1. Why is there a recall?
In response to a request from the Food and Drug Administration (FDA), Allergan voluntarily recalled specific models of their Biocell® textured implants and tissue expanders due to an increased risk of developing BIA-ALCL. This move does not affect the company's Natrelle smooth-walled implants, which are the only implant Dr. Gumucio uses in cosmetic surgeries and a majority of his breast reconstruction cases.
2. What is BIA-ALCL?
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not a breast cancer, rather it is an uncommon and highly treatable type of lymphoma that can develop around breast implants. When diagnosed early, BIA-ALCL is readily curable. Early stages of BIA-ALCL is treated by the removal of the breast implant and surrounding capsule.
There have been 573 confirmed cases of BIA-ALCL and 33 fatalities attributed to BIA-ALCL worldwide since the disease was first reported 20 years ago. The risk of developing BIA-ALCL is approximately 1 in 3817 to 1 in 30000 women with textured breast implants. There have been no reported cases of BIA-ALCL connected to smooth-walled implants.
Symptoms of BIA-ALCL include swelling of the breast, persistent pain, or a lump in the breast or armpit. If these symptoms occur, they most often develop 8-10 years after initial placement of the textured breast implant. If you are not experiencing any of these symptoms then the FDA does not recommend removing or exchanging your implants.
The American Society for Plastic Surgeons (ASPS) provides a wealth of information on breast implant safety and BIA-ALCL at American Society of Plastic Surgeons.
3. How does the recall affect me?
For the past 12 years, Dr. Gumucio has only used smooth-walled breast implants in his cosmetic surgeries. For his breast reconstruction patients, he has used smooth-walled breast implants for the past 4 years. There are some instances where he has used textured tissue expanders and implants in breast reconstruction patients. Since tissue expanders are a temporary device that are exchanged for breast implants within 12-18 months, there is little risk of developing BIA-ALCL. In fact, there have been no reported cases of BIA-ALCL connected to textured tissue expanders.
Allergan recalled all of their Biocell® textured implants and tissue expanders, include:
- Natrelle Saline-Filled Breast Implants
- Natrelle Inspira Silicone-Filled Textured Breast Implants
- Natrelle Silicone-Filled Breast Implants
- McGhan BioDimensional® Silicone-Filled Biocell® Textured Breast Implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expanders with and without Suture Tabs
For Dr. Gumucio's breast reconstruction patients affected by the recall, most of you will be receiving a letter from Allergan regarding your Biocell® textured implants, and the option of utilizing the Biocell® Replacement Warranty (www.allergan.com). This recall does not mean your textured implants need to be removed, unless you are experiencing specific symptoms. You do need to be aware of the symptoms to watch out for in this rare, but serious, condition. If you have any concerns or questions, please call our office at 706.613.6650 to schedule a consultation with Dr. Gumucio.
4. What are my next steps?
If you have textured implants and are happy with your look and have not experienced any symptoms, the FDA does not recommend removing the implants. Dr. Gumucio does recommend that you continue to attend your regularly scheduled follow-up appointments, and remain aware of any changes to the size, feel, or shape of your breast. If you notice any unexpected changes in your breast shape you should contact our office at 706.613.6650.
If you no longer wish to have your breast implants or wish to explore options of smooth-walled implants, Dr. Gumucio is happy to discuss your options during a consultation