Allergan Breast Implant Lawsuit Related to Lymphoma (BIA-ALCL)

Textured Breast Implant Recall: What You Need to Know

Rosenfeld Injury Lawyers LLC is currently investigating potential lawsuits related to a reported cancer risk associated with Allergan Inc.'s Biocell line of breast implants.
In July 2019, the U.S. Food and Drug Administration (FDA) issued a voluntary recall request warning that women with Allergan textured breast implants 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.

Elevated Risk of Anaplastic Large Cell Lymphoma Associated With Allergan Breast Implants

If you or someone you know has Allergan implants, you should be aware of the increased risks they might pose.

The United States FDA has cautioned that patients who receive these implants are six-times more likely to develop a rare type of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL)—a type of non-Hodgkin's lymphoma—than those implanted with other brands.

Rosenfeld Injury Lawyers LLC can assist you and your family. If you or a loved one has textured implants manufactured by Allergan, you likely have many questions and concerns. Our breast implant injury attorneys can ease your worries and advise you of all available legal options.

The FDA Asks Allergan for a Biocell Breast Implants Voluntary Recall

The FDA announced that its recall request was based on newly submitted medical device reports that found 481 cases of BIA-ALCL worldwide—12 resulting in death—linked to Allergan's Biocell implants and tissue expanders. In response, Allergan agreed to remove these products from the global medical marketplace.

Biocell is Allergan's marketing brand for the proprietary technology used in its textured implant products—not the name of an existing brand. The recall affected Allergan's Natrelle products mostly. The different types that were recalled are listed in the section below.

Why Biocell Breast Implants Are 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.

The texture causes the device to remain relatively stable and not shift inside the body, as breast implants with smooth surfaces can.

Breast implant brands from other manufacturers also feature finely textured surfaces.
However, the unique surface of Biocell implants is believed to create friction or irritation in a woman's breast tissue that leads to a significantly higher risk of developing cancer than other textured implant brands.

What the FDA Says About the Breast Implant

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

BIA-ALCL with textured implants from other manufacturers marketing in the U.S., and continued distribution of Allergan's Biocell textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."

The FDA does not currently recommend that women have their Allergan Natrelle saline or silicone implants removed unless they are experiencing symptoms.

It Took Almost a Decade for the FDA to Recall Allergan Breast Implants

Concerns about Allergan's Biocell implants have been building for some time. It can be argued the FDA has addressed the problem quite late.

By the government's admission, the administration first identified a possible association between breast implants and the development of ALCL in 2011.There were reports that Allergan textured breast implants were unsafe back in March of 2017.

The product was removed from the market in thirty-eight other countries before the FDA issued its Allergan recall request.

In December 2018, sales of textured Allergan breast implants were suspended in the European Union as well as Israel, Brazil, and Australia. In May of 2019, Canada restricted the use of Biocell implants as well.

With so many other countries deciding that the implants are unsafe, it is unfortunate that the FDA took so much time to issue its warning on the dangers of Biocell products.

Lawsuits 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.

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.

The Class Action Lawsuit Against Allergan

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 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 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.

The class-action lawsuit claims these reimbursement levels are insufficient. The plaintiffs also accuse the company of failing to report adverse events associated with its implant brands to the FDA as required by federal law.

The women state that the company knew since at least 2006 of a possible connection between the implants and ALCL, causes of action include negligence, failure to warn, and violations of the Illinois Consumer Fraud Act.

Allergan's Dirty Tricks to Evade Liability

One of the reasons why having an Allergan lawsuit attorney is so important is that the company has shown that it is not above dirty tricks to defeat people seeking legal remedies.

When Allergan offered to replace breast implants, it did not advise patients that they would need to sign a release to take advantage of the offer.

This would have taken away their right to legal action, and the patients might not have realized it until it was too late. In response, the court issued an order that restricted how Allergan would be allowed to communicate with plaintiffs.

Multi-District Litigation in New Jersey with a Growing Number of Cases

Currently, the Allergan personal injury lawsuits that were filed by individual plaintiffs have been moved to the federal district court in New Jersey as part of multidistrict litigation.

This means that all of the filed cases have been consolidated together for purposes of discovery. However, they are all separate lawsuits when it comes to trial in court (different than other class actions). At some point, the court will choose bellwether cases from the pool of plaintiffs for trial.

