A half dozen women have filed a breast implant cancer lawsuit alleging Allergan hid breast implant cancer risks for years.

What Are the Breast Implant Cancer Risks?

The cancer most often referred to as breast implant-associated cancer is not actually breast cancer. Instead, the disease is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare cancer of the immune system.

Despite being linked with breast implants, BIA-ALCL is not a breast cancer—in fact, it is a type of lymphoma cancer specifically associated with breast implants. BIA-ALCL is usually treatable when caught early, often originating in the scar tissue capsule that develops near the implant. Doctors generally recommend removing the implants and the scar tissue capsule.

Despite the fact that this disease is typically curable, it is still important to pay attention to symptoms and seek medical attention so that BIA-ALCL can be caught early on and treated.

The main symptoms of BIA-ALCL include:

• Persistent swelling in the implant area
• Presence of a mass or pain in the implant area

These symptoms may not appear right away—in fact, they may occur way after the surgical incision heals, even years after the implant placement.

Typically, treatment will include surgery to remove the implant and the affected scar tissue surrounding the implant. In some cases, patients may need to undergo additional chemotherapy and/or radiation therapy.

The FDA first became aware of a possible association between breasts implants and ALCL in 2011, and the connection has become clearer over time as more data have emerged. But Allergan may have known years earlier than that.

According to one proposed class action lawsuit, Allergan knew as far back as 2006 that its Biocell textured breast implants could cause an increased risk of the development of BIA-ALCL.

In July, the U.S. Food and Drug Administration (FDA) reported an update on worldwide medical reports received through January 5, 2020. New numbers show 733 unique cases of BIA-ALCL were reported to the FDA, and of those, 620 were reported regarding Allergan implants. At least 47 cases did not identify the breast implant manufacturer.

Of the 733 cases, 496 reportedly involved textured implants, but 209 cases did not name the surface type.

According to the American Society of Plastic Surgeons, women with textured breast implants are estimated to have a 1 in 2,207 to 1 in 86,029 risk of developing BIA-ALCL within their lifetimes. The reason for the extensive range of risk is that the numbers are based upon confirmed cases and the sales information of textured implants from the last 20 years. Very early reports of BIA-ALCL might not have been linked to breast implants at all.

Which Breast Implant Causes Cancer?

While no breast implants have been determined to definitively cause cancer, a number of highly textured breast implants have been associated with a higher risk of BIA-ALCL.

Several Allergan Natrelle Biocell textured products were subject to an FDA recall after the FDA found those with Allergan Biocell textured implants appeared to experience breast implant cancer risks 6 times that of women with other implants.

Did Allergan Hide Breast Implant Cancer Risks?

Allergan allegedly avoided sending reports of BIA-ALCL cases to the FDA’s Manufacturer and User Facility Device Experience database (MAUDE) by submitting spreadsheets through the FDA’s non-searchable Alternative Summary Reporting (ASR) Program.

While the public and physicians have access to the MAUDE database, not even physicians had access – nor were most aware of the existence of – the ASR Program. The ASR Program began in 1997 and granted exceptions to certain manufacturers that were allowed to satisfy FDA reporting mandates without making the issues with their medical devices known to doctors or the public. The FDA announced the end of the ASR Program in June 2019.

How Did the FDA Discover the Risks?

According to a report from AP News in November 2018, the FDA asked breast implant manufacturers in the summer of 2017 to review summary reports and resubmit data for every individual report of a breast implant complication. The FDA only took this step after a group of injured breast implant patients visited a lawyer who said he wasn’t able to find any reports on his clients anywhere in reports filed with the FDA.

After the revised reports were submitted, the FDA received more than 4,000 breast implant injury reports in the final months of 2017, plus an additional 8,000 breast implant injury reports in the first half of 2018.

Women report many of the complaints regarding breast implants involve the development of Breast Implant Illness (BII), which is marked by severe muscle and joint pain, weakness, brain fog and debilitating fatigue. The FDA recently suggested that any woman who is considering breast implants should be provided information about the risks of BII and of the more rare, but potentially deadly, BIA-ALCL.

Have Any Lawsuits Been Filed?

Yes, a group of six women has filed a proposed class action lawsuit against Allergan over allegations the breast implant cancer risks were not disclosed to them.

The plaintiffs allege that Allergan purposefully filed mass spreadsheets to the FDA’s Alternative Summary Reporting System in an effort to hide the alleged link between its breast implants and BIA-ALCL.

The Breast Implant Cancer Risks Lawsuit is Kosto et al. v. Allergan Inc., Case No. 2:19-cv-13512, in the U.S. District Court for the Eastern District of Michigan.

Where Can You Seek Legal Help?

If you or someone you love has developed a breast implant–related illness, especially BIA-ALCL, after getting textured breast implants, you may be able to file a lawsuit and pursue compensation. While filing a lawsuit cannot take away the pain and suffering caused by cancer, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Certain attorneys specialize in medical device issues. While filing a lawsuit may feel like an overwhelming task, you may seek a free case evaluation by a lawyer who works with Top Class Actions and knows Allergan’s background and history of other cases regarding BIA-ALCL. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.

Get a Free Case Evaluation

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