Allergan Breast Implant Lawsuits 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 Cancer
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 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 Allergen'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.
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.
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.
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 legal advisors have answered some of the most pertinent questions below that include:
How do I Find out if My Implants are Recalled?
Look below for a complete list of all Allergan implants that have been recalled.
How Long do Allergan Implants Last?
Most breast implants are designed to last one or two decades based on their construction materials, including silicone and saline. On average, one out of every five women with implants have the devices removed or replaced every eight to ten years.
How Often Should Breast Implants be Checked?
The Food and Drug Administration recommends that women with silicone implants undergo an MRI (magnetic resident's image) screening in the first three years after undergoing breast augmentation surgery followed by every two years.
Our Allergan and Mentor the Same Company?
In recent years, the Food and Drug Administration and Health Canada approved the manufacturing and use of textured breast implants made and distributed by Allergan and Mentor. However, Mentor is a subsidiary of Johnson & Johnson.
What do You do With an Allergan Implant?
If your Allergan breast implant was recalled, it is essential to speak with your doctor. At your appointment, your physician can perform an objective medical evaluation. 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 Allergan implant might have ruptured and needs replacing. In some cases, and 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).
Our Allergan Smooth Implant Safe?
The recent FDA recommended recall on Allergan textured implants due to results showing that there was a higher risk of BIA-ALCL (breast implant-associated anaplastic large cell lymphoma). The recall did not affect the company's smooth breast implants.
What are the Signs of Anaplastic Large-Cell Lymphoma and how is it Treated?
BIA-ALCL is not breast cancer, but a type of non-Hodgkin's lymphoma (cancer of the lymphatic system) that is usually found in scar tissue and fluid surrounding the implant. Without medical intervention, the t-cell lymphoma could spread throughout the body.
Nearly every type of cancer associated with Biocell implants is not identified and treated as breast cancer. However, a diagnosis doesn't mean there is not a cause for concern.
ALCL can be fatal if it is not diagnosed early enough or if the woman does not get appropriate treatment. Common warning signs of BIA-ALCL are fluid buildup around the Allergan Natrelle silicone implant (seroma) or a mass or lump in the vicinity, usually some years after implantation.
Symptoms often manifest themselves as persistent swelling or pain near the implant and, in some cases, a rash on the skin of the breast. The treatment for BIA-ALCL in most patients involves plastic surgeon removal of the implant as well as the capsule of scar tissue surrounding it.
The surgeon must remove all potentially cancerous tissue, which means the surgery can be quite invasive and challenging for the patient. Most BIA-ALCL can be successfully treated with surgery, but in some cases, chemotherapy or radiation might be necessary.
Which Breast Implants 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.
What are the Symptoms of Breast Implant Cancer?
Women suffering from BIA-ALCL might experience common symptoms by 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 implant or in the breast
- Any change in the size or shape of the breast(s)
Did the FDA Wait too Long to Act?
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.
What Happens if You do not Replace Your Breast Implants?
Most breast implant makers manufacture their devices with durable materials. However, over time, there may be a need to replace the implant for various reasons, including a decrease or increase in size.
Some women notice the deflation in one or both implants, which could be a significant problem, especially if the breast implants were inflated with saline. However, capsular contracture is a significant problem in the scar tissue that can squeeze the implant, distort its appearance, and cause significant pain.
Can Breast Implants get Infected Years Later?
If you have undergone implant placement in recent months or years, there is a potential for developing effusion or infection. Any flu-like illness or laryngitis associated with tender or unusually swollen breasts may have occurred from bacteremia (bacteria in the bloodstream) due to an infection.
Can Breast Implants be Removed and not Replaced?
Many women undergo breast 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.
Which Allergan Implants Have Been Recalled?
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.
What Should I do if I Have Allergan Biocell Implants?
If you have Biocell implants, what you should do depends on your circumstances. The FDA recommends the following:
- Be aware of the symptoms of ALCL and speak to your health care provider if you experience any of them. You will likely need to undergo diagnostic tests to verify if you have ALCL. You might need to undergo removal of silicone-filled breast implants and lymph nodes.
- If you have ALCL caused by Biocell implants, your physician will likely recommend that undergo breast implant surgery to have the implants and the scar capsule surrounding them removed.
- Those without symptoms should not have the implants removed at this time to follow FDA recommendations. There are several different Allergan products included in the recall, but the overall risk of developing ALCL is low even with recalled products.
The FDA believes that it is generally safer to keep breast implants rather than undergo surgery to have them removed if you have no symptoms, and your doctor is not recommending their removal.
Additionally, women who have or are considering getting implants should be aware of the risks and symptoms of BIA-ALCL, regardless of the brand of implant. The FDA has determined that textured implants of all types by all manufacturers carry a greater risk than smooth-surface implants.
What is the Status of Allergan Breast Implant Lawsuits?
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.
What are My Options for Taking Legal Action?
If Allergan's implants caused you to develop ALCL, you have the option of bringing a product liability claim against the company. This claim is different from a medical malpractice lawsuit in that it is not an action against the surgeon who implanted the devices but the manufacturer who was negligent when manufacturing, marketing, selling, and distributing the product.
There are several reasons to consider taking legal action against Soft Touch, McGhan, and Natrelle Biocell Allergan implant manufacturer. You can receive financial compensation for your injuries if your lawsuit is successful, which you can use to pay for your medical care and living expenses while you are recovering.
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.
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.
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 qualified breast implant injury attorneys at Rosenfeld Injury Lawyers to discuss your legal options. We have helped hundreds of clients just like you win the compensation they deserved from negligent 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, so there is a legal fee charged only after we are successful in winning compensation on your behalf. Call us today.