These Breast Implants Have Been Recalled Because of Their Link to a Rare Cancer
You never want to see the words “breast implant” and “cancer” next to each other in a headline. But such news stories have been circulating recently after the Food and Drug Administration (FDA) requested that a manufacturer voluntarily recall certain kinds of breast implants connected to a rare kind of cancer.
“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL,” the FDA’s July 24 release reads. Allergan complied.
When SELF reached out to Allergan over email the week after the recall, a spokesperson from the company told us that they voluntary recalled the BIOCELL textured breast implants and tissue expanders "as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the [FDA]." By that point, there were already similar recalls to get this type of implant off the market in other countries, including France, Canada, and Australia, according to the FDA.
The idea of breast implants potentially causing cancer is genuinely scary, even more so for anyone who has them (or is thinking about getting them). Here’s everything you need to know about the recall, including the kind of cancer it’s been connected to and what to do if you have breast implants.
What exactly was recalled?
This recall applies to BIOCELL textured breast implants and tissue expanders (devices used to stretch a person’s skin before breast augmentation or reconstruction after a mastectomy) from Allergan.
Before we get into the details of what BIOCELL means, the first thing to know if you have breast implants and are worried: Textured implants are uncommon in the United States, making up only 10 percent of breast implants sold in this country, according to the FDA. Their texture can help the implant stay in place better and reduce the risk of a complication called capsular contracture, which happens when the scar capsule that naturally forms around an implant during the healing process begins to tighten, squeezing the implant, the FDA explains. But most people in the United States get what are called smooth breast implants, which generally feel the softest and may have the most natural movement out of all breast implants, according to the American Society of Plastic Surgeons (ASPS). (The United States is unusual in this regard—textured implants account for up to 80 percent of the market share in countries like France, Canada, and Australia, according to the FDA.)
To break things down even more, fewer than half of the textured implants sold in the United States—so, less than 5 percent of the total breast implant market share—are of the macro-textured variety that includes the recalled implants, the FDA says. A macro-textured breast implant essentially has bigger, deeper divots on its surface than a micro-textured or smooth implant.
OK, now about BIOCELL. BIOCELL refers to a unique type of macro-textured surface that only Allergan uses in its products, the FDA explains. The recall covers all styles of Allergan’s BIOCELL textured breast implants, including both silicone and saline-filled ones. It also includes BIOCELL tissue expanders (which are also macro-textured), the FDA explains.
You can find a complete list of recalled products at the bottom of the FDA’s safety communication here.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D. said in the organization’s press release.
What is the link between these implants and cancer?
The potential connection between breast implants and breast implant-associated anaplastic large cell lymphoma is not new.
“The first case was reported in 1997, and for about the first decade we knew of less than a dozen cases or so,” Mark W. Clemens, M.D., a Fellow of the American College of Surgeons, and an associate professor of plastic surgery who co-leads a multidisciplinary clinical and laboratory research team investigating BIA-ALCL at MD Anderson, tells SELF.
The FDA first publicly noted the potential connection back in 2011 in a safety update on breast implants. But with only 60 reported cases worldwide, the agency didn’t have enough data to establish a link. “There was very little known about it, and it was questionable if there really was an association or if it was coincidental,” explains Dr. Clemens, who has been studying BIA-ALCL since 2014. Over the past eight years, the FDA has been monitoring the accumulating data and sharing updates. In February 2019, the FDA issued a statement with more information about BIA-ALCL but didn’t yet issue a request for a recall.
The tipping point that prompted them to do so was the 116 new unique cases and 24 deaths that have come to the agency’s attention since then. (A unique case means the cancer was in only one breast. In a couple of instances, patients had BIA-ALCL in both breasts, which counted as two cases.) In total, the agency now knows of 573 unique cases globally and 33 patient deaths from BIA-ALCL. (The PROFILE registry, a collaboration between the FDA, the ASPS, and the Plastic Surgery Foundation, recognizes about 735 unique cases worldwide. The FDA bases its numbers solely on medical device reports (MDRs) submitted to the agency, hence the discrepancy.)
