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Side Effects of the Bard Crurasoft™ Hernia Patch

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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November 13, 2023, C.R. Bard Bellwether Trial Update

According to the United States District Court, the 4th bellwether trial involving C.R. Bard et al, which is scheduled to take place in Jan. 2024 in Rhode Island state court, features plaintiff Jacob Bryan in the case management conference. In 2018, Bryan filed a class action lawsuit in Rhode Island after suffering complications following placement with a 3DMax Bard hernia mesh implant [1].

These complications, including hernia mesh deformation and ongoing pain, have led to a continued need for medical care and potentially additional surgery for Bryan, according to the Rhode Island class action lawsuit.

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.

Central to Bryan’s bellwether trial class action MDL are allegations similar to those in other Bard hernia mesh cases. Bryan claims in the Rhode Island bellwether test trial that C.R. Bard and Becton Dickinson, or BD, failed to adequately warn the public and medical community about the risks associated with the Bard hernia mesh.

This includes allegations of failing to mention known risks and downplaying the potential seriousness and frequency of adverse effects. The Bard hernia mesh lawsuit also raises questions about the design and manufacturing of the 3DMax hernia mesh, suggesting that flaws in these areas may have contributed to the complications suffered by recipients.

The C.R. Bard Hernia Mesh Ring May Break and Cause Pain, Infection, and Other Complications.

Hernia Mesh MDL

According to the American Bar Association 2021 publication, Bard Hernia mesh patch lawsuits filed in Rhode Island state court have evolved into multidistrict litigations (MDLs), a legal mechanism that consolidates similar lawsuits against a common defendant for pretrial proceedings. 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.

What is a Surgical Mesh?

As stated by ScienceDirect, 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.

Surgical mesh constructed from synthetic materials can be found in knitted mesh or non-knitted sheet forms, while synthetic materials may be absorbable, non-absorbable, or a combination of the two.

Animal-derived meshes are composed of animal tissue that has been processed and disinfected to be used as an implanted device. These animal-derived meshes are absorbable, and most tissues used to produce these implants are from a pig or cow source.

Non-absorbable mesh is designed to remain in the body indefinitely; however, these products may degrade over time. These meshes are used to provide permanent reinforcement to the repaired hernia.

The absorbable mesh will be absorbed and lose strength over time and is not intended to provide permanent reinforcement to the repair site. As the material is absorbed, new tissue growth is intended to provide strength to the repair site.

Bard Hernia Mesh Complications

According to the U.S. Food and Drug Administration (FDA) 2023 notice [4], C.R. Bard hernia mesh implants have been linked to the following adverse health complications:

  • Erosion
  • Adhesion
  • Bowel obstruction
  • Infection
  • Recurring hernias
  • Fistulas
  • Perforations
  • Internal bleeding
  • Seromas
  • Migration
  • Mesh shrinkage
  • Chronic pain

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 erosion and shrinkage

A 2023 study published in Scientific Reports found high rates of hernia mesh shrinkage or contraction following hernia repair surgery. The shrinkage of hernia mesh is a common reason for hernia recurrence [5].

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.

It is a common misconception that because hernia mesh is not biologically inert, all hernia mesh will experience some level of shrinkage after it has been implanted. However, the degree of shrinkage depends on the type of mesh used and its means of anchoring.

Mesh shrinkage depends on the properties of the mesh and its anchoring device: in a long-term experimental study conducted on sheep, 2 mesh forms were used, Physiomesh (large pore, lightweight) and Ventralight (small pore, mediumweight), with 3 forms of anchor, ProTackTM, SecurestrapTM or GlubranTM.

Shrinkage of Physiomesh was significantly higher (17.7% to 35.7%) than that of Ventralight (19.3% to 22.2%), but it was observed that shrinkage was higher with the Protack anchor than with either Glubran or Securestrap.

Additionally, it is said that mesh fixation can be done either with sutures or with metal tacks, and in one study it was observed that shrinkage was greater when tacks were used than when sutures were used.


According to a 2020 study published in Cureus, bleeding is another common complication following hernia surgery [6]. Small hematomas (localized bleeding into the wound) are not uncommon post-inguinal hernia surgery and typically resolve without medical intervention within a few weeks. Bleeding during inguinal hernia can occur due to vessel dissection, improper port placement, or trauma during fixation of the mesh with tackers.

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.

As stated by the National Center for Biotechnology and Information in their 2020 study, bleeding is most worrisome in patients who require aspirin during surgery due to heart risk or take blood thinners such as Coumadin (warfarin), Lovenox (enoxaparin), Plavix (clopidrogel), Xarelto (rivaroxaban), Pradaxa (dabigatran) []. The risk of a heart attack or blood clot while off the blood thinner should be balanced against the risk of bleeding from the hernia surgery.

Hernia Mesh Migration

According to the Caspian Journal of Internal Medicine research from 2022, during hernia repair surgery, the surgeon sews the surgical mesh implant into the abdominal wall. Mesh migration may occur in cases where the mesh detaches and moves out of its original position [8]. Migration can lead to complications including fistulas, adhesions, abscesses, and bowel obstruction. It can also cause infections.

