Worried About Breast Implant Associated ALCL? Here’s What You Need to Know

In 2016, the World Health Organization, and subsequently the FDA, officially linked certain breast implants to a very rare form of cancer called breast implant associated anaplastic large cell lymphoma, or BIA-ALCL. Since then, public health officials and plastic surgeons have been conducting research and learning more about the disease and its risk factors.

Media coverage of BIA-ALCL has also increased, leading many women who have breast implants or who are considering breast augmentation to wonder if breast implants are safe. To help you answer this question for yourself, I want to share data from peer-reviewed studies and clarify the known risks, as well as clear up some common misconceptions.

BIA-ALCL is not the same as breast cancer

BIA-ALCL is a type of non-Hodgkin’s lymphoma, or cancer of immune cells. It is not breast cancer. Anaplastic large cell lymphoma (ALCL) is a family of diseases, and different forms of ALCL can actually occur in various locations throughout the body, not just the breasts. Every year, about 1,400 men and women without breast implants are diagnosed with some form of ALCL.

BIA-ALCL is a specific incidence of ALCL that develops in the scar tissue (capsule) surrounding breast implants. It is rare, not aggressive, and almost always fully treatable with surgery.

Your risk of developing BIA-ALCL if you have breast implants is very low

As of July 2019, 573 unique cases of BIA-ALCL have been reported to the FDA, including 33 deaths worldwide. To put this in perspective, consider that right now millions of women in the U.S., and many millions more worldwide, have breast implants. Each year, about 300,000 women undergo breast augmentation in the U.S, and about 100,000 undergo breast reconstruction (although not all reconstructions involve implants, many do).

Textured implants have the strongest association with BIA-ALCL

Based on the data we have, we know the risk of BIA-ALCL is significantly higher if you have textured breast implants, or you have had them in the past. Of the 660 MDRs received by the FDA, 425 involved textured implants, 39 involved smooth implants (although many of these women had previously had textured implants), and 196 were not specified. Currently, the lifetime risk is estimated to be between 1 in 3,817 (0.026%) and 1 in 30,000 (0.0033%) if you have had textured implants.

The brand of textured implant appears to matter too. According to a 2017 study published in Aesthetic Surgery Journal, textured implants made using the salt-loss texturing process, such as Allergan’s Biocell textured implants, have the strongest association with BIA-ALCL: 1 in 3705, compared with 1 in 60,631 for Mentor Siltex implants, and 1 in 200,000 for Sientra textured implants.

Common symptoms of BIA-ALCL are breast pain, swelling, and seroma

BIA-ALCL typically presents as breast pain, swelling, and/or seroma (fluid accumulation), usually several years after breast augmentation or reconstruction surgery. In most cases, patients will experience these symptoms in the early stages of the disease, when it is fully treatable. Pain and seroma are not always BIA-ALCL, but you need to have them checked to rule out the possibility. If BIA-ALCL is diagnosed or suspected, your surgeon may recommend having your breast implants removed.

BIA-ALCL is a specific incidence of ALCL that develops in the scar tissue (capsule) surrounding breast implants. It is not aggressive, it is rare, and it is almost always fully treatable with surgery.

If detected early, BIA-ALCL is treatable with breast implant removal and capsulectomy

Early stage BIA-ALCL is almost always confined to the capsule tissue and fluid immediately surrounding the breast implant and treated by removing the breast implants and capsules. The ideal procedure in this case is a complete or total capsulectomy, which involves first removing the breast implant from the capsule and then removing the capsule from the breast cavity. This technique helps to ensure that all BIA-ALCL cells are removed from the body without requiring an overly large incision.

In a small number of cases, a secondary therapy such as radiation or chemotherapy is needed to fully eliminate the BIA-ALCL; however, for the vast majority of patients, capsulectomy and implant removal alone cures the disease.

Keep in mind that of the 457 confirmed cases of BIA-ALCL in the U.S., 9 women have died from the disease. Worldwide, there have been 17 confirmed deaths over the entire time authorities have been aware of the disease (circa 2011). In all cases, the patient received a late diagnosis. Importantly, none of these patients ever received a complete surgical excision of the breast implant and capsule.

If you are not experiencing any problems, there is no need to have your breast implants removed

Given the low risk of BIA-ALCL, as well as the fact that BIA-ALCL has so far only been found in patients who were experiencing symptoms, it is not recommended that patients who are asymptomatic have their implants removed prophylactically (i.e., as a preventative measure). Nor is there a need to have textured implants exchanged for smooth implants.

If you are happy with your implants and have no symptoms, I recommend that you simply:

• Continue with follow-up care as recommended by the FDA and your plastic surgeon. For most patients, this means a visit to your plastic surgeon every couple of years, as well as routine imaging (ultrasound or MRI) if you have silicone filled implants.

• Participate in routine mammography and self breast exams as recommended by your doctor.

• Get to know your breasts and consult your doctor about any changes, particularly unexplained changes in breast shape, size, or firmness and/or pain.

That said, if at any point you want to have your breast implants removed, whether for aesthetic preference, a change in lifestyle, or concern over BIA-ALCL or another issue, I encourage you to consult with a board certified plastic surgeon about your options for breast implant removal. While there is no need to remove breast implants you are happy with, there is also no reason to keep breast implants that you no longer want.

If you still have questions about BIA-ALCL, please reach out

I do hope reading this has helped you better understand BIA-ALCL. If you have any more questions, or you are considering your options for breast implant removal in Richmond, I welcome you to contact my office by phone at 804-355-3410—or fill out the contact form here. My staff and I will be happy to help you get the answers you need.