Anaplastic large cell lymphoma (ALCL) is a rare type of lymphoma, or cancer of the immune cells. ALCL is considered a “blood cancer” and is not breast cancer. Breast implant-associated ALCL is a distinct type of ALCL involving the capsule or fluid surrounding a breast implant.

The American Society of Plastic Surgeons (ASPS), ASERF and Food and Drug Administration (FDA) have not found a specific factor which causes BIA-ALCL. Implant texturing, bacteriologic contamination and genetic factors have been implicated and are undergoing further study. Bacteria that cause inflammation have been found in areas surrounding the affected breast, which could contribute to disease.

Most people are diagnosed when they seek medical treatment for implant-related symptoms such as pain, lumps, swelling, fluid collection, or asymmetry that developed after their initial surgical sites were fully healed.  In reported cases, BIA-ALCL was diagnosed as long as 32 years after (and on average, eight years) following the implant surgery. 

If you develop swelling in the breast area surrounding the implant, you should undergo an ultrasound scan. Mammograms are not useful in diagnosing BIA-ALCL.

There are an estimated 10-11 million women worldwide with breast implants. While total numbers vary in the scientific literature, there have been 100-250 known cases of ALCL in women with breast implants worldwide. Fewer than 10 patients are diagnosed per year with this disease. The only study demonstrating an association between breast implants and BIA-ALCL estimated an incidence of 1 in 300,000.

According to the Food and Drug Administration (FDA), the association of ALCL and breast implants is roughly the same for women receiving implants for aesthetic cosmetic purposes and for reconstructive purposes. The association appears to be the same for saline, silicone and polyurethane implants. However all known cases of breast implant-associated ALCL have involved textured implants, rather than smooth implants.

Evidence suggests that textured implants can cause more inflammation compared to smooth implants and increase risk of BIA-ALCL. Penn State physicians have observed a connection between textured implants and occurrence of BIA- ALCL and have discontinued use of textured implants for safety of our patients. It is best to talk to your physician about known risks and potential complications associated with the type of implants used. 

If you have not experienced any symptoms or changes in breast associated with BIA-ALCL then you do not need more than routine check-ups.  If you experience a change in her breasts – especially if there is swelling or a lump – you should undergo examination and appropriate imaging, including ultrasound and fine needle aspiration of any fluid surrounding the implant.

There is no current recommendation for additional screening or removal of implants for women with no symptoms. From what is known about this association between implants and ALCL, the FDA recommends women do not change their routine medical care and follow-up. Contact your plastic surgeon if you notice swelling, fluid collection or unexpected changes in breast shape. Have regular imaging evaluations as recommended by your provider, including mammograms and, if you have silicone implants, periodic MRI to detect ruptures. The FDA and the Institute of Medicine maintain that breast implants do not impair breast health or cause breast cancer, and scientific evidence continues to support that FDA-approved breast implants have a reasonable assurance of safety and effectiveness.

When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant separating it from the rest of the breast. Treatment of breast implant-associated ALCL for most patients is removal of the implants and any mass associated with the capsule that held the implants. In all but a few cases, the disease has been fully resolved by this surgery alone. The majority of patients require no additional treatment.

This form of ALCL tends to progress slowly and cause few symptoms. The majority of patients may be adequately treated with removal of both the implant and the capsule. As with other forms of lymphoma, however, breast implant-associated ALCL can be aggressive, and some cases reported included disease spread to the lymph nodes and death.

Additional information and resources on BIA-ALCL are available online at www.plasticsurgery.org/alcl and by searching "ALCL" on RADAR.

The information in this document reflects the latest understanding and recommendations available on the topic from the FDA, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery and was compiled from resources available at the links below.

• U.S. Food & Drug Administration
• The American Society of Plastic Surgeons
• The American Society for Aesthetic Plastic Surgery