In light of a 2019 recall over breast implants linked to cancer, those who have had or are considering having breast reconstruction or breast augmentation surgery may be concerned about which breast implants are safe.

At the urging of the U.S. Food and Drug Administration (FDA), Allergan in July 2019 recalled its Biocell and Natrelle textured breast implants. Several lawsuits have already been filed.  

What are textured breast implants?

Breast implants are often used in reconstructive surgery for patients who have undergone mastectomies, as well as in those who choose breast augmentation surgery for cosmetic reasons.

In addition to cup size, anyone undergoing breast implant surgery must choose between implants with a smooth outer shell or a textured one. Both types of implants can be filled with silicone gel or saline solution.

Textured breast implants have a sandpaper-like surface and are firm once the shell is filled. Some patients and doctors prefer textured implants for specific reasons, including a reduced risk of scarring. Textured breast implants are also less likely to shift position because they develop scar tissue that sticks to the implant, according to the American Society of Plastic Surgeons.

Even though some studies have shown that breast implants may be able to help prevent breast cancer, certain implant may actually increase the risk of cancer.

Which breast implants are linked to cancer?

Because of the large number of breast implants on the market, those who have undergone breast augmentation or breast reconstruction surgery may be concerned about which types of breast implants are linked to cancer.

Upon its review of various data, the FDA found that breast implants with textured surfaces produced by Allergan may be linked to cancer. Specifically, the textured implants raised concerns of an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While one might assume that BIA-ALCL is a breast cancer, it is not — it is actually a rare form of non-Hodgkin lymphoma.

Based on the FDA’s assessment of the available data, whether the textured implants are made with silicone or saline was not a risk factor for BIA-ALCL. The FDA also noted that there are safe alternatives to textured implants.   

Not to be confused with breast cancer, BIA-ALCL — the type of cancer linked to textured breast implants — is a rare form of lymphoma that attacks the immune system.

Unlike breast cancer which forms in the breast tissue, BIA-ALCL forms in the scar tissue capsule which develops around the breast implant. Usually, BIA-ALCL is found in the scar tissue and fluid close to the implant. However, it can in some cases spread throughout the body. While the risk of developing BIA-ALCL is low, it is a serious and potentially deadly disease.

While BIA-ALCL is treatable, there have been a small number of fatalities reported. Worldwide statistics as of January 2021 show that there have been 993 cases since the initial case report in 1997, according to the American Society of Plastic Surgeons. In the U.S., there have been 355 suspected and confirmed cases of BIA-ALCL, but this is an issue that has affected breast implant patients across the globe. BIA-ALCL has reportedly been linked to 36 known deaths worldwide.

What breast implants cancer symptoms should you watch for?

People who have textured breast implants do not need to have them removed, according to Terence M. Myckatyn, MD, professor of surgery in the Division of Plastic and Reconstructive Surgery at Washington University in St. Louis. Rather, they should be monitored annually and contact their doctors if certain symptoms arise.

There are a number of symptoms associated with BIA-ALCL. Dr. Myckatyn advises those with textured breast implants to call their doctor if they notice retention of excessive fluid surrounding the implant, breast hardening or lumps, armpit lumps, as well as any pain, asymmetry, or swelling. He noted that the symptoms of breast implants linked to cancer usually arise within seven to nine years following the surgery.

Has there been an FDA recall?

Of the reported cases of BIA-ALCL, Allergan BIOCELL implants were reportedly associated with 481 cases as of July 2019. In fact, of the 13 patient deaths at the time which had information about the implant manufacturer, 12 of the deaths were associated with Allergan breast implants. Based on these results, the FDA found that Allergan implants were associated with a significantly increased risk of BIA-ALCL.

“Based on the currently available information, including the newly submitted data, our analysis demonstrates that 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.,” the FDA noted. “[C]ontinued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”

Due to these risks, on July 24, 2019, the FDA requested that Allergan voluntarily issue a breast implant recall due to cancer concerns in connection with the company’s Biocell line of textured implant products. The FDA specifically requested that the pharmaceutical company recall various textured breast implants linked to cancer, including its Natrelle saline-filled and silicone-filled breast implants.

Allergan’s recall of Biocell and Natrelle textured breast implants included 246,381 products distributed between September 2014 and July 2019. In the recall notice, Allergan acknowledged that based on the FDA’s analysis, the company’s textured breast implants are associated with a higher risk of developing BIA-ALCL than those who have other types of textured implants.

Allergan’s breast implants linked to cancer is a Class I recall, indicating that exposure could result in severe health consequences or fatality.

In September 2022, the FDA announced a second type of cancer found in the scar capsule around breast implants – squamous cell carcinoma. This cancer is less common than BIA-ALCL amongst breast implant patients and has not yet resulted in a recall.

Can you file a breast implant cancer lawsuit? 

Those who have been diagnosed with breast implant cancer due to Allergan’s textured implants may have incurred significant medical costs, out-of-pocket expenses, and time lost from work. They may also have experienced emotional distress and other compensable non-economic damages.

Several people have already filed breast implant cancer lawsuits against Allergan, alleging that the company not only failed to warn about the risks associated with its textured breast implants, but that the breast implant manufacturer actively concealed information indicating there may have been a risk.

If you suffered physical, financial, or emotional harm resulting from breast implants linked to cancer, you may be able to file a breast implant cancer lawsuit or join a class action lawsuit to recover compensation for your damages. An attorney who handles cases related to medical device injuries can explain your legal rights and remedies.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.