Allergan Breast Implant Recall

You may have been alarmed to hear the news about the Allergan breast implant recall. It is important that you understand what occurred.

The FDA requested that breast implant manufacturer Allergen voluntarily recall specific styles of breast implants, as these styles have been linked with an increase in cases of a very rare cancer called BIA-ALCL, or “breast implant associated anaplastic large cell lymphoma.”

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What is BIA-ALCL

BIA-ALCL is not a cancer of the breast tissue, but a form of non-Hodgkin’s lymphoma, an immune system cancer. It develops in the scar tissue surrounding certain breast implants, and in the fluid around the implant. The risk of developing BIA-ALCL is very low. These implants are not common in the USA, with only five percent of women having them placed in an augmentation.

Which Allergan implants were recalled?

Only certain styles of Allergan products have been recalled. The recalled styles are BIOCELL macro-textured implants and tissue expanders.

The macro-textured versions of these products have a unique shell surface produced only by Allergan. The recalled versions include:

Natrelle saline-filled implants, BIOCELL
Natrelle silicone-filled implants, BIOCELL
Natrelle highly-cohesive, anatomically shaped silicone implants
Natrelle Plus tissue expander, BIOCELL
Natrelle tissue expander with suture tabs, BIOCELL

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What are the symptoms of BIA-ALCL?

The symptoms of BIA-ALCL include:

Fluid buildup around the implant
Swelling
Pain
Lumps in breast or armpit
Capsular contracture
Rash on breast

How is BIA-ALCL Treated?

Thankfully, if caught in the early stages, removing the implants and scar tissue is all that is needed to treat BIA-ALCL. It is essential that any woman with breast implants stays aware of any changes, but in the case of the BIOCELL macro-textured implants, being alert to changes in your breasts is even more important. If the condition is caught later, the treatment may call for surgery, chemotherapy, and radiation.

The first step in treatment is to determine if you have the condition at all. The fluid that has collected around the implant will be extracted by needle, and tested for CD30, a marker of BIA-ALCL.

If found, surgery will be performed to remove the breast implant and the scar tissue surrounding it, which is typically all that is needed to resolve the condition, when caught early.

New implants cannot be placed for at least three months. 93 percent of women found to have BIA-ALCL have been found to be disease-free after three years.

How long after breast augmentation can you develop BIA-ALCL?

Most cases of BIA-ALCL developed many years after breast augmentation surgery. The disease was found to develop near the breast implant, within the scar tissue, not in the breast tissue itself. It develops two to twenty-eight years after breast augmentation surgery.

Are smooth-shell breast implants safe?

BIA-ALCL has only been found to develop in women with macro-textured breast implants or tissue expanders. The disease has not been associated with smooth-shell implants from Allergan or other manufacturers.

Should I have my implants removed?

The FDA advises that women who have recalled implants do not have them removed unless they are experiencing symptoms, and the disease confirmed. If you have any of the symptoms of BIA-ALCL, a test can be performed to determine whether the disease is developing. It is performed by extracting fluid from around your breast and sending it to be evaluated for the markers of BIA-ALCL.

Am I at risk of developing BIA-ALCL?

BIA-ALCL appears to develop strictly in cases in which macro-textured implants or tissue expanders were placed. If you have standard implants, or even textured implants from a different manufacturer, you are probably not at risk. The only implants recalled were manufactured by Allergan, those with the BIOCELL macro-textured shells.

What does the surgery entail?

The surgery to remove macro-textured implants is more extensive than just removing the implant. If you are not experiencing any symptoms, you have no need to undergo this surgery, although it is a personal decision. The surgery involves removing the implant, along with the scar tissue around it.

Why were the BIOCELL products recalled?

The BIOCELL line of products is macro-textured, with a rougher surface than other styles and brands. It is theorized that the surface of the implants or tissue expanders creates ongoing inflammation, which eventually develops into BIA-ALCL, but until further research is conducted, the cause is not yet known.

The women who developed the disease may have had other health factors that contributed to developing BIA-ALCL. The BIOCELL implants from Allergan were recalled in excess of caution, and the risk of developing the disease remains very low.

How can we help?

Dr. Neil Tanna, our double board-certified plastic surgeon, has an extraordinary level of education and experience, and is dedicated to his patients. If you have concerns about BIA-ALCL, it is important that you have accurate facts. Most women have nothing to worry about, but it is always important to be alert to changes in your breasts, whether you have implants or just natural breast tissue. If you are considering replacing your implants or removing them altogether, we are available to discuss your options.