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FDA Update on Rare Breast Implant-Associated Type of
| DisclosuresMarch 21, 2017
The US Food and Drug Administration (FDA) has provided an update on
breast implant–associatedd anaplastic large cell lymphoma.
In January 2011, the agency identified a
possible association between breast implants and the development of
anaplastic large cell lymphoma (ALCL).
Since then, "we have strengthened our understanding of this
condition and concur with the World Health Organization designation of
breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a
rare T-cell lymphoma that can develop following breast implants,"
FDA said in a statement March 21.
OVER 350 CASES, 9 DEATHS
The FDA notes that most data suggest that BIA-ALCL occurs more often
after implantation of breast implants with textured surfaces rather than
those with smooth surfaces.
As of February 1, 2017, the FDA has received a total of 359 medical
device reports (MDRs) of BIA-ALCL, including 9 deaths. Of the 231 reports
that included information on the implant surface, 203 concerned textured
implants and 28, smooth implants.
Of the 312 reports that included information on implant fill types, 186
described implants filled with silicone gel and 126, implants filled with
"It is important to note that details on breast implant surface and
fill type are limited. While the MDR system is a valuable source of
information, it may contain incomplete, inaccurate, untimely, unverified,
or biased data," the FDA says.
During the last 6 years, a "significant body" of literature has
been published on BIA-ALCL, including additional case histories and
comprehensive reviews of the natural history and long-term outcomes of
the disease, the agency notes. "All of the information to date
suggests that women with breast implants have a very low but increased
risk of developing ALCL compared to women who do not have breast
Most cases of BIA-ALCL are treated by removal of the implant and the
capsule surrounding the implant, and some cases have been treated by
chemotherapy and radiation. However, because BIA-ALCL has "generally
only been identified in patients with late onset of symptoms such as
pain, lumps, swelling, or asymmetry, prophylactic breast implant removal
in patients without symptoms or other abnormality is not
recommended," the FDA said.
The exact number of cases of BIA-ALCL worldwide is unknown.
The FDA is continuing to collect and evaluate information about BIA-ALCL.
For now, the agency recommends that clinicians who have patients with
breast implants take the following action:
- Be aware that most confirmed cases of BIA-ALCL have occurred in women
with textured breast implants. Provide the manufacturer's labeling as
well as any other educational materials to your patients before surgery
and discuss with them the benefits and risks of the different types of
- Consider the possibility of BIA-ALCL in a patient with late-onset,
persistent peri-implant seroma. In some cases, patients presented with
capsular contracture or masses adjacent to the breast implant. A patient
with suspected BIA-ALCL should be referred to an appropriate specialist
for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and
representative portions of the capsule and send for pathology tests to
rule out BIA-ALCL. Diagnostic evaluation should include cytologic
evaluation of seroma fluid with Wright-Giemsaâ€“stained smears and cell
block immunohistochemistry testing for cluster of differentiation and
anaplastic lymphoma kinase markers.
- Develop an individualized treatment plan in coordination with the
patient's multidisciplinary care team. Consider current clinical practice
guidelines, such as those from the
Plastic Surgery Foundation or the National Comprehensive Cancer
Network (NCCN) when choosing your treatment approach.
- Report all confirmed cases of ALCL in women with breast implants to
the FDA's MedWatch
- Submit case reports of BIA-ALCL to the
PROFILE Registry to contribute to a better understanding of the
causes and treatments of BIA-ALCL.