In February, the U.S. Food and Drug Administration (FDA) identified the potential that breast implants cause lymphoma. Specifically, the agency announced a correlation between breast implants and the development of an uncommon immune system cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

What Are the Risks of Breast Implants?

Breast implant augmentation is a plastic surgery in which implants are placed in the body – either under the breast tissue or the chest muscles – to enhance the breasts’ appearance. Although breast augmentations are fairly common, there are risks associated with the surgery and implants.

According to the Mayo Clinic, breast augmentation may lead to breast pain, infections, changes in sensation of the nipple or breast, along with implant issues. Implants may leak or rupture, causing complications and requiring removal or replacement.

Patients may also experience a complication known as capsular contracture. When the body heals after breast augmentation, a scar tissue capsule is formed around the implant. In some cases, this scar tissue capsule can become firm or misshapen – distorting the shape of the breast.

Any of these complications could require removal or replacement in order to manage the problem. Although these complications can be serious, implants are also associated with life-threatening cancer known as ALCL.

What is ALCL?

Anaplastic Large Cell Lymphoma is an immune system cancer that can develop anywhere in the body. However, WebMD notes that ALCL is most commonly found in the lymph nodes and skin.

BIA-ALCL specifically is found within the surrounding scar tissue near the breast implant rather than in the breast itself. It is not technically breast cancer—instead, it is a type of non-Hodgkin’s lymphoma (that is, cancer that targets the immune system). While this is typically a curable disease, it is important to catch early.

Symptoms of BIA ALCL may include breast pain, lumps in the breast or armpit, breast swelling, changes in breast appearance, fluid buildup, skin rashes, and a hardening of the breast. Although these symptoms are related to the cancer, they may also be caused by less serious conditions. A doctor can help patients determine if they are suffering from BIA ALCL or a more mild problem.

Without treatment, a BIA-ALCL diagnosis can be serious and even lead to death. Treatment typically involves surgery to remove the implant, as well as the scar tissue surrounding the implant. In some cases, patients may additionally require chemotherapy and/or radiation therapy.

So far, hundreds of cases of BIA-ALCL have been diagnosed. The breast implants most associated with lymphoma are textured implants.

What Does the FDA Say About Breast Implant Lymphoma Risk?

The first indication of the possibility that breast implants cause lymphoma was in 2011. However, after a recent review of reports, the FDA sent out a warning letter to health care providers, informing about the association between breast implants and BIA-ALCL. The agency noted that it had received reports that patients with breast implants face an increased risk of developing BIA-ALCL inside the scar capsule next to the implant.

Though reports of BIA-ALCL have included all types of breast implants, the FDA noted that most of the reported cases have involved those who received textured implants specifically.

According to the FDA, at least 457 people have been diagnosed with BIA-ALCL in the United States. Of these patients, nine have so far died as a result of their battle with cancer. Globally, 573 instances of BIA-ALCL have been reported, and 33 total deaths.

So: should people be worried about the risk that breast implants cause lymphoma? Right now, people with breast implants should be aware of the possible risk, and also be on the lookout for BIA-ALCL symptoms that may indicate a more serious problem. It is important to remember that BIA-ALCL typically takes many years after the placement of breast implants.

While the FDA notes that there is no definitive proof that breast implants cause lymphoma, the agency did warn patients to look out for swelling, lumps, or pain in the area of the implants, and in general to be aware of the possible risk.

The FDA and the American Society of Plastic Surgeons is working together to determine the actual risk of breast implant lymphoma.

“Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL,” the FDA’s safety announcement stated.

While the FDA has not recommended that patients have their implants removed unless they begin to exhibit BIA-ALCL symptoms, the agency has recommended that health care providers stop implanting Allergan breast implants in patients.

Which Breast Implants Are Affected?

A number of breast implant products may be linked with an increased risk of BIA-ALCL, especially textured breast implants. The FDA has received Medical Device Reports (MDRs) from BIA-ALCL and BIA-ALCL-related deaths linked with these textured implants.

Because of this risk, the FDA asked the pharmaceutical company Allergan to recall its BIOCELL textured breast implants. Allergan agreed to this request and has issued a voluntary recall for its BIOCELL implants from both the U.S. and the global markets.

This recall was later identified by the FDA as a Class I recall. Recalls in this category are considered to be the most serious of the recalls regulated by the agency. Typically, Class I recalls are associated with serious injuries or even death.

According to the FDA, the vast majority of BIA-ALCL cases were associated with Allergan breast implants (481 out of 573). The agency notes that, according to the information currently available, “the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.”

Have Textured Breast Implants Been Banned Elsewhere?

The FDA is in the process of investigating breast implant lymphoma, but in other countries around the world, the concern that breast implants cause lymphoma has already led to the banning of textured implants.

France banned certain textured breast implants because of this risk in April 2018, Canada has banned one type of textured implant, and other countries are reportedly considering following in their footsteps.

Should I Pursue Breast Implant Litigation?

If you have developed a breast implant-related illness after getting textured breast implants, especially if you have developed Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA ALCL), you may be able to participate in a class action lawsuit investigation.

Of course, filing a lawsuit cannot undo the pain and suffering caused by breast implant lymphoma, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, transportation costs, and more.

Pursuing litigation may seem overwhelming and complicated, especially in an emotionally difficult time like after a significant diagnosis, but Top Class Actions can connect you with an experienced medical device attorney. Consulting an attorney can help you determine if you have a claim, navigate litigation, and maximize your compensation.

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This article is not legal advice. It is presented
for informational purposes only.