Why Everyone Is Talking About Breast Implant Safety Right Now

Michelle Stacey, Allure: July 29, 2019.


Candyce Kirbyson wanted a bit more. At 105 pounds, she had A-cup breasts. So at 32, the Seattle-area mom decided to get implants. But she got a lot more. A laundry list of ailments, in fact. Hives and muscle weakness. Numbness and tingling in her arms and legs. Insomnia and chronic sinusitis. At various points in Kirbyson’s 14-year slog through doctor’s offices, MRIs, and emergency-room visits, it was suggested (among many other potential diagnoses) that she had “mold toxicity,” sometimes known as “sick-building syndrome.”

Kirbyson wondered if it had to do with her new office. “I was on and off antibiotics that would work for a while, and then my hives and inflammation would come back,” she says. “I sometimes felt like I was getting early Alzheimer’s, like my brain wasn’t working. I tried integrative medicine, functional medicine, ENTs. Nobody could figure out what was going on, and doctors said it was all in my head. I felt like I was dying.”

Never once did Kirbyson suspect the implants as the source of her sickness since she didn’t have pain in her breasts and not one doctor had ever raised the possibility.

Then late last year, she read an article that led her to a Facebook group that described similar symptoms. “I started crying my eyes out, because everything I was reading was what had happened to me,” she says. Kirbyson consulted a local plastic surgeon who was mentioned in the group and had her implants removed in January.

Slowly, her symptoms are diminishing. “My energy is back, my brain fog is lifting, the tingling and hives are happening less,” she says. “I’m 500 percent sure that my whole system broke after I got implants.”

An alarming conclusion, particularly since breast augmentation is the most popular plastic surgery. There were almost 314,000 procedures in the U.S. in 2018, up 4 percent from the previous year. In a 2011 report, the Food and Drug Administration estimated that between 5 and 10 million women worldwide have breast implants. Admittedly, fears about potential dangers have surrounded implants since their inception in 1961. But past concerns were that they would rupture and leak.

The new fear factor: Could simply letting these things exist in your body be ruinous? Claims like Kirbyson’s — that breast implants have triggered inexplicable chronic illness — are growing, and new reports show a direct line from implants to a rare lymphoma. In March, the FDA held a public advisory committee meeting on breast implants to discuss these issues. Sides were taken, and tensions ran high.

One of the speakers, Diana Zuckerman, the president of the National Center for Health Research, who has been a voice in the debate for decades, says: “I was struck by how often the answer to a question was ‘We don’t know.’ We don’t know which implants are better or worse, or how often people get sick. Women deserve to know what their odds are of getting sick because of their breast implants, and we can’t answer that question.”

Doctors and the FDA concede that there is still much to learn, says Grant Stevens, the president of the American Society for Aesthetic Plastic Surgery (ASAPS) and a clinical professor of plastic surgery at the Keck School of Medicine of USC. But after 35 years of performing breast implants on more than 10,000 patients, he’s convinced that the vast majority have few problems with the devices.

Women suffering from what they call breast implant illness (BII) beg to differ. Though not a disease, BII has recently gained credibility. So much so that the FDA has incorporated the patient-coined term into its website among cautions about implants, citing “systemic symptoms” as one potential risk, although “what causes them are poorly understood.”

In the run-up to its March meeting, the FDA listed examples of the top reported BII markers: fatigue, brain fog, rash, joint pain, and memory loss (amid an exhaustive 87-item list of other possible issues, including “ear ringing” and “throat-clearing”).

“BII is not a diagnosis,” says Stevens. “It’s a collection of symptoms — about 22 of which I have myself at any given time. [But] I’ve looked into the eyes of women who say they’re going through it, and I know they’re not making it up. They’ve seen a bunch of doctors; they’re frustrated; they’re scared.”

There have been no formal studies on BII to mollify those fears. (The first of its kind is starting now, funded by the Aesthetic Surgery Education and Research Foundation, according to Stevens.) It’s difficult to track symptoms that are so subjective and wide-ranging, and Laurie A. Casas, the former president of ASAPS’s Aesthetic Surgery Education and Research Foundation and a clinical professor of plastic surgery at the University of Chicago Medicine, says many manufacturers have “had trouble getting” follow-up reports on patients who use their implants — an FDA requirement.

In March, the agency issued warning letters to two companies, Mentor and Sientra, for falling far short. In a statement to Allure, Mentor admits they “continue to encounter challenges,” due to the low percentage of U.S. patients who use their textured implants. Sientra told us that many of its patients have family and work obligations that preclude them from follow-ups, but says it’s committed to helping bridge that gap by compensating patients and doctors.

“I think some companies did a lousy job,” says New Jersey–based plastic surgeon Caroline Glicksman. “You tend not to hear from patients who are doing fine. These manufacturers should incentivize women who take time and spend money to show up for follow-ups every year.” One company that did that, Ideal, was able to track nearly 95 percent of its patients for five years by offering a balloon payment at the end of the study, potentially granting each woman $5,000 to $8,000.

The recent establishment of several breast implant “registries” could also help to assess long-term safety. “Ideally, we want to track every implant in every patient over the lifetime of the implant,” says Casas. “These studies should have a control group of women of the same age that do not have implants. That way we can understand the incidence of these symptoms in women of the same age who have and do not have implants.”

That raises the question: Could it be that breast implants aren’t for everyone? Many doctors are intrigued by the potential of using genetic tests to determine whether someone might have inflammatory or allergic “markers” that would indicate they’re a bad fit for the devices, says Casas. That’s a possibility the FDA is now entertaining, saying in a statement: “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. They develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”

That small number of patients is radicalized. The Breast Implant Illness and Healing Facebook group, for one, has grown from a few hundred members to more than 70,000 in the past three years. Its message — your breast implants are making you sick — is powerful. But that power can be a double-edged sword, says Nashville-based plastic surgeon Melinda Haws. “Many women have turned to social media for support and information when their doctors were unsympathetic,” she says. “Unfortunately, the support groups, in many cases, have become more trusted than the plastic surgeons. If I’ve got a pain in my knee, I can search the Internet for the cause. But I still have to see an orthopedic surgeon.”

BII’s symptoms can make many patients feel helpless and unnecessarily guilty, since it’s an elective surgery. “Many women have described to me the negative impacts on their family and their jobs that they believe have come from this procedure,” says Haws, adding that such worries can compound and worsen insomnia and anxiety.

For patients like Kirbyson, advice from the BII group was transformational. However, for Celeste Greene*, it presented a red herring. Greene got her first implants at age 21. They were saline and lasted six good years, until they began to feel hard and she traded them for silicone implants. She soon developed some symptoms similar to Kirbyson’s, went through full-panel tests with no conclusive diagnosis, and three years later, found solace and enlightenment in the same Facebook group.

Within about nine months of finding the group, she had her implants removed. As she recovered, Greene felt markedly better. Fast-forward a few months, and all of her symptoms returned. It took another year, a divorce, and finding out that her estrogen was abnormally low (“My endocrinologist said it was like that of a 60-year-old woman!”) for Greene, now 36, to get a complete picture. She is now positive that job stress, studying for board exams to keep that job, an abusive marriage, and hormone irregularities were collectively the “perfect storm” that caused her malaise. “It was an expensive lesson.”

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