Bard Crurasoft Hernia Patch Lawsuit | 2025 Latest Updates

Since 2005, reports of similar Bard hernia patch defects surfaced, posing potentially life-threatening risks to the thousands of Americans who had been implanted with the devices. According to various reports, the product, which consists of a “memory recoil ring” that opens once the patch has been inserted, can break and cause organ punctures and fistulas—abnormal passageways between intestinal organs.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

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Latest Bard Crurasoft Hernia Patch Lawsuit Updates

January 8, 2025 – A Rhode Island jury ordered Becton, Dickinson, and Co.’s C.R. Bard subsidiary to pay $4.8 million in a hernia mesh lawsuit. The verdict was reached after a month-long bellwether trial in Providence Superior Court.

November 13, 2023 – According to the United States District Court, the 4th bellwether trial involving C.R. Bard is scheduled to take place in January 2024 in Rhode Island state court. Plaintiff Jacob Bryan filed a class action lawsuit in Rhode Island after suffering complications following placement with a 3DMax Bard hernia mesh implant [1].

Defendants failed to warn or notify doctors, regulatory agencies, and consumers of the severe and life-threatening risks associated with polypropylene, the complaint states. Defendants were responsible for the research, design, development, testing, manufacture, production, marketing, promotion, distribution and sale of 3DMax, including providing the warnings and instructions concerning the product.

2013 – Bard previously settled 2,600 Kugel Mesh defective product cases for $184 million.As of January 2025, approximately 24,099 cases have been filed in the Rhode Island MDL, and approximately 38,000 cases have been consolidated in the Ohio MDL. Unlike class-action lawsuits, where plaintiffs are treated as a single entity, a hernia mesh MDL allows individual plaintiffs to retain their separate identities [2].

This approach streamlines the legal process, reduces redundancy, and ensures consistent rulings on common issues, while still allowing individual cases to proceed to a hernia mesh trial if necessary, the ABA said.

FDA Reports and Statistics

The U.S. Food and Drug Administration (FDA) has been monitoring hernia mesh products closely due to numerous adverse event reports:

  • The FDA received over 55,000 adverse event reports on hernia mesh devices in 2023.
  • Recent reports indicate over 100 problems, including several involving death due to complications associated with defective hernia mesh products.
  • Between 1% and 8% of hernia mesh surgeries result in infection.
  • Shrinkage rates in lightweight Physiomesh ranged from 17.7% to 35.7%.

Bard Crurasoft Hernia Patch Injuries & Side Effects

Recipients of Bard Crurasoft Hernia Patch implants have reported a range of serious complications, many requiring additional surgeries [4].

    • Pain and Discomfort: Most frequent symptom, with tenderness and bruising near the incision site. Pain may appear in the stomach, abdomen, groin, leg, or testicles.
    • Bleeding and Infection: Chronic infections may cause redness, heat, or fluid accumulation near the implant site (seroma).
    • Bowel Obstruction: Adhesions may block the large or small intestine, leading to severe complications requiring surgical intervention.
    • Erectile Dysfunction: Reported in men post-surgery, including ED, loss of sensation, and testicular shrinkage due to reduced blood supply.
    • Hernia Recurrence: Migration, adhesion, or perforation of the mesh may lead to recurrence despite initial repair.

Immediate and Long-Term Complications

Complication Severity Level Frequency of Occurrence Statistics
Bleeding Moderate 0.5% – 2.3% Hematoma incidence: 0.5% to 2.3% [6].
Infection Severe 1% – 8% Surgical site infection rates: 1% to 8% [9].
Bowel Perforation Severe Rare Less than 1% incidence [6].
Mesh Migration Moderate Estimated 2.7% Occurs in 2.7% of cases [8].
Chronic Pain Severe 0.3% – 68% Significant life impact for up to 3.8% [6].
Adhesions Moderate Up to 3.2% Adhesion formation: up to 3.2% [8].

Hernia Mesh Erosion and Shrinkage

A 2023 study in Scientific Reports highlighted high rates of hernia mesh shrinkage, which can lead to hernia recurrence [5].

Key findings include:

  • Shrinkage Rates: Lightweight Physiomesh exhibited higher shrinkage (17.7% to 35.7%) compared to medium-weight Ventralight mesh (19.3% to 22.2%).
  • Anchor Impact: Mesh shrinkage was higher with metal tacks like ProTack™ compared to sutures or other anchors.
  • Postoperative Impact: Shrinkage remains a leading cause of hernia recurrence despite advancements in mesh design.

