For women considering breast implants after breast cancer surgery, trauma, injury, or breast augmentation simply for cosmetic reasons, the FDA wants you to be aware of an increased risk of a rare cancer associated with breast implants.
A link between the rare cancer, known as BIA-ALCL (breast implant-acquired anaplastic large-cell lymphoma), was first suspected in 2011. BIA-ALCL is a rare form of non-Hodgkin’s T-cell lymphoma, a cancer of the immune system. BIA-ALCL frequently grows in the scar tissue that develops around breast implants.
When the FDA first published its health advisory in 2017, women with breast implants who also developed BIA-ALCL had filed 359 Adverse Event Reports with the FDA reporting their cancer. Since its first advisory last year, the FDA has received an additional 55 reports of women with breast implants developing the disease.
Additional data and research by the World Health Organization (WHO) and the U. S. Food and Drug Administration (FDA) confirm there is an increased risk of developing BIA-ALCL with textured breast implants.
The reports and data suggest there is a lifetime risk of developing the rare lymphoma, and that textured breast implants present a higher risk, although it is unknown why the risk is greater than for women who have smooth surface implants.
Each year, almost 300,000 women in the United States have breast implantation surgery, and women can choose between smooth surface or textured implants, filled with either saline or gel. The material contained within the implant, whether saline or gel, does not appear at this time to present a significant risk factor.
The FDA is currently aware of nine women with breast implants who have died from BIA-ALCL but does not know how many more women with breast implants may be at risk for developing the disease.
FDA Recommendations if You Have Breast Implants
The number of women with breast implants who develop this rare lymphoma is very low compared to those who undergo breast implantation surgery but there are still things you should do to monitor your health and your implants for signs of the disease.
- Because the cancer risk is very low, the FDA does not recommend removing your breast implants simply as a precautionary measure.
- Contact your healthcare provider immediately if you develop pain, swelling, lumps, or notice asymmetry.
- Regular mammograms are important so continue with your yearly mammogram. You should also ask for a mammogram technician who is specifically trained to administer the diagnostic procedure on women with breast implants.
- If you have silicone implants, the FDA recommends you undergo an MRI within the first 3 years of your implantation surgery, and every two years following your first MRI, to ensure there is no rupture and your implants are not leaking silicone.
As always, the best advice is to discuss in detail the risks and benefits of breast implantation with your healthcare provider, and keep your provider informed of any changes in your health and your breast implants. The WHO found evidence of late-onset of this type of cancer, typically 10 years after implantation, which is why it is so important to continue to regularly monitor your health and the health of your implants.
The good news if you have breast implants is that the number of women who develop this rare cancer is very low, and the cancer is usually treatable, and typically not fatal, if caught early. Treatment of the disease usually involves removal of the implants and disease tissue. Radiation and chemotherapy are not always necessary but determined on a case-by-case basis.