When recent Muscle & Fitness Hers cover model Karen McDougal opted for breast augmentation surgery in 1996, her doctor didn’t mention any risks beyond a small chance of capsular contraction, a complication that can occur when scar tissue builds up. McDougal had cautiously chosen saline implants. “My doctor said, ‘You have the safe ones—they’re just water. They’ll last you a lifetime.’”

But after about seven years, McDougal’s health started to deteriorate. She was sick for weeks at a time. Her vision became blurry, and the whites of her eyes turned pink. As time went on, she developed migraines and noise sensitivity so severe she couldn’t tolerate the sound of her own voice, and experienced frequent blackouts as well as Raynaud’s disease, a circulation problem that causes the tips of your fingers to turn white and numb. Her doctors diagnosed depleted hormones and thyroid issues, but no matter how many specialists she went to, no one could explain what was wrong. “No one had any answers,” she says. “I literally felt like I was dying.”

McDougal never suspected her implants were the problem—when a friend confided that his wife was having her implants removed because they were making her sick, she rolled her eyes. But as her symptoms progressed, she began looking online and discovered other women with symptoms similar to hers, including chronic fatigue, insomnia, persistent infections, rashes, and more, all supposedly caused by the body rejecting their implants.

Doubting doctors

Many members of the medical community dismiss the theory that the body can reject implants just as it might an organ transplant. With silicone, your body forms an envelope of scar tissue around the implant, effectively insulating it, notes Debra Johnson, M.D., a plastic surgeon in Sacramento, CA, and president of the American Society of Plastic Surgeons. For the silicone to leak into your body, both the implant and the capsule of scar tissue would have to break at the same time, she says. It could happen, but it would take something dramatic, like a major car accident or being stabbed. And even then, your body would quickly try to surround the silicone and wall it off again.

When it comes to the symptoms reported by McDougal and others, Johnson acknowledges that there are certainly women who have chronic fatigue, muscle aches and pains, and other health issues, and they also have breast implants. But she doesn’t view that as enough to prove cause and effect. In fact, research that has been done in the past two decades has uniformly failed to uncover any sort of link, she argues. “The breast implant syndrome being described as of late involves all pretty vague symptoms that a lot of people have who don’t have breast implants,” Johnson says. “Back in the ’90s we didn’t have any large long-term epidemiological studies, and that was a problem. Since then there have been huge studies done, and the manufacturers jumped through a million hoops with the FDA to prove [silicone implants’] safety. There has been no evidence to suggest cause and effect.”

But some researchers and medical professionals are beginning to come around to the idea that implants do have inherent risks, beyond those of the procedure itself. In 2011, the FDA warned that anaplastic large-cell lymphoma, a type of cancer of the immune system, may be linked specifically to implants (saline or silicone) with a textured surface. This past year it solidified its stance, definitively drawing a link between the implants and lymphoma, which researchers now believe may affect between one in 3,000 and one in 10,000 women in the U.S. with this type of implant. It’s treatable, sometimes simply by removing the implant, though other times it requires a specialized course of cancer treatment.

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Removing the risk 

For McDougal, the only acceptable option was to have her implants “explanted”. She found a plastic surgeon, David Rankin, in Jupiter, FL, who has developed an expertise in the field for removing the entire capsule while minimizing cosmetic flaws. Rankin estimates he’s done about 400 explant surgeries; these days he does about one explant for every implant. According to Rankin, symptoms like McDougal’s are a rare but real side effect of an otherwise safe procedure, making up what he estimates to be just 1% of cases.

Unfortunately, better-defined statistics and high-quality medical studies about breast implant illness don’t seem to exist, says Diana Zuckerman, Ph.D., an epidemiologist and public-health analyst who leads the nonprofit National Center for Health Research in Washington, D.C. Despite the two decades of breast implant research cited by Johnson, she isn’t impressed. “Most studies are funded by those who have an interest in showing a lack of problems,” says Zuckerman, who was responsible for the first federal government hearing on breast implant safety in 1990. Critics point out the high dropout rate in the studies, with as many as 85% of patients being lost to follow-up. “It’s impossible to know if they’re happy and healthy on their honeymoon in Tahiti or if they’re sick and pissed and their doctor is no longer speaking to them,” says Zuckerman.

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In the handful of small studies that look at the type of hard-to-diagnose symptoms of women like McDougal, the focus isn’t specific to breast implants but rather “adjuvants”—substances in a variety of products and devices, from vaccines to silicone implants to mineral oil fillers, that are thought to cause an immune reaction in some people. (Even saline implants like McDougal’s are housed in a silicone shell.) While these products are generally considered safe—after all, adjuvants are intentionally added to vaccines to improve the immune response, and silicone has been used in medical devices for 60 years—some patients may be predisposed to negative immune reactions based on sheer luck of the genetic draw. For example, risk may be increased in patients with type-1 diabetes. And a 2013 study of 80 women with autoimmune symptoms thought to be linked to breast implants found that 75% had pre-existing allergies, raising the suspicion that people with allergies may be more likely to have a bad reaction.

Patient advocates like Zuckerman say implant complications are like a game of whack-a-mole; new problems seem to pop up every few years. “The first ones sold in the 1960s got hard as a rock,” says Zuckerman. “So they made them more liquidy. Then they leaked and that wasn’t good, so they added polyurethane covers to make them softer. But that broke down to a carcinogen. Every few years they do something different, hoping this new thing will reduce the complication the old implants caused.” Right now, firmer “gummy bear” implants, approved in 2013, are thought to be more cohesive and less likely to leak. But it’s a different type of silicone, so it’s still an unknown, according to Zuckerman. Complications don’t generally appear until the five-year mark, she says.

However, implants are not likely to last forever. Just like a credit card that can develop a crack if it’s folded back and forth repeatedly, breast implants can lose their integrity over time. According to the FDA, almost all women with implants will face additional surgeries. Surgeons often recommend replacing implants every 12 to 15 years, before complications occur.

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You should also be prepared to pay for follow-up medical care, including MRI screenings every two years to check for ruptures, since they may not be covered by insurance. That’s a problem, says Zuckerman, because it’s not uncommon for a woman to get implants at a young age on an installment plan. If they start leaking or making her sick, she might need $10,000 to have them removed. “Insurance won’t cover it, and few plastic surgeons will take them out on the installment plan,” says Zuckerman. “I’ve known women with silicone leaking into their bodies who can’t afford to remove them.”

For her part, McDougal received her explant surgery just a couple of weeks after her photo shoot to be on a 2017 cover of M&F Hers. The result, she says, was almost immediate. The day after her procedure, her vision was no longer blurry, and her joint pain had improved. Four months later, she rates her health improvement at about 90%. Others have seen similar effects—a 2013 study published in The Netherlands Journal of Medicine found 36 out of 52 women had significant reduction of symptoms after their implants were removed.

All women, of course, have the right to choose whatever procedures may make them feel more confident in their bodies. But Zuckerman stresses that the FDA needs to do a better job of requiring long-term studies. “If it’s not possible to have 100% safe implants, good research would at least allow women to make an informed decision—and to know which are the good ones so they’re fully aware of what they are dealing with.”