From almost the minute Natalie Bailey underwent breast reconstruction in 2016, she had problems with her textured implants. The two-time breast cancer survivor felt constant pain and swelling. “They just did not get along with my body,” she says.
As media reports began to emerge in 2017 that a small number of women with the same implants had developed a rare cancer of the immune system, Bailey went in for testing. She did not have the cancer, but she did have a buildup of fluid and enlarged lymph nodes. So she went under the knife again, this time enduring a four-and-a-half-hour-long surgery to have the implants removed.
Last week, Allergan announced it is voluntarily recalling those textured breast implants under pressure from the U.S. Food and Drug Administration (FDA). Textured implants have been linked to a rare form of cancer known as breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and implicated in 33 deaths. Twelve out of the 13 deaths in which the specific manufacturer was known were in patients who had Allergan implants at the time they were diagnosed.
The Allergan implants were banned in Canada in May and pulled from the European market in December 2018.
The recall is of little comfort to Bailey and many other breast cancer survivors and previvors (someone who is high risk for breast cancer and acting preventively) who have undergone breast reconstruction and who now worry that they have put themselves at unnecessary risk.
“Here I am, praying I do not get another form of cancer,” says Bailey, 45. “It feels like a cruel, cruel joke.”
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Understanding BIA-ALCL and Breast Implant Illness
BIA-ALCL is a cancer of the immune system, not a form of breast cancer, that develops in the scar tissue and fluid around a breast implant.
Silicone breast implants generally come in two categories: textured and smooth, which refers to differences in the shell surrounding the gel on the inside, explains Daniel Maman, MD, a board-certified plastic surgeon with 740 Park Plastic Surgery in New York.
“The texturing on the shell of the implant interfaces with the surrounding breast tissue,” says Dr. Maman. “It’s predicted that either a mechanical or a bacterial contamination of this textured cell stimulates tissue growth. And we know that anytime there is tissue growth, there is also potential for abnormal tissue growth.” (Allergan also recalled its textured tissue expanders, which are used to stretch skin and muscle in order to make room for implants.)
BIA-ALCL is different from “breast implant illness,” a broad umbrella term sometimes used to describe symptoms ranging from pain and fatigue to autoimmune complications. Right now, that is not a recognized medical diagnosis.
“What we don’t know is whether some women are more likely to develop this because of genetic predisposition, or whether some kinds of implants are more likely to cause it,” says Diana Zuckerman, PhD, the president of the National Center for Health Research in Washington, DC, who has studied breast implant illness. “What we do know is that women who have these symptoms, if they get their breast implants taken out carefully and appropriately, the vast majority get better.”
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What Is the Cancer Risk for Textured Breast Implants?
Experts emphasize that overall, women’s risk of developing BIA-ALCL is low. Worldwide, 573 cases of BIA-ALCL have been linked to textured breast implants, the FDA reports. Of those, 481 cases involved Allergan implants.
According to the American Society of Plastic Surgeons, there were more than 300,000 breast augmentation surgeries in the United States in 2017 alone. In 2016, there were more than 100,000 reconstruction surgeries performed in this country. Globally, millions of women have implants, so the overall risk of developing BIA-ALCL is relatively low.
What Are Experts and the FDA Advising for Women With Textured Implants?
The implants will no longer be sold and healthcare providers should no longer use them, the FDA said in its announcement of the voluntary recall last week.
While evidence suggests that removing the implants leads to recovery in many, though not all, women who develop BIA-ALCL, the FDA is not currently recommending removal for women who do not have symptoms of the cancer, like pain and swelling around the implant site. According to the FDA, determining whether a woman has developed BIA-ALCL typically involves a physical examination, imaging, and testing the fluid or tissue around the implant.
“Surgery has risks … and you don’t want thousands of people getting surgery they don’t necessarily need and may never need in order to prevent problems they might not ever get,” says Dr. Zuckerman.
“On the other hand, a lot of people don’t want things in their body that can cause harm,” Zuckerman says. “So it’s a tricky situation.”
Indeed, since the recall, surgeons say they have been inundated with questions from patients seeking clarification on what type of implants they received, and what the news means for them.
“On the day of the announcement, we got a massive flurry of calls, texts, and emails from patients,” says Maman. One major complicating factor is whether insurers will cover an exchange. Most insurers will if the surgery is considered medically necessary, but women may have to fight to make that case, he says.
Although Maman has not used textured implants in the past five years, he does have some patients who got the implants before that. He does not believe that there is any medical urgency to have the implants removed if there are no symptoms. But he encourages anyone with concerns to come see him.
How Breast Cancer Survivors and Previvors Are Coping
Sally Wolf, 44, who has textured Allergan implants, emailed her surgeon’s office after the recall. She was told that there was no cause for concern, or intervention, in the absence of symptoms.
Wolf, a native New Yorker who has advanced breast cancer, says that while it does feel funny to say “my breasts were recalled,” she is not alarmed.
“I believe the most important thing any patient can do is to listen to both her body and her doctor, and I don’t hear either currently saying, ‘These need to come out,’” says Wolf. “As a result, this is not causing me anxiety, it's simply another reminder that vigilance is important at every step of this journey. But it is not leading me to second-guess anything about my situation, particularly given how much I trust my plastic surgeon.”
Similarly, 25-year-old Kelsie Beeler, who currently has textured Allergan implants, says she is “not fazed” by the news. She has a BRCA gene mutation and underwent a prophylactic bilateral mastectomy when she was 20, about two months after her mother passed away from metastatic breast cancer.
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Initially, Beeler, who resides in Fayetteville, Arkansas, had smooth implants, one of which slipped out of place and damaged the muscles in her neck, upper back, and shoulder, to the point where she was unable to pick up her child. She had the implants exchanged for textured ones in January of this year, and she has been much happier.
“I like them, they’re comfortable. It’s the most comfort I’ve had in almost five years,” Beeler says.
“The percentage and risk [of BIA-LCL] is so low, and I’m finally comfortable and able to play and do things with my son,” she adds. “I’m not going to let this recall get me down.”
But others, like 31-year-old Hilary Corts, who also chose to have a prophylactic mastectomy after testing positive for the BRCA gene mutation, feel more conflicted about their potentially increased lymphoma risk.
“The FDA says do nothing and don’t worry, and my thought on that is it’s easy for them to say when they’re not sitting with the implants inside of them,” she says.
After Corts, who resides in Los Angeles, learned of the recall, she immediately reached out to her plastic surgeon, who reassured her that there is no urgency to make a change, although he did recommend that she get smooth implants when she needs to have them switched out down the road. (Implants are not considered lifetime devices.) Then he said that if it would make her more comfortable, and if she could get insurance coverage, she could absolutely come in sooner. Corts has scheduled a consult for September.
“It feels like a setback, because I removed my breasts to reduce my risk of cancer,” Corts says, “not to gain a new — albeit lower — risk of another one.”