Updated February 24, 2020
Breast Implants and ALCL
Dr. Kirby discusses the risks and realities of BIA-ALCL
In early 2017, the FDA officially confirmed a link between textured breast implants and a rare form of cancer called anaplastic large cell lymphoma, or ALCL. I believe it is important to discuss the facts with my patients instead of relying on sensationalized headlines. As with anything else, the more you know about it, the better equipped you are to make an educated decision.
To help answer some of your questions, I’d like to tell you what we know about the disease, the actual risk of ALCL among women with breast implants (it’s actually very low), and what you can do to ensure your health and safety.
Note: this information is current as of June 2018.
What is BIA-ALCL?
BIA-ALCL is a rare and highly treatable type of lymphoma (cancer) that can develop within the scar tissue (capsule) surrounding a textured breast implant. ALCL is not breast cancer, and it does not behave like breast cancer. In fact, not all ALCL is related to breast implants, and the disease on a broader scale is actually more common in men. BIA-ALCL specifically refers to “breast implant associated” ALCL.
In most cases, BIA-ALCL can be completely eliminated if detected early. Current data reports that 93% of patients treated for BIA-ALCL with a total capsulectomy (surgical removal of the breast implant and surrounding scar tissue) are disease-free at 3-year follow-ups.
What is my risk of BIA-ALCL?
The lifetime risk of developing BIA-ALCL if you have or have had textured implants is estimated to be between 1 in 3,817 and 1 in 30,000 worldwide. Most cases have occurred in Australia. Recent epidemiological studies place the lifetime prevalence of BIA-ALCL at 33 per 1 million patients with textured breast implants. Compare this to your 1 in 8 risk of developing breast cancer, whether or not you have ever had breast implants. As of September 2017, the FDA has received only 414 medical device reports of BIA-ALCL (that is, 414 doctors and/or pathologists have reported a suspected or confirmed case of ALCL), out of millions of patients who have breast implants. Worldwide, 16 deaths have been confirmed as a result of ALCL.
What causes ALCL?
According to research, two things must occur for BIA-ALCL to develop. First, you must have a genetic mutation that enables the abnormal cells to develop. Second, you must also have a bacteria called Ralstonia picketti present in the biofilm surrounding the implant. (A biofilm is a layer of microbial growth that is completely normal and, in the vast majority of cases, harmless).
Textured implants are also believed to be associated with BIA-ALCL. To date, almost all cases of BIA-ALCL have occurred in patients who have textured implants or who have had them in the past.
Are textured implants safe?
Many patients and plastic surgeons are shying away from textured breast implants due to the BIA-ALCL association. This is understandable. Keep in mind, however, that about 70,000 textured implants are placed in the U.S. each year, while only 414 reports of ALCL have been reported since the FDA began recording MDRs over a decade ago. The risk of ALCL remains very low, even with textured implants. Therefore, once educated about the facts about ALCL, most patients feel comfortable moving forward with their implant of choice, whether that is textured or smooth.
In our practice, smooth implants have been most popular with patients, even before our current awareness of ALCL. Nationally, textured implants make up about 12.7% of the market. I may still suggest textured shaped implants for certain patients based on measurements, breast history, and how busy their schedule is.
What are the symptoms of BIA-ALCL?
Possible signs of BIA-ALCL include a “water balloon” type of fluid collection, a new bump or mass in the breast, sudden asymmetry, or a new, nagging, or unrelenting pain. These symptoms can occur anytime after breast implant placement, with the average BIA-ALCL diagnosis being made after about 9.2 years. Your plastic surgeon may order imaging such as ultrasound, mammogram or MRI to further investigate.
Any concerning change in the breast at any time should be evaluated by your plastic surgeon. Even cosmetic breast augmentation patients with new breast problems can have breast imaging covered by insurance. Patient sometimes worry about this, as quite often other complications from cosmetic surgery are not covered.
How is BIA-ALCL treated?
An MRI plus a needle aspiration of the fluid surrounding the implant will be checked for markers of BIA-ALCL. If confirmed, the treatment is to surgically remove both breast implants and the surrounding breast implant capsule. New, smooth breast implants can typically be replaced during the same procedure, if desired. Chemotherapy and/or radiation are usually not necessary except in advanced cases.
How can I avoid BIA-ALCL after breast augmentation?
At this time, there is not yet a test to determine if you have the genetic mutation that makes you more prone to developing ALCL. Soaps used during surgery are known to kill the R. Picketti bacteria. Choosing smooth-shelled implants would be a good option if you are particularly worried about ALCL. Regular breast exams are key to ensuring your breast health, whether or not you are experiencing problems.
How can I stay up to date on the risks and treatments for ALCL?
I recommend getting accurate facts first and foremost. As we all know too well, not every news source is trustworthy, and sensational headlines are made to get attention. Chances are, the journalist isn’t a physician. It’s best to get your information from reliable sources, such as those below:
- The Plastic Surgery Foundation PROFILE Registry
- The American Society of Plastic Surgeons BIA-ALCL Resources
- The FDA Breast Implants Medical Device Information
- MD Anderson Cancer Center
Additionally, you are welcome to contact our office to ask questions, or if you are interested in breast augmentation or breast implant removal or replacement, schedule a consultation with me. Please call 817-292-4200 or contact us online.