The Gore DualMesh and DualMesh Plus are implantable hernia mesh devices made by Gore Medical, a division of W.L. Gore & Associates. These implants are made from Gore’s trademarked plastic, Gore-Tex. However, the DualMesh and DualMesh Plus have several defects that can lead to chronic pain and serious medical complications, including a severe infection. Thousands of hernia mesh lawsuits have been filed against Gore for injuries caused by their implants.
- 1. Gore’s DualMesh and DualMesh Plus
- 2. Identifying a Gore DualMesh or Gore DualMesh Plus
- 3. Why Gore’s DualMesh implants are defective
- 4. No recall for Gore’s DualMesh hernia implants
1. Gore’s DualMesh and DualMesh Plus
The Gore DualMesh and the Gore DualMesh Plus are both medical implants that are used in hernia surgeries. Unlike other hernia mesh implants, Gore’s DualMesh devices are made of Gore’s trademarked material, Gore-Tex. Gore-Tex is made of polytetrafluoroethylene (PTFE), also known as Teflon, that has been stretched to increase the size of the pores in the material. The resulting material is expanded PTFE, or ePTFE. Water vapor can to pass through ePTFE or Gore-Tex, but water cannot.
Hernia mesh products made of Gore-Tex were first approved by the U.S. Food and Drug Administration (FDA) in 1995.1
Both the DualMesh and the DualMesh Plus are made of two layers of Gore-Tex. One is smooth, and designed to prevent the implant from sticking to unwanted tissues. The other side is rough, to help the device incorporate with the weakened muscle that permitted the hernia.
DualMesh implants are used during hernia surgeries. Once a surgeon has made an incision and corrected the hernia, they can implant a Gore DualMesh or DualMesh Plus over the place where the internal tissue has pushed through the weakened muscle or abdominal wall. The rough side of the DualMesh implant faces inwards, towards the hernia, and is designed to create scar tissue that strengthens the muscle. The smooth side faces outward so the implant does not stick to other tissues or organs, like the patient’s bowels.
2. Identifying a Gore DualMesh or Gore DualMesh Plus
There are several unique traits with the Gore DualMesh and the DualMesh Plus that can help patients identify their implant:
- Both of Gore’s devices look like a thick, white fabric that has a plastic feel, rather than the visible mesh that most other hernia implants have, and
- Both the DualMesh and the DualMesh Plus have a smooth side on one face of the implant, while the other face looks like corduroy.
Gore DualMesh and DualMesh Plus implants can also be identified by product number, which depend on the model, shape, thickness, and size of the implant.
Product numbers for the DualMesh are2:
| Shape | Dimensions | Thickness | Product Number |
| Rectangular | 7.5 x 10 centimeters | 1 millimeter | 1DLMC05 |
| Rectangular | 8 x 12 centimeters | 1 millimeter | 1DLMC02 |
| Rectangular | 18 x 24 centimeters | 1 millimeter | 1DLMC06 |
| Rectangular | 20 x 30 centimeters | 1 millimeter | 1DLMC07 |
| Square | 12 x 12 centimeters | 1 millimeter | 1DLMC09 |
| Oval | 10 x 15 centimeters | 1 millimeter | 1DLMC03 |
| Oval | 15 x 19 centimeters | 1 millimeter | 1DLMC04 |
| Oval | 26 x 34 centimeters | 1 millimeter | 1DLMC08 |
| Rectangular | 18 x 24 centimeters | 2 millimeters | 1DLMC202 |
| Rectangular | 20 x 30 centimeters | 2 millimeters | 1DLMC203 |
| Oval | 10 x 15 centimeters | 2 millimeters | 1DLMC200 |
| Oval | 15 x 19 centimeters | 2 millimeters | 1DLMC201 |
| Oval | 26 x 34 centimeters | 2 millimeters | 1DLMC204 |
The product numbers for the Gore DualMesh Plus are3:
| Shape | Dimensions | Thickness | Product Number |
| Rectangular | 7.5 x 10 centimeters | 1 millimeter | 1DLMCP05 |
| Rectangular | 8 x 12 centimeters | 1 millimeter | 1DLMCP02 |
| Rectangular | 18 x 24 centimeters | 1 millimeter | 1DLMCP06 |
| Rectangular | 20 x 30 centimeters | 1 millimeter | 1DLMCP07 |
| Oval | 10 x 15 centimeters | 1 millimeter | 1DLMCP03 |
