Breast Implant Associated ALCL: The Facts About Your Risk

You may have heard on the news or through social media that breast implants have been linked to a rare form of cancer called Anaplastic Large Cell Lymphoma (ALCL). Patient health and safety is our utmost concern for our plastic surgeons and staff at The Swan Center, and this is important news that may concern many of our patients. However, sensationalized media headlines can lead to confusion about what actual risk breast implants carry for women. Let’s look at the facts in context.

What is Anaplastic Large Cell Lymphoma (ALCL)?

ALCL is not breast cancer. It is a type of non-Hodgkin’s lymphoma that affects cells in the immune system. It can occur anywhere in the body, and it occurs in women and men who have never had breast implants as well as those who do have implants. Breast implant associated ALCL, or BIA-ALCL refers to cases of ALCL that developed in patients after they received breast implants.

The FDA has been monitoring the possibility of an association between breast implants and ALCL since 2011, after a small number of cases were reported in women who had breast implants. Likewise, the Plastic Surgery Foundation (PSF), a research organization founded by the American Society of Plastic Surgeons, established PROFILE (Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma, Etiology and Epidemiology) registry in 2012 to track any possible link.

Since this time, the FDA and PSF have gathered enough data from clinical incidence reports and statements from health regulatory organizations to declare a statistically significant association between having breast implants and developing ALCL. In other words, the FDA does believe that women with breast implants have a higher chance of developing the disease than the general population. How high? Let’s look at the numbers.

Your lifetime risk of getting struck by lightning is 1 in 13,000, or 0.007%, nearly twice your risk of getting ALCL

What is my risk of getting BIA-ALCL after breast augmentation?

If you are among the millions of women in the United States who have breast implants, the risk of ALCL remains extremely low. A recent epidemiological study estimates a 33 in 1 million lifetime chance of developing ALCL if you have textured breast implants—that’s a .003% chance. (Your lifetime risk of getting struck by lightning is 1 in 13,000, or 0.007%, nearly twice your risk of getting ALCL). Data indicates the risk is even lower if you have smooth breast implants. More facts:

• Since 2010, 660 total medical device reports (which are different from confirmed cases) of BIA-ALCL related adverse events have been made to the FDA, including 9 deaths. Nearly 300,000 women get breast implants every year in the U.S., and an estimated 11 million women worldwide have breast implants.
• As of September 2018, the FDA estimates 457 unique cases of BIA-ALCL in the US have been reported to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE) database, which is maintained jointly by the American Society of Plastic Surgeons, the Plastic Surgery Foundation, and the FDA.
• There is no apparent difference in the risk of developing ALCL for silicone implants than for saline
• There appears to be a higher risk associated with textured implants vs. smooth implants.
• On July 24, 2019, the FDA requested that Allergan voluntarily recall BIOCELL textured implants, which have been shown to be closely linked to confirmed cases of BIA-ALCL. This includes: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants.

Is BIA-ALCL treatable?

The majority of breast implant-associated ALCL are treated by removing the patient’s breast implants, as well as the surrounding scar tissue, or capsule. Chemotherapy and/or radiation has been used in some cases. According to the MD Anderson Cancer Center and Plastic Surgery Foundation, most patients who receive appropriate treatment for ALCL have a good prognosis, with implant removal surgery fully treating the disease in most cases.

There is no need to abandon your plans to get breast implants if you would like to enhance your breasts, or if you are facing breast reconstruction. The overall risk for complications after breast augmentation remains very low when performed by an experienced, board certified plastic surgeon.

What to do if you have breast implants

Neither the FDA nor the medical community recommends that patients have their breast implants removed if they are not experiencing any problems. In fact, the normal risk of complications from undergoing a second surgery to remove implants, while very low when performed by a qualified plastic surgeon, are likely greater than your risk for developing ALCL.

The best thing to do is to continue with routine recommended screenings, including mammograms (if applicable) and MRI if you have silicone implants.

Do see your plastic surgeon as soon as possible if you are experiencing any of the following, as these are potential symptoms of BIA-ALCL:

• You develop persistent pain in one or both breasts
• You notice swelling in one or both breasts later than 6 months after surgery, when normal post-op swelling should have subsided

Additionally, you should contact your plastic surgeon if ever you have a concern or question about your breast implants.

If you have been considering breast augmentation…

There is no need to abandon your plans to get breast implants if you would like to enhance your breasts, or if you are facing breast reconstruction. All surgery carries some risk, and the overall risk for complications after breast augmentation remains very low when performed by an experienced, board certified plastic surgeon.

In its statement, the FDA recommends that patients educate themselves about breast implants before having surgery—we have always encouraged our patients to research their options and learn about the benefits and potential drawbacks of each implant type. In fact, we spend a considerable amount of time with each patient discussing implant options.

Given the current information we have about BIA-ALCL, it is reasonable to consider smooth implants if you are concerned about further reducing the small risk of developing the disease.

Please don’t hesitate to contact us

If you have questions or concerns about the news regarding BIA-ALCL or any other issue related to plastic surgery, our board certified plastic surgeon and staff at The Swan Center will be happy to assist you. Please call our office at 770-667-0904 during office hours or contact us online anytime.

Article updated with new FDA report numbers on February 12, 2019.