About the FDA’s Recall of Biocell Textured Implants
- Posted on: May 30 2020
As if the past few months of the coronavirus haven’t made us all anxious enough, if you’ve also been considering breast augmentation you may have heard some other news that made you anxious. The FDA recalled a certain type of breast implant, and you’re now wondering what’s up with that.
Since Dr. Lipton has performed countless breast augmentation procedures for our patients from Lewisville and surrounding areas, let’s use this blog to fill you in on what the FDA did and what it means.
What is BIA-ALCL?
The first step came in March 2017 when the FDA first announced it had found evidence of a link between textured breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. In the announcement, the FDA called the cancer “breast implant-associated anaplastic large-cell lymphoma” (BIA-ALCL).
Then in May 2019, Health Canada suspended the sale of Allergan Biocell breast implants. In July, the FDA followed suit with a ban. It made a voluntary recall request to Allergan for all of its Biocell textured implants.
What the FDA said
The FDA requested that Allergan recall all Biocell textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system. Based on the currently available information, the FDA’s analysis demonstrated that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers in the U.S. That’s why the FDA instructed Allergan to stop distribution.
The ban applies only to this specific type of textured implant, Biocell. The same associations have not been found with other types of textured implants. It appears the lymphoma develops in the scar tissue that forms around the Biocell textured implants.
There is no recommendation for women to remove these implants, as the number of cases is exceedingly low. Still, women who have received Allergan Biocell macro-textured implants should be on the lookout for any signs such as swelling, lumps, and pain in the breast.
What is ALCL?
ALCL is a very rare cancer that can develop in any part of the body, most commonly the lymph nodes and skin. Research suggests that BIA-ALCL is usually found near the breast implant within the surrounding scar tissue, not in the breast itself. The lifetime risk for developing BIA-ALCL from a Biocell implant is estimated to be from one in 4,000 to one in 30,000.
How is BIA-ALCL treated?
This is still a very low risk. Plus, when BIA-ALCL is caught early it is usually curable. Treatment involved surgical removal of the implants and the scar tissue capsule.
Do you have questions about breast implants? Please call Dr. Lipton at (972) 420-0023 to schedule a consultation and he can fill you in.
Posted in: Breast Augmentation