Allergan Knew Of Breast Implant Cancer Risks Since 1990s, Lawsuit Claims

  • Written by: Irvin Jackson

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According to allegations raised in a product liability lawsuit filed against Allergan, the manufacturer has known that side effects of its breast implants could cause cancer since at least the 1990s, yet continued to sell textured designs that have been associated with the development of anaplastic large cell lymphoma (ALCL) .

The complaint (PDF) was filed by Carol Burnside in the U.S. District Court for the District of Colorado on April 10, naming Allergan and Inamed Corporation as defendants.

Burnside indicates that she underwent a double mastectomy in 2004, after being diagnosed with precancerous lesions. A year later she underwent breast reconstructive surgery with breast implants. However, one of those appeared to have ruptured, and she was implanted with Allergan’s McGhan style 410 implants.

For several years after, she experienced swelling and pain in her left breast, which lead to explant surgery in April 2017. That time it was discovered that cancer had developed in the tissue surrounding the implant and she was diagnosed with a rare form of cancer now commonly referred to as breast implant-associated lymphoma (BIA-ALCL).

Breast Implant Lymphoma Warnings

The FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and anaplastic large-cell lymphoma (ALCL) in January 2011.

In 2017, the agency issued an updated statement about emerging information on the breast implant lymphoma problems, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real.

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of the risks.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer. As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.

However, the lawsuit indicates that the first cases of BIA-ALCL were reported as far back as 1994. The lawsuit claims Allergan knew this information and withheld it from consumers and the medical community to protect its profits.

“Despite Defendants’ knowledge of an association between breast implants and ALCL dating back to the 1990’s, Defendants purposefully failed to comply with their clearly-established post-market surveillance obligations and in doing so have exposed many hundreds of thousands of women to life-altering and avoidable cancer,” Burnside’s lawsuit states. “At the time the McGhan Breast Implants were placed into Carol Burnside’s body, she was not advised, nor did she have any independent knowledge, that the McGhan Breast Implants were anything other than safe, life-long products. Nor was she advised that the product was associated and/or known to cause BIA-ALCL.”

Last month, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.

Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.

As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, other women are also raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.

Product liability lawyers in the U.S. are now reviewing other potential breast implant cancer lawsuits against Allergan and other manufacturers, for women diagnosed with the ALCL in recent years.

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  1. Jessie Reply

    I have suffered tremendously from this misinformation and still working towards better health. But now more than ever I’m fighting for the other women who can’t because they are too sick to fight for themselves!! The difficulty we are facing to get diagnosis is just a small part of the problem. The biggest problem is that we are robbed of our time and lives with no discipline for the Manufacturer’s and Physician’s that failed to do right by thousands of consumers. I won’t stop until they can prove us wrong. So far they haven’t been able to!!!!

  2. Tammy Reply

    What if you have had to quit work from autoimmune but are having breast pain and have allergen silicone smooth and do not have insurance to find out if it is cancer. I have an antibody that shows up with cancer

  3. Stephanie Reply

    I had my Allergan 410 implants removed last month after learning about the ALCL risk. It makes me mad that I had these put in after having breast cancer, then had to undergo another surgery to avoid cancer.

  4. Colette Reply

    I have been diagnosed with BIA ALCL CD30 ALK negative. I start chemo next week with possible radiation afterwards because it has spread to my chest wall and clavical all on my right side. I’m a single parent with a 14 year old son. I’m also holding a full time job down as I go thru all of this. This has turned my life and my sons life upside down . Our voices need to be heard. Women need to know what to look for. Doctors need to be informed so they know who to send their patient to for proper diagnosis. The band aid must be pulled away to reveal this horrible disease.

  5. Rachael Reply

    I’m in the UK and also contracted ALCL from Allergan implants that were put in after cancer during reconstruction. Struggling working full time now and no help from nowhere. Allergan should be ashamed and compensate these unfortunate woman.

  6. christina Reply

    I had to remove my breast implants due to capsular contraction. When I had them removed March 25, 2019. (Received my x-plant). To my surprise the the (Right Breast) had a ruptured implant. Now I am left disfigured in the left breast from capsular contraction. Allergen wants me to sign a medical release for $3500.00 should I just sign and be done? From what I understand no attorney will take on allergen for my pain and suffering or reconstruction of the mess these implants have left me in.

  7. Mary Kay Reply

    Allergan Inamed gave me Thyroid Cancer. Had a total Thyroidectomy. 6 months later a recurrence. 28 lymph nodes removed. Thyroid Cancer Radioactive Iodine Cancer Treatment twice.

  8. Iva Reply

    it casing me pain from day one i have swelling and tenderness

  9. Jennifer Reply

    I’ve had Allergan smooth saline implants put in to replace Mentor implants in Oct 2009. In 2013 my left implant was ruptured. I should have been under warranty for both implants to be replaced and have the $1200 financial assistance. That did not happen and only the left implant was replaced and no financial assistance was given. Then in Nov 2019 my right implant ruptured. I could have avoided this had they replaced them both the fist incident. I am in great pain now in both breast. Do not feel well. Out of money for the cost of both replacements. I’m so sad and upset about the entire ordeal it’s caused me great depression including thoughts of suicide. This company needs to be held accountable. Please let me know if I have a case. I’m sick and have been dealing with pain and suffering for over a decade.

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