Allergan Breast Implant Lawsuit
There are several reasons why people choose to receive breast implants. A boost in self-confidence for some, reshaping their chest after surgery, like a mastectomy for others. Regardless of their reason for undergoing breast augmentation, patients deserve the confidence that their implants are safe and won’t make them sick or have other adverse side effects, regardless.
BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma, is rare cancer believed to be related to textured Allergan BIOCELL breast implants and tissue expanders. Many women have reported incidents and consulted their doctors about whether they should get their breast implants removed.
Allergan issued a global product recall in 2019 and lost its CE mark within Europe. A CE mark ensures that there is sufficient clinical data and research performed before a product can be sold. A CE mark also guarantees that the implants will not interfere with any hospital equipment or other life saving devices. Allergan consented to a voluntary recall for every Biocell textured breast implant and tissue expander. However, the corporation only agreed to cover the cost of the implant itself and refused to assist women with the medical bills related to problematic devices.
Why Are People Filing Lawsuits Against Allergan Breast Implants?
Several lawsuits have been brought against the company due to the link between Allergan’s breast implant product and ALCL. A rare T-cell lymphoma called ALCL typically appears in the tissue surrounding a breast implant. Non-Hodgkin lymphoma is a subtype of this condition, developing into a BIA-ALCL or linked with breast implants ALCL. The FDA ordered Allergan to recall those breast implants with texture in July 2019 due to their association with cancer incidences and fatalities. Some individuals and medical professionals assert that Allergan did not warn about the risks associated with the product. It was also claimed that Allergan, now a subsidiary of AbbVie, failed to submit reports regarding breast implant surgery as required by post-marketing studies.
The following medical expenses are being sought as compensation by people who had Biocell textured implants:
- Cancer treatment
- Pain and suffering
- Surgical removal
- Lost wages
- Diagnostic testing
- Medical monitoring
What Is the Allergan Breast Implant Made Of?
Breast enhancement techniques involve Allergan implants with saline and silicone shells. Round implants or teardrop shape implants are two choices offered by Allergan. Round implants have a fully circular appearance, whereas teardrop implants mimic the form of the breast. Silicone elastomer is used to create the newest and most technologically advanced implants, Natrelle Inspira breast implants. A thin silicone gel with intricate connections envelops its shell.
BIA-ALCL: What Is It?
Anaplastic large cell lymphoma (BIA-ALCL) connected to breast implants is not a type of breast cancer, although it has detrimental repercussions. It is a non-Hodgkin lymphoma subtype that affects the immune system and can ultimately be fatal. Because it causes the T cells to overproduce the anaplastic lymphoma kinase (ALK1) protein, which promotes the growth of specific cancer cells, the tumor is also known as a T-cell lymphoma. Chemotherapy, radiation therapy, implant removal, and surrounding tissue removal are all effective treatments for most patients.
The following signs and symptoms frequently identify BIA-ALCL:
- Pain around the implant
- Excess fluid or mass around the breast
Rashes can occasionally appear on the breast skin.
The disease might spread or metastasize to other body parts if BIA-ALCL is not caught in time for treatment. If caught in time, the breast implant and surrounding scar tissue may be removed. The average time between getting a breast implant and being diagnosed with BIA-ALCL seems to be around eight years, and many patients get their implants removed in advance.
How Are Allergan Breast Implants Linked to BIA-ALCL?
Creating scar tissue to retain breast implants with texture in place may trigger inflammatory processes that raise the risk of ALCL. The chance of developing linked with breast implants ALCL, or BIA-ALCL, is thought to be increased by bacterial contamination, familial history, and texture of the breast implants.
Compared to textured implants made by other companies, Allergan implants are linked to a six times higher risk of BIA-ALCL. At least 573 instances of BIA-ALCL, including 33 fatal cases, have been reported to the FDA as of August 2019. 12 out of 13 deaths when the implant maker could be established were related to Allergan implants, which accounted for 84% of the reports.
Has the FDA Issued Any Warnings Regarding Allergan Breast Implants?
After reviewing new evidence and investigating the link between Allergan breast implants and BIA-ALCL death, the FDA concluded that:
- Patients must be aware of the dangers of BIA-ALCL if they have had breast augmentation surgery or plan to have it done.
- Smooth implants had a lower risk of BIA-ALCL than implants with a textured surface.
- Some textured tissue expanders shouldn’t be utilized.
Has the Allergan Breast Implant Been Recalled?
