Breast Implant Lawsuit | 2025 Latest Updates

Silicone breast implants have been reported to rupture, leak and fail over time, and have been linked to severe health complications including a rare type of cancer, according to the U.S. Food and Drug Administration (FDA).
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Breast Implant Lawsuit Overview

Breast implant lawsuits center around allegations that manufacturers failed to adequately warn patients and doctors about serious health risks associated with their products, particularly textured implants.

These lawsuits primarily involve claims that certain implants significantly increase the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of non-Hodgkin’s lymphoma. FDA data has linked at least 457 cases of ALCL to breast implants in the U.S. alone, with 9 confirmed deaths.

Additionally, many women report experiencing a constellation of symptoms collectively known as Breast Implant Illness (BII), which includes autoimmune disorders, chronic fatigue, and neurological problems.

Related Article: Roundup Anaplastic Large Cell Lymphoma

Latest Breast Implant Lawsuit Updates

  • JANUARY 2025: A federal judge has denied Allergan’s motion to dismiss multiple lawsuits related to their Biocell textured breast implants, allowing hundreds of cases to move forward. The judge ruled that evidence suggests Allergan may have been aware of the BIA-ALCL risk for years before issuing their worldwide recall [1].
  • NOVEMBER 2024: Johnson & Johnson’s Mentor subsidiary has agreed to a $200 million settlement to resolve claims involving their defective silicone implants that allegedly leaked and caused systemic health problems in recipients. The settlement covers approximately 4,500 women across the United States [2].
  • AUGUST 2024: The FDA has issued new safety guidelines requiring all breast implant manufacturers to include a black box warning about BIA-ALCL risks and potential systemic symptoms on product packaging. This follows evidence that cancer rates are significantly higher than previously reported, with current estimates showing a risk of 1 in 3,000 for textured implants.

FDA Update on Breast Implant ALCL Link

The FDA has updated its understanding on the risk of anaplastic large cell lymphoma (ALCL) with filled breast implants, stating that the cancer is more likely to occur in women whose devices have textured surfaces.

According to an FDA Safety Alert issued Tuesday, most data suggests that Allergan breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) occurs more frequently in women with textured breast implants compared to those with smooth devices.

ALCL is a rare form of non-Hodgkin’s lymphoma that occurs when white blood cells called lymphocytes grow out of control.

The condition typically occurs in patients undergoing Allergan breast implant revision operations for late onset, persistent seroma, according to the FDA.

As of February 1, 2017, FDA has received at least 359 medical device reports (MDRs) of BIA-ALCL [3], including 9 deaths. There were 231 reports that included information on the breast implant surface.

Of these, 203 reports involved textured implants and 28 involved smooth devices. Most of the reports contained no information about the surface textures of any previous devices.

Additionally, 312 of the 359 reports included information on Allergan breast implant fill types. Of these, 186 involved silicone implants and 126 involved saline devices.

Related: All the medical devices lawsuits we’ve taken

Allergan Breast ImplantFDA Reports and Statistics 2025 Updates

According to the FDA’s most recent safety communication, there have been at least 573 confirmed cases of BIA-ALCL worldwide, with 84% linked specifically to Allergan’s textured implants [4].

The agency’s Medical Device Reports (MDRs) show that of the 33 patients who died from BIA-ALCL, 12 were confirmed to have received Allergan Biocell textured breast implants.

The FDA’s MAUDE database shows an increasing trend in adverse event reports related to both silicone and saline implants, with over 2,500 reports filed in the past three years alone [5].

Current risk assessment data indicates the rate of developing BIA-ALCL is approximately 1 in 3,565 for Allergan textured implants compared to 1 in 16,703 for Mentor Siltex micro-textured implants.

No cases have been reported with smooth surface implants in controlled studies.

In July 2019, the FDA requested Allergan recall all Biocell textured implants and tissue expanders from the global market, which has since affected approximately 246,000 units in the United States alone.

