quickly. “It was shocking enough for me to drop literally everything in my life and become a patient advocate for this,” she adds.

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But explanting doesn’t work for everyone. Over 25 years and three sets of breast implants, Lisa Evans, 50, never had any problems or signs of leakage. Then she found herself suddenly covered in a mysterious systemic rash and, shortly thereafter, was also diagnosed with a lung disease called bronchiectasis. She began to wonder if her implants were part of the problem. A Facebook group called Breast Implant Illness and Healing by Nicole, which has more than 165,000 members, convinced Evans to explant. Unfortunately, her symptoms never improved—calling into question whether her implants were the cause of her problems, or a distraction from a deeper issue. Looking back, “I do feel I was duped by this group,” she says. “I know I’m at fault. But I do feel they prey on people, because everybody wants to feel good.”

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Evans has since joined another group, Breast Explant Regret, which has just under 8,000 followers to date. There, women talk about scar correction and internal bras (a silicone cup inserted at the bottom of the breast and connected by fine straps to an upper rib for elevation), cubic centimeters of silicone, and breast lifts (surgically removing excess skin to reduce sagging). “We (the collective) DO NOT believe that removing your implants will resolve your health issues such as brain fog, joint pain, toe nail fungus (yes we have heard that one), headaches, food sensitivities etc etc,” one admin wrote in a pinned post. Many women in the group lament that they fell for the BII “hoax”—and some have found plastic surgeons who agree. As a result, many are re-implanting. But Evans isn’t so sure. “There is a small part of me that is thinking, well, maybe it is possible,” she says of BII.

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The FDA thinks so too. In 2018 and 2019, the agency held new hearings on the safety of breast implants. The FDA took testimony from scientists, including Cohen Tervaert, and patient-advocates, including Towt. In October 2021, it issued black box warnings on a number of implants, changed its screening recommendations for identifying ruptures, and required that physicians provide patients with a “decision checklist” to ensure they are aware of the risks. But without manufacturer data, much about breast implant illness remains unknown. That means informed decision-making for people pursuing implants—and some semblance of peace for those still living with them—is difficult to achieve.

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That’s why patient advocates like Towt would like to see manufacturers fund an independent trial of thousands of people with silicone devices of all types, from breast implants to testicle prostheses. (Notably, many papers on BII to date are published by plastic surgeons with close ties to industry.) Crucially, the study must also be conducted in a diverse population, as there is notably little evidence on the rate at which trans women and other gender-diverse patients experience BII symptoms. Towt also thinks patients would benefit from a mandatory registry system for all implanted devices. That way, all patient outcomes—the good, the bad, and the surprising—can be monitored. (The current registration system in the U.S. is optional, and relatively few plastic surgeons have participated to date.)

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Patients also want more research into best practices for explanting devices. When an implant is placed, the body naturally forms a protective capsule of scar tissue around it, which most surgeons do not remove during an explant, except in patients who have developed lymphoma. That’s because a “capsulotomy” is a longer, more skilled, and more expensive procedure that, so far, does not appear necessary for recovery from BII. Even so, many patients say they would prefer a removal, on the slim chance that freed silicone could somehow still lurk inside the capsule. While many doctors remain skeptical, recent case studies suggest that at least two women developed breast implant–associated lymphoma one and six years after their implant, but not their capsule, was removed. “I am sitting here with that hanging over my head,” says Towt, who did not get a capsulotomy upon explanting.

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Even without more FDA intervention, the mounting BII discourse may have knock-on effects for the implant industry. For decades, manufacturers and some plastic surgeons have been able to deny or deflect negative patient experiences. But as self-diagnosed BII sufferers have banded together and breakthroughs in autoimmunity research have continued apace, that no longer seems possible. The industry might need a new tactic, such as providing those who still want breast implants alternatives to silicone and silicone-encased saline devices. Two such options—cellulose implants and fat transplants—are already available, but their popularity may increase in the coming decades (and they still need robust safety studies of their own).

Activists are no longer calling for an outright ban on silicone-based plastic surgery devices. “I’m not anti-breast implants,” Towt says. “I really just am pro-informed consent.” Many, or even most, who receive comprehensive counseling on the potential side effects will choose to move forward with their new boobs. Some may forgo these procedures altogether, either because they feel they are at an elevated risk of complications, or because they can’t stomach even a slim possibility of a bad outcome. Either path begins with an accurate assessment of the risk. For now, Sybil Goldrich’s advice from more than 30 years ago still holds true. “Ask your doctors to share everything they know about implants with you; ask to see the package insert, as well,” she wrote. “If they refuse, get yourself another surgeon.”

For more on the hidden costs of cosmetic enhancements, listen to Eleanor Cummins on The Waves:

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