Bard hernia mesh may be responsible for thousands of injuries including mesh migration, organ perforation and hernia recurrence. Because of these injuries, C.R. Bard and Davol are facing thousands of Bard hernia mesh lawsuits.
C.R. Bard and its Davol division are one of the largest suppliers of medical and surgical products in the U.S. and one of the biggest manufacturers of hernia mesh, used in hernia repair procedures. Hernia repair is a common surgical procedure performed in the U.S. about one million times each year, many of these surgeries use hernia mesh products. While most surgeries are successful, thousands of patients may have been injured by Bard hernia mesh.
Bard and Davol are facing thousands of lawsuits for injuries that may have been caused by Bard hernia mesh. Injuries cited in lawsuits include:
- Severe pain
- Abdominal infection
- Mesh migration
- Bowel adhesion
- Bowel obstruction
- Intestinal or organ perforation
- Hernia recurrence
- Revision surgery to remove and/or repair
When complications of hernia mesh implantation are severe, and when hernia re-emergence has occurred, the patient may require additional surgery or surgeries to remove, repair and replace a defective mesh device. Each additional surgery will increase the risk for pain, infection and further complications.
|Manufacturer||Hernia Mesh Product|
|Bard||3D Max Mesh|
Bard (Marlex) Mesh Dart
Kugel Hernia Patch
Modified Kugel Hernia Patch
3D Light Mesh
AlloMax Surgical Graft
Bard Mesh PreShaped
PerFix Light Plug
Ventralex Hernia Patch
Ventralex ST Patch
Ventralight ST Patch
Composix Kugel Hernia Patch
Bard Hernia Mesh Recall
Like most surgical mesh products, Bard hernia mesh is a Class II medical device. Bard hernia mesh was eligible for marketing under a shortcut FDA 510(k) pathway which allowed Bard and Davol to skip costly clinical trials. The manufacturer was allowed to claim that the products were “similar” to other products already on the market. Consequently, Bard hernia mesh was introduced for use in surgical procedures, never having been tested in humans.
Bard itself, has a poor safety record and has a history of using plastic that was not intended to be used in humans. In 2005 and 2007, Class I recalls were issued for Composix Kugel Patch, manufactured by C.R. Bard due to threat of severe injury that could be caused by the plastic used in the mesh which could splinter and migrate away from the implantation site. A Class I recall indicates that use of a defective product is likely to cause harm.
The company faced similar concerns over some of its transvaginal mesh which also used Marlex plastic. The manufacturer of Marlex plastic had stated that it should not be used in humans. Despite the concerns raised over Composix Kugel mesh, other Bard products are still on the market.
Bard hernia mesh products that may cause serious adverse events or complications include:
- 3D Max and 3D Max Light
- Composix, Composix E/X and Composix L/P
- Marlex Mesh
- Kugel and Modified Kugel
- Perfix Plug and Perflix Light
- Ventralex Hernia Patch and Ventralex ST Patch
- Ventralight ST
- Ventrio and Ventrio ST
Bard Hernia Mesh FDA Warnings
Hernia mesh products manufactured by C.R. Bard and its Davol division, have been linked to a risk of serious adverse events and complications. Because of a high number of adverse event reports, the Food and Drug Administration has constructed a consumer advisory page regarding the risks of hernia mesh products.
Surgical mesh is used in about 90% of the nearly one million hernia repair procedures done each year. Hernia mesh manufacturers face tens of thousands of lawsuits for injuries caused by their products, including numerous deaths. In addition to lawsuits which have already been settled for Composix Kugel Mesh and transvaginal mesh, Bard and Davol are facing at least 2,000 lawsuits for other hernia mesh products in local, state and federal courts.
Over 1,800 Bard hernia mesh lawsuits filed in federal courts have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Ohio as MDL 2846. Multidistrict litigation allows for pooling of plaintiff and defendant information for a more efficient trial process. In MDL cases, a select number of bellwether trials will help to determine how likely success will be for the remaining cases. In some cases, if plaintiffs are successful, a manufacturer may offer settlements to members of the MDL.
No trial dates for bellwether or other cases have been announced but more Bard hernia mesh lawsuits may be expected.
What can a Bard Hernia Mesh lawyer do for me?
Patients who have undergone surgery to repair an abdominal hernia, and were implanted with a Bard hernia mesh product, who experienced serious side effects or complications related to their hernia repair, may be eligible for compensation.
Past medical injury cases have provided compensation to cover medical treatment costs, lost wages and pain and suffering. Though each case is unique and must be evaluated separately by a lawyer, people who suffered side effects or complications from a Bard hernia mesh procedure should have their case evaluated.
Complications that may qualify for compensation include:
- Hernia recurrence
- Mesh erosion, migration or shrinkage
- Bowel obstruction or intestinal paralysis
- Organ perforation
- Severe or chronic pain
- Pelvic Inflammatory Disease or Sepsis
- Have required or been recommended to have hernia mesh removal and repair
Victims or loved ones of those who were diagnosed with one or more of the following after receiving a hernia mesh implant may be eligible for compensation. Each case of hernia mesh injury is unique and there are no guarantees, but you should seek evaluation by a Bard hernia mesh attorney.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Hernia Surgical Mesh, U.S. Food and Drug Administration (2018)
- Hernia mesh litigation mounts, NH Business Review, (2/2018)
- Transfer Order, C.R. Bard MDL 2846, Judicial Panel on Multidistrict Litigation (8/2018)