Sunday, February 10, 2019


FDA issues 2019 update on BIA-ALCL

The American Society of Plastic Surgeons (ASPS)
 would like to make members aware of a Feb. 6
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. .