In response to an FDA request, Allergan is recalling its BIOCELL textured breast implants and tissue expanders. Medical device reports received by the FDA indicate that BIOCELL products increase patient risk of developing a rare kind of lymphoma known as BIA-ALCL. Fortunately, the overall risk is still considered low.
At Revalla Plastic Surgery & Medical Aesthetics, Dr. Lisa Hunsicker is monitoring the situation so we can provide the best care and most up-to-date information to our patients. We understand that it can be worrisome to hear of a potential issue with your breast implants. Your well-being is our priority, as always, and we are here to address your questions and concerns.
Why did the FDA Request a Recall?
The FDA’s recall request was prompted by the identification of an increased risk of anaplastic large cell lymphoma (BIA-ALCL) in patients with BIOCELL breast implants. BIA-ALCL is a cancer of the immune system.
So far, 481 cases of BIA-ALCL have been linked to Allergan textured implants. The FDA has found that the risk of BIA-ALCL is about 6 times higher with Allergan’s textured implants than with other textured implants on the market. With that said, the FDA still considers patients with these implants to have a “low risk of developing BIA-ALCL.”
It is important to understand that while the FDA requested that BIOCELL products be taken off the market, implant removal or replacement is not recommended if there are no BIA-ALCL symptoms. The recall is intended to stop further implantation and sale of McGHAN, INAMED, and Allergan Natrelle® breast implants.
What to do about the Allergan Recall
Know your Implants
As with any type of implanted medical device, it’s important to maintain a record of the product information. In terms of this recall, the first thing to do is find out if your implants are included in the affected products.
If you are unsure what type of implants you have, refer to your implant card or call our office. You can find a list of affected products here.
Know the Symptoms of BIA-ALCL
Awareness of BIA-ALCL symptoms allows you to monitor your health more effectively. Common symptoms include:
- Changes in the shape of your breasts, including asymmetry or enlargement
- Lumps in the armpit or breast
- Fluid accumulation
- Hardening of the breast
If you experience any of these symptoms, contact our office immediately.
Monitor your Breast Area
If your implants are among the recalled Allergan products, it is advised that you check your breast area for the symptoms listed above. If symptoms are present, contact our office right away. Most cases of BIA-ALCL are treatable with implant and scar tissue removal when identified in the early stages.
Asymptomatic patients should continue monitoring the breast area for any changes in shape or consistency. According to the FDA’s recommendations, it is not necessary to have your Allergan textured implants removed or replaced unless you are experiencing symptoms of BIA-ALCL.
However, if you prefer to have your Allergan textured implants replaced with smooth implants, that option is available to you. Call our office to schedule an appointment. Information on Allergan’s replacement policy for affected implants can be found here.
Contact Us with any Questions
Dr. Hunsicker wants you to feel comfortable and confident with your breast implants. We welcome your communication and are committed to supporting you and your well-being. Please do not hesitate to call us at 720-283-2500.