BIA-ALCL: Breast Implant Safety Update

ROCHESTER, N.Y., July 26, 2019 /PRNewswire-PRWeb/ -- Yesterday, the U.S. Food and Drug Administration (FDA) announced a voluntary global recall of Allergan's BIOCELL® textured breast implants due to its risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of immune system cell cancer.

It's important to note that at this time the FDA does not recommend removal of these or other types of breast implants in patients who have no symptoms due to the low risk of developing BIA-ALCL.

This recall does not affect Allergan's NATRELLE® smooth or MICROCELL® breast implants.

What is BIA-ALCL?

BIA-ALCL is a rare and highly treatable type of non-Hodgkin's lymphoma that can develop around breast implants; it is not breast cancer. When diagnosed early and treated properly, this disease is curable.

The current lifetime risk of BIA-ALCL is estimated to be one in 3,817 to one in 30,000 women with textured implants based upon current confirmed cases and textured implant sales data over the past two decades. As of February 6, 2019, there have been 660 cases of BIA-ALCL reported worldwide and 21 known deaths worldwide.

"The risk of contracting BIA-ALCL is very low, so unless there are symptoms such as a sudden swelling of the breast years after surgery, women do not need to have their implants removed. However, we recommend all women get their implants checked regularly by their surgeon," says Dr. William J. Koenig, board-certified plastic surgeon at the Quatela Center for Plastic Surgery.

What are the symptoms of BIA-ALCL?

BIA-ALCL usually presents with persistent swelling of the breast and less commonly a lump under the breast. It's important to note that breast swelling is a common symptom immediately after breast augmentation, however BIA-ALCL most commonly develops several years after the procedure.

If you notice any change in the size or shape of your breast, always make an appointment with your plastic surgeon for an exam.

Textured vs smooth breast implants and BIA-ALCL

BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. Textured breast implants account for only 10% of all breast implants sold in the U.S., according to the FDA. Specifically, macro-textured implants (BIOCELL® implant) represent less than 5% of all breast implants sold in the United States.

To date, there have not been any confirmed BIA-ALCL cases that involve only a smooth implant. Patients of the Quatela Center for Plastic Surgery can be assured that Dr. Koenig routinely uses smooth implants and of his 5,000 breast augmentation cases, he has used BIOCELL® textured implants less than five times.

"The safety of our patients is always our number-one priority and we will continue to communicate any safety concerns for our patients," says Dr. Koenig.

Key facts of BIA-ALCL

• In 2011, the FDA first identified a possible association between breast implants and the development of BIA-ALCL.
• BIA-ALCL is an extremely rare form of non-Hodgkin's lymphoma; it is not breast cancer.
• BIA-ALCL has not been associated with the use of smooth implants.
• The current lifetime risk of BIA-ALCL is estimated to be 1:3817 - 1:30,000 women with textured implants.
• Dr. Koenig routinely uses smooth implants; he has used BIOCELL® implants less than five times in his 5,000+ breast implant procedures.
• Asymptomatic patients should not have their implants removed.

For more information:
https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
https://www.plasticsurgery.org/patient-safety/bia-alcl-summary

SOURCE Quatela Center for Plastic Surgery