Bard Hernia Mesh Lawsuit

Bard Mesh is a monofilament polypropylene surgical mesh used to treat hernias. The mesh helps to support the injured area while also allowing for the surrounding body tissue to properly grow into the mesh. Hernia mesh patches can also come in several different sizes in order to fit any hernia injury.

Types of Bard hernia mesh products

C.R. Bard and its subsidiaries manufacture several mesh products. Each product has a specific use. The company is also facing lawsuits over issues with mesh products being used in breast surgeries. The hernia mesh products discussed in the master complaint for the consolidated litigation mentions the following products:

• Composix E/XMesh
• Composix Kugel Hernia Patch
• Kugel HerniaPatch
• Marlex Mesh
• Modified Kugel Hernia Patch
• PerFix Plug
• SpermaTex
• Ventralex Hernia Patch
• Ventralex ST Hernia Patch
• Ventrio Hernia Patch
• Ventrio ST Hernia Patch
• Visilex Mesh
• 3DMaX Mesh 

Specific lots of the Bard Composix Kugel Mesh patch were recalled in December 2005. Davol, Inc. issued the recall after finding that the memory recoil ring could buckle or break when placed in the body. The recall notice was expanded multiple times between December 2005 and January 2007.

All of the recalls were classified by the FDA as Class I, the highest level of recall for medical products. Class 1 recall products are thought to be dangerous or defective enough to cause serious health problems or death.

Review a detailed list of lot numbers and product codes affected by the Bard hernia mesh recall.

How Bard hernia mesh is used in surgery

The purpose of hernia mesh is to reinforce weakened tissue and help reduce the risk of hernia recurrence. It’s used in both open surgery (where mesh is placed through an incision) and laparoscopic surgery (minimally invasive with smaller incisions).

Hernia repair surgery is a very common procedure. Since hernias often have a high chance of coming back, surgical mesh is used to reduce that chance.

• Unsuitable materials: Bard products are made from a polypropylene that has been called “unsuitable” and “toxic to tissue.” The plaintiffs’ cases say the polypropylene contains about 15 additional compounds that can leach out of the mesh and make inflammatory reactions worse.
• Degradation of mesh: Mesh may flake and break down over time, which can cause toxic compounds to be released into the body. This can lead to inflammation and damaged, scarred or overgrown tissues. Heat begins the degradation process. At room temperature, there is typically no reaction. However, at human body temperature (98.6 °F), the degradation accelerates. Degradation can lead to an increased surface area, which may provide more opportunities for bacteria to grow.
• Mesh weight: Mesh weight is an important factor in how compatible the product is with a person’s body. Heavyweight mesh may be more prone to causing undesirable foreign body reactions and changes in the mesh structure. Most of Bard’s hernia mesh products are made of heavyweight mesh.
• Pore size: The smaller the pore size of a mesh product, the greater the risk of inflammation, mesh shrinkage, contracture (tissues around the mesh permanently tightening) and scars. Pore size should be at least 3mm, but most of Bard’s hernia mesh products have pore sizes closer to 1mm.
• Sepra Technology (ST): Bard’s Sepra Technology is intended to prevent adhesions to underlying organs during the “critical healing process.” Coatings on the side of the mesh facing inward are supposed to dissolve and leave the body within 30 days. This should reduce foreign materials in the body. However, plaintiffs allege Sepra Technology does not prevent adhesions and that the coating dissolves too quickly once implanted, exposing uncoated polypropylene to underlying organs. Such exposure can result in severe infections, abscesses and fistulas.
• Composite Meshes: Composite meshes have multiple layers of mesh. The layers of Bard’s composite hernia mesh products may shrink and contract at different rates. This can cause deformation of the mesh, such as buckling, folding or crumpling. Deformed mesh may be more likely to contact the underlying tissue and organs. Such exposure can cause severe infections, erosion, abscesses and fistulas.
• Polyethylene Terephthalate (PET) Memory Recoil Ring: The PET ring is a plastic ring sewn between two layers of polypropylene, intended to help surgeons with initial placement of the mesh. The ring doesn’t have a purpose after placement, but remains in the body.
  However, the ring may pose a number of risks because it wasn’t designed to handle bodily forces. This can lead to deformation of the patch and broken rings. These changes may cause an array of problems, including organ adhesions, erosion, bowel perforation, fistula formation and even death. Bard recalled some of the 11 Composix Kugel patch lots containing the ring. This left several defective products on the market. 
  Around December 2013, Bard recalled the PET ring in the Ventralex Patch and Modified Kugel Patch and replaced it with the PDO ring, which the body can absorb. Then, at an unknown date, Bard recalled the Kugel Hernia Patch altogether. According to their website, the defendants no longer manufacture, market or distribute the Kugel Hernia Patch.
• SorbaFlex Memory Technology Polydioxanone (PDO) Ring: Bard designed and manufactured an absorbable ring to replace the PET ring. The PDO ring is meant to facilitate the initial surgical placement of the mesh and then be fully absorbed within 6 to 8 months, according to the defendants. Plaintiffs allege this device, too, may cause health problems including organ adhesions, erosion, bowel perforation, fistula formation and even death.

