One in 20 American women has breast implants—a figure surpassing the population of Connecticut. Odds are, you or someone you know is intimately familiar with these devices. And perhaps, in recent weeks, you’ve seen social media posts or newspaper headlines, often alarmist, linking breast implants to various health concerns. Beyond the bold print, many reports struck us as rather spongy—written, it almost seems, in a way intended to sway opinions rather than deliver the facts of a complicated health story.
And complicated it is: Just last week, the US Food & Drug Administration (FDA) called a meeting of the General and Plastic Surgery Devices Panel to, as they state on their site, “discuss and make recommendations regarding the benefits and risks of breast implants indicated for breast augmentation and reconstruction.” The panel, comprising doctors across specialties, heard two days of testimony from medical experts, breast implant manufacturers and patient advocates, plus additional commentary from the general public.
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Among the seven topics explored at the hearing were two highly publicized health issues: a rare cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and an emerging condition dubbed “breast implant illness” or “BII.” We spoke with plastic surgeons who attended the hearing to tease out the latest truths about breast implant safety in 2019.
WHAT EVIDENCE EXISTS SUPPORTING THE SAFETY OF BREAST IMPLANTS?
There are a number of published, peer-reviewed studies, but before we delve into those, let me first share some history to lend context to the recent safety inquiry. This is not the first time breast implants have come under fire. There are individual case reports linking silicone gel implants to systemic disease dating back to the ‘60s, a time when implants were largely unregulated. Interestingly, the FDA wasn’t granted authority over medical devices until 1976, at which point, they “grandfathered” previously approved devices. They didn’t demand data on breast implant safety and efficacy until 1988. Come ‘92, when manufacturers failed to produce sufficient proof, the FDA placed silicone implants on moratorium, allowing them to be used only for breast reconstruction following cancer treatment. Saline implants remained on the market.
Now, hearing this, one might jump to the conclusion that silicone implants were banned because they were shown to be harmful. But, in truth, they were pulled from the market due to an absence of reliable evidence in either direction. “The implant manufacturers had simply never conducted high-quality studies on these devices,” says St. Louis, MO plastic surgeon Patricia McGuire, MD.
The first epidemiological study—or investigation aiming to determine whether certain diseases occur more in women with implants than in those without—came about two years later in 1994. Led by esteemed rheumatologist Sherine Gabriel, MD, and published in the New England Journal of Medicine, the study looked for evidence of 12 types of connective-tissue disease, plus three other illnesses, and found “no statistically significant elevation in the relative risk of any of the specified connective-tissue diseases or other disorders among the women with breast implants as compared with the control subjects.” Papers echoing these findings punctuated medical journals throughout the ‘90s, including a landmark report compiled by the Institute of Medicine of the National Academy of Sciences, which stated: “The committee finds no convincing evidence for atypical connective tissue or rheumatic disease or a novel constellation of signs and symptoms in women with silicone breast implants.” The FDA reintroduced silicone implants in 2006 with a condition: manufacturers must continue to monitor their safety (the potential link to rare systemic disease, in particular) by enrolling large numbers of patients in long-term studies.
In the years since the moratorium, 10-year outcome studies have repeatedly shown 95 to 98 percent satisfaction rates among breast augmentation patients. (In fairness, there were also studies cut short and criticized for inadequate enrollment and/or follow-up.) A 2015 Annals of Internal Medicine review, looking at 32 separate studies by a process of meta-analysis, determined: “The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes.” And the devices have evolved to include greater safeguards, like more cohesive (non-migrating) gels and a barrier coat atop shells intended to thwart seepage, notes Eugene, OR plastic surgeon Mark Jewell, MD. (For the record, medical-grade silicone has been used for decades in everything from brain shunts and pacemakers to intravenous tubing.)
DO ANY STUDIES SHOW A LINK BETWEEN IMPLANTS AND DISEASE?
