Kugel® Hernia Mesh Lawsuit | 2025 Latest Updates

Kugel Hernia Mesh Lawsuit Overview

Kugel hernia mesh lawsuits target Davol Inc. and its parent company C.R. Bard over their Composix Kugel hernia mesh patches that contain defective “memory recoil rings” which can break inside patients’ bodies.

The U.S. Food and Drug Administration (FDA) has classified the Kugel mesh recall as Class I, its most serious type, reserved for devices that could predictably cause serious health problems or death [1].

As of 2008, the FDA had received nearly 100 reports of serious injuries and deaths associated with the larger versions of these patches.

The litigation expanded in January 2008 when a Federal Court judge increased the scope of lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings,” after reports of complications including bowel obstructions, adhesions, and fistula formation.

Latest Kugel Hernia Mesh Lawsuit Updates

January 8, 2008: A Federal Court judge expanded the scope of the Hernia Patch Lawsuit to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.”

This significant expansion substantially increases the number of potential plaintiffs who can pursue compensation for mesh-related injuries [2].

December 2007: The FDA initiated an investigation into the manufacturing practices at Davol’s facility following numerous complaints about Kugel mesh defects, including buckled mesh, patch shriveling, and edges curling up, in addition to the breaking memory recoil rings that prompted the initial recalls.

December 2005: Davol Inc. issued a recall for the larger versions of the Kugel Mesh Hernia Patch after finding a link between the patches and serious side effects.

The recall was prompted by reports of the “memory recoil ring” breaking under the stress of placement in the abdomen, leading to severe complications including bowel obstructions, perforations, and chronic intestinal fistulae.

Kugel Hernia Mesh Statistics and Usage Data

Understanding the scope of Kugel hernia mesh usage and associated complications provides context for the ongoing litigation:

• Approximately 750,000 hernia repair surgeries are performed annually in the United States.
• A significant percentage of these surgeries involve the use of hernia mesh products.
• The FDA received nearly 100 reports of serious injuries and deaths associated with the larger versions of the Kugel Mesh Hernia Patch.
• Studies show that Kugel repair has a recurrence rate of 6.3%, compared to 1.1% for Lichtenstein repair techniques.
• 1.6% of patients in the Kugel patch group experienced severe chronic pain in the inguinal region.
• The economic impact of hernia mesh complications includes costs for revision surgeries, extended hospitalizations, and lost productivity.
• Healthcare costs associated with hernia mesh complications can exceed $50,000 per affected patient.

FDA Reports on Kugel Hernia Mesh

The FDA has closely monitored the Kugel hernia mesh since reports of complications began emerging:

• As early as August 2001, the FDA began receiving reports of complications and failures of the Kugel mesh patch.
• By December 2005, enough adverse event reports had accumulated to warrant a Class I recall of larger Kugel mesh patches.
• The FDA has received reports describing problems beyond memory recoil ring breakage, including “buckled mesh,” “patch shriveling,” and “edges curled up”.
• Additional reports describe mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated,” and “folded”.
• The FDA continues to monitor adverse events related to all hernia mesh products, including the Kugel patch.
• The FDA advises patients who have received hernia mesh to obtain information on the manufacturer, brand name, Unique Device Identifier (UDI), and material from their doctor’s office or from the hospital where their surgery was performed.

Kugel Hernia Mesh Injuries & Side Effects

The Kugel Mesh Hernia Patch has been associated with numerous serious complications when the memory recoil ring breaks or when the mesh fails to function properly.

These complications can emerge months or even years after implantation.

• Bowel Perforation: Broken rings or migrating mesh can puncture the intestines, causing severe infections, sepsis, and potentially life-threatening conditions requiring emergency surgery.
• Bowel Obstruction: The mesh or broken ring can block the intestines, preventing normal passage of food and waste, causing severe pain, vomiting, and requiring urgent medical intervention.
• Chronic Intestinal Fistulae: Abnormal connections form between the intestines and other organs or the skin, allowing intestinal contents to leak into areas where they shouldn’t be, leading to infections and nutritional problems.
• Infection: Bacterial colonization of the mesh material can lead to chronic infections that are difficult to treat with antibiotics alone and often require surgical removal of the mesh.
• Adhesions: Scar tissue forms between the mesh and surrounding tissues or organs, causing chronic pain and potentially leading to bowel obstruction or infertility.
• Hernia Recurrence: Failure of the mesh to properly support the abdominal wall can allow the hernia to return, necessitating additional surgery.
• Chronic Pain: Persistent discomfort in the surgical area that may be debilitating and significantly impact quality of life.

Kugel Patch Post-Surgery Care and Rehabilitation

Do You Qualify for a Kugel Hernia Mesh Lawsuit?

