(NATIONAL) -- On
Wednesday the Food
& Drug Administration
issued a statement
for the public regarding
its understanding of
disease known as
implant-associated anaplastic large cell lymphoma (BIA-ALCL).
we are working to update and enhance the information we have on this
association, including updating the total number of known cases of
BIA-ALCL and the lifetime risk of developing BIA-ALCL as reported in
said Binita Ashar, M.D., director of the division of surgical devices
in FDA’s Center for Devices and Radiological Health.
hope that this information prompts providers and patients to have
important, informed conversations about breast implants and the risk
of BIA-ALCL. At the same time, we remain committed to working in
partnership with all stakeholders to continue to study, understand
and provide updates about this important public health issue."
FDA has been closely tracking the relationship between breast
implants and BIA-ALCL,
rare type of non-Hodgkin's lymphoma since it
first identified a
been working to gather additional information to better characterize
and quantify the risk so that patients and providers can have more
informed discussions about breast implants,” said
the FDA is
providing an updated number of medical device reports (MDRs) (also
known as adverse event reports) and medical literature estimates
regarding risk reviewed by the agency since the last public update in
FDA says it is now
aware of 414 total cases of BIA-ALCL. Additionally, studies reported
in medical literature estimate that the lifetime risk of developing
BIA-ALCL for patients with "textured
ranges from 1 in 3,817 to 1 in 30,000.
agency is also updating the content and format of the
the agency’s breast implant "post-approval
to make current information about these important studies easier for
patients to read and understand.
update does not change the agency’s recommendations regarding
to obtain a breast implant is a very personal decision that patients
and their providers should make based on individual needs and with
the most complete information about risks and benefits," said
the agency's statement.