Breast Implant Recall

On July 24, 2019, the FDA, The U.S. Food and Drug Administration, took significant action to protect women from Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) by requesting a voluntary breast implant recall of certain textured breast implants from the U.S. market due to the risk of BIA-ALCL.

As a breast implant specialist, Dr. Matthew Galumbeck, a board certified Plastic Surgeon, wants to give you the most up to date information regarding this breast implant recall.

Below are some frequently asked questions about the textured breast implant recall.

WHAT IS BIA-ALCL AND WHY IS THERE A VOLUNTARY BREAST IMPLANT RECALL?
The FDA first identified the relationship between BIA-ALCL and breast implants in 2011. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a cancer of the immune system. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant and can spread throughout the body. Although rare, this cancer is serious and can lead to death, especially if not treated promptly. In most patients, it is treated successfully with surgery to remove the implant and surrounding scar tissue. Adjuvant treatment may include chemotherapy and radiation therapy. The FDA has instituted this recall because of the increased risk of developing cancer with textured implants

 

WHAT ARE THE RISK FACTORS FOR BIA-ALCL?
BIA-ALCL seems to develop exclusively in women who currently have or used to have textured breast implants, rather than smooth implants. All manufacturers of textured implants including Allergan, Mentor and Sientra reported cases of BIA-ALCL in women using their textured implants.

WHAT ARE THE CHANCES OF GETTING BIA-ALCL?
Depending on the study, BIA-ALCL occurs in 1:3800 to 1:30,000 women with textured breast implants.

WHERE IN THE BREAST HAS BIA-ALCL BEEN FOUND?
BIA-ALCL is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. The illustration to the right shows the location of the BIA-ALCL in these reports. In most cases, the BIA-ALCL cells were found in the fluid surrounding the implant (seroma).

breast-implant-recall-galumbeck-plastic-surgery

WHAT ARE THE SYMPTOMS OF BIA-ALCL?
Persistent swelling of the breast, breast pain or a breast mass are the usual presenting symptoms of BIA-ALCL.

HOW IS BIA-ALCL DIAGNOSED?
Your doctor will take a sample of the fluid around the breast implant as well as a tissue sample to look for evidence of this cancer.

DOES THE FILL OF THE IMPLANT INCREASE THE RISK OF BIA-ALCL?
Based on current data, neither silicone nor saline fill of the implants increase the risk of BIA-ALCL. Only the textured surface of the implant increases the risk of developing this cancer.

WHAT OPTIONS DO YOU HAVE?
Although rare, BIA-ALCL has prompted the FDA to impose a voluntary recall of certain textured breast implants.
If you or a loved one has any questions about your breast implants or your risk for BIA-ALCL, we would be happy to see you for an evaluation. Call 757-491-3204.

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