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.

Additional symptoms of hernia mesh migration include nausea, fever, chills, vomiting, swelling, redness, skin irritation, fluid buildup, and weight loss. It’s also possible that no symptoms will present until the migrated mesh creates a medical emergency.

Infected hernia mesh implants

According to a 2022 study published in the Journal of Gastrointestinal Surgery [9], hernia mesh infection occurs when bacteria develop on mesh replacement devices, causing symptoms including fever, inflammation, and pain. Some types of mesh are more likely to become infected, and the risk of infection goes up in patients with additional health issues such as obesity or type 2 diabetes.

Hernia mesh infections are deep infections that occur around the mesh implant. They are different from wound infections that occur at the surgical site.

Infections in mesh implants typically develop within months or even years following hernia mesh surgery. This complication may occur because of poorly designed mesh. Studies have found that between 1 and 8% of people who had mesh hernia repair surgery may experience an infection.

Hernia Mesh vs. Stitches

As stated in a 2020 study published in BJS Open, one of the big 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]. This is particularly true if the mesh is defective or contains a polypropylene coating. If a perforation occurs, this 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.

If you were implanted with a hernia mesh device, symptoms of mesh failure may include constipation, fatigue, fever, irritable bowel, severe pain, and urinary issues. If you notice any of these symptoms, you should consult your healthcare provider immediately. Unfortunately, hernia mesh complications can occur within days to even years after hernia mesh surgery.

It’s important for your healthcare provider 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 find out how to do this by contacting the lawyers at Schmidt & Clark, LLP.

Symptoms of Hernia Mesh Failure

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.

Pain and Discomfort
The most common symptoms of hernia mesh failure are pain and discomfort, which may be accompanied by bruising or swelling. These symptoms may be linked to a skin rash near the bulge or incision.

Depending on the type of hernia, pain may occur near the stomach, abdomen, groin, leg, or testicles. In some cases, tenderness and pain may be the only symptom of hernia mesh complications.

Bleeding and Infection
Chronic infections are another common complication of hernia mesh failure. Some infections may be severe, causing patients to see redness and feel heat near the area of the repair.

Hernia mesh failure may also lead to an increased risk of seroma, which is when fluid accumulates near the implant site. The buildup of fluid may cause secretions, which could potentially lead to an infection.

Bowel Obstruction
An inability to use the bathroom could be an indicator of hernia mesh failure. Bowel obstruction is a blockage that develops in the large or small intestine, causing difficulty with urinating or defecating.

A bowel obstruction may be caused by an adhesion, which occurs when scar tissue adheres to the mesh. In severe cases, bowel removal may be necessary.

Erectile Dysfunction
Patients with hernia mesh failure may suffer changes in sexual functions, such as the inability to become physically aroused. Specifically, men who have undergone hernia repair surgery have reported erectile dysfunction (ED), loss of sensation, and difficulty achieving orgasm.

Some patients also reported swelling, slight pain, harness, and a reduction in testicle size. Studies have found that hernia mesh complications may reduce blood supply to the testicles, which may require testicular removal surgery.

Hernia Recurrence
Research shows hernia recurrence is less likely when hernias are repaired with mesh; however, it is possible for a hernia to return. A variety of hernia mesh complications, such as migration, adhesion, fistula, and perforation, may lead to recurrence.

Eligibility Criteria for Filing a Bard Hernia Mesh Lawsuit

To file a C.R. Bard hernia mesh lawsuit, potential plaintiffs must meet specific eligibility criteria. Typically, these criteria include having undergone C.R. Bard hernia repair surgery where hernia mesh was used, experiencing complications or injuries believed to be caused by the hernia mesh devices, and undergoing or being recommended for revision surgery to address these complications.

It’s crucial for affected individuals to consult with legal professionals to assess their eligibility and understand the potential legal remedies available to them.

How to Choose a Bard Hernia Mesh Lawyer

Choosing the right lawyer for a hernia mesh lawsuit is pivotal. Given the complexity of these cases and the formidable resources of hernia mesh manufacturers, it’s essential to select an attorney with a track record of handling hernia mesh MDL against large corporations.

Experience in medical device lawsuits, a deep understanding of the medical implications, and a commitment to client advocacy are key attributes to look for. Potential plaintiffs should also consider the attorney’s past settlements and verdicts, client testimonials, and their approach to client communication.

Detailed Monthly Updates on C.R. Bard Mesh MDL Case Numbers by Manufacturer

Staying updated on the progression of hernia mesh MDLs is crucial for affected individuals and their legal representatives. As of 2023, detailed monthly breakdowns reveal the number of MDL cases filed against various manufacturers.

These statistics provide insights into the scale of the hernia mesh MDL, the manufacturers most frequently named in hernia mesh lawsuits, and the potential implications for future cases. Regular updates can also shed light on emerging trends, global settlement discussions, and other pivotal developments in the litigation landscape.

