In February 2010, Allure’s former contributing editor-at-large, Joan Kron, broke news that plastic surgeon Garry Brody, a professor emeritus of the University of Southern California, found more than 30 suspected or confirmed cases worldwide of an exceedingly rare form of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL) in patients with saline and silicone-gel breast implants. In more than half of the cases, the malignant cells were detected in the fluid or scar tissue surrounding the implants. And the majority of implicated implants had what’s known as textured shells—meaning the surface is deliberately roughed up during manufacturing to allow the implant to grip onto the tissue inside the chest and better stay in place.
Brody’s findings immediately prompted four plastic surgery organizations to come together and convene an advisory council of experts from plastic surgery, epidemiology, pathology, oncology, and the FDA to collect and evaluate all reports of ALCL in women with breast implants. The FDA began providing updates in 2011.
Last Tuesday, the FDA released its most recent update on the panel’s findings, which states, “Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant–associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.”
Now, if you’re a human — especially one of the 310,444 humans in the U.S. who got breast implants last year, according to the American Society for Aesthetic Plastic Surgery (ASAPS), or among the 5 to 10 million with implants worldwide — your pulse probably quickened at the words “increased risk of developing ALCL.” And alarming headlines, like “9 Deaths Are Linked to Rare Cancer From Breast Implants” from the New York Times — followed by incomplete reporting — certainly aren’t assuaging any fears. But according to our experts — all of whom are intent on correcting misinformation and offering much-needed perspective — there is no need to panic.
“I’m shocked by these recent headlines,” says Laurie A. Casas, a senior clinician educator at the University of Chicago Pritzker School of Medicine, and a past president of the Aesthetic Surgery Education & Research Foundation (ASERF), one of the groups appointed to the advisory council in 2011. (While Casas, herself, didn’t participate on the panel, she was part of the group of experts who formalized the approach that the plastic surgery community and FDA would take in investigating the case studies. Or, as she puts it: “We were the genesis.”) “How do you go from a simple FDA update to these sensational reports of breast implants causing BIA-ALCL? We need to be very clear on the facts here. The FDA is not saying breast implants cause BIA-ALCL. They are not saying textured implants cause BIA-ALCL. They are simply updating information from 2011, and relaying that the current data suggests BIA-ALCL can occur in patients following breast implant surgery with textured implants more often than smooth.”
The FDA update is significant, because when last we covered this news, we knew of approximately 30 instances of BIA-ALCL in breast implant patients. As Kron reported, of those 30 cases, the implant type (textured versus smooth) could be identified in only 25 cases. In 23 of the 25 cases, the implants had textured shells. Now, fast-forward seven years: As of February 1, 2017, the FDA has received a total of 359 reports of BIA-ALCL, including those nine deaths the New York Times highlighted. Two hundred and thirty-one of those reports included details about the implant’s surface: 203 (88 percent) were reported to be textured, 28 (12 percent) to be smooth. Additionally, 312 of the 359 reports revealed the type of fill used in the implants: 186 contained silicone gel and 126 were saline-filled.
That’s a lot of figures, but we still don’t have all the facts — including those concerning the outstanding 128 implants of which the surface type was unknown. Also, as Casas notes, we don’t know the full pathology of the people who died, to determine what they died from. Furthermore, the FDA admitted in its update that the reports in its registry “may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers may change.” And, as Casas points out, “this is an ongoing registry of cases,” making the facts involved that much more fluid.
And while 359 cases in roughly six years is both considerable and disconcerting, putting that number in context is crucial. (Our heads are spinning, too, but bear with us.) If 310,444 people got implants in 2016, and presumably two per patient, that would be 620,888 individual implants placed in a single year. Now factor in near-equivalent numbers of implants for the years between 2011 and 2016. “We’re talking millions of implants surgically placed in women since 2011,” says Casas. “While there is an association between breast implants and this disease, it would be irresponsible to label it cause and effect, as there isn’t evidence showing a direct link. The only link is that these cases have occurred in women who have had breast implants.”
While a definitive cause has yet to be determined, and research is ongoing, a 2016 study in the Aesthetic Surgery Journal suggests that a chronic inflammatory process, possibly triggered by a low-grade bacterial infection, may be what sparks the cancer’s development. “And anyone who has a foreign material put inside her body is subjected to the potential for infection — be it from hip replacements, heart valves, or beast implants,” says Casas.