Yes. Last fall, researchers at the University of Texas MD Anderson Cancer Center combined data from two manufacturers’ post-approval studies, intending to compare incidence rates of “certain rare harms” in breast implant patients to those of the general public. They found silicone implants to be associated with higher rates of Sjögren’s syndrome, scleroderma, rheumatoid arthritis, stillbirth and melanoma. The paper was widely discredited by plastic surgeons for its flawed methodology (merging conflicting data from separate studies with distinct reporting mechanisms), poor follow-up rates (meaning subpar participation), and inclusion of self-reported complaints from patients (versus physician-verified diagnoses). Based on the these shortcomings, “the report’s conclusions should be viewed with caution,” warned Binita S. Ashar, MD, the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. Also last year, an Israeli study linked implants to autoimmune/rheumatic disorders like Sjögren’s, systemic sclerosis and sarcoidosis. “That’s probably a reasonable population-based study, [and] there may be an association,” says Dr. Jewell. Other plastic surgeons question its credibility, citing the senior author’s known bias and reputed agenda, and the fact that researchers “could not ascertain whether these diseases occurred before or after the placement of implants, and did not verify diagnoses or establish the total number of patients with implants, thereby creating an artificially high rate,” notes Santa Monica plastic surgeon Steven Teitelbaum, MD.
WHAT ARE THE MAIN SAFETY CONCERNS SURROUNDING BREAST IMPLANTS TODAY?
BIA-ALCL, for one: This is a clearly defined cancer of immune cells that can develop in the scar tissue (aka capsule) surrounding silicone and saline breast implants with textured shells. “There are no confirmed cases in women exposed only to smooth implants,” says Seattle plastic surgeon Lisa Sowder, MD. (What’s the difference? Textured shells are roughed up to better grip the breast tissue and stay in place. All teardrop-shaped, or “anatomic,” implants are textured.) BIA-ALCL has been on plastic surgeons’ radars for about ten years now, adds Dr. Sowder.
BII is newer and more nebulous, commonly marked by brain fog, memory loss, joint pain, headache, fatigue, fever, anxiety, hair loss, rashes and more. While BII isn’t an official medical diagnosis, and there are no tests to prove or disprove its existence, it’s typically described as a constellation of systemic symptoms that some women attribute to their implants (be they saline, silicone, smooth or textured). “These women have real symptoms, but no one can figure out what’s wrong with them, because their labs, X-rays and exams tend to be normal,” explains Dr. McGuire. With little to no data to corroborate or explain patients’ maladies, plastic surgeons are struggling for answers. “It’s hard, because these are very subjective symptoms—things we can’t objectively measure, but that make a person feel lousy,” says Nashville plastic surgeon Melinda Haws, MD, who chairs the newly created BII task force for the American Society for Aesthetic Plastic Surgery (ASAPS). “In the ‘90s, vague symptoms were investigated only as they related to established connective-tissue disorders, not as separate entities. But this, whatever this is, we haven’t looked at it before.” New studies being initiated by ASAPS and its research arm, the Aesthetic Surgery Education and Research Foundation (ASERF), will soon begin tracking the symptoms of patients who have implants removed, and analyzing their scar-tissue capsules for bacterial content, genetic markers, and other etiological clues.
WHAT CAUSES BIA-ALCL?
Doctors theorize that four factors contribute to the development of BIA-ALCL: textured implants, chronic inflammation incited by bacteria, a genetic predisposition, and time (it typically takes about eight years for the disease to take shape). “Current data supports the significant role bacteria play in BIA-ALCL,” says Dallas, TX plastic surgeon William P. Adams, Jr., MD. “Bacteria have evolved in medicine—strains that weren’t causing problems 20 years ago have grown more virulent.” Which may explain why the disease is only a recent phenomenon even though textured implants have been used since the ‘70s. What’s more, he adds, “studies show there are exponentially higher numbers of bacteria on textured implants compared to smooth, and many more bacteria on heavily textured implants because of their high surface area and roughness.” This is a crucial distinction: Textured implants vary in granularity. Those with a more aggressive “macrotexture” provide a better breeding ground for bacteria. Over time, the bugs form a biofilm, sparking chronic inflammation that ultimately gives rise to this rare T-cell lymphoma.
WHAT IS THE RISK OF DEVELOPING BIA-ALCL?