Preservation of Faulty Bard Hernia Mesh Products for Evidence

In Bard hernia mesh lawsuits, preserving the faulty mesh products is of paramount importance. Before undergoing revision hernia mesh surgery, patients should coordinate with their medical and legal teams to ensure the defective mesh products are preserved post-removal.

A 2018 court order established guidelines for storing and preserving these meshes, emphasizing their significance as evidence in potential hernia mesh lawsuits. Proper preservation can bolster a plaintiff’s case, providing tangible proof of the mesh’s defects and their implications.

What’s the problem?

As claimed by the FDA, the Bard CruraSoft Patch is a new soft tissue repair product that features a dual-sided Bard CruraSoft Patch with specially designed PTFE mesh on one side to reinforce soft tissue [12]. On the other side, an ePTFE patch minimizes adhesions to the prosthesis. The Bard CruraSoft patch is designed specifically for the repair of the hiatal defect during laparoscopic fundoplications and paraesophageal hernia procedures.

In December 2005, C.R. Bard issued a recall after it had learned of the serious product defects [13]. 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.

Hernia mesh products can lead to serious, life-threatening injuries including:

  • Bowl perforation
  • Bowel obstruction
  • Chronic intestinal fistulae
  • Serious infection
  • Death

Rhode Island Bard MDL Hernia Mesh Lawsuit

Many consider Rhode Island to be the most favorable state to seek compensation against Bard as a result of defective hernia mesh. There is currently a consolidated MDL for Bard Mesh in Rhode Island state court.

However, there is also a Bard / Davol Multidistrict Litigation pending in the Federal Court for the Southern District of Ohio. This Federal litigation is for all Bard mesh comprised of polypropylene plastic hernia mesh.

Jury Orders BD to Pay $4.8 Million in Hernia Mesh Bellwether Trial

According to Reuters, Becton, Dickinson, and Co’s C.R. Bard Inc. subsidiary was ordered to pay a record $4.8 million in a hernia mesh lawsuit filed by a Hawaii man who claimed he suffered serious complications after receiving the company’s hernia repair mesh [14]. The verdict for Plaintiff Paul Trevino and his wife Earlynn in Providence state court came after a month-long bellwether trial.

Trevino alleged in his 2018 lawsuit that the so-called Ventralex hernia repair mesh, made of the plastic polypropylene, burrowed into his tissue, causing pain and inflammation and ultimately requiring corrective surgery, Reuters said. The Trevinos’ case was the first to go to trial in the state litigation.

What is Hernia Repair?

According to a Harvard Medical School 2023 study, hernia repair is a surgical procedure used to fix a hernia [15]. The procedure is also referred to as a herniorrhaphy mesh implant.

A hernia occurs when part of an internal organ protrudes into a part of the body where it should not (most commonly in the abdominal area). A small portion of the intestine, or a piece of fat, pokes through a weak area in the muscular wall of the abdomen. This causes an abnormal bulge under the skin of the abdomen, usually near the groin or navel.

In addition to patch recalls, the FDA recalled some of the parent company Salute devices and warned that Davol was in serious violation of the law and that they could take further regulatory steps without notice, including inventory seizure, injunctions preventing product sale, or monetary penalties.

In all, Kugel Mesh Hernia Patches have been recalled three times by the FDA and received nearly 100 reports of problems related to the patch, several involving death.

Hernia Mesh Settlement Value

As stated above, there is a massive amount of prior litigation over hernia mesh and other types of mesh used in surgeries in other parts of the body. Many of the problems with hernia mesh implants centered around their incompatibility with the human immune system.

After being implanted, the devices triggered an immune system attack which caused severe health complications. Another problem was that the outer coating of the mesh degraded too quickly, causing the mesh to attach to other organs or tissues.

However, awards in hernia mesh claims depend on the specifics of each case – the severity of the plaintiff’s injuries, the strength of the case, and the seriousness of the damage caused by the defective mesh. It is possible some manufacturers represent large corporations that have deep pockets, but it is impossible to say exactly what the average settlement value will be.

Pursuing Compensation in a Bard Hernia Mesh Lawsuit

Across the U.S., lawsuits have been filed against C.R. Bard and other hernia mesh manufacturers alleging that their products were defectively designed, leading to adverse health complications after being used as directed. These firms have also been accused of failing to warn patients of potential risks and adverse side effects.

Similar to product liability lawsuits, damages in a hernia mesh lawsuit bellwether trial can include medical bills, lost wages, pain and suffering, emotional distress, loss of enjoyment of life, and loss of consortium (compensatory damages).

Punitive damages are a separate type of damages that can be obtained in a hernia mesh lawsuit. These are awarded as punishment against a corporation, typically for acts like knowingly hiding risks, purposely failing to warn patients and doctors, and deliberately avoiding FDA regulations.

A hernia mesh attorney at Schmidt & Clark, LLP, can help you estimate what your case could be worth.

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The Product Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of bellwether trial lawyers that focus on the representation of plaintiffs in hernia mesh repair lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

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



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