(CNN) — Textured breast implants made by Allergan were recalled globally this week after the US Food and Drug Administration reported an increased number of cancer cases and deaths linked to the products.
If you’re one of the hundreds of thousands of people who have the textured implants, you might be concerned.
Here’s what you should know.
What are textured breast implants?
Textured implants have a rough outer shell, with a surface that feels kind of like sandpaper. They’re typically used for implants with a teardrop shape, which are fuller on the bottom and can look more like a natural breast. The texture is designed to help the implant stick to the surrounding soft tissue, making it less likely to move around and look distorted, Dr. Colleen McCarthy, a reconstructive surgeon at Memorial Sloan Kettering Cancer Center, wrote in an email to CNN.
As you might expect, smooth implants have a smooth outer surface. Though they tend to move around a lot more, that movement isn’t a concern because they are symmetrically shaped and look the same despite their positioning.
Why are these breast implants being recalled?
Allergan’s textured breast implants have been linked to an elevated risk of a cancer called breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL. BIA-ALCL is a cancer of the immune system, not breast cancer.
The FDA said that the risk of BIA-ALCL with Allergan’s Biocell textured implants is six times higher than with other textured implants, and added that continued distribution of Allergan’s Biocell implants would likely cause “serious, adverse health consequences and potentially death from BIA-ALCL.”
How many people are affected?
Textured implants aren’t as common in the US as they are in other countries, according to the FDA. The agency says that textured implants make up about 10 percent of all implants in the US, with Allergan’s textured implants accounting for less than five percent of that.
Still, hundreds of thousands of people are estimated to have the textured implants from Allergan, Dr. Binita Ashar, director of the office of surgical and infection control devices at the FDA, said at a press conference on Wednesday. She added that the FDA will get more information on those numbers in the coming weeks.
Which products are part of the worldwide recall?
These are the Allergan implants that have been recalled.
- Natrelle Saline-Filled breast implants: styles 163, 168, 363 and 468.
- Natrelle Silicone-Filled breast implants: styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF and TSX.
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants: styles 410FM, 410FF, 410MM, 410 MF, 410 FL, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, 410 LX.
These are the tissue expanders that have been recalled:
- Natrelle 133 Plus Tissue Expander.
- Natrelle 133 Tissue Expander with Suture Tabs.
If you’re not sure about the manufacturer or model of your implants, ask your surgeon or get medical records from the place that performed your surgery.
I currently have one of the recalled implants. Should I get it removed?
For now, the FDA isn’t recommending that patients with textured breast implants get them removed unless they’re showing symptoms. Though the risk of developing cancer from Allergan’s textured implants is higher than other implants, it’s still pretty rare overall. The cancer is also considered easily treatable if it’s detected in time.
“Most patients diagnosed with BIA-ALCL will be cured by removal of both breast implants along with the scar tissue, or capsule, surrounding each implant,” McCarthy said. “A small minority of patients will also require chemotherapy and radiation.”
Understandably though, an elevated risk of cancer can be scary for patients, regardless of how rare it is. The American Society of Plastic Surgeons recommends that patients who are still concerned have a conversation with their health care providers about the best course of action.
If I want to get my textured implants removed, do I have to pay out of pocket?
The American Society of Plastic Surgeons has advocated for insurance companies to cover the cost of breast implant removal and other treatments for patients diagnosed with BIA-ALCL, McCarthy said.
Some insurance companies will cover the removal and/or replacement. If you don’t have symptoms of the cancer right now, it’s best to contact your insurance provider to see what they’ll pay for.
What symptoms should I be on the lookout for?
BIA-ALCL typically develops about seven to 10 years after the textured breast implants are put in, according to Alan Matarasso, president of the American Society of Plastic Surgeons.
Any abnormal swelling in one particular breast is a red flag. Patients should also be on the lookout for pain, rashes, itchiness, firmness, masses or changes in the size and shape of the breast.
McCarthy said it’s important to note that these signs do not necessarily mean a person has BIA-ALCL. They can also be from a leaking implant or other causes of swelling. If you experience any of these symptoms, it’s important to see your health care provider and get it checked out.
Weren’t these implants banned in other countries?
Yes. In December 2018, Allergan halted sales of two types of textured breast implants in Europe after France refused to renew approval for them. Then in April of this year, France issued a sweeping ban on two types of textured breast implants across six manufacturers because of the link to a heightened risk of cancer.
Canada soon followed suit with a ban on Allergan’s Biocell implants. And in July, Australian authorities proposed a ban on 25 models of textured breast implants.
Why weren’t textured breast implants recalled in the US until now?
The FDA first identified a possible link between breast implants and lymphoma in 2011, but the agency says that at the time, it couldn’t determine what factors increased the risk of cancer.
Though other countries took steps to ban the implants earlier this year, the FDA was slower in its decision. The agency said it based its decision on the results of a public hearing held in March, as well as new data reported to the FDA since then.
There have been 573 unique cases of BIA-ALCL, and 33 people have died from the cancer worldwide. Out of those 573 cases, 481 of them involved Allergan’s Biocell implants, according to the FDA. The agency said it knew the manufacturer of the implant in 13 of the deaths — Allergan was the manufacturer in 12 of those cases.
The manufacturer for the remaining 20 deaths is unknown.
It’s important to note that so far, the FDA has only pushed for a recall of Allergan’s textured breast implants — other companies in the US still have textured implants on the market.
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