The terrible pain associated with a hernia injury is difficult enough to deal with in itself. But when you add in the excruciating abdominal pain and other serious injuries associated with a defective hernia mesh patch, it can become almost too much to bear. Plaintiffs allege this is what happened to thousands of patients who used Composix Kugel Mesh hernia repair patches manufactured by C.R. Bard subsidiary Davol Inc.

A wide range of injuries have been reported in patients who were given Bard hernia mesh products. Complications and injuries that have been associated with Bard hernia repair patches include:

• Abscess
• Abdominal abscess formation
• Abdominal tenderness
• Adhesion to internal organs
• Chronic and excessive inflammation
• Chronic pain
• Deformation of mesh, which can inhibit function or cause issues with nearby bodily structures
• Distended abdomen
• Erosion
• External fistulas
• Foreign body response
• Fluid in abdomen
• Granulomatous response (a chronic inflammation accompanied by a tight gathering of immune cells around an infection)
• Improper wound healing
• Infection
• Internal fistulas
• Mesh migration
• Nerve damage
• Organ perforation
• Pelvic inflammatory disease
• Perforation of intestinal walls
• Peritonitis
• Persistent surgical site drainage
• Post-surgical infections
• Recurrence of hernia
• Rejection of mesh
• Scarification
• Sepsis
• Seroma formation
• Severe persistent abdominal pain
• Tissue damage and death

People who experienced serious or severe hernia mesh injuries may still be able to file a Bard lawsuit.

Symptoms of hernia mesh complications

There are some symptoms to be aware of if you think you may be experiencing complications from your hernia surgery:

• Fever
• Hematomas (bleeding outside blood vessels, often appearing as a large purple bruise)
• Infection around the incision
• Internal injuries to tissues, organs or blood vessels
• Issues emptying your bladder
• Pain
• Seromas (pockets of clear fluid under the skin)

Long term health risks of Bard hernia mesh complications

Hernia mesh may also cause several long term health risks, including:

• Chronic pain
• Internal organ damage
• Reduced quality of life
• Risk of additional surgeries

Bard hernia mesh litigation began with patients alleging that the manufacturers of this product knew or should have known it was defective but didn’t properly warn patients of the potentially severe complications. Thousands of these cases have been consolidated into a federal court MDL, In re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, MDL No. 2846. This MDL was established on August 2, 2018.

There are also state court consolidated cases. For example, Motley Rice attorneys Donald Migliori and Jonathan Orent hold leadership positions in In re: Davol/ C.R. Bard Hernia Mesh, a docket consolidated in Rhode Island Superior Court. 

Hernia mesh manufacturer C.R. Bard and subsidiary Davol Inc. are the potentially liable defendants in these cases. The federal MDL is currently the second-largest active MDL. There are also other hernia mesh MDLs against Atrium’s C-Qur, Covidien and Ethicon’s Physiomesh. 

As of May 1, there were 24,078 pending actions in the federal Bard hernia mesh MDL. 

Bard hernia mesh settlements

Notable settlements have been made in a variety of hernia mesh cases:

• In 2011, C.R. Bard, Inc. agreed to settle 2,600 lawsuits filed by patients who experienced serious medical issues from Composix Kugel Mesh hernia patches. This settlement amount totaled around $184 million.
• In 2015, C.R. Bard Inc. settled 3,000 pelvic mesh cases and agreed to pay $200 million. The women in these cases alleged they experienced serious long-term complications from the pelvic mesh inserts. 

By October 2024, a global resolution settlement agreement was announced for a large majority of the Bard hernia mesh lawsuits. 

Bard hernia mesh verdicts

Several of the hernia mesh bellwether trials resulted in verdicts in favor of the plaintiffs:

• In March 2022 in the Southern District of Ohio, a jury ruled in favor of design defects claims made by plaintiffs Antonio Milanesi and his wife Alicia Morz De Milanesi. Antonio Milanesi had C.R. Bard’s Ventralex mesh implanted in 2007, experienced complications and needed another surgery in 2017. The plaintiffs were awarded $255,000 in damages.
• In August 2022, a Rhode Island jury ordered Becton Dickinson, a subsidiary of C.R. Bard, to pay $4.8 million to plaintiff Paul Trevino. Trevino claimed he experienced severe gastrointestinal injuries as a result of Ventralex hernia mesh. The plaintiff also alleged that the mesh was made with low-quality polypropylene plastic making it unsafe to insert into the human body. Trevino was represented by Motley Rice medical device lawyer Jonathan Orent.
• In November 2023, a federal jury ordered C.R. Bard and Davol Inc. to pay $500,000 to Aaron Stinson who alleged he suffered from pain and complications due to a flawed hernia mesh.

The last Bard hernia mesh bellwether trial was postponed indefinitely in early 2024. Instead, Judge Edmund A. Sargus, Jr. ordered the leadership for both sides of the lawsuit to attend mediation.

The pain and difficulty of dealing with defective medical devices not only impacts you, but your family as well. We will put our resources and experience in complex medical litigation toward seeking justice for you and your loved ones.

If you’re unsure whether a potentially defective product was used during your procedure, a hernia mesh attorney at Motley Rice may be able to help. Our law firm’s previous medical litigation experience includes representing clients harmed by:

• Artificial Tears
• Breast implants
• CooperSurgical IVF treatments
• Duodenoscopes/Endoscopes
• Surgical staplers

Read more about our medical device litigation experience.