You may qualify for a Kugel hernia mesh lawsuit if:

• You underwent hernia repair surgery where a Composix Kugel Mesh Patch was implanted.
• Your surgery occurred before the recall in December 2005 or you received a patch from recalled lots.
• You experienced complications such as bowel perforation, obstruction, infection, adhesions, or required revision surgery.
• Your complications required medical intervention, including additional surgeries, hospitalization, or ongoing treatment.
• You can provide medical records documenting both your original hernia repair surgery and subsequent complications.

Even if you’re unsure whether you received a Kugel mesh patch specifically, you may still qualify if you experienced unusual complications following hernia repair surgery.

Many patients were not informed of the specific type of mesh used in their procedure.

Evidence Required for a Kugel Hernia Mesh Lawsuit

To build a strong case for your Kugel hernia mesh claim, you’ll need to gather the following types of evidence:

• Medical Records: Documentation of your original hernia repair surgery, including operative reports that may identify the specific mesh product used.
• Product Identification: Information about the specific Kugel mesh product implanted, including lot numbers if available.
• Complication Documentation: Medical records detailing your complications, treatments, additional surgeries, hospitalizations, and ongoing care.
• Physician Statements: Statements from your surgeon or other medical providers connecting your complications to the Kugel mesh.
• Imaging Studies: CT scans, MRIs, or X-rays showing the broken ring or other mesh complications.
• Explant Records: If your mesh was removed, pathology reports and surgical notes documenting the condition of the mesh.

Damages You Can Recover

If successful in your Kugel hernia mesh lawsuit, you may be entitled to compensation for various damages, including:

• Medical Expenses: Costs for additional surgeries, hospitalizations, medications, and ongoing treatments related to mesh complications.
• Lost Income: Compensation for wages lost due to inability to work during recovery from complications and treatments.
• Pain and Suffering: Damages for physical pain and emotional distress caused by mesh complications.
• Permanent Disability: Compensation for long-term or permanent impairments resulting from mesh complications.
• Loss of Quality of Life: Damages for limitations on daily activities, hobbies, and family relationships.
• Punitive Damages: In cases where manufacturers are found to have acted with gross negligence, additional damages may be awarded to punish wrongdoing.

Detailed History of the Kugel Hernia Patch Development

According to a study published in the World Journal of Methodology in July 2021, the Composix Kugel hernia mesh patch, a groundbreaking innovation in hernia repair surgery, has a rich history that traces its evolution over the years.

Developed by Davol Inc., whose parent company is C.R. Bard, this Bard-Davol Kugel patch was designed to offer a minimally invasive solution for hernia repair surgery.

Robert Kugel placed a sutureless mesh in the PPS in 1999, and this mesh is known as the Kugel hernia patch. This patch was later modified to a so-called “direct Kugel patch” for placement of the mesh by means of a minimal incision in the IL. Double-sided polypropylene mesh (e.g., Prolene Hernia System; Ethicon, Inc.) and the direct Kugel patch have become widespread on a commercial basis.- Tomohide Hori, Department of Surgery, Shiga General Hospital.

However, the journey of the Kugel Patch wasn’t without challenges. Over time, reports emerged that the memory recoil ring of the Kugel patch had the potential to buckle or break, leading to complications.

Despite these hurdles, the Composix Kugel hernia mesh patch remains a testament to medical innovation, reflecting the continuous quest for better surgical solutions.

Kugel Hernia Mesh Recall Information

The Kugel Hernia Mesh recall process unfolded in several phases as additional safety concerns emerged:

• December 2005 Initial Recall: Davol Inc. recalled the larger versions of the Composix Kugel Mesh Patch after discovering that the “memory recoil ring” could break under stress, causing serious complications.
• March 2006 Expanded Recall: The recall was extended to include additional lots of the large oval and large circle Composix Kugel Mesh patches.
• January 2007 Further Expansion: Davol expanded the recall again to include several other sizes and lots of the Composix Kugel Mesh patches.
• FDA Classification: The FDA classified these recalls as Class I, its most serious category, indicating a reasonable probability that use of the product would cause serious adverse health consequences or death.
• January 2008 Litigation Expansion: A Federal Court judge expanded the scope of lawsuits to include all Davol/Bard Marlex/Teflon patches, regardless of whether they contained the memory recoil ring.

The FDA advised that patients who received Kugel mesh products before the recalls who are not experiencing symptoms do not need to take action.

However, anyone experiencing symptoms that could be related to ring breakage or mesh complications should seek medical attention immediately.

Technical Aspects of the Kugel Mesh Patch

At its core, the Kugel mesh patch is a marvel of medical engineering. Comprising two layers of mesh surrounding a flexible “memory recoil ring”, the design of the Kugel patch allows for easy insertion through a small incision.

Once inside, the memory recoil ring expands, positioning the kugel patch securely over the herniated area.

