Bard Hernia Mesh – Side Effects & Warnings

C.R. Bard is one of the largest manufacturers of hernia mesh products, some of which may be responsible for serious complications such as hernia recurrence, mesh migration and intestinal blockage.

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Bard Hernia Mesh

hernia mesh

Hernia mesh products manufactured by C.R. Bard and subsidiary, may have been responsible for thousands of serious medical injuries. Bard is facing more than 2,000 hernia mesh lawsuits for complications caused by several Bard and Davol hernia repair mesh products.

Complications of Bard hernia mesh surgery may include:

  • Severe or chronic pain
  • Serious infection
  • Mesh shrinkage
  • Mesh migration
  • Organ perforation
  • Bowel obstruction
  • Bowel adhesion
  • Hernia recurrence
  • Death

In most cases of hernia mesh complications, hernia revision surgery will be required to remove the defective mesh and to repair both original hernia and new tissue damage that may have occurred. In some cases, multiple hernia revision and reconstructive surgeries will be required which present additional risk for post-surgical complications.

Bard Surgical Mesh for Hernia Repair

Hernia mesh is a net-like surgical device constructed of natural or synthetic material, primarily plastics. Hernia mesh is used in about 90% of the near 1 million hernia repair surgeries, the majority of which comes from a few companies including C.R. Bard.

Bard hernia mesh products include devices which have been manufactured by C.R. Bard, Bard’s Davol division, and Becton Dickinson which acquired Bard in 2017.

Bard hernia mesh devices include:

  • 3DMax Mesh and 3DMax Light
  • Composix, Composix E/X Mesh and Composix L/P
  • PerFix Plug and Perfix Light
  • Sepramesh IP
  • Ventralex Hernia Patch and Ventralex ST Hernia Patch
  • MarlexMesh
  • Kugel Mesh and Modified Kugel Mesh
  • SpermaTex
  • Visilex
  • Ventrio and Ventrio ST
  • VentralightST

Bard Hernia Mesh Side Effects and Complications

Hernia mesh was designed to help stabilize tissue in hernia repair procedure. Initially, it was thought to reduce hernia recurrence but since 2000, hernia mesh complications and the need for revision surgery have been on the increase.

Side effects of hernia surgery itself are similar to other operative procedures including pain, swelling and discomfort. When hernia mesh has been poorly designed or adverse events occur, complications may include mesh migration, organ perforation, bowel obstruction or other serious injuries. In severe cases, mesh complications may result in death.

Due to a high number of adverse events and serious complications which have raised concerns over hernia mesh including Bard products, the U.S. Food and Drug Administration (FDA) created a hernia mesh consumer education page.

Bard Hernia Mesh FDA Warnings and Recalls

Hernia mesh products manufactured by C.R. Bard have caused serious concerns due to the type of plastics that were used in construction of the devices. Bard’s Composix Kugel patch and several of its transvaginal mesh products were made using Marlex plastic which was never intended to be used in human patients and which was found to splinter and migrate from the implantation site.

In 2005 and 2007, two separate Class I recalls were issued for Composix Kugel Patch. Class I recall indicates the product was likely to cause serious injury or harm and is the most serious type of recall that can be issued. Despite the knowledge that Marlex plastic’s manufacturer had warned Bard against using the plastic in their product, the company continued to do so. This may have resulted in thousands of serious injuries, potentially including a number of deaths which were caused by C.R. Bard’s products and actions.

C.R. Bard Hernia Mesh Lawsuits

Nearly 2,000 Bard hernia mesh lawsuits have been filed in federal court and more have been filed in state and local courts. Attorneys from Seeger Weiss are members of the executive committee for Bard hernia mesh cases which are part of the multidistrict litigation (MDL-2846) lawsuits.

Read more about Bard hernia mesh lawsuits.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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