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This is an important message for health care providers
from the U.S. Food and Drug Administration.
FDA is notifying health care providers that
women with breast implants may have a very small but
increased risk of developing Anaplastic
Large Cell Lymphoma in the area immediately
surrounding the implant.
Anaplastic Large Cell Lymphoma, or ALCL,
is a rare type of non-Hodgkin's lymphoma.
FDA is aware of about 60 reports of ALCL diagnosed
in women with breast implants,
so this is a rare finding given that an estimated 5
to 10 million women have received breast implants
worldwide.
FDA conducted a detailed review of 34 cases
reported in the scientific literature.
These cases occurred in women with saline and
silicone-gel filled breast implants.
The women sought treatment for implant-related
problems that usually occurred years after
getting the implant --- problems such as pain,
lumps, swelling, or asymmetry.
You can find FDA's analysis of these cases on
fda.gov/breastimplants.
Here are FDA's current recommendations for
health care providers who care for patients with
breast implants: Continue to provide routine care to
your patients--keeping in mind that ALCL has been
diagnosed in the peri-implant region of
some women.
If you suspect ALCL, refer the patient to an
appropriate specialist for evaluation.
To test for ALCL, obtain fresh peri-implant seroma
fluid and representative portions of the fibrous
capsule for pathology evaluation.
If your patient is diagnosed with
peri-implant ALCL, individualize her
treatment plan using a multidisciplinary team approach.
There is no uniform or standard treatment for
peri-implant ALCL.
Most patients have been treated with surgery and
some patients also received radiation therapy,
chemotherapy or both.
For asymptomatic patients,
FDA does not recommend prophylactic breast
implant removal solely due to concerns related to the
development of ALCL.
We don't know if breast implants cause ALCL or if
certain kinds of implants increase the risk more
than others.
To better characterize this disease,
FDA is asking clinicians to report all confirmed
cases of ALCL in women with breast implants to
MedWatch, FDA's safety and adverse event reporting
program.
You can report online at fda.gov/MedWatch or by
calling 1-800-332-1088.