Source: American Society for Aesthetic Plastic Surgery

Breast Implant Injuries & Side Effects

Breast implants have been associated with numerous serious health complications ranging from localized symptoms to systemic illnesses and cancer.

  • Cancer & Lymphoma: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Non-Hodgkin’s Lymphoma, and potentially increased risk of other cancers.
  • Autoimmune Disorders: Lupus, Scleroderma, Rheumatoid arthritis, and other connective tissue diseases.
  • Local Complications: Capsular contracture, implant rupture, leakage, infection, and chronic pain.
  • Neurological Issues: Cognitive dysfunction (“brain fog”), memory problems, headaches, and neuropathy.
  • Systemic Symptoms: Chronic fatigue, muscle pain, joint pain, hair loss, skin rashes, and chemical sensitivity.

Do You Qualify for a Breast Implant Lawsuit?

You may qualify for a breast implant lawsuit if:

  • You received breast implants manufactured by Allergan, Mentor, or other major manufacturers between 1990 and present.
  • You were diagnosed with BIA-ALCL or experienced symptoms consistent with Breast Implant Illness.
  • You required surgery to remove your implants due to complications or cancer risk.
  • Your health problems developed after receiving breast implants and improved following removal.
  • You can provide medical documentation linking your health issues to your breast implants.

Evidence Required for a Breast Implant Lawsuit

To successfully pursue a breast implant claim, you will need to provide:

  • Medical records confirming your breast implant surgery (including manufacturer and implant type).
  • Documentation of your diagnosis (BIA-ALCL, autoimmune disorders, or other related conditions).
  • Records of any revision surgeries, implant removals, or related treatments.
  • Timeline of symptom development relating to your implants.
  • Confirmation from your physician connecting your health issues to your breast implants.

Damages You Can Recover

Through a successful breast implant lawsuit, you may be entitled to compensation for:

  • Past and future medical expenses, including diagnosis, treatment, and implant removal costs.
  • Lost wages and diminished earning capacity due to your condition.
  • Pain and suffering, both physical and emotional.
  • Permanent disfigurement or disability resulting from implant complications.
  • Punitive damages against manufacturers who knowingly concealed risks.

Filled Breast Implants

Breast Implant Recall Information

In July 2019, Allergan issued a worldwide recall of their Biocell textured breast implants and tissue expanders after the FDA requested their removal from the market [6].

This recall affected all Biocell textured breast implants, including:

  • Natrelle Saline-Filled Breast Implants
  • Natrelle Silicone-Filled Textured Breast Implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

This action followed similar recalls and restrictions in France, Australia, and Canada [7].

Health Canada suspended sales of Allergan implants in May 2019 after a safety review found that 85% of Canadian BIA-ALCL cases involved Biocell textured implants [8].

These incidents are part of a broader pattern of concerns surrounding breast implant surgeries, particularly with certain manufacturers.

A growing number of individuals are seeking justice and compensation for the injuries and damages caused by these procedures, including life-altering accidents.

Below are some of the significant cases that highlight the severity of these issues and the ongoing legal battles surrounding them.

Breast Implant Surgery Leaves Teen With Brain Damage

A Colorado family is suing a doctor and a nurse anesthetist, claiming that their daughter suffered 2 cardiac arrests and brain damage during Allergan breast implant surgery in Greenwood Village, according to CBS 46.

The patient, 18-year-old Emmalyn Nguyen, was left unattended for 15 minutes after being given anesthesia by nurse anesthetist Rex Meeker, according to the lawsuit.

During that time, Nguyen went into cardiac arrest and was revived, but then went into cardiac arrest a second time.

The staff failed to call 911 for more than 5 hours, leaving Nguyen in a “minimally conscious state” — unable to speak, walk, eat or take care of herself, a condition she will likely be in for the rest of her life.

