Breast Implant-Associated ALCL Understanding and Treatment Evolves

Lloyd B. Gayle, MD, director of plastic surgery, vice-chairman of surgery, Maimonides Medical Center

Lloyd B. Gayle, MD

Surgery has been the mainstay of treatment for patients with breast implant—associated anaplastic large cell lymphoma (ALCL). However, much remains unknown about the etiology of this rare disease and which patients are at risk of developing it, said Lloyd B. Gayle, MD.

"Based on available data and current National Comprehensive Cancer Network guidelines, the cornerstone of treatment is surgical unblocked resection," said Gayle, director of Plastic Surgery Resident Education and associate professor of clinical surgery at Weill Cornell Medical College. "As we start accumulating more data, we will be able to provide more information to patients."

Though the incidence of breast implant—associated ALCL is not fully understood, a multidisciplinary effort is being made to identify patients with the disease earlier on.

In terms of etiology, certain textured implants appear to increase an individual's risk of developing breast implant—associated ALCL, explained Gayle. Although these patients should not have their implants removed without symptomatic cause, they should be informed of their risk, added Gayle.

In an interview with OncLive, Gayle, who is also director of plastic surgery, vice-chairman of surgery, Maimonides Medical Center, attending surgeon in plastics at the Hospital for Special Surgery, and an associate attending surgeon in the Division of Plastic Surgery at NewYork-Presbyterian Hospital, discussed the current treatment of patients with breast implant—associated ALCL and remaining questions that need to be addressed.

OncLive: What are some of the current treatment options for patients with breast implant-associated ALCL?

Gayle: Breast implant—associated ALCL is a relatively new entity, so treatment modalities are evolving. The cornerstone to this is understanding that with early diagnosis, specifically in patients with stage I/II disease where there is no spread beyond the breast, the capsule, and the surrounding soft tissue, treatment is best rendered with a total capsulectomy. [Total capsulectomy] is now defined as an unblocked resection, which is to say the removal of the implant, the surrounding capsule, and any surrounding mass within the soft tissue.

The use of radiation therapy and chemotherapy are adjunct to this but do not have a primary role in patients with relatively early disease.

Treatment for patients with breast implant—associated ALCL is interdisciplinary. Patients are seen by plastic surgeons and surgical oncologists. Often, they are seen by radiation oncologists and medical oncologists to determine whether additional treatment is indicated.

What causes breast implant-associated ALCL?

Unfortunately, we do not yet completely understand [the cause of breast implant—associated ALCL]. Early on, we thought the disease was associated with a biofilm that creates an ongoing inflammatory-type reaction. [We thought] the reaction resulted in a metaplastic change in lymphoproliferative processes. It is clear, certainly in terms of consistent culture results, that we have not been able to demonstrate whether chronic infection plays a major part in [breast implant–associated ALCL development]. Now, that [research] has taken a bit of a back seat to the current thinking.

All implants have some microlevel of heavy metal residue associated with them from the manufacturing process. Whether or not this plays a role in breast implant-associated ALCL remains unclear.

Clearly, the more aggressive textured devices such as the Biocell textured implants manufactured by Allergan have a much high predilection [to breast implant—associated ALCL]. The vast majority of breast implant–associated ALCL cases have been associated with these implants. There is something regarding the surface of this more aggressive, deeper pore implant that is associated with the creation of breast implant–associated ALCL. However, it is still not completely clear what the true etiology of the disease is.

What needs to be done to push the needle forward in the space?

The issue has less to do with surgical developments, and more in understanding and developing early diagnostic modalities. What do we do with patients who present in the clinic? Is there a simple, quick, office-based study that can be done? Is there a serologic study that can be done?

Moreover, taking a step backward, is there a way to preemptively identify the patients who are at risk [of developing breast implant—associated ALCL]? Is there a genetic factor that is associated with the disease that allows us to determine which patients should not receive this type of implant?

The incidence [of patients with breast implant—associated ALCL is still relatively small. The [incidence] ranges from 1 in 355 patients to 1 in 86,000 in terms of associated risk ratios. We need to home in on what the true number is. Is the previous presence of a textured tissue expander still a significant risk, or is it only the implant that is at hand? Almost all cases have had some prior experience with or exposure to a textured device.

There is still so much that we don't know in terms of the diagnostic workup and which patients are at risk. Because the numbers are still relatively small, the data are very hard to glean.

Textured devices from Allergen have been voluntarily removed from the marketplace. The current recommendation is to not preemptively remove these devices from patients unless they present with symptoms, or unless they have other drivers such as capsular contracture, aesthetic concerns, or implant rupture. In those cases, you should proceed with implant removal.

From the standpoint of trials at present time, there are none that I am aware of with respect to treatment modality. We are seeing so few of these cases that it is hard to establish any true trial status at this point.

Is there anything else you would 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 risk [for breast implant—associated ALCL]. Allergen has made their patients aware of the potential risk for breast implant–associated ALCL through letters and phone calls. We have reached out to patients as well.

Additionally, we have an ongoing educational process at our office to ensure that our patients are aware of the fact that though they are at risk, nothing acute needs to be done for their treatment or management.