Health authorities in Australia, Europe, Brazil, and Israel halted Allergan textured breast implant sales in 2018, two years after the World Health Organization identified the non-Hodgkin’s lymphoma subtype BIA-ALCL. Until July 2019, an analysis revealed that an Allergan implant had a six-fold higher risk of BIA-ALCL than competing treatments; the business kept selling its implants throughout the US. The FDA then asked Allergan to recall its BIOCELL textured breast implants.
The FDA requested the following Allergan textured breast implant recall:
- McGhan Magna-Site Tissue Expander
- McGhan Style 134 Croissant-Shaped Tissue Expander
- McGhan BioDimensional Silicone-Filled Biocell Textured Breast Implants
- Natrelle 133 Tissue Expanders without and with suture tabs
- Natrelle 133 Plus Issue Expanders
- Natrelle Inspira Silicone-Filled Breast Implants
- Natrelle 140 Highly Cohesive Anatomical Shaped Silicone-Filled Breast Implants
- Natrelle Silicone-Filled Breast Implants
- Natrelle Saline Breast Implants
- Style 133 Biospan Tissue ExpanderAge-related macular degeneration
The company agreed to cover some of the implant cost as part of the recall but refused to cover surgical or medical expenditures related to cancer concerns. Even though they weren’t given a cancer diagnosis, some recipients have been encouraged by this to pursue lawsuits. Additionally, people who were diagnosed with BIA-ALCL and are suing Allergan for damages have done so.
What Consumers Should Do If They Have an Allergen Breast Implant That Has Been Recalled?
Consumers with Allergen breast implants that have been recalled are urged to get in touch with their doctors to go over their choices and decide whether getting the implant removed is in their best interests. Patients should receive routine examinations to monitor changes to the implant’s sizes or texture and watch for any prolonged pain or swelling close to the implant site.
Seeking medical treatment as soon as possible is crucial to prevent the most severe effects of BIA-ALCL cancer. A skilled physician can administer diagnostic procedures to ascertain whether a patient has cancer. If cancer is found, the doctor would probably advise surgical removal of the implant and the malignant tissue. Cancer may spread to other body parts and be lethal if not detected and treated promptly.
What Current Lawsuits Concerning Allergan Breast Implants Exist?
Two women sued Allergan in 2019 because the company’s breast implants caused them to develop BIA-ALCL. The two ladies, from Michigan and California, experienced warning signs of BIA-ALCL as soon as 14 months after the breast augmentation procedure. They claim that Allergan refuses to cover the breast implants’ removal cost, a crucial component of treating BIA-ALCL. By 2020, 64 more women joined the lawsuit.
More women are expected to file separate lawsuits or join the class-action case. Because BIA-ALCL symptoms may require some time to develop, it might take time before more women file lawsuits against Allergan.
What Do We Know About the Breast Implant Lawsuits?
According to the United States Food and Drug Administration (“FDA”) and World Health Organization, anaplastic large cell lymphoma and breast implants are related. Anaplastic large-cell lymphoma is an uncommon variety of non-Hodgkin’s lymphoma often seen in the scar capsule around the implant.
Breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”) is the name given to the condition. Although there have been rare ALCL cases concerning women who have gotten smooth breast implants, most of those with texture breast implants have been affected.
The World Health Organization recognized BIA-ALCL as a kind of T-cell lymphoma that can arise after breast implantation in 2016. All 33 European nations, Israel, Brazil, and Australia, prohibited the sale of textured Allergan breast implants in December 2018 after finding that these implants carried a higher risk of ALCL. An internal safety investigation by Health Canada in May 2019 resulted in the suspension of Allergan’s authorization for its BIOCELL breast implants.
The FDA scheduled a two-day meeting of its Advisory Committee in May 2019 to review breast implants’ benefits and disadvantages and suggest the best course of action in light of worries about BIA-ALCL. The FDA demanded that Allergan voluntarily remove all their textured breast implants and related tissue expanders from the US market on July 24, 2019, to protect patients.
Following a review of recently reported adverse event reports regarding BIA-ALCL, the FDA asked for this recall. The FDA stated that it discovered that “continued distribution of Allergan’s BIOCELL textured breast implants could lead to serious, negative health effects and potentially death from BIA-ALCL” and that “the risk of BIA-ALCL with Allergan BIOCELL textured implants stands roughly six times higher than that of BIA-ALCL textured implants through other marketing manufacturers within the US.”
Breast Implant Cancer Treatment & Injuries
Anaplastic large cell lymphoma linked to breast implants is not breast cancer but a non-Hodgkin’s lymphoma subtype. Anaplastic lymphoma kinase (ALK1), a protein that T-cells make in excess, causes the disease when a particular gene is mutated.
