I’m Dr. Matthew Kilgo, Board Certified Plastic Surgeon with the Long Island Plastic Surgical group. I’ve been in practice since 2001, almost 20 years. Breast Implant Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL, is a rare form of non-Hodgkin’s lymphoma. It is not breast cancer. Breast cancer originates in the tissue of the breast itself. This cancer is a cancer of the immune system, which occurs within the scar capsule, or the fluid surrounding the implant.
It’s worthwhile, I think, to discuss the difference between the different types of implants. Implants can be described based on what’s inside the implant, or the fill, and what is on the outside of the implant, or the shell. The fill can either contain saline or silicone. And the shell can be either textured or smooth. And this is predominantly a disease associated with textured implants.
There have been no case reports, case series, or registries that have demonstrated the development of BIA-ALCL in a patient with a purely smooth implant history that’s well detailed. While it can occur in patients with smooth implants, generally those patients have either had a textured implant in place prior to that, or their history is unclear and not detailed enough for the FDA to confirm that they didn’t have a textured implant in place prior to that. Having said that, we still don’t have enough information to be able to exclude smooth implants as a potential cause for BIA-ALCL in the future.
When the FDA looks at their data worldwide and in the United States, the vast majority of these cases are caused by Allergan BIOCELL Textured implants. And those implants were taken off the market at the request of the FDA in 2019 and are no longer available for implantation.
At this point in time, the FDA is not recommending removal of textured breast implants in patients who do not have BIA-ALCL for two reason; the first is that it’s a rare disease, and the risk of developing a complication from the surgery required to remove the implants, with or without the capsule, is greater than the risk of a patient developing BIA-ALCL in the future. And the second reason is that to date we don’t have any prophylactic procedures, whether it’s implant removal only, implant removal with capsulectomy that has definitively been shown to decrease the risk, or mitigate the risk, of developing BIA-ALCL in the future.
The most common present symptom is swelling of the breast. And it’s typically fairly significant, and it usually occurs years after implantation. And that is secondary to what’s called a late seroma, which is fluid buildup around the implant within that scar capsule. Other less common symptoms include a mass around the implant in the scar capsule, which presents as a lump in the breast, an enlarged lymph node, firmness of the breast, pain in the breast, breast assymetry, or a rash on the breast.
If the patient develops symptoms consistent with BIA-ALCL, they should make an appointment to see their healthcare provider as soon as possible for a complete physical examination. And if there are any findings consistent with BIA-ALCL on examination, the patient would typically undergo an imaging study which might be a breast ultrasound or a breast MRI to look for fluid around the implant, a mass in the capsule, or an enlarged lymph node. If any of those things are found, the next step would be to have a diagnostic procedure where either fluid is removed, or tissue is removed in order to send it off for markers to determine whether or not BIA-ALCL is present.
Once that’s established, the patient would typically see a medical oncologist to undergo testing to rule out distant disease and then particularly in early stages, surgery is the treatment of choice, which usually involves removal of the implant and the capsule as well as any associated masses or soft tissue associated with that.
Surgery in the early stages is typically curative and often times patients won’t need any further treatment. I think any patient who’s deciding on breast implant surgery, and that goes for any patient having any type of surgery, should be fully aware of the risks and benefits of the procedure and when we’re talking about breast implant surgery, BIA-ALCL should be one of those topics. Although it’s rare, it is something that needs to be discussed.
The FDA continues to follow new cases through their medical device reports, both in the United States and worldwide. They’ve also partnered with the American Society of Plastic Surgeons, and the Plastic Surgery Foundation to create a patient registry called the Profile Registry. The goal of that is to create a scientific database for research that will hopefully help us get a better understanding of the disease and to improve our ability to detect and diagnose BIA-ALCL and to manage and treat these patients.