Allergan Breast Implant Lawsuit for Lymphoma and BIA-ALCL
Allergan Inc.'s breast implants include saline and silicone devices used in breast reconstruction or augmentation. The company is one of the largest breast implant manufacturers in the world. They market themselves as the top selected breast implant choice by leading US physicians in breast augmentation surgery.
In July 2019, the US Food and Drug Administration (FDA) issued a voluntary recall request warning that women who received an Allergan textured breast implant could face an elevated risk of developing a rare form of lymphatic cancer.
If you or a loved one has developed cancer after undergoing breast augmentation with Allergan implants, you might be eligible to receive a substantial settlement in a defective medical device lawsuit against the device manufacturer.
Contact our defective medical device attorneys at (888) 424-5757 (toll-free phone number) or use the contact form today to schedule a free consultation and receive immediate legal advice. All confidential or sensitive information shared with our personal injury lawyers remains private through an attorney-client relationship.
Elevated Risk of Breast Implants Anaplastic-Large Cell Lymphoma Associated with Allergan Products
There are increased risks associated with using Allergan implants and tissue expanders. Women using their products through cosmetic surgery should be aware of the danger.
The United States FDA (Food and Drug Administration) has cautioned that patients receiving these implants are six times more likely to develop a rare form of breast cancer (breast implant-associated anaplastic-large-cell lymphoma or BIA-ALCL), a type of non-Hodgkin's lymphoma, than those implanted with other brands.
The T-cell lymphoma, or BIA-ALCL, causes T-cells to produce an excess amount of a protein known as anaplastic lymphoma kinase (ALK1). Anaplastic lymphoma kinase triggers an increase in the growth of cells in the lymph tissue that forms in the scar tissue surrounding a breast implant, or “scar capsule.”
Rosenfeld Injury Lawyers, LLC can assist you and your family. If you or a loved one has textured implants manufactured by Allergan, you may have many questions and concerns. Our breast implant injury attorneys can answer your questions and advise you of all available legal options.
FDA Requests a Voluntary Recall of Allergan Biocell Breast Implants
The FDA announced that its recall request was based on newly submitted medical device reports that found 481 cases of BIA-ALCL (breast implant-associated-anaplastic-large-cell lymphoma) worldwide, with 12 resulting in death, linked to Allergan Biocell implants and tissue expanders.
Why Are Biocell Breast Implants So Dangerous?
The company's Biocell line of implants features a fine surface texture that helps them stay in place inside the body. The roughened surface of the implant was designed to adhere the device to the tissues in the breast and is different from other implants.
Implant brands from other manufacturers also feature finely textured surfaces. However, the unique surface of Biocell textured implants is believed to create friction or irritation in a woman's breast tissue, which leads to a significantly higher risk of developing cancer than other textured implant brands.
FDA Allergan Breast Implants Recalled Only After a Decade
Concerns about certain textured breast implants by Allergan have been growing for some time, with the FDA only recently addressing the problem after almost a decade:
- By the government's admission, the administration first identified a possible association between implants and the development of ALCL in 2011.
- There were reports that Allergan textured breast implants were unsafe in March 2017.
- The product was removed from the market in thirty-eight other countries before the FDA issued its Allergan recall request.
- In December 2018, textured Allergan breast implants were suspended in the European Union, Israel, Brazil, and Australia.
- In May 2019, Canada also restricted the use of Biocell implant products.
The FDA does not currently recommend that women have their Allergan Natrelle saline or silicone-filled breast implants removed unless they are experiencing symptoms. According to the FDA's announcement:
"Based on the currently available information, including newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of cell lymphoma BIA-ALCL with textured implants from other manufacturers marketing in the US.”
“Continued distribution of Allergan's Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."
Class-Action Against Allergan for Defective Breast Implants
As a result of the allegedly defective breast implants, injured patients and their families are not filing lawsuits against the company. Instead, Allergan is facing both a class-action lawsuit seeking the costs of the implant and personal injury cases brought by women who have received a cancer diagnosis.
As is often the case with nearly every medical device recall, shortly after the FDA Biocell announcement in August 2019, two women who had received these implants, one from Illinois and one from Arizona, filed a class-action lawsuit against Allergan in a federal district court in New Jersey.
The plaintiffs are identified as Jane Doe #1 and #2. Their lawsuit seeks reimbursement for the original cost of the implants, medical expenses associated with implant removal, and cancer testing.
Following the FDA action, Allergan announced that it would cover the costs of non-textured replacement implants for people with Biocell breast implants who want to replace them but won't pay for the associated surgical fees.
The company said it would reimburse patients for up to $1,000 in cancer testing costs and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL (breast implant-associated anaplastic large cell lymphoma).