The reason why textured implants may result in this cancer is unknown. Research, however, indicates that it might be connected with inflammation that causes the scar tissue to grow and keep the implants in place. A family history of lymphoma and bacterial infection at the surgery site are possibilities.
Although BIA-ALCL is dangerous and can be fatal, it is thought to have a low incidence rate. A painless but noticeable swelling within the lymph nodes (such as those in the armpit or neck) is typically one of ALCL’s initial symptoms. A loss of appetite, extreme fatigue, a fever, and night sweats could follow. A mass or pain could also exist near the breast implant. Analyzing an enlarged lymph node to check for lymphoma cells is necessary for a precise diagnosis.
Seven hundred thirty-three cases of anaplastic large cell lymphoma connected to breast implants were reported to the FDA on January 5, 2020. Among these, 620 (85%) reports involved breast implants made by Allergan, 66 (9%) reported implants made by Mentor, Sientra, and other businesses, and 47 (6%) reported implants whose manufacturer was unknown. 36 deaths were recorded in these BIA-ALCL reports. According to data on adverse events that are currently accessible, it takes an average of 8 years from implantation to ALCL diagnosis.
Proper identification of BIA-ALCL in its early stages allows for frequent removal of the implant and accompanying scar tissue as a treatment. However, ALCL can potentially spread to other body areas, requiring chemotherapy and radiation treatments. It is essential to emphasize the importance of early diagnosis.
News Report About Breast Implant Cancer
Textured breast implants from Allergan have been linked to an uncommon cancer type.
Although there doesn’t seem to be a high cancer incidence, the FDA requested Allergan to start the Biocell implant recall “Once the evidence proves that a particular manufacturer’s product appears to have been related to significant harm to patients, including death.” NPR.
Are cancer and breast implants related in any way? If so, how significant is the risk?
According to research, BIA-ALCL is typically discovered in the scar tissue around the breast implant rather than the actual breast. A textured implant is thought to carry a lifetime risk of BIA-ALCL development from one in 1,000 to one in 30,000. Surgery is used to treat the cancer risk and remove the implants. BIA-ALCL is typically treatable if discovered early. Cited at the Mayo Clinic
Has There Been a Settlement regarding the Allergan Lawsuit?
The Allergan litigation still needs to be resolved as of 2022. The COVID-19 pandemic, which forced many lawsuits to get postponed until it is safe to restart in-court procedures, may have contributed to the delays in the cases. Others may still join the class-action lawsuit in the Allergan case.
Compensation in a Breast Implant Lawsuit
We will seek the following compensation for you if you or a loved one develops anaplastic large cell lymphoma (ALCL) following receiving breast implants:
- The costs of previous and future medical care and funerals due to the injuries are significant.
- The physical and mental pain and suffering from the past and future, as well as from the treatment and recovery period, are considerable.
- The loss of estate (in the event of death) and past and future wages are substantial.
- Lost earning potential in the past and the future.
- Lost enjoyment of life in the past and the future.
- Punitive damages, as necessary, may be awarded.
Breast Implant Lawsuit Settlement Amounts
In a federal court in New Jersey, an MDL regarding Allergan textured breast implants was launched in December 2019. Over 900 lawsuits were still ongoing in the MDL as of October 2021.
The first stage of the litigation process, which initiates settlement talks, is the creation of an MDL. Once the MDL is established, fact-finding and trial preparation can start, which opens the door for actual settlement negotiations.
Should You Consider Filing an Allergen Breast Implant Lawsuit?
Following breast augmentation surgery, anyone diagnosed with or the loved ones of those who passed away due to a BIA-ALCL diagnosis may be entitled to compensation in a medical liability or wrongful death case.
Patients who received textured breast implants or tissue expanders made by Allergan Biocell may be qualified to participate in a class action lawsuit demanding damages for the recall’s related expenses. The filing of the case is expected in July 2019.
In the litigation, damages are sought for:
- Costs related to the implant’s surgical removal
- Monitoring and testing for medical conditions
- Lost wages
- Suffering and Pain
- and more
Statute of Limitations for Allergan Breast Implant Lawsuits
Regarding the Allergan breast implant lawsuits, it’s important to note that there have been various legal issues associated with these implants, such as the recall of certain textured breast implants due to concerns about a link to an uncommon cancer type called breast implant-associated anaplastic large cell lymphoma. Lawsuits related to these issues could involve claims of product liability, negligence, or other legal theories.
