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Breast implant associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Posted July 29, 2019 in BIA-ALCL

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Breast implants (both saline and silicone) have been linked to the VERY RARE development of a form of cancer. This cancer is a Lymphoma and not a breast cancer.

To date, 573 cases of BIA-ALCL have been reported worldwide (around 300,000 cosmetic breast enhancement procedures were performed in just the US in 2018. This doesn’t include the breast reconstruction procedures that use breast implants which is likely at least the same number. Add in the implant cases performed worldwide and you can begin to understand the rarity)

To date, 100% of confirmed cases were associated with TEXTURED breast implants. A small number (around 30) of unconfirmed cases involve smooth implants and are still being investigated.

The greater the degree of texturing has been associated with the highest number of BIA-ALCL cases. More than 80% of documented cases are associated with Allergen’s BIOCELL implants, which are highly textured.

There have been 33 deaths associated with BIA-ALCL. Deaths are most commonly associated with improper treatment most likely due to missed diagnosis prior to the recognition of this cancer.

How do you know if you have it and what should you do?

Presentation is typically many years after implant placement and is seen as a late fluid collection around the implant. To the patient, this looks like the breast swelled up and can be tight and painful.

Most of these fluid collections are benign. Diagnosis is made by collecting a sample of this fluid and analyzing it for specific markers. If the fluid does not contain these markers, the patient does not have BIA-ALCL. If it is positive, imaging studies are done to assess extent of the disease.

Treatment, in most cases, is limited to the removal of the implant and the entire capsule (Scar surrounding the implant) as the majority of cases are confined to this capsule.

The is no recommendation by any agency (FDA) or medical body (AMA, ACS, ASPS, ASAPS)for preventative removal of textured implants.

North Dallas Plastic Surgery Patients

No textured implants have been used in this practice in more than 25 years. While we are fortunate in this fact in retrospect, the decision not to use textured breast implants was based on the surgeons’ clinical judgment, surgical goals and experience. There are many recognized indications for the use of textured implants.

Dr. Pollock would be happy to personally discuss this issue and answer any questions upon request

Update on new developments

The FDA has requested that Allergan recall all BIOCELL textured breast implants and tissue expanders

BIOCELL is a unique texturing to Allergan textured implants and has been associated with 84% (481/573) of BIA-ALCL  cases and 92% (12/13) of associated deaths which have been reported worldwide.

There is still no recommendation for patients without symptoms for preventative removal of these or any textured implants at this time.

References

FDA:

www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

American Society of plastic surgeons

www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources

American Society of Aesthetic Plastic Surgeons

https://www.surgery.org/sites/default/files/BIA-ALCL-FAQ.pdf

http://www.surgery.org/downloads/blasts/BIA-ALCL/

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