A rare cancer may be caused by breast implants according to a new FDA advisory. Suspicions of a link between BIA-ALCL (breast implant-acquired anaplastic large-cell lymphoma) and breast implants first arose in 2011. With additional data since 2011 and recognition by the World Health Organization (WHO) of the link, the FDA now agrees there is an increased risk of developing BIA-ALCL in women with breast implants.

The FDA confirmed the link after receiving 359 Adverse Event Reports of women with BIA-ALCL who also had breast implants. BIA-ALCL is a rare non-Hodgkin’s T-cell lymphoma, a cancer of the immune system that frequently encapsulates itself in the scar tissue around breast implants.

Over 300,000 women in the United States each year have breast implantation surgery either for breast augmentation or cancer reconstruction surgery. Breast implants have either a smooth or textured surface, and are filled with either silicone gel or saline.

Within the 359 Adverse Event Reports, 203 out of 231 women who commented on their breast implant surface had textured surface implants compared with only 28 women with smooth surface implants. The FDA believes the textured surface implants are more likely to cause problems but neither the FDA nor doctors know why they pose of a greater risk of developing BIA-ALCL.

Whether the implants were silicone gel or saline filled did not appear to be a significant risk factor.

Nine women have died since questions about a link first arose, but the FDA has no idea how many women may be at risk for the disease.

Recommendations to Women With Breast Implants

The FDA cautions that women with breast implants do not need to change their regular medical routine but should regularly monitor their implants for signs of the disease and be aware of their increased risk for this rare cancer.

The FDA does not recommend removing breast implants as a precaution since the cancer risk is very rare, unless there are signs of pain, lumps, asymmetry or swelling. If any of these symptoms occur, contact your doctor immediately.

The WHO reported in 2016 the cancer appears on average of 10 years after implantation. The cancer typically stays around the implant site although there are instances where the cancer broke off and spread.

Good news for BIA-ALCL patients is that the cancer is treatable, and usually not fatal, if caught early. Most cases are treated with surgical removal of the capsule and implants, although chemotherapy and radiation may be necessary depending on the extent of the disease.

Women should continue to receive regular mammograms and ask for a mammogram technician specifically trained to give mammograms to women with breast implants.

The FDA also recommends that women with silicone gel implants get periodic MRIs to confirm their implants are not leaking and there is no rupture. FDA guidelines recommend an MRI within the first 3 years after implantation, and every two years thereafter.

Before agreeing to any type of breast implant surgery, the FDA recommends researching on your own and discussing with your doctor the risks and benefits of breast implants including the risks of textured-surface versus smooth-surface breast implants.

Physician Recommendations

Although the disease is rare, the FDA recommends doctors consider the possibility of BIA-ALCL in patients with breast implants who have late-onset symptoms. Because the cancer risk is so low, the FDA recommends against removing breast implants in the absence of complaints of pain, lumps, asymmetry or swelling.

Read the full FDA Advisory here: