Recently Allergan voluntarily recalled BioCell textured breast implants and expanders due to ongoing concerns about their association with an extremely rare form of lymphoma – anaplastic large-cell lymphoma (BIA-ALCL).
ALCL has been associated with textured breast implants from all manufacturers, but the majority of cases worldwide have been in patients with Allergan’s BioCell implants. A worldwide registry monitoring this rare, but treatable lymphoma has documented over 570 cases. To keep it in perspective, this is out of an estimated 25,000,000 – 30,000,000 breast implant patients in the world. No confirmed cases have been associated with smooth implants, which are the most widely used type of breast implant in the US.
The FDA has been monitoring the situation and recently issued a safety communication describing the symptoms of BIA-ALCL including breast pain and swelling occurring on average, 8 years after implantation. If you have textured breast implants, please read this information carefully. If you have symptoms, schedule a follow-up appointment with your plastic surgeon.
The FDA and other health authorities (including the American Society of Plastic Surgery) are not recommending the removal or replacement of textured breast implants in asymptomatic patients. If you are not showing symptoms, there is no need to be concerned. Allergan’s recall of these products means they are not currently for sale, and unused implants already in stock in offices and hospitals are not being implanted.
Allergan just announced that for women with BioCell implants who choose to have them removed, they will provide a free pair of smooth silicone implants.
“For patients in the U.S. who, as a result of the recall announcement on July 24, 2019, choose to replace their BIOCELL textured devices with smooth devices in consultation with their plastic surgeon, Allergan will provide Allergan smooth device replacements for free. The program will run for 24 months, until July 24, 2021, and will apply to revision surgeries on or after the date of the recall announcement, July 24, 2019.
The decision to get a breast implant revision is a personal decision between patients and their plastic surgeons, and must be decided based on the appropriate discussion of benefits and risks. As part of this program, Allergan will not provide surgical fee assistance to revision patients. This decision is in-line with the FDA’s recommendation not to remove textured implants.”
Our practice can provide consultation and treatment to patients who want to consider this option, though we are not routinely recommending replacement of these implants, also in line with the FDA and ASPS position.
There are additional, accurate and up-to-date resources available to you for further information on BIA-ALCL:
- The latest article: https://www.newbeauty.com/search/?q=biocell
- Check out the official BIA-ALCL Talking Point/ FAQ’s as of July 2019.
- Read more about the Allergan recall please click here.
We will keep you informed of further developments should they arise.
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