Of the 573 cases the FDA reports, 481 (or 84 percent of those for which the manufacturer is known) occurred in people with Allergan implants. And while the implant manufacturer is only known in 13 of the 33 deaths, 12 of them were confirmed to have Allergan breast implants at the time of diagnosis, the FDA says. Based on this data, the risk of getting BIA-ALCL is about six times higher with Allergan BIOCELL textured implants than with textured implants from other U.S. manufacturers, according to the FDA. (No cases or deaths have been associated with tissue expanders, which were recalled as a precaution because the material is the same as the implants.)
There are some gaps and nuances in the data, though. While the vast majority of cases in which the implant surface type is known are textured implants (67 percent), 5 percent of cases did occur in people with smooth implants. However, according to the FDA analysis, in seven of the 26 cases making up that 5 percent, the person previously had textured implants; for the others, their implant history is not known. In 28 percent of the cases, we don’t know if the implant surface was smooth or textured. While we can’t completely rule out smooth implants, we’d expect to see many more cases if they were a strong risk factor for BIA-ALCL, given how massively they outsell textured implants in the United States. The data we have indicate this is virtually exclusive to textured implants, Dr. Clemens says.
Worth noting: The condition is not entirely unique to Allergan implants. Of the 92 cases of BIA-ALCL that are not associated with BIOCELL implants, 7 percent of them occurred with implants from a manufacturer called Mentor; 7 percent of them are from unknown manufacturers; and the remainder occurred with various other manufacturers, according to the FDA.
While a few cases have occurred with other kinds of textured implants, as of now, the FDA’s message is that those are still generally considered safe enough to stay on the market. “We will continue to monitor BIA-ALCL across other products,” an FDA spokesperson tells SELF in an email statement. “If action is needed in the future, we will not hesitate to do what is necessary to protect patients.”
What is BIA-ALCL, exactly?
Since all of this is so unnerving, a disclaimer first: BIA-ALCL is a rare, slow-growing cancer that will never impact most people with breast implants. It’s highly, highly unlikely that you will get BIA-ALCL if you have breast implants. “The vast, overwhelming majority of [people with these types of implants] will not develop this disease,” Dr. Clemens says. You can find estimated rates in the medical literature ranging from one in 3,817 patients (on the high end) to one in 30,000 patients (on the low end), according to the FDA.
As for BIA-ALCL characteristics, even though it occurs in the breast area, it isn’t actually breast cancer. Instead, it’s a type of non-Hodgkin’s lymphoma, or cancer of the immune system, the FDA explains, that begins around the implant. Usually, it occurs not within the actual tissue of the breast, but in that fibrous scar capsule we mentioned that forms around the implant, or in the fluids inside that capsule called the seroma. In some cases, if it becomes advanced, BIA-ALCL can spread to the lymph nodes nearby and, more rarely, throughout the body, according to the Cleveland Clinic.
BIA-ALCL presents with localized symptoms that typically begin years after the implants are put in. (According to the FDA analysis of 573 global cases, this can happen anywhere from zero to 34 years after a person’s implant surgery—or last implant surgery, if they’ve had multiple—with a median of eight years from surgery to diagnosis.)
The main symptoms are persistent swelling or pain in one breast in the area of the implant, per the FDA, and sometimes a lump under the skin. The swelling, due to fluid collection around the implant, tends to come on very quickly once the cancer develops, Dr. Clemens says, causing a noticeable asymmetry between the breasts
Diagnosing BIA-ALCL usually entails a physical exam, imaging tests, and collection of a sample of the fluid or tissue around the implant, the FDA explains. Treatment is relatively straightforward: Surgical removal of the implants and surrounding scar tissue. “The prognosis is for the most part very good,” says Dr. Clemens, who helped develop the National Comprehensive Cancer Network (NCCN) clinical treatment guidelines for BIA-ALCL (first established in 2017 and updated this year). Since the cancer tends to grow slowly and stay local, according to the NCCN treatment guidelines, surgery is enough to treat most cases, especially when it’s caught early, says the FDA. However, some patients with advanced BIA-ALCL might need additional treatments, such as chemotherapy or radiation therapy.