The postoperative recurrence rate of inguinal hernia has recently been greatly reduced by replacing tissue repair methods with mesh repair methods, the researchers said. However, there are still exists some cases of recurrence, and intraoperative findings in recurrent cases have revealed mesh shrinkage and migration.

Bleeding Risks

Bleeding complications are a significant concern, particularly for patients on blood thinners like warfarin or aspirin [6].

Common causes include:

  • Surgical Technique Issues: Improper port placement or trauma during mesh fixation can result in intraoperative bleeding.
  • Vascular Risks: Bleeding from arteries or veins near the surgical site is a critical concern, requiring precise surgical techniques to minimize complications.

In a 2020 study, bleeding is considered to be the most worrisome in patients requiring aspirin during surgery due to heart risk or taking blood thinners such as Coumadin (warfarin), Lovenox (enoxaparin), Plavix (clopidrogel), Xarelto (rivaroxaban), Pradaxa (dabigatran) [].

For hernia repair with mesh, additional adverse events include migration or shrinkage (contraction) of the mesh itself, which may more likely be associated with the previously mentioned complications of hernia repair. – The FDA said. 

Hernia Mesh Migration

Mesh migration can occur years after hernia repair surgery [8].

Key points include:

  • Complications: Possible fistulas, adhesions, abscesses, bowel obstruction, and severe infections.
  • Symptoms: Nausea, fever, chills, vomiting, and swelling, although some cases remain asymptomatic until a medical emergency arises.

Mesh migration is a rare consequence of incisional hernia repair with a prosthetic mesh, the researchers concluded. It can happen years after a hernia repair and it is additionally crucial to consider as a differential diagnosis in all patients who show unusual symptoms or abdominal pain.

Infected Hernia Mesh Implants

The Journal of Gastrointestinal Surgery (2022) reports that hernia mesh infections often develop months or years post-surgery [9].

Key findings include:

  • Risk Factors: Patients with obesity or type 2 diabetes face higher infection risks.
  • Deep Infections: These differ from wound infections and are typically caused by bacteria colonizing the mesh implant.
  • Prevalence: Between 1% and 8% of hernia mesh surgeries result in infection.

Bleeding can occur intraoperatively from the cremasteric artery, the internal spermatic artery, branches of the inferior epigastric vessels, deep circumflex artery and the external iliac vessels, iliac circumflex vessels, and obturator vessels, the study’s authors said. Careful surgical technique with attention to proper hemostasis and pressure generally obviates the need for formal vascular intervention.

According to a ConsumerNotice publication from 2024 [11], hernia mesh complications may be easy or difficult to identify, depending on the severity of the issue.

Hernia Mesh vs. Stitches

As stated in a 2020 study published in BJS Open, one of the significant differences between using surgical mesh and sutures is that a mesh product has the potential to move or shrink, leading to severe health complications [10], such as with a defective or polypropylene-coated mesh. Perforation can cause a severe infection called sepsis.

Mesh repair of umbilical hernia has been associated with a reduced recurrence rate compared with suture closure, but potentially at the expense of increased postoperative complications and chronic pain, the researchers said.

Do You Qualify for a Bard Crurasoft Hernia Patch Lawsuit?

You may qualify for a Bard Crurasoft Hernia Patch lawsuit if:

  • You were implanted with a Bard Crurasoft Hernia Patch.
  • You experienced serious side effects including pain, infection, bowel obstruction, or hernia recurrence.
  • Your injuries required medical treatment or hospitalization.
  • You can provide medical documentation linking your injuries to the Bard Crurasoft Hernia Patch.

Evidence Required for a Bard Crurasoft Hernia Patch Lawsuit

To support a hernia mesh lawsuit, the following documentation is essential:

  • Medical Records: Complete records of the initial hernia repair surgery and any subsequent revision surgeries
  • Surgical Reports: Detailed reports from the surgeon regarding the implantation and removal of the mesh
  • Imaging Studies: X-rays, MRIs, or CT scans that may indicate complications such as mesh migration or perforation
  • Adverse Event Reports: Any documentation related to complications experienced post-surgery

Your healthcare provider needs to keep the hernia mesh after extracting it from your body, as this will be a key piece of evidence in your case.

