When Allergan Pharmaceuticals announced a recall of its textured Biocell breast implants and tissue expanders last summer, the news grabbed headlines — and made many women who had undergone breast reconstruction uneasy.
The implants were linked to a rare form of an immune system cancer known as breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL), and were implicated in 33 deaths.
Breast cancer survivors and previvors (women who have a predisposition to developing breast cancer, and sometimes undergo prophylactic mastectomy and reconstruction) struggled to make sense of what the recall meant for them. Some worried they’d unwittingly put themselves at risk for an entirely different type of cancer.
“I think there was a lot of anger in the breast cancer community at first,” says Ashadee Miller, 36, who was diagnosed with breast cancer in the fall of 2017 and got textured Allergan implants just months before they were recalled. “Now I think there is a lot of fear and misinformation.”
To cut through the confusion, here are five basics women should ask their healthcare team.
1. How Do I Know What Type of Breast Implants I Have?
Like many women with breast cancer, Miller says she did a huge amount of research about her treatment and reconstruction options. But when the recall news hit, she realized she didn’t actually know the specific model or manufacturer of her implants. Experts say that is common.
“I’m definitely fielding questions,” says Deanna Attai, MD, a breast surgeon at UCLA Health in California. “I tend to see two categories of women. There are the patients who have received an FDA recall letter, and they’re saying: ‘My implants are on the recall list, what am I supposed to do?’ Then there is the other group of patients who are worried but are not sure what their implants are.”
Women in the latter group should attempt to find their device identification card, which provides the style and serial number of their implants. Or they can call their plastic surgeon’s office to find out.
The process can be stressful. Miller likens the experience of checking her serial number against the recall list to playing the lottery, but the opposite. “You’re hoping, hoping the numbers don’t match.”
2. What Does the Official Word From the U.S. Food and Drug Administration (FDA) Mean for Me?
Allergan voluntarily recalled its textured Biocell implants and expanders at the request of the FDA. The FDA is not, however, recommending that women without symptoms of BIA-ALCL have them removed, because it says the risk of developing the cancer is relatively low.
Healthcare providers and cancer survivors say the situation is more complex.
“Patients with recalled implants, who are not having problems, are in some ways the most challenging group,” says Dr. Attai. “Many patients who have already gone through breast cancer and treatment are not comfortable with a ‘watch-and-wait’ approach when it comes to another possible cancer.”
3. What Signs and Symptoms Should I Be Watching For?
According to the FDA, women should primarily be on the lookout for persistent pain and swelling around the implant. That is because BIA-ALCL doesn’t develop in the implant itself; it develops in the fibrous scar tissue (known as the capsule) that forms around the implant.
“If the patient sees any swelling in the breast or changes in the breast, they should see the plastic surgeon who put them in,” explains Daniel Maman, MD, a board-certified plastic surgeon with 740 Park Plastic Surgery in New York City.
“But my recommendation to all my patients, whether they have textured implants or smooth implants, is that they should see the doctor who put them in once a year,” Dr. Maman says. “Just like you see your primary care doctor once a year.”
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4. What Would an Exchange Surgery Be Like for Me?
“For most women, it’s not as simple as taking [the textured Allergan implants out] and putting in new nontextured implants,” says Attai. “If you’re taking the implants out because of the patient’s concern about developing anaplastic large cell lymphoma, it makes sense to remove the capsule (the scar tissue around the breast implant, known as a total capsulectomy) as well. That’s a bit more involved.”
For example, the plastic surgeon may be more likely to leave in a surgical drain, a long tube temporarily placed after surgery to collect excess fluid buildup, she says. And, of course, all surgery comes with risk.
Women and their healthcare providers must also decide what type of implants to switch to. That can be a difficult physical and emotional calculus, as many patients had specific reasons for getting textured implants in the first place, like slippage concerns. (Textured implants were designed to sidestep an annoying aspect of smooth implants—their tendency to slide around.) Others might consider eschewing reconstruction altogether, like Melissa Miles, 45, who was diagnosed with breast cancer in 2014 and says she is “vacillating back and forth” about whether to have her textured Allergan implants removed.
“If I do decide to switch them out, I don’t know if I really want to do implants again — and that opens up a whole new thing,” she says. “What are my reconstruction options? How do I feel about maybe deciding to go flat? I really don’t know what to do next.”
5. Will Insurance Cover Removal of My Textured Implants?
Because the recall is still relatively new, there are not clear answers to the question of insurance coverage. Allergan has said that it will provide smooth replacement implants for free, but that does not include surgical fees.
“It’s a concern, especially because the FDA’s not recommending that these be removed,” says Attai. She adds that a woman’s coverage is likely to “depend so much on her particular insurance.”
Some women are girding themselves for an uphill battle. “I printed out my insurance manual and I highlighted it, and it says basically that if you are medically required to have surgery, it will be covered,” says Sarah Teague, 34, who tested positive for a BRCA1 mutation in 2015, four years after her mother died of breast cancer. “I’m concerned that it’s really going to be up to my insurance whether or not they want to.”
“If they’re not willing to cover it, I think as advocates we need to get that changed, big-time,” Teague adds. “I will be very loud about it. I will be knocking on whoever’s door. I need to let them know it’s not fair.”