| Oval | 15 x 19 centimeters | 1 millimeter | 1DLMCP04 |
| Oval | 26 x 34 centimeters | 1 millimeter | 1DLMCP08 |
| Rectangular | 8 x 12 centimeters | 1.5 millimeters | 1DLMCPH02 |
| Rectangular | 18 x 24 centimeters | 1.5 millimeters | 1DLMCPH06 |
| Rectangular | 20 x 30 centimeters | 1.5 millimeters | 1DLMCPH07 |
| Oval | 10 x 15 centimeters | 1.5 millimeters | 1DLMCPH03 |
| Oval | 15 x 19 centimeters | 1.5 millimeters | 1DLMCPH04 |
| Oval | 26 x 34 centimeters | 1.5 millimeters | 1DLMCPH08 |
| Rectangular | 18 x 24 centimeters | 2 millimeters | 1DLMCP202 |
| Rectangular | 20 x 30 centimeters | 2 millimeters | 1DLMCP203 |
| Oval | 10 x 15 centimeters | 2 millimeters | 1DLMCP200 |
| Oval | 15 x 19 centimeters | 2 millimeters | 1DLMCP201 |
| Oval | 26 x 34 centimeters | 2 millimeters | 1DLMCP204 |
All DualMesh Plus implants that are 1.5 millimeters thick also come with holes to increase the incorporation of the implant on the abdominal wall.
3. Why Gore’s DualMesh implants are defective
Gore’s DualMesh line of hernia implants have been found to be defective in two major ways: They slowly shrink over time, and they are very prone to causing serious infections.
3.1 Gore-Tex shrinks after being implanted
Several medical studies have found that Gore’s DualMesh hernia mesh implants shrink over time.4
Shrinking implants are the same defect that has plagued hernia mesh devices that are made out of polypropylene. When hernia mesh implants shrink, they tug on the scar tissue they have created and that have grown into the mesh’s pores. When nerves have formed in that ingrowth, as well, the shrinking mesh can cause serious and chronic pain.
3.2 DualMesh implants have high rates of infection
The most prominent problem that Gore’s DualMesh line of hernia mesh implants have had is a rate of infection well above the industry standard.5 The larger pores in expanded PTFE or Gore-Tex have proven to be breeding grounds for bacteria. Bacteria can grow especially well on the rough side of DualMesh implants, which faces the hernia and abdominal wall and is supposed to create scar tissue and integrate into the tissue.
These infections can be difficult for patients to beat, as the bacteria continues to grow on implant and infects the tissue. In many cases, antibiotics are not enough and surgeons need to remove the implant. However, because the implant is designed to grow into the abdominal wall, removing the DualMesh implant can be very difficult.
4. No recall for Gore’s DualMesh hernia implants
In spite of the problems associated with Gore’s DualMesh and DualMesh Plus implants, neither Gore nor the FDA has issued a recall.
However, the propensity for DualMesh implants to cause severe infections has led many surgeons to turn to alternative implants to use for hernia procedures. As a result, fewer and fewer patients have had DualMesh implants in recent years.
References:
- U.S. Food and Drug Administration – 510(k) Approval of Gore-Tex DualMesh Plus.
- Gore DualMesh Product Catalogue.
- Gore DualMesh Plus Product Catalogue.
- See Konerding MA, Chantereau P, Delventhal V, Holste JL, Ackermann M, “Biomechanical and histological evaluation of abdominal wall compliance with intraperitoneal onlay mesh implants in rabbits: a comparison of six different state-of-the-art meshes,” Medical Engineering and Physics 34(7):806-16 (September 2012); Carter PR, LeBlanc KA, Hausmann MG, Whitaker JM, Rhynes VK, Kleinpeter KP, Allain BW, “Does expanded polytetrafluoroethylene mesh really shrink after laparoscopic ventral hernia repair?” Hernia 16(3):321-5 (June 2012); Jonas J, “The problem of mesh shrinkage in laparoscopic incisional hernia repair,” Zentralbl Chir 134(3):209-13 (June 2009) (translated from German).
- See Sanders D, Lambie J, Bond P, Moate R, Steer JA, “An in vitro study assessing the effect of mesh morphology and suture fixation on bacterial adherence,” Hernia 17(6):779-89 (December 2013).