According to a May 2020 study published in the ANZ Journal of Surgery, here’s a general overview of how the Kugel Mesh Patchworks:

1. Placement:
   • During hernia repair surgery, the Kugel Mesh Patch is positioned over the hernia defect, which is the weakened or damaged area in the abdominal wall.
2. Material:
   • The patch is typically made of a synthetic material, often polypropylene, which is a durable and commonly used material in hernia mesh devices.
3. Design:
   • The Kugel Mesh Patch is named for its innovative design, which includes a flexible, spring-like ring that allows the mesh to be folded for insertion through a smaller incision. Once in place, the ring springs open, securing the mesh over the hernia defect.
4. Reinforcement:
   • The mesh serves as a physical barrier, reinforcing the weakened abdominal wall and preventing the protrusion of tissues through the hernia opening.
5. Tissue Integration:
   • Over time, the patient’s tissues are expected to grow into and around the mesh, creating a more stable and integrated repair. This process is known as tissue ingrowth.
6. Healing and Recovery:
   • As the tissues heal and the mesh provides support, the patient is expected to experience reduced symptoms and a lower risk of hernia recurrence.

Kugel Mesh Compared to Other Hernia Repair Products

The medical market offers various hernia mesh products, each with its unique features and benefits. The Composix Kugel hernia mesh patch stands out for its innovative “memory recoil ring” design, but how does the Kugel patch compare to others?

For instance, the traditional gold standard Lichtenstein onlay mesh repair (LMR), another popular choice, boasts flexibility and elasticity.

According to ScienceDirect, a study presented at the 30^th Annual Meeting of the Association for VA Surgeons in May 2006, compared Prolene Hernia System (PHS) mesh repair to the LMR for inguinal hernias [3].

The authors hypothesized that the recurrence rate of PHS mesh would be lower compared with the LMR with overall similar complication rates.

For the study, the researchers reviewed 622 charts during two distinct time periods, with 321 associated with PHS mesh and 302 with LMR.

The median follow-up for this study extended to 17 months. No statistically significant differences were observed concerning age, race, gender, or comorbidities between the two groups.

Additionally, in the PHS mesh group, there was a trend toward decreased overall complication rates with significantly lower seroma/hematoma rates. Therefore, the PHS mesh repair may represent a superior alternative for the repair of inguinal hernias. – Dr. Samir S. Awad, Professor and Vice-Chair for Surgical Quality and Safety in the Division of Trauma, Bariatric, and Acute Care Surgery at Baylor College of Medicine.

On the whole, a noticeable trend toward reduced complications was evident in the PHS mesh group as opposed to the LMR group (PHS mesh = 17%, LMR = 23%, P = .07), particularly marked by a significant variance in hematoma/seroma rates (PHS mesh = 6.9%, LMR = 12.6%, P = .015), the authors said.

Lastly, a notable decrease in the recurrence rate was identified in the PHS mesh group when compared to the LMR group (PHS mesh = 0.6%, LMR = 2.7%, P = .04).

Our study shows, during a median follow-up of 17 months, improved outcomes by using the PHS mesh compared with the gold standard Lichtenstein onlay mesh for inguinal hernias with significantly lower recurrence rates.

Kugel Hernia Patch Complications and Outcomes

A 2009 study by the Ulster Medical Journal compared the immediate and long-term postoperative outcomes of Lichtenstein and Kugel repair of inguinal hernia [4].

Between 1996 and 2006, a series of 219 consecutive individuals underwent inguinal hernia repair, with 92 undergoing a conventional Lichtenstein repair and 127 opting for a Kugel patch procedure.

An examination of patient characteristics, the duration of postoperative hospital stays, and complication rates was conducted through a retrospective analysis of medical records.

The evaluation of recurrence and persistent groin pain was carried out using postal questionnaires, with a subsequent telephone interview for those who did not respond. Individuals presenting symptoms or evident groin swelling underwent reevaluation by one of the authors.

The average monitoring duration encompassed 60 months (spanning from 9 to 132 months). Similar occurrences of immediate complications were noted in both groups.

There was no significant difference in the immediate complication rates between the two groups. Although recurrence and chronic groin pain rates are higher with Kugel repair, this was not statistically significant.- Bobby Dasari, Dept of Colorectal surgery, Royal Victoria Hospital.

Regarding recurrence rates, Lichtenstein repair demonstrated a rate of 1.1%, while the Kugel patch group exhibited a higher rate at 6.3% (p = 0.09).

Notably, none of the individuals in the Lichtenstein group reported severe chronic pain in the inguinal region, while 1.6% of patients in the Kugel patch group experienced such complaints.

