The U.S. Food and Drug Administration (FDA) sounded the alarm on July 6, 2019. The agency had received 573 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Although the FDA first identified a link between ALCL and breast implants in 2011, a lack of data restricted their statements to a call for more research into the connection.
In 2016, the World Health Organization (WHO) validated the FDA’s suspicions, designating BIA-ALCL as a T-cell lymphoma that can develop from breast implants. In March of the same year, the FDA held a public advisory committee meeting to further explore the many concerns stemming from this issue, and on July 24, 2019, the agency requested a voluntary recall of breast implant maker Allergan’s textured breast implants, noting that the risk of BIA-ALCL with these medical devices was six times higher than with those from other manufacturers.
Unfortunately, medical and scientific communities still lack the breadth and depth of data they need to paint a complete picture of the BIA-ALCL problem as it exists both nationally and globally. Many aspects of this condition remain a mystery.
This is why any insight offered by an expert in this area merits focused attention.
And this is why it was good to see an interview of Lloyd Gale, MD, in the March 20, 2020 issue of Oncology Nursing News. Gale is an associate professor of surgery at Weil Cornell Medical College and chief of plastic surgery at Maimonides Medical Center. The surgeon’s information about BIA-ALCL and perspectives on diagnosis and treatment offer valuable insights to a growingly concerned public.
Current Understanding of Causes
In the interview, Gale walks through current ideas about BIA-ALCL that the scientific community continues to explore. It doesn’t take much reading between the lines to realize that the exact cause of this lymphoma in breast implant recipients is still unknown. However, Gale talks about common elements that may present clues:
- Biofilm that creates inflammation
- Heavy metal residue from the manufacturing of breast implants
- The unique surfaces of textured implants, which connect with more cases of BIA-ALCL
Treatment Options for BIA-ALCL
Gale stresses that treatment options for BIA-ALCL continue to evolve. In more fortunate cases of early detection, current treatment involves removing the implant, along with the surrounding capsule and mass. Such patients receive treatment from multiple health disciplines, including surgical oncologists and plastic surgeons.
Radiation and medical oncology physicians may enter the picture to determine the need for additional treatment. However, Gale notes that chemotherapy and radiation therapy generally do no play a role in treating patients with stage I or II BIA-ALCL, provided the lymphoma has not spread beyond the breast capsule and surrounding soft tissue.
Outlook for Treatment and Surgical Developments
The outlook Gale shares for BIA-ALCL has less to do with surgical developments and more to do with diagnostic issues. The surgeon laments the small data pool available for advancing the medical community’s understanding of the condition and its association with breast implants, particularly the textured form of these devices.
With more data, it will be easier to identify patients who stand a greater risk for developing this rare form of lymphoma—perhaps even doing so pre-emptively, so they have a chance to make an informed choice, perhaps thwarting their development BIA-ALCL, and thus making its treatment a non-issue.