Alex K. Wong, an associate professor of surgery and director of plastic surgery research at the Keck School of Medicine of the University of Southern California, and one of the surgeons quoted in the New York Times’s story, offered this comment to Allure on the FDA’s statement: “While it is certainly concerning that breast implants have been linked to patient deaths, it is important to know that BIA-ALCL is very rare and in most cases completely curable by surgical removal of the implant and surrounding capsule. This news should prompt further research into the disease and other related disorders, and motivate patients and surgeons to more frequently monitor the status of breast implants by physical exam or MRI. Despite the small risk, I believe [implants] are safe when properly used by qualified plastic surgeons, and that they provide a benefit to patients, especially those seeking breast reconstruction following a mastectomy. The literature also has demonstrated that those who have breast augmentation for cosmetic reasons have positive benefits related to quality of life.”
Wong went on to say that textured implants are less common in his practice — he estimates using smooth-surface implants in about 90 percent of patients. In fact, just 12.7 percent of implants placed per year in the U.S. are textured, according to recent data from ASAPS. “I’ll still use textured when indicated, and when there is a clear benefit, but I educate my patients about this rare disease and what to do if they have concerning symptoms,” he adds. Wong also notes that the data from the FDA update will continue to influence his practice.
According to David Shafer, an attending plastic surgeon at Lenox Hill Hospital and Manhattan Eye, Ear, and Throat Hospital, textured implants may offer certain advantages: “Some studies show you get less scar tissue with textured shells, and they do help keep the implants from rotating or changing positions, since their surface is like Velcro,” he says. Still, “the vast majority of my patients choose smooth implants, as they have a more natural feel,” he adds.
Casas estimates using 70 percent textured implants on her patients — partly because teardrop-shaped implants (as opposed to round) only come with textured shells, and a fair number of women require the form and definition that they provide. While choice of implant is ultimately the patient’s to make, “most women have an anatomical issue that dictates what type of implant will best make them look the way they want to look,” Casas says. “If one’s breast doesn’t naturally have much shape to it, and we’re trying to create a full teardrop appearance, then I’ll usually suggest a shaped, textured implant, as they won’t rotate or flip. If someone already has a pretty shape, and is just on the small side, we can use a round, smooth implant. But I give my patients all choices and discuss all risks. BIA-ALCL has been part of my informed consent since 2010.”
Before vilifying an entire category of implants, it’s important to recognize that each implant manufacturer uses a different type of texture, produced by a unique process, such as salt extraction or stamping. “So this is a very complicated issue in terms of finding out the true cause,” says Shafer. “It could end up being a specific kind of texture, or a certain type of implant, or eventually, we may learn that the disease has nothing at all to do with the texture. More detailed studies are needed.”
Meanwhile, makers of breast implants are aiming to raise awareness about BIA-ALCL. One major manufacturer, Allergan, tells Allure, “Patient safety is always our first priority. However rare, Allergan takes this disease seriously and is actively working to help advance the knowledge of this disease, understand the association of BIA-ALCL and textured implants, and educate the community.” Their educational outreach efforts range from collaborating with the FDA to ensure their implants’ labeling documents include crucial decision-making information for doctors and patients, to expanding the global medical community’s awareness of the disease by conducting “surgeon education meetings and webcasts on this topic in the U.S. and internationally.”
Mentor, another leading supplier of breast implants, tells Allure that they “are guided by patient safety, and the science and data support the safety and efficacy of our FDA-approved breast implant products.” What’s more, they “fully support the FDA’s efforts to gather additional data and study BIA-ALCL in patients with breast implants, and will continue to work with industry groups, physician scientists, and health authorities across the globe to better understand the associated risks and causes of BIA-ALCL.”
Implant manufacturer Sientra offers a similar statement to Allure: “Patient safety is our top priority, and Sientra continues to support all medical research, education and FDA initiatives to better understand BIA-ALCL. We continue to work closely with the FDA to assure that we are able to provide women with the highest quality and safest implant options. Based on the most recent data, the risk of acquiring BIA-ALCL from breast implants is approximately .003 percent, or 1 in every 30,000 cases. Board-certified plastic surgeons are the most knowledgeable people to explain this risk and the treatment options in the extremely rare instance of its occurrence.” (As a point of comparison, the risk of breast cancer in American women, is, on average, one in eight, according to the National Cancer Institute.)
Currently, the FDA is not recommending the prophylactic removal of implants in healthy patients who aren’t experiencing problems, and notes that BIA-ALCL “has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry.” (The disease typically presents as a swelling of the breast 3 to 14 years after breast-implant surgery; it can also manifest as a lump in the breast or armpit.) The FDA reiterates in its update, “BIA-ALCL is a very rare condition.” Of course, if you notice any abnormalities with your breast implants at any time, see your surgeon right away.