Statute of Limitations for Kugel Hernia Mesh Lawsuits

The time limit to file a Kugel hernia mesh lawsuit varies by state and depends on several factors:

• Product Liability Statutes: Most states have a 2-4 year statute of limitations for product liability claims, starting from when the injury was discovered or should have been discovered
• Discovery Rule: Many states apply a “discovery rule,” meaning the statute of limitations begins when you discover or reasonably should have discovered that your injury was caused by the Kugel mesh
• Tolling Provisions: Some states have “tolling” provisions that can extend the statute of limitations in certain circumstances, such as when the manufacturer concealed information about product defects
• Special Considerations: If the patient died as a result of complications, wrongful death statutes of limitations may apply instead, which are typically 1-3 years from the date of death

Given these variations and complexities, it’s crucial to consult with an experienced attorney as soon as possible if you believe you have been injured by a Kugel hernia mesh. Waiting too long could permanently bar your right to seek compensation.

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FAQs

1. How do I know if I have a Kugel hernia mesh patch?

You can determine if you have a Kugel hernia mesh patch by reviewing your surgical records, operative report, or implant card. If these aren’t readily available, your surgeon or the hospital where your procedure was performed should have records of the specific mesh product used in your surgery.

2. What symptoms might indicate a problem with my Kugel hernia mesh?

Symptoms that may indicate complications with your Kugel hernia mesh include persistent or new abdominal pain, fever, nausea, vomiting, inability to pass gas or stool, abdominal swelling or distension, redness or drainage at the surgical site, and recurrence of the hernia. These symptoms warrant immediate medical attention.

3. How long after my hernia surgery might complications from a Kugel mesh appear?

Complications from Kugel hernia mesh can appear anywhere from days to years after implantation. Some patients experience problems immediately after surgery, while others may develop complications months or even years later when the memory recoil ring breaks or the mesh migrates.

4. What should I do if I suspect my Kugel hernia mesh is causing problems?

If you suspect your Kugel hernia mesh is causing problems, seek immediate medical attention, especially if experiencing severe pain, fever, or signs of infection. Contact your surgeon to discuss your concerns, obtain and review your medical records, and consult with an attorney experienced in hernia mesh litigation.

5. Can I file a lawsuit if my Kugel hernia mesh was implanted years ago?

Yes, you may still be able to file a lawsuit even if your Kugel hernia mesh was implanted years ago. Many states apply a “discovery rule,” which means the statute of limitations begins when you discover or reasonably should have discovered your injury was related to the mesh, not when it was implanted.

6. What is the average settlement amount for Kugel hernia mesh lawsuits?

Settlement amounts for Kugel hernia mesh lawsuits vary widely depending on factors such as severity of injuries, medical expenses, lost wages, and individual case circumstances. While some cases have settled for tens of thousands of dollars, others involving more severe complications have resulted in settlements or verdicts of hundreds of thousands or even millions.

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

No, you do not necessarily need to have your Kugel mesh removed to file a lawsuit. Many successful claims have been brought by patients who still have the mesh implanted but have experienced complications. However, if your mesh has been removed, the explanted device can provide valuable evidence for your case.

8. What are the risks associated with the Kugel Patch in hernia repair?

Risks associated with the Kugel Patch include infection, pain, mesh migration, and adhesion to internal organs. Some patients may also experience allergic reactions to the materials used in the patch, bowel obstruction, perforation, or the formation of abnormal passages (fistulae) between organs.

9. How does a laparoscopic hernia repair surgery differ from open surgery?

Laparoscopic hernia repair is minimally invasive, using small incisions and a camera to guide the surgeon. It generally results in less pain, shorter recovery time, and smaller scars compared to open surgery, though it may be more costly due to increased technology and operating room time.

10. What complications can arise from a defective Kugel Patch?

Complications from a defective Kugel Patch can include bowel perforation, fistulas, chronic pain, and the need for additional surgeries to remove or replace the patch. These complications can be serious and require immediate medical attention, potentially leading to long-term health issues or even death in severe cases.

See all related medical device lawsuits our lawyers have taken on.

Get a Free Kugel® Hernia Mesh Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for injuries caused by Kugel hernia mesh. Most states impose a statute of limitations of 2-4 years from when you discovered or should have discovered your injury was related to the mesh. Waiting too long could permanently bar your right to seek compensation.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your potential Kugel hernia mesh claim
• No upfront costs or fees – we only get paid if you receive compensation
• Experienced representation from attorneys specializing in defective medical device litigation
• Comprehensive support gathering medical records and evidence of product defects
• Access to medical experts who can establish the connection between your Kugel mesh and your injuries

Don’t risk losing your right to compensation – contact our experienced team today to discuss your case and explore your legal options.

Free Case Evaluation: Again, if you have problems following hernia surgery, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

References

1. https://www.fda.gov/medical-devices/surgical-mesh-used-hernia-repair/surgical-mesh-used-hernia-repair-information-patients
2. https://www.aboutlawsuits.com/kugel-mesh-hernia-patch-lawsuit-expanded-2/
3. https://www.sciencedirect.com/science/article/abs/pii/S0002961007002000
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699199/