Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a relatively newly discovered illness, which leaves many questions for both patients and providers.
We recently spoke with Lloyd Gale, MD, associate professor of surgery at Weil Cornell Medical College and chief of plastic surgery at Maimonides Medical Center, about the illness, and what the next steps in diagnosis and treatment are.
Oncology Nursing News: Can you give an overview for treatment options for BIA-ALCL?
Gale: Breast implant-associated anaplastic large cell lymphoma is a relatively new entity. So, treatment modalities are continuing to evolve. The cornerstone to this is understanding that with early diagnosis (that is, in patients with stage I or II disease where there's no spread beyond the elements of the breast capsules and the surrounding soft tissue elements), treatment is best rendered with a total capsulectomy, which we've now defined as a unblocked resection. This is to say removal of the implant, the surrounding capsule, any surrounding mass within the soft tissues. The use of radiation therapy and chemotherapy are adjunct to this and do not have a primary role in treating patients with relatively early disease.
This is an interdisciplinary treatment pathway. So, patients who we're seeing are seen by both plastic surgeons and surgical oncologists. They're often seen by radiation oncology and medical oncology for the question of whether or not additional treatment is indicated.
Based on available data and per NCCN guidelines, the core treatment is really surgical and unblocked resection.
Is the cause of BIA-ALCL understood?
Unfortunately, we still still don't understand. Early on, we thought this was associated with a biofilm. That biofilm then creates this ongoing inflammatory action that then results in some metaplastic change in the lymphoproliferative process. It's unclear, and certainly in terms of consistent culture results, we've not been able to demonstrate that chronic infection has really played a major part. So, I think this is taking a little bit of a backdoor to the current thinking.
All implants have some micro-level of heavy metal residue associated with them from the manufacturing process. Whether or not this has a role to play remains unclear.
Clearly the more aggressive textured devices, the so-called Biocell devices manufactured by Allergan, have a much higher prevalence. The vast majority of cases have been associated with these implants. So, there's clearly something associated with this more aggressive, deeper-pore, associated with the surface of the implant that is associated with the creation of the process. But it's still to-date not completely clear what the true etiology is.
Moving forward, what do you hope to see in this field as far as treatment and surgical developments?
The issue is less in surgical developments. It's more in early diagnostic modalities. What do we do in the patient who presents in the office? Is there a simple, quick office-based study that can be done?
Moreover, taking a step back, is there a way to preemptively identify the patients who are clearly at risk? Is there a genetic factor associated with this that then allows us to determine that this is a patient who should not have this type of implant going forward?
The numbers still are relatively small. The range is anywhere from 1 in 355 to 1 in 86,000 in terms of associated risk ratios. So, I think we need to hone down a little bit more on what the true number is. It's not clear what the denominator is in this circumstance.
Is the previous presence of the tissue expander that's textured, for instance, still a significant risk, or is it only the implant that is at hand? Almost all of the cases that have been present to-date have had some associated prior experience or exposure to a textured device.
There's still so much that's not known as far as the diagnostic workup, in terms of determining who is at risk. Because the numbers are still relatively small, the data is really hard to glean.
Are there any research efforts or trials looking at this?
In the trials that I'm directly involved in or aware of, the key right now is that the textured devices from Allergan have been voluntarily removed from the marketplace. The current recommendation still is not to preemptively remove these devices from these patients unless they are presenting with symptoms or unless they have other drivers such as capsule contracture, aesthetic concerns, or implant rupture, to then proceed with implant removal.
I think that from the standpoint of trials at present time, there are certainly no trials that I'm aware of, with respect to treatment modality. We are seeing so few of these cases that I think it's hard to establish any true trials at this point.
Is there anything else you'd like to mention?
From the standpoint of patient awareness, all patients with textured devices or who have had a history of textured devices should be made aware of the risks. Certainly, letters and phone calls have been executed by Allergen to make their patients aware. We've reached out to patients and we have an ongoing educational process in our office to make certain that our patients are aware of the fact that while they are at risk, there is nothing acute that needs to be done for their treatment or management.
At the end of the day, as we start accumulating more data, we'll have a better ability for us to hone down and provide more information for patients moving forward.