The class-action Allergan breast implant lawsuits claim these reimbursement levels are insufficient. The plaintiffs also accuse the company of failing to adequately warn and report adverse events associated with its implant brands to the FDA, as federal law requires.
The Statute of Limitations in Your Breast Implant Lawsuit
You must track the statute of limitations closely in your state. Implants can sicken patients anytime, even years after the initial surgery.
In an Allergan breast implant suit, there should be no delay in seeking medical treatment should there be any chance that you may have lymphoma. The statute of limitations begins to run from the moment you have a confirmed diagnosis.
Defendants are typically ruthless at trial to avoid paying and taking responsibility for their actions. They will not hesitate to argue that your statute of limitations began to run on the date you first had a symptom as opposed to when you had a formal cancer diagnosis.
The personal injury attorneys at Rosenfeld Injury Lawyers, LLC is investigating potential Allergan breast implant claims related to a reported cancer risk associated with Allergan Inc.'s Biocell line of silicone or saline implants.
FDA - Breast Implants That Are Linked to Cancer
Women who have Allergan Biocell textured breast implants may be at an increased risk for developing a specific type of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), according to the FDA:
- On May 14, 2020, the US Food and Drug Administration (FDA) issued a warning letter to two breast implant manufacturers, Allergan of California and Ideal Implant Incorporated of Texas.
- The companies failed to comply with regulatory requirements in studies conducted by the FDA to determine the potential risks and safety of two Allergen textured breast implants recalled in 2019.
- The FDA first requested Allergan issue a voluntary recall of several implant products in July 2019. The recalled breast implants were due to the long-term risk and safety studies.
- In early September 2019, the FDA requested a recall of all Allergan Biocell textured implants. Later that month, the FDA recalled Natrelle textured breast implants
- The FDA issued the request in a bid “to protect women from implant-associated anaplastic large cell lymphoma (BIA-ALCL).”
BIA-ALCL is a condition that only a medical doctor and medical monitoring can diagnose.
Biocell Textured Breast Implants Recall
These are the Biocell textured breast implants that the FDA has listed as part of its voluntary recall:
- McGhan and Natrelle 410 textured breast implants, styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle saline textured breast implant styles 168, 363, 468
- Natrelle and McGhan 410 Soft Touch breast implant, styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle Inspira textured breast implants styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX.
- Allergan Natrelle and McGhan Round Gel textured breast implant styles 110, 110 Soft Touch, 120, 120 Soft Touch.
- Natrelle Komuro breast implants, styles KML, KMM, KLL, and KLM
- Natrelle Ritz Princess textured breast implants, styles RML, RMM, RFL, RFM
- Natrelle 150 Full Height and Short Height double lumen textured breast implant
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV,
133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX,
T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Allergan Natrelle 133 Plus tissue expanders styles 133P-FV, 133P-MV, 133P-LV, 133P-MX,
133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX,
T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T,
The recall does not affect all Biocell textured breast implants and tissue expanders, including Allergan's Natrelle Smooth or Microcell breast implants and tissue expanders.
FDA Cancer Statistics Regarding Implants
Although the FDA issued its warning for all breast implants, the agency recognized that most reported cases have been in individuals with textured implants.
- The FDA reported that it counted 1,130 global BIA-ALCL cases as of April 1, 2022, with 505 coming from the United States.
- The FDA stated that 59 people died from BIA-ALCL cancer, including 14 from the US.
- The FDA is still working with the American Society of Plastic Surgeons to understand breast implants' exact risk for cancer.
- Estimates indicate that 1 in 3,817 patients will develop BIA-ALCL. Other estimations are far more modest, stating only 1 in 30,000 patients will develop breast implant cancer.
The FDA stated, “Though the number of identified ALCL cases is small compared to the estimated 1.5 million patients who receive breast implants and tissue expanders worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.”
Signs of Anaplastic Large-Cell Lymphoma and How It is Treated
BIA-ALCL is not breast cancer but a type of non-Hodgkin's lymphoma (cancer of the lymphatic system) usually found in scar tissue and fluid surrounding the implant. Without medical intervention, T-cell lymphoma could spread throughout the body.
Nearly every type of cancer associated with Allergan implants is not identified and treated as breast cancer, yet this does not minimize the cause for concern. ALCL can be fatal if it is not diagnosed early on and appropriate treatment is provided.
Symptoms of Breast Implant Cancer
One problem for patients is that these silicone or saline implants can be like a ticking time bomb in the body.
If they do not remove and replace the implants, they have a potentially dangerous medical device in their body that can trigger a potentially life-threatening condition at any time. The danger is that these breast implants can manifest as long as they are in the human body.
Women suffering from BIA-ALCL might experience common symptoms of changes in the shape or size of the breasts after the surgical area is completely healed. In the years following the procedure, one breast may have a different shape (asymmetrical) in appearance.
