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Allergan, the makers of the BIOCELL line of breast implants, issued a voluntary recall for the Natrelle brand of textured implants and tissue expanders at the end of July 2019. While extremely rare, data has revealed an increased risk of developing BIA-ALCL (breast implant-associated anaplastic large cell lymphoma) in women with this brand of textured implants.

Which Allergan implants were recalled?

The only implants recalled by Allergan are their Natrelle textured implants, in both saline and silicone, as well as textured shell tissue expanders.

What are textured implants?

Textured implants are either silicone or saline, with a rough-textured shell, developed to keep the implants in place, and reduce the risk of capsular contracture, for which they have been effective. Textured implants more thoroughly adhere to the surrounding tissue, keeping them from rotating, which some surgeons felt was beneficial, particularly for teardrop-shaped or “anatomically-shaped†implants.

Textured implants vary in degree of texture on the silicone shell. The most extensive texture on a breast implant is called “macro-textured.†The recalled Allergan implants are the macro-textured versions.

How common are textured implants?

We have not used textured implants in many years.  Textured implants are not often used in breast augmentation in the United States. According to the FDA, textured implants make up only 10 percent of the implants in women in our country.  About half, or 5 percent, are the macro-textured variety.

Why were macro-textured implants recalled?

Over years of research, there has emerged that there is a heightened risk of developing BIA-ALCL in women with macro-textured implants. While the risk is still very low, the FDA requested a voluntary recall as a cautionary measure.

It has been theorized that textured implants may lead to a higher likelihood of developing BIA-ALCL due to the rougher texture creating an environment that allows the growth of bacteria, which can become trapped crevices of these implants, but this theory is not confirmed.

What is BIA-ALCL?

BIA-ALCL or breast implant-associated anaplastic large cell lymphoma is a rare form of non-Hodgkinâ€s lymphoma that is a cancer of the immune system, not the breast tissue. The risk of developing this cancer is estimated to be in the range of 1 in 3,000 to 1 in 30,000. BIA-ALCL develops slowly, and If caught early, it is very treatable.

What are the symptoms of BIA-ALCL?

Symptoms of BIA-ALCL are persistent pain, swelling, or a lump around the breast. If you experience any of these symptoms, get tested. BIA-ALCL is diagnosed by a physical exam, tests, and the evaluation of fluid that has collected around the implant.

What is the treatment for BIA-ALCL?

The treatment for BIA-ALCL is a removal of the implant and the surrounding scar tissue. The likelihood of a full recovery extremely high when it is identified early. The textured implant can then be replaced with a smooth version.

What should I do if I have Allergan recalled implants?

If you know your breast implants were the Allergan Natrelle brand but you have no symptoms of BIA-ALCL, the FDA advises against having them removed. Keep an eye on your breasts, and if you experience any changes, get your breasts evaluated by your surgeon. If you are experiencing any symptoms, get tested. The symptoms you have could be something else entirely.

Are other brands of textured implants recalled?

Manufacturers other than Allergan offer textured implants. The difference with the Allergan variety is the extent of the texture on the shell. The analysis by the FDA showed that the risk of developing BIA-ALCL is about six times higher with these implants. It is unknown if other manufacturers of textured implants will follow suit.

How can I protect myself in the future?

Breast implants are one of the safest devices used in surgery. They have been researched and tested continuously since the 1960s. If you are interested in learning more about breast implants and augmentation, Dr. Sullivan can help answer any questions and guide you in choosing the best implants and procedure type to attain your desired results.


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