The association between textured breast implants and Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) has been known and
closely monitored for several years. Just two months ago The FDA officially
stated that they would not ban textured breast implants. But that position was
revised when additional lymphoma cases were reported prompting Allergan Inc., maker of the textured
Biocell breast implant, to recall the devices most strongly associated with
this rare but serious complication.
Most breast implants have a smooth outer coating. Some
manufacturers offer the option of a textured coating on the surface of the
implant to reduce the incidence of implant slipping or flipping. These implants
have been used in both elective breast augmentation surgery and in breast
reconstruction after mastectomy. The interaction between the body’s immune
system and the textured product has triggered a rare form of lymphoma in 570
reported cases. 80% of those cases
involved the Allergan Biocell product.
The recall effectively pulled all of the Allergan Biocell
textured breast implants out of operating rooms across the US on Wednesday
morning. Surgeons report patients arriving for a scheduled operation and the
surgeon and staff having to make last minute changes to their surgical plans
based on unforeseen changes in product availability.
The recall does not call for the removal of textured breast
implants already placed in patients. This is because BIA-ALCL is rare. Every
operation has some degree of risk and to subject a woman to unnecessary surgery
with the goal of reducing the risk of a rare lymphoma is overall of no benefit
to the patient. But this risk calculation gives no comfort to a woman with
textured breast implants who is worried about her lymphoma risk.
BIA-ALCL usually presents as pain and swelling in the
breast, long after the breast reconstruction or augmentation operation has
healed. Current recommendations are for vigilant observation in patients with
textured implants in place. If pain or swelling develops then these symptoms
should be reported to a physician for evaluation which may include breast exam
and ultrasound, with possible needle aspiration or biopsy.
The recall is intended to keep the implants associated with
the greatest lymphoma risk from being used in the future, but women who already
have these implants in their bodies face a tough decision. Watchful waiting is
the recommendation, but for many women (especially prior breast cancer
survivors) this might not feel like an acceptable plan. In those cases, I
recommend discussing surgical risk with your breast or cosmetic surgeon and for
women who are good surgical candidates, elective removal and replacement can be
considered.