It’s estimated that 20 to 35 million women worldwide have breast implants. According to the FDA, BIA-ALCL occurs in between 1 in 3,817 and 1 in 30,000. To offer a more accurate assessment, Australian researchers calculated the risk specific to different types of textured implants, and reported a 1 in 82,000 risk with “microtexture” implants (think: fewer peaks and valleys) and a 1 in 3,200 risk with “macrotexture.” To date, there have been 427 documented cases and 19 deaths worldwide, most resulting from delayed diagnoses and improper treatment in the years before doctors understood the disease. “Today, we’re diagnosing it much earlier and death rates are improving,” says Dr. Teitelbaum. As Houston, TX plastic surgeon Mark Clemens, MD stated at the hearing, “Current research focuses on determining genetically at-risk populations.”
WHAT ARE THE SIGNS OF BIA-ALCL?
Given the vital importance of early detection, every woman with implants should know what to look for. The first symptom is usually swelling of the breast over days or weeks due to a collection of fluid around the implant. The disease can also present as a lump in the breast or armpit, sudden firmness of the breast, or pain. If you notice any change in your breasts, see your plastic surgeon right away, so she or he can do an ultrasound or MRI, drain any fluid, and test it for CD30, a key marker for activated T-cells.
HOW DO DOCTORS TREAT BIA-ALCL?
According to Dr. Teitelbaum, 85 percent of patients can be cured by surgery alone—removing the implants and surrounding capsules—while 15 percent require surgery plus chemotherapy and/or radiation to target malignant cells that have spread to the lymph nodes or adjacent tissues. While rare and highly treatable when caught early, “it is 100 percent a cancer in those who have it,” notes Chicago plastic surgeon Laurie Casas, MD. During the FDA hearing, a panel member urged doctors to keep this in mind when using overly optimistic terms to describe the general prognosis for BIA-ALCL.
IF TEXTURED IMPLANTS FUEL BIA-ALCL, WHY USE THEM?
As BIA-ALCL numbers have climbed, many plastic surgeons have abandoned textured implants. Dr. McGuire quit them three years ago after several colleagues’ patients developed the disease. “This is elective surgery, and to me, the risk of cancer is just not worth it,” she says. Still, she acknowledges the benefits of textured implants. Referring to the macrotexture type, she says, “When those cases went well, they were the best I ever had: They gave a very natural-looking result—the breasts were soft and stayed in position.” She still gets great outcomes with smooth implants, she says, “but they’re not quite to the finesse of what I got with shaped.”
Dr. McGuire, like most of her peers, believes textured implants—smooth, too, for that matter— should be used only by board-certified plastic surgeons (who are trained to curtail risk) and that a patient’s anatomy should absolutely dictate a need for textured (correcting asymmetries or congenital abnormalities, like constricted lower poles, for instance). While a variety of doctors outside of plastics perform breast augmentation, board-certified plastic surgeons are regularly educated on BIA-ALCL via plastics-specific journals, webinars and meetings. (In a survey of non-plastic surgeon primary care providers, 80 percent were unfamiliar with the disease.) Currently, only one major implant manufacturer restricts sales to board-certified plastic surgeons—and this same company has the lowest rate of BIA-ALCL.
“Textured implants, when clinically indicated, are safe provided requisite steps are taken to minimize bacterial contamination of the implant,” says Dr. Jewell. These 14 aseptic steps are validated in a 2017 study conducted by Drs. Adams and Jewell along with six other global plastic surgeons, who pooled data on 21,650 patients implanted with 42,035 macrotextured implants. In every operation, surgeons adhered to the 14-point plan. Patients were followed for an average of 11.5 years post-op. The expected number of BIA-ALCL cases, based on current risk for this particular implant, was 14. The actual number of BIA-ALCL cases reported was zero. “We believe that’s very strong evidence of a relationship between meticulous, high-level surgical technique and a reduced risk of BIA-ALCL,” says Dr. Adams.
BACK TO BII: WHAT SHOULD PATIENTS DO IF THEY’RE EXPERIENCING SYMPTOMS?
Don’t panic: “We do not know whether these symptoms occur more frequently in women with implants than in the same population of women without implants. We don’t know if they’re correlated,” says Dr. Teitelbaum. And as Dr. Haws points out, these are the same types of symptoms that can come from medication changes or shifting hormones. Still, in the last few years, BII support groups have sprouted across social media, quickly accruing thousands of members with similar ailments and stories. Your first stop should be your plastic surgeon, who can examine you, order a medical work-up and refer you to a rheumatologist if indicated. Implant removal is always an option—your body, your choice—but it’s not a surefire fix.