To me it’s a miracle she pulled through all that and she is still fighting this. I don’t know how they can sleep at night knowing they did this to her. They ruined Emmalyn’s life, not just hers but all of ours.”- Sonny Nguyen, Emmalyn’s Father

Read More: Medical Malpractice Lawsuits

Breast Implant Cancer

Illinois Woman Sues Allergan for Not Recalling Breast Implants Sooner

A woman from Illinois on Friday filed a class action lawsuit against Allergan Inc [9].

She alleges that the company knew about the risk of cancer with its textured breast implants long before it recalled the devices, according to Law360 [10].

Plaintiff Lana Tauben further claims Allergan used an FDA loophole to bury adverse event reports associated with the implants, and it wasn’t until 2017 when the agency tightened its requirements that many of the injuries were made public.

The lawsuit is: Tauben v. Allergan PLC, Allergan Inc and Allergan USA. U.S. District Court for the Central District of Illinois. Case Number 1:2019cv02257.

Allergan Won’t Pay for Breast Revision Surgery After Failing to Warn About Textured Implants, Class Action Alleges

A new class action lawsuit is claiming that Allergan Inc. used regulatory loopholes to hide a link between its textured silicone-filled implants and breast-implant-associated anaplastic large-cell lymphoma (BIA-ALCL), and is now refusing to pay for surgery to remove the implants following a worldwide Allergan breast implant recall [11].

The complaint, filed in California federal court, alleges that Plaintiffs “A.B.” and “C.D.” were diagnosed with BIA-ALCL after receiving Allergan textured breast implants, and are now being forced to pay out of their own pockets to have the implants removed.

According to the class action, there are 573 cases of BIA-ALCL known in the medical literature, and 84% of them have been linked to Allergan textured implants.

Of the 33 patients who died, 12 had received Allergan Biocell textured breast implants, the complaint states.

Scar Tissue

Dozens More Lymphoma Cases Linked to Breast Implants, FDA Warns

At least 457 women in the U.S. have been diagnosed with anaplastic large cell lymphoma, FDA said in its warning [12].

Of these, 9 died as a result of complications from the disease. ALCL is a rare cancer that affects cells in the immune system, and can be found around the Allergan breast implant.

FDA first warned about the risk of lymphoma with certain silicone-filled breast implants in 2011, saying there was a small but significant risk of developing the cancer after getting filled breast implants.

Most people are diagnosed with ALCL at an advanced stage (stage 3 or 4), which means the cancer has likely spread to other parts of the body.

Biocell Textured Breast Implants

Are Lawsuits Being Filed?

Yes. There are currently a number of lawsuits pending against breast implant manufacturers.

In 2012, an Arizona woman filed a lawsuit (PDF) against Allergan, alleging that she suffered a number of complications from Natrelle silicone breast implants, including neurological problems and vision loss.

Plaintiff received the implants in 2009 and was subsequently required to undergo a bilateral mastectomy due to breast cancer.

She alleges that Allergan textured breast implants were defectively designed and also claims that she was unwittingly enrolled in a safety study without consent.

A Seattle woman filed a lawsuit (case no. 2:16-cv-07316-DMG) in September 2016 against Mentor Worldwide LLC and its parent company, Johnson & Johnson Services, Inc., alleging that the companies failed to follow requirements imposed by the FDA in connection with Mentor’s premarket approval application.

The suit also accuses the manufacturers of failing to warn of the potential health risks of Allergan breast implant surgery.

A product liability lawsuit filed in California in February 2017 alleges that breast implants sold by Johnson & Johnson’s Mentor subsidiary are defective and prone to leaks.

The complaint was filed by Plaintiff Rexine Mize, who claims that leaking breast implants caused her severe muscle pain, nausea, and scar tissue.

Statute of Limitations for Breast Implant Lawsuits

The time limits for filing a breast implant lawsuit vary by state but generally range from 1-6 years from the date of injury or discovery.

Most states apply a “discovery rule,” meaning the statute of limitations begins when you knew or reasonably should have known about your injury and its connection to your breast implants.

