Breast Implant Safety

Breast implants are among the most thoroughly researched and evaluated medical devices. Recently, breast implant manufacturer Allergan has issued a voluntary worldwide recall of its BIOCELL® textured breast implants and tissue expanders due to the increased risk of BIA-ALCL, or “breast implant associated anaplastic large cell lymphoma” a rare cancer.

What is BIA-ALCL?

BIA-ALCL is an immune system cancer that has been found to develop in some women who have textured breast implants. This is not a cancer of the breast tissue itself but develops in the scar tissue capsule around the implant.

How many women with textured implants have developed BIA-ALCL?

To date, 717 cases of BIA-ALCL have been reported in women with textured implants, leading to a worldwide recall of the implants by Allergan on July 24, 2019. Some other manufacturers produce textured implants and may also recall those implants, but the Allegan versions have the highest incidence of BIA-ALCL.

Should I have my textured implants removed?

Women with textured implants who are not experiencing any symptoms are not advised to have their breast implants replaced. Some women, for their own peace of mind, may take the step to have textured implants removed and replaced with smooth implants. If you have concerns about developing BIA-ALCL, testing is available.

What causes BIA-ALCL?

While the cause of the disease is not fully understood, it is believed that the cancer is likely linked to:

Textured implants placed in breast augmentation.
A genetic predisposition. To date, two published reports have revealed information that a genetic predisposition due to a gene mutation may increase the risk of developing BIA-ALCL.
Inflammation. Chronic inflammation in the capsule surrounding textured implants may be triggered by an allergic response, bacteria, or an unidentified factor.
Time after implant placement. BIA-ALCL typically appears several years after the implants were placed, an average of eight years following augmentation. Cases of BIA-ALCL have been found in women early as two years after implant placement, and as late as 28 years after augmentation.

What are the symptoms of BIA-ALCL?

The symptoms of this rare cancer include:

Unexplained breast enlargement or swelling
Asymmetry
Fluid buildup within the breast capsule
Lump in breast or armpit
Hardened breast
Skin rash on breast

You should be aware that after undergoing breast augmentation with smooth implants, it is normal to experience breast swelling and bruising, which fades in the weeks following surgery.

Can you get BIA-ALCL from smooth implants?

No confirmed cases of BIA-ALCL have been reported with smooth implants. Dr. Hamawy uses only smooth implants in his breast augmentations.

How is BIA-ALCL diagnosed?

If you have symptoms, such as unexplained breast swelling, you should call your physician and get tested. Testing involves an evaluation with ultrasound to check for fluid collection, a capsular mass or to identify the presence of lymph node swelling. A mammogram cannot identify BIA-ALCL. Should fluid be present, a sample is collected with a needle and then sent to a lab for testing for the markers of BIA-ALCL.

Does Princeton Plastic Surgery use textured implants?

Dr. Hamawy at Princeton Plastic Surgeons uses only smooth implants in breast augmentations.

Click to download Allergan's recall letter to patients

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Princeton Plastic Surgeons, based in the New Jersey area, boasts board-certified surgeons who specialize in procedures such as facelifts, breast lifts, breast augmentations, and tummy tucks.