In 2011, the Food and Drug Administration (FDA) identified a possible link between textured breast implants and a rare form of lymphoma known as breast-implant-associated anaplastic large-cell lymphoma, or BIA-ALCL.
Eight years later, in July 2019, the FDA requested that Allergan, the manufacturer of a type of textured implant, recall specific models from the U.S. market due to the risk of BIA-ALCL. Allergan has issued a worldwide recall of their BIOCELL textured implant products and related tissue expanders. The aggressive surface has been found to have six times greater risk for ALCL than other textured surfaces. This implant type represents less than 5% of the breast implants sold in the United States.
Updated figures from the FDA reported 573 cases of BIA-ALCL worldwide and 33 deaths from the cancer. Of that number, 481 cases have been clearly attributed to Allergan Biocell implants, the agency said. In 13 of the deaths where the type of implant was known, 12 were linked to Allergan implants.
Textured surface implants are very rarely used at UT Southwestern, but if you already have them, it’s understandable you may be concerned about your potential risk for this disease. That’s why we’ve compiled this list of frequently asked questions and answers about BIA-ALCL. It is important to note that the FDA is not recommending removal of textured implants in woman with no symptoms.
“Timely recognition and intervention is key to curative treatment when it comes to BIA-ALCL. Waiting too long to get help can make BIA-ALCL more dangerous and treatment more difficult.”
Where in the breast has BIA-ALCL been found?
In the case studies reported in the literature, BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration below shows the location of the ALCL in these reports. In most cases, the ALCL cells were found in the fluid surrounding the implant (seroma) or contained within the fibrous scar capsule. Image courtesy of the U.S. Food & Drug Administration.
Is BIA-ALCL breast cancer, and what are the symptoms?
Though it develops around the breast and implant, BIA-ALCL isn’t breast cancer. It’s actually a lymphoproliferative deformity classified as a slow growing type of non-Hodgkin’s lymphoma, or a disorder of the immune system. BIA-ALCL initially appears in the fluid surrounding the breast implant, between the capsule and implant. If left untreated, the disease can progress to involve the surrounding capsule and tissues.
The main symptom of BIA-ALCL is painless swelling of the breast in a patient who has a history of receiving a textured surface breast implant. Although breast swelling is a common symptom immediately after any implant surgery, BIA-ALCL most commonly develops years after the procedure. Half of all cases of BIA-ALCL reported to the FDA have been diagnosed within seven to eight years after implant surgery, though the American Society of Plastic Surgeons (ASPS) notes that symptoms can appear two to 28 years after the procedure.
Infections, rupture of a breast implant, and changes in the capsule surrounding the implant, as well as other processes, can cause breast swelling, so it is important to see your plastic surgeon as soon as possible if you notice any swelling or other concerns related to your breasts.
What are the risk factors for BIA-ALCL?
BIA-ALCL seems to develop exclusively in women who currently have or used to have textured breast implants, rather than smooth implants. There have not been any reported cases of BIA-ALCL in women who have had only smooth-walled implants. We are fortunate to have many choices regarding breast implants for reconstructive and cosmetic indications. These options should be thoroughly discussed between the patient and plastic surgeons.
Researchers are not sure why the type of breast implant plays such a key role in developing BIA-ALCL, but there are several theories under investigation regarding the risk associated with textured implants, including:
- Greater surface area of the implants
- Inflammation of the surrounding tissue
- Possible genetic links
The lifetime risk of a woman with a textured breast implant developing the disease is between one in 3,817 and one in 30,000. Those numbers do not indicate that your breast implant is a time bomb ticking away in your chest, and you do not necessarily need your implant removed if it’s textured and you have not noticed any symptoms. However, it is a risk that requires observation on your part and good, regular interactions between you and your plastic surgeon.
BIA-ALCL has developed in women with silicone implants as well as saline implants, according to FDA data, but the data indicate only what type of implants each patient had at the time of diagnosis. It is possible that some patients had their implants replaced before being diagnosed.
In roughly equal numbers, BIA-ALCL affects women who have had breast reconstructive surgery and those who have had cosmetic breast enhancement. Of the cases reported in the United States, 56 percent of patients had received their implants for cosmetic reasons while 44 percent had received their implants after a mastectomy.
Related reading: The truth about breast implant-related cancer risk
What should I do if I think I might have BIA-ALCL?
The most important thing to do is to maintain regular checkups with your board-certified plastic surgeon. If you notice any change in the size or shape of your breast, make an appointment with your plastic surgeon for an exam. Breast implants do not last forever; any will require replacement at some point. Regular visits with your plastic surgeon help ensure your breast health. It is important to contact your doctor should changes occur.
Timely recognition and intervention is key to curative treatment when it comes to BIA-ALCL. Waiting too long to get help can make BIA-ALCL more dangerous and treatment more difficult.
How is BIA-ALCL treated?
We begin by testing the fluid that collects around a patient’s breast implant for a substance called CD30, which is a protein in cell membranes that shows up abnormally in cases of BIA-ALCL. If this test is positive, most patients will need surgery to remove the scar tissue, or capsule, around the implant, as well as the breast implant itself. Other surgical treatments may occur depending on when the patient presents for diagnosis. Our plastic surgeons delay replacement of breast implants for a minimum of three months prior to consideration of further augmentation.
Late diagnosis of BIA-ALCL may allow the lymphoma to progress, requiring not only surgery but also consideration of chemotherapy and radiation treatment; 93 percent of patients treated are disease free at three years following treatment.
Where can I find more information about BIA-ALCL?
Our plastic surgeons in Dallas and Frisco have the expertise to answer your questions about BIA-ALCL and determine whether you might be at risk for the disease. I also encourage my patients to learn as much as they can from the FDA and the ASPS.
It is important that you work closely with a plastic surgeon who is certified by the American Board of Plastic Surgery (ABPS), which maintains standards for education and certification of plastic surgeons nationwide. You can verify whether a plastic surgeon is ABPS-certified or search for a certified surgeon near you on the ABPS certification search page.
Additionally, other women can be a great source of information for BIA-ALCL and how it can affect your life. In July 2018, a group of BIA-ALCL survivors from across North America met here in Dallas to appear in a video for the Plastic Surgery Channel to raise awareness of the disease. These women appeared on our own NBC 5 during their visit.
While BIA-ALCL is an important consideration for any woman who has had a textured surface breast implant, it is not a cause for panic. Know the facts, keep an eye on how your implants look and feel, and let your plastic surgeon know right away if you notice any changes.
If you or a loved one has any questions about your breast implants or your risk for BIA-ALCL, we would be happy to see you for an evaluation. Call 214-645-2353 (Dallas) or 214-645-2375 (Frisco) or request an appointment online.