What causes BIA-ALCL?
Doctors have the same question. They’re working with various theories. “We have several of the key pieces, but we do not have the full picture yet,” Dr. Clemens says.
As with many cancers, there can be a genetic component. “We do know that these patients tend to have genetic mutations that likely predispose them to the development of the disease—mutations similar to those seen in other types of lymphoma and, more rarely, other cancers,” Dr. Clemens explains.
Another factor is how long a person has had the implant, Dr. Clemens says, given that the median amount of time from surgery to diagnosis is eight years (per the CDC data).
There also must be something about these implants in particular that could lead to BIA-ALCL when other implants usually don’t. Research has suggested that BIOCELL implants shed particulate debris at a higher rate than other kinds of textured implants, Dr. Clemens says. One leading theory is that these particulates may trigger an inflammatory response in the area of the implant, Dr. Clemens explains. Inflammation is often a totally natural and often harmless immune response, but it appears that this local inflammation may, over time, lead to the kind of chronic inflammation that can prompt DNA damage precipitating cancer. What’s more, textured implants are believed to cause more inflammation than smooth implants, according to the Cleveland Clinic. But these are still just theories.
Allergan declined to respond to these inflammation-related claims because they do not comment on external research, according to an email statement from the company. “Patient safety is a priority for Allergan, and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns,” a company spokesperson tells SELF in an email.
By the way: There is zero indication that BIA-ALCL is related to breast implant illness (BII)—a patient-coined term for a constellation of generalized symptoms like fatigue, brain fog, memory loss, and joint pain. While breast implant illness is not a medically recognized diagnosis and we don’t know what causes these symptoms, it’s been cited often and long enough for the FDA to address it as a risk of breast implants and for researchers to investigate it. But rest assured, it is not connected to BIA-ALCL. This makes sense given that BIA-ALCL symptoms are nearly always local, Dr. Clemens notes, whereas BII symptoms are systemic.
Does this mean that if you have these implants, you should get them removed?
If you have any of the recalled implants but do not have BIA-ALCL or any of its symptoms, the FDA does not recommend removal. “However, FDA encourages patients to speak with their surgeons regarding their individual benefit, risks, and options,” a spokesperson tells SELF.
That might sound like totally bonkers advice at first if you’re worried about this. “Patients ask me, ‘So I have to just wait until I get cancer to do something?’” Dr. Clemens says. “But that's not exactly true or a good way to think about it.”
Remember, this cancer is rare overall. Then, you have to consider that “removal can have serious complications in and of itself,” as Dr. Clemens points out. In order to get rid of the tissue where BIA-ALCL cancer cells can form, you would have to remove not only the implant but the scar tissue capsule around it—a more involved surgery than regular implant removal, per the FDA. Ultimately, “You do not want to subject all of the [people] with those implants to a needless procedure,” Dr. Clemens says.
What should you do, then?
Know what to look for, keep an eye on your implants, and try your absolute best not to freak out.
“All patients with breast implants—regardless of surface texture or brand—should familiarize themselves with the symptoms of BIA-ALCL, monitor for changes in the look or feel around their breast implants, and discuss any concerns that they may have with their health care professional,” an FDA spokesperson tells SELF. The agency also advises keeping a record of your implant model name and manufacturer (which, if you don’t already have, you can obtain from your surgeon or surgery center).
As critical as it is for anyone with implants to be aware of BIA-ALCL, “It's also important for people to be reassured that this is an extremely uncommon disease, and highly treatable when it does occur,” Dr. Clemens adds.
And for anyone considering implants who is scared off by this recall? The good news is that the products clearly linked with this disease are off the market. As for other kinds of textured implants—which, again, are already very rare in the United States—the tiny but real risk of developing BIA-ALCL may well factor into that decision.
“Going forward, this will definitely be an important part of the conversation [people] have with their surgeons when deciding what type of implants to get,” Dr. Clemens says.
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Originally Appeared on Self