The common symptoms associated with breast implant-associated anaplastic large cell lymphoma include:
- Pain and tenderness in the breast
- Fluid accumulation or swelling around the textured implants or in the breast
- Any change in breast size or shape
Developing Effusion or Infection
You may develop effusion or infection if you have undergone implant placement in recent months or years. A breast implant illness such as flu-like symptoms or laryngitis associated with tender or unusually swollen breasts may have occurred from bacteremia (bloodstream bacteria) due to infection.
Women undergoing breast augmentation surgery will require monitoring and care of their breasts for the rest of their lives to detect any possible implant ruptures or abnormalities. As long as the implant remains in their body, they should schedule an MRI every two years.
Hold Allergan Accountable for This Allegedly Defective Product
However, legal action through lawsuits filed by plaintiffs can also serve a higher purpose, holding Allergan Biocell accountable for its actions.
Although the company's products and recalled certain breast implants were taken off the market in thirty-eight other countries, Allergan chose not to remove its Biocell textured implants from the US market.
FDA Requests Allergan Remove Its Product from Use
They only complied when the FDA requested its removal, even though it allegedly had indications for years that the product posed a potential danger to the public. Despite knowing about the threat, they needed to adequately warn consumers.
Implant removal surgery is often not covered by health insurance. Yet, Allergan has decided that the company will not pay for surgical removal and diagnosis costs. Patients are left having to foot a massive bill on their own if they choose to be proactive and remove this potentially carcinogenic implant from their bodies.
FAQs About Your Allergan Breast Implants Cancer Lawsuits
If you underwent a surgical procedure involving Allergan breast implants recently or years ago, you are likely concerned about the recent developments of their defective devices.
Our law firm is actively investigating Allergan textured breast implant cases involving large cell lymphoma, BIA-ALCL cancer, and lymphoma. We encourage you to contact our office for a free consultation with an attorney experienced with breast implant cancer lawsuits.
What Should I Do If My Breast Implant Surgery Involved Allergan Biocell Implants?
If you have one or two textured breast implants, what you should do depends on your circumstances. The FDA recommends the following:
- Be aware of the symptoms of ALCL, a form of non-Hodgkin's lymphoma, and speak to your healthcare provider if you experience any of them.
- You will likely need to undergo diagnostic tests to verify if you have ALCL.
- If you have ALCL caused by their implants, your physician will likely recommend that you undergo breast implant surgery to remove the implants and the scar capsule surrounding them.
- According to FDA recommendations, women without symptoms should not have the implants removed at this time.
The FDA believes it is generally safer to keep saline or silicone-filled breast implants rather than undergo removal surgery if you have no symptoms and your doctor is not recommending their removal.
The FDA has determined that textured implants of all types by all manufacturers carry a greater risk of scar tissue and other health issues than smooth-surface implants.
What Should You Do If You Have an Allergan Breast Implant?
If your Allergan breast implant was recalled, you should speak with health care providers as soon as possible, as only a medical doctor can diagnose BIA-ALCL.
Your physician can perform an objective medical evaluation at your appointment and may suggest that you undergo medical monitoring. The results can help identify any of the signs and symptoms of BIA-ALCL.
How Do You Know When Breast Implants Need Replacing?
If you notice any changes in the size, shape, or tenderness of your breast tissue, your silicone-filled breast implants might have ruptured and need replacing.
Occasionally, implant replacement is required if you have developed an infection in the breast or capsular contracture (the body's immune system response to form material).
Is Allergan's Smooth Breast Implant Safe?
The recent FDA recommended a recall of Allergan textured implants due to results showing a higher risk of BIA-ALCL (breast implant-associated anaplastic large cell lymphoma). The recall did not affect the company's smooth breast implants.
Can Biocell Breast Implants Be Removed and Not Replaced?
Many women undergo breast reconstruction or augmentation to revise the size and shape of their breasts through implantation. Reversing the procedure is possible and often done in cases where the implant is no longer practical, needed, or safe to use.
Typically, breast implant-associated anaplastic cell lymphoma is found in scar tissue and fluid in the surrounding area after the implant is removed.
Let Rosenfeld Injury Lawyers Help You with Your Breast Implant Lawsuit
If you or a loved one has been diagnosed with ALCL, a form of non-Hodgkin's lymphoma caused by Allergan breast implants, we encourage you to contact the injury attorneys at Rosenfeld Injury Lawyers, LLC at (888) 424-5757 or use the contact form to discuss your legal options.
We have helped hundreds of clients win the compensation they deserve from negligent medical device manufacturers. Our injury case law firm offers all potential clients a free case evaluation.
As with all our medical device cases, we work on a contingency fee basis, with our legal fee only payable when we successfully win compensation on your behalf.
All information shared remains confidential in the attorney-client relationship. Call us today.