WHAT SHOULDN’T WOMEN DO IF THEY SUSPECT BII?
Succumb to Dr. Google. Every surgeon I interviewed expressed concerns about a rampant myth being perpetuated online that the only viable “cure” for BII is an en bloc capsulectomy, which is a means of removing implants and their capsules as single, intact units (presumably to prevent “contaminants” from spilling out or being left behind). “It can be somewhat dangerous in terms of trying to get the capsule off the chest wall, especially if implants are behind the muscle and the capsule is on the ribs,” explains Dr. Jewell. The procedure offers limited visibility; typically requires an eight- to 11-centimeter incision; and risks damaging neighboring muscles, ribs, even lungs. And according to Dr. Adams, “there has never been a study or research presented or published showing any benefit to an en bloc capsulectomy.” What’s more, it’s simply not an option for everyone: “It works best on tight, hard capsules [which make for a cleaner dissection],” says Dr. Haws. “When scar tissue is soft and wispy, I can’t always guarantee an en bloc—but the second I say this to a BII patient, the conversation stops, and she no longer trusts me.” (Other doctors report similar scenarios: “Patients leave the office supposing you aren’t technically capable of an en bloc, when really, every board-certified plastic surgeon can do these. In fact, the enormous incision required allows for a much easier procedure,” adds Dr. Teitelbaum.) For thin, normal-appearing capsules, prudent surgeons prefer to do a precise capsulectomy, carefully removing as much capsule as possible with the implant still inside, and then making a tiny slit in the capsule through which to deliver the implant, before resecting remaining scar tissue—all through the smallest possible incision while diminishing the chance of injury.
DO BII PATIENTS GET BETTER AFTER REMOVING IMPLANTS?
Some do, yes. But right now doctors can’t predict which women, or even which symptoms, will improve with explantation. Here’s what they do know: In a Canadian study of patients who explanted during the ‘90s moratorium, those with a diagnosed autoimmune disease did not recover following surgery. Among “patients who had normal labs and no established disease, and believed they would get better, 80 percent improved after implant removal,” explains Dr. McGuire. What’s behind this? Some say a placebo effect. Others surmise that taking the weight off a patient’s chest—both literally and figuratively—can provide a sort of emotional and physical relief. For certain women, adds Dr. Sowder, removing implant capsules may also eliminate the source of chronic inflammation that’s been causing them to feel sick. “No matter the reason,” says Dr. Teitelbaum, “some women do improve after removal, and that’s what’s most important.”
IS THERE A WAY TO PREDICT WHO WILL DEVELOP SYMPTOMS?
Not at this time. “We still have to sort out what it is that might make someone not a candidate for breast implants,” says Dr. Casas. “Hopefully new studies will reveal if there’s a predisposition here, so we can someday say to patients, ‘You have the specific criteria shown in studies to increase a person’s chances of having an adverse reaction to this foreign material, and based on this, I’m recommending you do not have this surgery.’” In the absence of such evidence, some doctors are urging women with established rheumatologic and autoimmune diseases, particularly those with a family history, to very carefully consider the decision to get implants, because, as Dr. McGuire notes, “there may be a small percentage of women whose bodies, for whatever reason, just don’t like any type of foreign material.”
WHAT WILL COME FROM THE FDA HEARING?
Most doctors aren’t expecting the agency to place restrictions on breast implants of any kind. They will likely call for more research into both BIA-ALCL and BII. (Organizations like ASAPS and ASERF have developed sophisticated data collection software and are funding research grants to help provide more valid scientific information.) The FDA may suggest improvements to informed consent documents for breast augmentation and reconstruction patients to ensure all risks are communicated clearly and updated as new information arises. Surgeons also foresee updates to the current MRI surveillance guidelines for silicone implants, as multiple testimonies focused on the need for a low-cost, accessible alternative to MRI, such as high-resolution ultrasound, which “can very easily check for fluid around implants and look at shell integrity,” notes Dr. Jewell. With rupture rates hovering around one percent per year, the screening timetable may change, too: “If you have a newer-generation cohesive gel implant, then it really makes sense to not even start screening—unless you have a symptom—until five or six years out,” says Dr. Casas. We’ll update you in the coming weeks as we learn more from the FDA.
