The safety of breast implants has come under a lot of scrutiny lately. There have been reports of breast implant illness and fears that they could cause certain kinds of cancer. And amid these concerns, some have wondered if breast implant removal might be the best course of action. Now, NPR reports that the pharmaceutical company Allergan has recalled textured breast implants after they were linked to a rare form of cancer.
In a news release, Allergan stated that it will no longer sell Biocell saline-filled and silicone-filled implants. The company clarified that its Natrelle smooth and Microcell implants and tissue expanders are not included in the recall, however.
“Patient safety is a priority for Allergan,” the company said in the release. “Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.”
NPR notes that the Food and Drug Administration (FDA) requested the recall due to an increase in diagnoses of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a type of non-Hodgkin’s lymphoma. Since February, the FDA has found 116 new cases of the cancer and 24 deaths related to it. According to the FDA, there have been 573 total cases of BIA-ALCL worldwide, 481 of which have been linked to Allergan implants. There have also been 33 deaths from the cancer so far, and Allergan had made the implants in 12 out of 13 cases where the manufacturer was known.
Overall, the risk of developing BIA-ALCL is still very small. NPR points out that more than 314,000 people in the U.S. got breast implants in 2018. Textured implants like those recalled are also more common in Europe and Asia than in the U.S.
Recall alert: At FDAs request, Allergan is recalling all of its Biocell textured breast implants to protect women from the risk of breast implant associated anaplastic large cell lymphoma. Affected products include both silicone and saline-filled implants https://t.co/EyBP0h4SCd pic.twitter.com/aysTFz5eSw— U.S. FDA (@US_FDA) July 24, 2019
In a safety communication for patients, the FDA wrote that it does not recommend breast implant removal unless you exhibit symptoms.
Warning signs of BIA-ALCL include swelling or pain near the site of your implant. The FDA also suggests keeping track of the manufacturer, device identifier, and implant model of your implants. According to The New York Times, the FDA held a hearing about breast implant safety in March. And in May, it determined that the risk of cancer was not high enough to ban the implants.
The risk of BIA-ALCL may be low, but it’s still important to be aware of these concerns. If you have breast implants and you’re concerned about the recall, talk to your doctor.