At this time, there are 375 lawsuits that are a part of this multidistrict lawsuit. This number has gone up dramatically over the past year. In July 2020, there were 143 lawsuits in this litigation.

Currently, the cases are at an early stage of the multidistrict litigation. As of this writing, the defendants have filed motions to dismiss the case.

This is a standard step in any large-scale litigation as defendants try to find a way to avoid having to go to trial either based on legal technicalities or what they claim to be deficiencies with the lawsuit.

The court recently held oral arguments on the motion to dismiss. Courts rarely deny these early motions to dismiss unless there is something wrong like missing the statute of limitations.

Assuming the court does not grant a motion to dismiss, the case will eventually be dismissed. At this point, trial is still years in the future, giving you time to file your lawsuit so long as you are still within the statute of limitations.

The Statute of Limitations in Your Breast Implant Lawsuit

The statute of limitations is one thing that you need to closely track in your state. Here, the breast implants can sicken patients at any time, even years after the initial surgery.

For purposes of the statute of limitations, it begins to run at the time that you knew or should have known that you were injured.

For purposes of your Allergan breast implant lawsuit, do not delay in seeking medical treatment if you feel that there is any chance that you may have lymphoma.

Defendants are typically ruthless at trial in an attempt to avoid paying and taking responsibility for what they have done. They will not hesitate to try to argue that your statute of limitations began to run on the date that you first had a symptom as opposed to when you had a formal cancer diagnosis.

Patients Can Be Sickened from a Breast Implant Years Later

One problem for patients is that these breast implants can be like a ticking time bomb in their bodies.
Since they do not need to remove and replace the implants, they have a potentially dangerous medical device in their body that can sicken them at any time in the future. The type of dangers that these breast implants pose can manifest itself so long as they are in the human body.

Breast Implants That Are Linked to Cancer

In the last few years, there has been significant concern involving textured breast implants, including those manufactured by Allergan.

However, the company's textured breast implants are not known to cause breast cancer, but breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The rare form of lymphoma can be life-threatening. Only a doctor can diagnose the condition.

The Recall Affects the Following Breast Implant Products

These are the Biocell implant varieties including filled texture breast implants that the FDA has listed as part of its voluntary recall:

• Natrelle saline breast implant styles 168, 363, 468
• McGhan and Natrelle 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
• 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 breast implant styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
• Natrelle and McGhan Round Gel implant styles 110, 110 Soft Touch, 120, 120 Soft Touch
• Natrelle Komuro breast implant styles KML, KMM, KLL, and KLM
• Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
• Natrelle 150 Full Height and Short Height double lumen implants
• 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
• Natrelle
• 133 Plus tissue expander 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,
• 133P-SV-T

The recall does not affect Allergan's Natrelle Smooth or Microcell breast implants and tissue expanders.

Frequently Asked Questions 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 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.

Hold Allergan Accountable for This Allegedly Defective Product

However, legal action can also serve a higher purpose—to hold Allergan accountable for its actions. Although the company's products were taken off the market in thirty-eight other countries, Allergan did not choose to remove its Biocell implants from the U.S. market until the FDA requested its removal, notwithstanding the fact that it allegedly had indications for years that the product posed a potential danger to the public.

What's more, breast implant removal surgery is often not covered by health insurance. Allergan has decided that the company will not pay the full costs associated with removal and cancer diagnosis.

This leaves patients having to foot a huge bill on their own if they choose to be vigilant and remove this potentially carcinogenic implant from their bodies.

Their lack of care in those who use their product is a further reason why the device maker should be held responsible for the potential harm caused by its defective devices.

Let Rosenfeld Injury Lawyers Help You With Your Breast Implant Lawsuit

If you or a loved one has been diagnosed with ALCL caused by Allergan breast implants, we encourage you to contact the injury attorneys at Rosenfeld Injury Lawyers to discuss your legal options including an Allergan breast implant lawsuit.

We have helped hundreds of clients just like you win the compensation they deserved from negligent medical device manufacturers. Do not let companies get away with knowingly selling defective products that can injure you or a family member.

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, so there is a legal fee charged only after we are successful in winning compensation on your behalf. Call us today.