Even though more than a full year has gone by since Allergan Natrelle implants were recalled due to a potential increased cancer risk, the breast implant maker admits that thousands of women may be unaware such risks exist.

AbbVie now owns Allergan, which said there’s no way to find the individual patients in the United States who received around 52,000 Natrelle textured breast implants because the company didn’t keep such device-tracking records, according to Fortune.com.

The company faced criticism for failing to make any real efforts to reach any of its customers to warn about the potential increased risk of cancer they may face due to the textured breast implants after the recall was initially announced in July 2019. Allergan launched a digital and social media ad campaign in mid-2020 to help reach patients with this information, more than 10 months since the recall announcement.

Natrelle Implants Overview

Natrelle breast implants are highly textured, but while the texture may help improve the stability of the implant within the breast tissue, patients who have received these implants throughout the world have seen an increased risk of breast implant-associated anaplastic large cell lymphoma, often referred to as BIA-ALCL, a rare kind of T-cell cancer of the immune system that tends to develop in or near the scar tissue capsule created by the textured breast implants, though it can spread and affect other areas of the body as well.

BIA-ALCL is a specific type of non-Hodgkin’s lymphoma cancer (or, cancer of the immune system) linked with breast implants. While BIA-ALCL is typically curable, it is imperative that it is caught and treated early on to reduce risk.

Researchers continue to try to determine why these textured implants may make a patient more apt to develop BIA-ALCL, but some theorize that the rough texture may induce a chronic inflammatory response in some patients. Other scientists wonder if bacteria become trapped in between the textured surface and the tissue, leading to a collection of microbes that cause chronic inflammation, which can in turn cause cancer.

Genetic mutations in JAK1 and STAT 3 genes also have been linked to an increased risk of a patient developing BIA-ALCL.

For the last decade, the U.S. Food and Drug Administration (FDA) has been aware of a possible connection between breast implants and the development of ALCL. However, at the time, the FDA was not aware of many cases of the disease, and with that lack of data it was impossible to determine the risk factors leading to the disease.

In the intervening years, the federal agency has been collecting information on BIA-ALCL to help determine the risk, and in 2016, the World Health Organization designated BIA-ALCL as a T-cell lymphoma that can develop after breast implants. Unfortunately, due to limitations in global reporting and the lack of sales data in the global breast implant market, the exact number of cases remains difficult to determine.

What Are Natrelle Implants Made From?

Allergan’s Natrelle textured breast implants consist of an outer casing or shell made of silicone elastomer because of the material’s ability to stretch, much like rubber. The implants are available as prefilled with silicone or saline solution. Some of the implants may be filled with saline solution after they are inserted and placed in the right position.

Implants are available with either a smooth or textured surface. Some women like the smooth implants because the implant moves more easily under the skin, much like actual breast tissue. However, textured implants are more apt to stay in place because tissue adheres better to the rough surface.

Allergan also offered Natrelle 133 Tissue Expanders with a textured silicone casing. Tissue expanders are filled with saline solution a little bit at a time over the course of weeks or months in order to stretch the patient’s skin and muscle. This allows the patient’s body to have the skin and tissue needed to cover the extent of the final implant.

How Long Do Natrelle Implants Last?

According to Allergan’s website, “Breast implants are not lifetime devices, and not necessarily a one-time surgery.”

Indeed, the average breast implants will last between 10 and 20 years. However, Healthline reports that up to 20 percent of patients experience either complications or cosmetic issues that compel them to seek surgical removal or replacement within eight to 10 years.

Why Was a Natrelle Inspira Implant Recall Made?

In July 2019, Allergan ordered a recall of its textured Natrelle Inspira breast implants after the FDA determined 481 cases of a certain type of non-Hodgkin’s lymphoma were associated with them.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) was diagnosed in 573 patients around the world. Thirty-three of those cases of cancer resulted in the deaths of the patients. According to WebMD, the manufacturer of the implants in the patients who died was known in 13 of the deaths, and 12 of them had Allergan breast implants.

Is There a Link Between Natrelle Implants and Cancer?

According to the FDA, “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’s statement goes on to say that the agency believes that pulling the implants from the market would likely ensure patients avoid serious health consequences and perhaps even death from BIA-ALCL.

So how did the FDA discover the potential risks associated with textured breast implants? According to a report from AP News in late 2018, the federal agency asked Allergan and other breast implant manufacturers back in the summer of 2017 to review summary reports and data for any breast implant complications associated with their products.

Despite origins near the breast, BIA-ALCL is not a type of breast cancer, but instead, is a rare cancer of the immune system.

After breast implant surgery, the breast tissue heals around the implant by developing scar tissue with an associated fluid pocket called a scar capsule. BIA-ALCL is most often found in the scar tissue and the fluid within the scar capsule, but the disease may spread to other parts of the body, and in these cases, can become life-threatening.

When caught early, BIA-ALCL can be successfully treated with the removal of the implant, scar tissue and scar capsule. Sometimes, patients also require additional chemotherapy treatment, radiation therapy, or a combination of both.

The FDA has warned patients with breast implants, especially textured breast implants, to be on the lookout for symptoms.

There are a number of potential symptoms that have been associated with BIA-ALCL. Swelling and pain due to fluid accumulation around the breast implant or the development of a lump next to the implant or in the lymph node in the armpit may indicate the onset of BIA-ALCL. Symptoms less commonly reported include skin rash, weight loss and a fever.

Although BIA-ALCL most often develops between seven and 10 years after the textured implant has been placed, some patients have reported symptoms earlier.

“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,” said the FDA in a safety announcement.

While the FDA and Allergan asked plastic surgeons to stop using the Natrelle breast implants, the FDA has noted that for patients with these implants that have not experienced symptoms, “removal of these or other types of breast implants is not recommended, due to the low risk of developing BIA-ALCL.”

Should You File a Natrelle Implant Lawsuit?

Both individual and class action lawsuits have been filed against Allergan by patients who say they were not adequately warned their Natrelle textured breast implants could increase their risk of developing BIA-ALCL.

Patients who have developed BIA-ALCL and those who have not been diagnosed with the rare cancer have filed suit.

If you or someone you love have received Natrelle breast implants, you may wish to speak with an attorney regarding your legal options.

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