Thousands of men and women have filed lawsuits against hernia mesh manufacturers like W.L. Gore & Associates, Inc. (Gore) for receiving failed hernia mesh implants.
Gore is the manufacturer of many medical devices used for hernia repair surgery. The company has been bombarded by lawsuits across the country for manufacturing hernia mesh products that can seriously injure the patient.
An estimated one million patients receive hernia repair surgery each year. Gore hernia mesh patches and plugs have caused many patients to suffer devastating complications due to defectively designed products. In addition to hernia mesh lawsuits, a number of women have filed lawsuits against the company for receiving failed transvaginal mesh implants to treat vaginal prolapse.
Gore and other various hernia implant manufacturers have been able to get swift approval for products through a clearance process with the FDA known as a 510(k). This process allows for products that are “substantially equivalent” to others on the market to avoid the long process of clinical trials. Without the clinical trials to test for failure or adverse reactions, manufacturers put patients at risk of experiencing similar complications to devices already known to fail.
Types of Gore Hernia Mesh
Gore hernia mesh lawsuits have included the following types:
- Gore-Tex Soft Tissue Patch
- Gore Bio-A Hernia Plug
- Gore Dualmesh Biomaterial
- Gore Dualmesh Plus Material
- Gore Synecor Intraperitoneal Biomaterial
- Gore Synecor Preperitoneal Biomaterial
In Gore’s most recent mesh patch development, the company received clearance through the U.S. Food and Drug Administration for its Synecor Preperitoneal biomaterial hernia repair device in 2017. The hybrid device is made up of a permanent synthetic mesh and bioabsorbable components intended to adapt to the body easier.
Synecor is constructed of two outer layers (Bio-A Web) meant to be absorbed by the body and a stable middle layer (polytetrafluoroethylene fiber) meant to minimize bacterial growth.
According to the Gore website, “..studies have shown that hernia repairs with the biosynthetic scaffold have low long-term hernia recurrence rates with improved quality of life for patients.” However, the quality of life for a number of patients has been diminished because of the aforementioned Gore hernia mesh products.
Both patients and surgeons can file a public report with the FDA through the Manufacturer and User Device Experience Database (MAUDE) if a device has caused complications. Many reports have detailed the excruciating details of hernia mesh failure.
Complications from Gore hernia mesh implants:
- Hernia recurrence
- Bowel obstruction
- Abdominal pain
- Organ damage
- Revision surgery
In the 1980s, hernia mesh became a popular treatment among surgeons. Hernias develop when a tissue or an organ squeeze through a compromised spot in the muscle or connective tissue. The result is a “bulging” mass that is very painful to live with. Sometimes it can be seen on the outside of the body, especially in the abdominal region.
Hernias can occur for a variety of reasons. Poor diet and nutrition, incorrectly lifting heavy objects, persistent coughing, sneezing, diarrhea or constipation can cause hernias due to the increased pressure on the body. Smokers are also at risk of developing a hernia due to a weakening of muscles throughout the body.
Surgeons use hernia mesh implants to strengthen the compromised tissue and keep the hernia from recurring (or re-opening). However, Gore hernia mesh has been known to malfunction for a variety of reasons and cause even more suffering to the patient.
Types of Hernia Mesh Implants
A common type of hernia mesh comes in the form of a patch or a plug. A hernia patch is a flattened material meant to prevent a hernia from pushing through the weakened muscle or tissue. It can be held in place by staples, tacks or surgical glue.
A plug is used to “plug” up space where a hernia originates. Surgeons mold the plug to fit each patient, is inserted into the original weakened spot and is then held in place by a flattened mesh. This is known as a “plug and patch” technique. A plug is typically used in the umbilical cord region or the inner groin (femoral canal).
Gore continues to manufacture hernia mesh, despite multiple lawsuits and public reports that detail repeated failure of its devices. Our law firm is currently accepting injury cases to hold Gore accountable for the injuries many men and women who have sustained injuries from hernia mesh products.