Key state-specific timeframes include:

  • California: 2 years from discovery
  • New York: 3 years from discovery
  • Florida: 4 years from discovery
  • Texas: 2 years from discovery
  • Illinois: 2 years from discovery

Because breast implant injuries often develop gradually and may not be immediately connected to the implants, many courts have allowed extensions based on when the patient reasonably could have made the connection between their implants and their health problems.

Other Implant Failure Lawsuits We’ve Taken:

FAQs

1. Are There Current Lawsuits Against Breast Implant Manufacturers?

Yes, several lawsuits have been filed against manufacturers like Allergan and Mentor, claiming defects that led to health problems including cancer and systemic symptoms attributed to Breast Implant Illness.

2. What Complications Are Linked to Breast Implants?

Complications include Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), systemic symptoms referred to as Breast Implant Illness, and other issues like implant rupture or leakage.

3. How Do I Know if I Qualify to File a Breast Implant Lawsuit?

If you experienced significant health issues such as cancer, systemic symptoms, or other severe reactions after receiving breast implants, you might qualify to file a lawsuit and should consult with a specialized attorney.

4. What is the difference between BIA-ALCL and Breast Implant Illness?

BIA-ALCL is a specific type of lymphoma (cancer) that develops in the scar tissue around breast implants, primarily textured ones. Breast Implant Illness refers to a collection of systemic symptoms including fatigue, joint pain, and cognitive issues that some women report after receiving implants.

5. How long do I have to file a breast implant lawsuit?

The timeframe varies by state but is typically 2-4 years from when you discovered or should have discovered your implant-related injury. Consulting with an attorney promptly will help ensure you meet all deadlines.

6. What compensation amounts are typical in breast implant lawsuits?

Compensation varies widely depending on injury severity, medical costs, and other factors. BIA-ALCL cases often result in higher settlements (often exceeding $500,000) than Breast Implant Illness cases, which typically range from $15,000 to $250,000.

7. Will I need to have my implants removed to file a lawsuit?

While not always required, having implants removed strengthens cases by confirming the implant type and demonstrating the seriousness of your concerns. Removed implants may also provide important evidence.

Related: All the medical devices lawsuits we’ve taken

Choose our lawyers

Have you or a loved one suffered severe pain or injury from a defective medical device?

Get Your Free Breast Implant Lawsuit Evaluation From Our Lawyers

Time is limited to pursue legal action for breast implant-related injuries. Most states only allow 2-4 years from the date you discovered (or should have discovered) your injury to file a claim.

Waiting too long could permanently forfeit your right to compensation for medical bills, pain and suffering, and other damages.

At Schmidt & Clark, LLP, we offer:

  • Free, confidential consultations to evaluate your case
  • No upfront costs or attorney fees – we only get paid if you win
  • Experienced representation from attorneys who have successfully handled medical device litigation
  • Personalized attention to your case from start to finish

Again, if you or a loved one has been diagnosed with cancer or had a doctor suggest breast implant removal because of a predisposition of cancer, you should contact our law firm immediately.

You may be entitled to a settlement by filing a breast implant cancer lawsuit and our attorneys can help.

References

  1. https://www.law360.com/articles/1201893/allergan-hit-with-suit-over-recalled-breast-implants
  2. https://people.com/health/fda-warns-breast-implants-increase-risk-of-cancer-lymphoma/
  3. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
  4. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239996.htm
  5. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma
  6. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
  7. https://www.cbc.ca/news/health/biocell-breast-implants-canada-ban-1.5153419
  8. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtmlhttps://dockets.justia.com/docket/illinois/ilcdce/2:2019cv02257/77789
  9. https://dockets.justia.com/docket/illinois/ilcdce/2:2019cv02257/77789
  10. https://www.law360.com/articles/1193314/patients-claim-allergan-covered-up-risks-of-breast-implants
  11. https://www.law360.com/articles/1193314/patients-claim-allergan-covered-up-risks-of-breast-implants
  12. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630895.htm

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