The statute of limitations for these lawsuits can depend on factors such as the lawsuit’s jurisdiction and the specific claims being made. Additionally, the date when the cause of action accrues, or the point at which a person knew or should have known about the harm caused by the implants, may also affect the statute of limitations.
Given the complexities involved, if you believe you have a legal claim related to Allergan breast implants, it’s crucial to consult with an attorney who specializes in product liability or medical device litigation. They can provide the most accurate and up-to-date information about the statute of limitations that applies to your situation.
FDA and Scientific Research on Textured Breast Implants
Specific Labeling Recommendations for Breast Implants to Enhance Patient Communication
The FDA released non-binding guidelines and guidance addressing the following cautions to be shared with women considering getting breast implants in October 2020. Breast implants have been linked to the development of an immune system cancer known as BIA-ALCL or breast implant-associated anaplastic large cell lymphoma is more common among patients who have textured breast implants compared to smooth implants, and deaths have resulted from BIA-ALCL; (2) the likelihood of developing problems increases over time; (3) some issues will require additional surgery; and (4) breast implants have not been considered lifetime devices. Visit FDA Recommendations & Guidance to read more.
Breast Implant-Associated Anaplastic Large Cell Lymphoma Questions and Answers
Breast Implant-Associated Lymphoma is a form of non-Hodgkin’s lymphoma, an immune system disease, and is not the same as breast cancer. BIA-ALCL is often seen in the fluid and scar tissue close to the implant, occasionally spreading to other body parts. Although the likelihood of getting BIA-ALCL is low, this cancer could be severe and fatal, mainly if it is not detected and treated early. Visit Food and Drug Administration Q&A to read more.
Medical Device Reports Regarding Anaplastic Large Cell Lymphoma Associated with Breast Implant
The Food and Drug Administration (FDA) received 733 medical device reports (MDRs) regarding BIA-ALCL from the US and other countries as of January 5, 2020. Check Food and Drug Administration Product Information to find out more.
The FDA urges Allergan to recall certain breast implants voluntarily.
The FDA urged Allergan, the producer of a specific type of textured implant, to recall particular types of their textured breast implants coming from the US market because of a risk regarding BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma. Check Food and Drug Administration Alerts to find out more.
Here are some Frequently Asked Questions About Allergan Breast Implant Lawsuits.
Q: How long will the lawsuit process take?
The duration of the lawsuit process can vary widely. It depends on factors such as the complexity of the case, the number of plaintiffs involved, the court’s schedule, and whether the case reaches a settlement or goes to trial. Lawsuit proceedings can take months or even years to resolve.
Q: Can individuals file a lawsuit if they have experienced complications from Allergan breast implants?
Yes, individuals who have suffered complications or injuries associated with Allergan breast implants may be eligible to file a lawsuit seeking compensation for medical expenses, pain and suffering, and other damages. Consulting with an attorney is recommended for personalized advice.
Q: How can I join the Allergan breast implant lawsuit?
To join the lawsuit, individuals typically need to find a law firm or attorney specializing in product liability or medical device litigation who is actively handling cases related to Allergan breast implants, like us at Hinds Injury Law Las Vegas. Attorneys can guide you through the process of filing a claim.
Q: Are all Allergan breast implants affected by the lawsuit?
No, the lawsuit pertains explicitly to Allergan’s textured breast implants, which the company voluntarily recalled in July 2019 due to the potential risk of BIA-ALCL.
Q: Is there a deadline to file a lawsuit against Allergan?
Yes, legal deadlines are statutes of limitations that vary by jurisdiction. It’s essential to consult with a lawyer as soon as possible to determine the applicable deadline for your case.
Q: Has the Allergan breast implant lawsuit been resolved?
The resolution of the lawsuit can vary for different individuals. Some cases have reached settlements or are in settlement negotiations, while others may still be pending in court. In addition, the results, outcome, and status of the lawsuit depend on individual circumstances and the progress of the legal proceedings.
How Do I Find an Allergan Breast Implant Attorney?
If you experienced BIA-ALCL following breast augmentation surgery which involved the implantation of Allergan breast implants, our law firm is currently accepting new Allergan lawsuits; therefore, you might have a case against Allergan. You should speak with our lawyer if you believe that Allergan’s recalled breast implants have caused you or a loved one harm. To arrange a free consultation or appointment to review your case, call Hinds Injury Law Las Vegas and start building a solid attorney-client relationship today.
Everyone impacted due to a cancer link or the Allergan BIOCELL textured breast implant recall must seek legal counsel. However, each case is distinct and must be assessed separately.
Despite allegations regarding these products, the US FDA has not revoked its approval of the medication or medical device.