What is Anaplastic Large Cell Lymphoma (BIA-ALCL)?
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL) – a rare type of non-Hodgkin’s lymphoma.
At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk. In a report summarising the Agency’s findings, the FDA emphasised the need to gather additional information to better characterise ALCL in women with breast implants.
Since then, the FDA has strengthened their understanding of this condition and agree with the World Health Organisation’s designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following a breast implant procedure.
At this time, most data suggests that BIA-ALCL occurs more frequently following the implantation of breast implants with textured surfaces rather than those with smooth surfaces.
FDA Announcement
BIA-ALCL is a rare condition and has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.
You can read more about a summary of Medical Device Reports and medical literature, as well as recommendations for patient care here.
All health care providers with patients who have breast implants should continue to provide them with routine care and support. Generally, BIA-ALCL has 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 abnormalities is not recommended.
Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants.
For those thinking of getting breast implants, make sure you talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants. Make sure this is something you want to do, be aware of all of the associated risks with getting breast implants, and most importantly, do your research!
The FDA is encouraging all health care professionals and patients to report all confirmed cases of ALCL in women with breast implants to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online or call 1-800-332-1088.
Read the full FDA alert here.
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