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.
Source: DailyBeauty – A beauty blog powered by NewBeauty Magazine –