Damages You Can Recover

Similar to those in product liability lawsuits, damages in a hernia mesh lawsuit can include:

  • Medical expenses for treatment, surgeries, and ongoing care
  • Lost wages and loss of earning capacity
  • Pain and suffering
  • Emotional distress
  • Loss of enjoyment of life
  • Loss of consortium (compensatory damages)

In some cases, punitive damages may also be awarded if gross negligence is proven.

Bard Crurasoft Hernia Patch Recall Information

In December 2005, C.R. Bard issued a recall after learning of serious product defects. Several months later, in March 2006, after 31 more ring breaks were reported—20 of which caused patient injury—the C.R. Bard recall was expanded to include several additional products and lot numbers, including the C.R. Bard large oval patches, the C Qur mesh, Bard Sepramesh, the extra large oval patches, and the large circle surgical mesh.

The FDA has recalled Bard Kugel Mesh Hernia Patches three times, and nearly 100 reports of problems related to the patch have been received, several of which involve death.

Statute of Limitations for Bard Crurasoft Hernia Patch Lawsuits

Plaintiffs need to be aware of the statute of limitations for filing a lawsuit related to hernia mesh complications:

  • Rhode Island: 3 years from the injury’s date or discovery
  • Ohio: 2 years from the date of injury
  • California: 2 years from the date of injury or discovery
  • New York: 3 years from the date of injury

FAQs

1. How do I know if my hernia patch implant is defective?

Symptoms of a defective hernia patch implant may include severe abdominal pain, fever, swelling, redness, infection at the surgical site, bowel obstruction, and recurrence of the hernia. Consult with a healthcare provider if you experience any of these symptoms.

2. What evidence is needed to support a hernia patch lawsuit?

Evidence includes medical records documenting the implantation and complications, proof of the specific type of hernia patch used, expert medical testimony linking the patch to the complications, and documentation of related expenses and losses.

3. What compensation can be sought in a Bard Crurasoft Hernia Patch lawsuit?

Compensation can include medical expenses, lost wages, pain and suffering, emotional distress, and costs for additional surgeries or treatments. In some cases, punitive damages may also be awarded if gross negligence is proven.

4. Can I join a class-action lawsuit for hernia patch complications?

Yes, if a class-action lawsuit is filed, affected individuals may be able to join. Contact a lawyer to discuss joining the class action or filing an individual claim.

5. What is the average settlement amount for Bard hernia mesh lawsuits?

The average settlement for Bard hernia mesh claims is estimated to be between $60,000 and $100,000, although individual results may vary based on case specifics.

6. What is a surgical mesh and why might it cause complications?

Surgical mesh is a medical device used to provide additional support for weakened or damaged tissues [3]. Most mesh devices are made from synthetic materials or animal tissue. Non-absorbable mesh is designed to remain in the body indefinitely but may degrade over time, potentially leading to complications.

7. What should I do with my removed hernia mesh if I’m considering a lawsuit?

Your healthcare provider needs to keep the hernia mesh after extracting it from your body, as this will be a key piece of evidence in your case. Your healthcare provider can learn how to do this by contacting the lawyers at Schmidt & Clark, LLP.

Related Articles:

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Time is limited to pursue legal action in hernia mesh cases, with statutes of limitations ranging from 2-3 years depending on your state. Don’t delay in seeking the compensation you deserve. The Product Liability Litigation Group at Schmidt & Clark, LLP is an experienced team of trial lawyers that focus on the representation of plaintiffs in hernia mesh repair lawsuits.

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References

  1. https://www.aboutlawsuits.com/wp-content/uploads/2018-11-12-Bryan-Complaint.pdf
  2. https://www.americanbar.org/groups/young_lawyers/resources/tyl/practice-areas/mdl-vs-class-action-place-plaintiffs-and-procedure/
  3. https://www.sciencedirect.com/topics/nursing-and-health-professions/surgical-mesh
  4. https://www.fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair
  5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9995439/
  6. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
  7. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml#REF4
  8. https://misuse.ncbi.nlm.nih.gov/error/abuse.shtml
  9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9021144/
  10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7260408/
  11. https://www.consumernotice.org/drugs-and-devices/hernia-mesh/

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