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Hernia Repair Surgery
Types of Hernia Mesh
Hernia Mesh and the FDA
Surgical mesh has been in use for decades and is currently used as hernia mesh in hundreds of thousands of hernia repair procedures each year in the U.S. Hernia mesh may help to provide stability after a hernia, while the abdominal tissue is recovering from injury and surgical repair. Unfortunately, many patients who have been implanted with hernia mesh may have serious post-surgical complications, some of which may take years to become evident but may also be fatal.
Injuries associated with hernia mesh products include:
- Abdominal infection
- Severe pain
- Mesh migration
- Tissue erosion
- Bowel adhesion
- Bowel obstruction
- Intestinal or organ perforation
- Hernia recurrence
In most cases, patients who experience serious side effects or develop complications after receiving a hernia mesh implant, will require revision surgery to remove the mesh and repair additional damage. Some patients may require multiple surgeries, each of which poses additional risk of infection, pain and increased recovery time.
|Manufacturer||Hernia Mesh Product|
|Atrium||Prolite Polypropylene Mesh
C-QUR Lite Mesh V-Patch
C-QUR Mesh V-Patch
|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
|Covidien||Parietex Composite Dual Facing Mesh|
|Ethicon||PROLENE 3D Patch Polypropylene Mesh
PROLENE Polypropylene Hernia System
ULTRAPRO COMFORT PLUG
ULTRAPRO Hernia System
PROLENE Soft Polypropylene Mesh
Physiomesh Flexible Composite Mesh
PROLENE Polypropylene Mesh
ULTRAPRO Partially Absorbable Lightweight Mesh
PROCEED Surgical Mesh
PROCEED Ventral Patch
Gore Bio-A Hernia Plug
|Gore Dualmesh Biomaterial
Gore Dualmesh Plus Biomaterial
|Medtronic||Duatene Bilayer Mesh
Parietene DS Composite Mesh
Versatex Monofilament Mesh
Symbotex Composite Mesh
|Parietex Flat Sheet Mesh
Parietex Plug and Patch System
Parietex Lightweight Monofilament Mesh
Hernia Repair Surgery
Hernia is a condition which develops due to a defect or split in fibers of the trunk muscles. The split may allow internal organs to protrude or bulge through the muscle layer which can pose a serious risk. People who develop abdominal or inguinal (groin) hernia may experience severe pain and are at risk of internal organ damage. Hernia repair is an urgent medical condition and, in some cases, may be considered an emergency.
Whether it occurs in the abdominal or inguinal (groin) area, a hernia may require surgical repair to reposition any protruding tissue or organ and to close the split which allowed for the prolapse. In some cases, hernia repair can be done with simple sutures but up to 90% of hernia repair procedures are currently performed using surgical mesh.
Types of Hernia Mesh
Surgical mesh products used in hernia repair are constructed of synthetic polymers, similar to plastic and may be combined with natural or animal tissue as a “composite”. In some cases, mesh may be “absorbable” and will dissolve over time as it is replaced with new tissue, but most hernia mesh products are “non-absorbable” and intended to be left in place, with new tissue growing around the mesh.
Components, particularly when natural tissue is used, may produce an allergic response or immune reaction which may lead to formation of scar tissue and adhesion of abdominal tissue to one or more organs such as the intestines. In other cases, the body may reject a mesh implant due to immune response and cause the mesh to erode tissue and migrate through the abdominal wall or perforate, impede or injure other organs such as the intestines.
Polypropylene, a synthetic polymer which is commonly used in and forms the foundation of most hernia mesh, may degrade over time. This degradation can result in mesh shrinkage which causes irritation, pain and inflammation. Over time, degradation of the polymer can increase the chance of hernia mesh injury.
Hernia Mesh and the FDA
The use of surgical mesh in hernia repairs began after the discovery of synthetic polymers in about 1935. By 1979 when the first laparoscopic hernia repair was performed, both procedures and surgical mesh itself had undergone several changes. Since the 1980s, surgical mesh used for hernia repair is generally marketed as “hernia mesh”, designed to be used in repair of abdominal or inguinal hernia. Similar products constructed of surgical mesh are used in other reconstruction or repair procedures such as transvaginal mesh used in surgical correction for pelvic organ prolapse or stress urinary incontinence.
Each type of surgical mesh is regulated by the Food and Drug Administration under the medical device division. Hernia mesh is categorized as a Class II medical device, indicating its use may pose a moderate risk of harm but often allows for marketing of products without requiring clinical testing in humans under the FDA’s 510(k) fast-track process. Manufacturers may be allowed to claim that new mesh products are similar to products already on the market and do not require testing.
There are multiple manufacturers of hernia mesh, several of which have been subject to FDA recalls.
- In 2005, 2006 and 2007, separate FDA recalls were issued for C.R. Bard’s Kugel hernia mesh due to breakage and degradation concerns which could result in bowel perforation or fistula.
- In 2012, Atrium’s C-QUR hernia mesh was the subject of FDA warning letter, recall and a lawsuit after the company was found to have failed to address manufacturing safety concerns.
- In 2016, Ethicon, a Johnson & Johnson company, was forced to recall one product from the Physiomesh line due to a high number of adverse events and higher than expected hernia recurrence rate. The company withdrew the product outside of the U.S. but have continued to market Physiomesh Open Flexible Composite Mesh in the U.S.
In 2005, 2006 and 2007, separate FDA recalls were issued for C.R. Bard’s Kugel hernia mesh due to breakage and degradation concerns which could result in bowel perforation or fistula.
In 2012, Atrium’s C-QUR hernia mesh was the subject of FDA warning letter, recall and a lawsuit after the company was found to have failed to address manufacturing safety concerns.
In 2016, Ethicon, a Johnson & Johnson company, was forced to recall one product from the Physiomesh line due to a high number of adverse events and higher than expected hernia recurrence rate. The company withdrew the product outside of the U.S. but have continued to market Physiomesh Open Flexible Composite Mesh in the U.S.
More than 50,000 hernia mesh lawsuits are estimated to be pending in federal, state and local courts. People or family members of those who were injured after receiving a hernia mesh product, should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.