ANAPLASTIC LARGE CELL LYMPHOMA

FDA issues 2019 update on BIA-ALCL

The American Society of Plastic Surgeons (ASPS)  would like to make members aware of a Feb. 6  statement by the Food and Drug  Administration (FDA)  updating the number of adverse event  reports submitted to the agency related to  breast implant-associated anaplastic  large cell lymphoma (BIA-ALCL). The statement notes that as of September 2018,  the agency has received 660 total medical  device reports (MDR) regarding BIA-ALCL  cases in the United States – an increase of  246 new MDRs (59 percent) from the  previous year’s update. Acknowledging  that the nature of the MAUDE database’s  reporting system is susceptible to duplicate  reports, the agency’s analysis suggests  there are only 457 unique cases,  including nine deaths, of BIA-ALCL  reported (since 2010). The FDA  also notes that while the MDR  system is a valuable source of information,  it is a passive surveillance system with  limitations, including incomplete,  inaccurate, untimely, unverified or  biased data in the reports. The  incidence or prevalence of BIA-ALCL  cannot be determined from this reporting  system alone, due to potential under- reporting, duplicate reporting and lack  of information about the total number  of breast implants.

The FDA update calls  for no changes in recommendations  regarding breast implants.  For patients with breast implants,  the FDA states there is no need to  change routine medical care and  follow-up, and there is no need to  test asymptomatic patients. BIA-ALCL is a rare condition that occurs  most frequently in patients who have  breast implants with textured surfaces.  Patients should discuss with their  health-care provider the benefits  and risks of textured-surface  versus smooth-surface implants. .