Breast implant manufacturer Allergan just recalled one type of implant after hundreds of Americans developed a rare cancer linked to the devices
- On Wednesday, breast implant manufacturer Allergan recalled its BIOCELL textured breast implants after the FDA requested the company do so.
- In February 2019, the FDA published a letter to doctors about a type of cancer linked to breast implants called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
- The FDA wants to raise awareness of the cancer, even though it's very rare. It's estimated to occur in one in 3,817 patients to one in 30,000 patients.
- A doctor told INSIDER people with implants should report any concerning changes to their doctors.
- For more stories, go to Business Insider SA.
On Wednesday, breast implant manufacturer Allergan removed its BIOCELL textured breast implants from the market after the Food & Drug Administration requested the manufacturer do so for safety reasons.
"Based on new data, our team concluded that action is necessary at this time to protect the public health," FDA Principal Deputy Commissioner Amy Abernethy said in a press release.
The request came after U.S. health officials urged doctors to stay on the lookout for breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, a rare form of cancer that's been linked to Allergan's textured breast implants.
In a letter to healthcare providers published in February 2019, the FDA said it wanted to increase awareness of BIA-ALCL, which the administration first reported was linked to implants in 2011. Since then, more research has been published on this link, the letter said.
As of September 2018, the FDA has received 457 unique reports of BIA-ALCL, including nine deaths "which may be attributable" to the cancer, the letter added. It also called for doctors to report any cases of the condition to the FDA.
"Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data ... suggests that patients with breast implants have an increased risk of BIA-ALCL," the letter said.
Right now, there's still a lot of information that experts don't know about BIA-ALCL, breast surgeon Dr. Deanna Attai, assistant clinical professor of surgery at UCLA's David Geffen School of Medicine, told INSIDER.
But the FDA's call to raise awareness and report cases of the condition could help.
"If they can get these cases reported, then maybe we can start understanding which patients are actually at risk... what's the history of the disease and the outcome of the disease, and just make sure that patients and physicians are attuned to this potential issue."
INSIDER spoke with Attai and with Dr. Elizabeth Min Hui Kim, surgical oncology director at Cancer Treatment Centers of America's Breast Cancer Institute, to learn more about the condition. Here's what you should know.
BIA-ALCL generally develops in the 'capsule' surrounding an implant
BIA-ALCL is a type of lymphoma, not breast cancer, meaning it affects white blood cells of the immune system, Kim explained. Generally, the cancer is found in the "capsule" that develops around an implant, according to the FDA.
"Normally, our body doesn't have capsules, but when the implant is placed, then the body produces this fibrous-like tissue layer around the implant, and that layer is called a capsule," Kim said.
The FDA letter noted that the majority of people who've gotten BIA-ALCL had textured breast implants versus smooth ones. Textured implants develop scar tissue that makes them less likely to move around inside the breast, according to the American Society of Plastic Surgeons (ASPS). Attai described their surface as being "pebbly" or "sandpapery."
But some cases have been reported in people with smooth implants, too.
For now, Kim said, there's still not enough evidence to know exactly why BIA-ALCL develops.
It's very rare and seems to be 'readily treatable' when caught early
Both Kim and Attai said that BIA-ALCL is very rare. Currently, research estimates that the incidence of BIA-ALCL in people with implants can vary widely, from one in 3,817 patients to one in 30,000 patients, the FDA letter said.
Attai added that, based on reports that have been published in the last few years, this form of lymphoma appears to be "readily treatable" when it's detected early.
It can show up years after implant surgery and the symptoms might include swelling
Some pain and swelling are expected immediately following a breast implant surgery, the FDA notes on its website.
But in most cases of BIA-ALCL, patients developed symptoms like pain, lumps, swelling, or breast asymmetry after they were fully healed from implant surgery, according to the FDA's letter. In fact, the symptoms usually show up years after the surgery, Attai said.
"It does seem that the majority of the cases ...present with a relatively sudden onset of what's called a seroma, which is a fluid collection," she added. "Basically, what the patient would notice is all of a sudden one side gets fairly swollen, [and] maybe painful."
People who have breast implants should 'be vigilant' about any changes
Breast augmentation is the most popular cosmetic plastic surgery performed in the US, according to data from the ASPS. Breast implants can be used in other contexts, too, including augmentation surgeries for transgender people and reconstruction for breast cancer patients.
Kim suggested that people with implants reach out to their physicians to get information on BIA-ALCL. She also said people newly diagnosed with breast cancer should ask doctors about surgical breast reconstruction methods that use a patient's own tissue, rather than implants.
"[This is] a potential concern, but I think it stresses the importance of long-term follow up whether you had your implants for breast cancer reconstruction or for cosmetic purposes," Attai said. "We don't have enough information to really make solid recommendations for an individual patient, except be vigilant and report any changes."
Caroline Praderio contributed to an earlier version of this story.
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