Rosenfeld Injury Lawyers LLC is investigating potential lawsuits related to a reported cancer risk associated with Allergan Inc.’s Biocell line of breast implants. The U.S. Food and Drug Administration (FDA) issued a voluntary recall request in July 2019 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 getting Allergan implants, you might be eligible to receive a substantial settlement in a product liability lawsuit against the device manufacturer.
If you or someone you know has Allergan implants, you should be aware of the risks they might pose. The FDA has cautioned that patients who receive these implants stand a six-times greater chance of developing 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 stands ready to 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 are here to ease your worries and advise you of your legal options.
- Why did the FDA ask Allergan to recall its Biocell breast implants?
- What are the signs of anaplastic large-cell lymphoma (ALCL) and how is it treated?
- Did the FDA wait too long to act?
- Which Allergan products have been recalled?
- What should I do if I have Biocell implants?
- Have any lawsuits been filed over Allergan implants?
- What are my options for taking legal action?
Why did the FDA Ask Allergan to Recall its Biocell Breast Implants?
The FDA said 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 market.
Biocell is actually Allergen’s name for the proprietary technology used in its textured implant products—not the name of an actual brand. It is mostly Allergan’s Natrelle brand that was affected by the recall, and the different types are listed in the section below. The company’s Biocell line of implants feature a fine surface texture that helps them stay in place inside the body. The way the roughened surface of the implant adheres to the tissues in the breast causes it to remain relatively stable and not shift inside the body, as breast implants with smooth surfaces have been known to do.
There are breast implant brands besides Allergan’s Biocell products that feature textured surfaces. However, the unique surface of Biocell implants is believed to create a 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 is not currently recommending that women have the implants removed if they are not experiencing symptoms.
What are the Signs of Anaplastic Large-Cell Lymphoma and how is it Treated?
BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the lymphatic system) that is usually found in scar tissue and fluid surrounding the implant but that can spread throughout the body.
Just because the cancer associated with Biocell implants is not breast cancer doesn’t mean it is not 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 collection of fluid around the 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 surgery to remove the implant as well as the capsule of scar tissue surrounding it. It is important that the surgeon gets all the potentially cancerous tissue, which means the surgery can be quite invasive and hard on the patient. Most BIA-ALCL can be successfully treated with surgery, but in same cases chemotherapy and/or radiation might be necessary.
Did the FDA Wait too Long to Act?
Concern about Allergan’s Biocell implants has been building for some time—in fact, it can be argued the FDA has addressed the problem quite late. By its own admission, the agency 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 38 other countries before the FDA issued its 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.
List of Recalled Allergan Products
These are the Biocell implant varieties that the FDA has listed as part of its voluntary recall:
- Natrelle saline breast implant styles 168, 363, 468
- Natrelle and McGhan 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 individual circumstances. The FDA recommends the following:
- Be aware of the symptoms of ALCL and speak to your doctor 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 Biocell implants, your physician will likely recommend that you have the implants removed as well as the scar capsule surrounding them.
- Those without symptoms should not have the implants removed at this time. There are a number of different Allergan products included in the recall, but the overall risk of developing ALCL is low even with recalled products. That is why 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 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 medical device recalls, 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 will 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, and also accuses the company of failing to report adverse events associated with its implant brands to the FDA as required by federal law and knowing since at least 2006 of a possible connection between the implants and ALCL, Causes of action includes 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, one of your options is bringing a product liability claim against the company. This 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 negligently made, marketed and sold them.
There are several reasons to consider taking legal action against Allergan. One of the most obvious is that if your lawsuit is successful, you can get financial compensation for your injuries which you can use to pay for your medical care and living expenses while you are recovering. However, legal action can also serve another purpose—to hold Allergan accountable for its actions. Although the company’s products were taken off the market in 38 other countries, Allergan did not choose to remove its Biocell implants from the U.S. market until the FDA asked them to.
What’s more, breast implant removal surgery is often not covered by health insurance. That and the fact that Allergan won’t pay the full costs associated with removal and cancer diagnosis is further reason why the device maker should be held responsible for the potential harm caused by its products.
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. As with all our medical device cases, we work on a contingency fee basis so there is only a legal fee charged once we are successful in winning compensation on your behalf. Call us today.