Apparently, the manufacturer of Gore-Tex believes that it is a versatile product because it also uses the material to make an implantable hernia mesh. W.L. Gore & Associates has been selling products made out of the material since 1969. The product is made out of a material called polytetrafluoroethylene. We know this product by its more well-known name of teflon. Many people who have either served in the military or spend time outdoors have heard of the brand Gore-Tex. The company is famous for its waterproof and windproof clothing. The company even makes boots out of the material.
W.L. Gore’s Line of Hernia Mesh Products
It is seemingly inconceivable that a product that is used to make boots can be implanted inside the body. W.L. Gore has built an entire medical products division out of products made out of Gore-Tex. Not only does it sell hernia mesh, but it also makes various surgical patches. W.L. Gore sells products such as:
- Dual Mesh Plus
- Bio A
W.L. Gore hernia mesh products are dual surface products. The company claims to design the hernia mesh with two different surfaces. One side is to encourage tissue integration, while the surface of the other side is to minimize tissue attachment. In other words, the hernia mesh aims to repair the hernia without getting completely tangled up in the surrounding tissue.
Gore Tex hernia mesh
However, the design also may increase the likelihood that the mesh migrates out of place. The dual surface design could potentially cause the mesh to shift out of position and impact surrounding organs or the bowel. Many of the injuries reported to the FDA have been consistent with mesh migration.
W.L. Gore is not one of the three largest makers of hernia mesh. The company does not release its sales figures because it is a privately-held company. However, its sales are lower than Ethicon, Atrium C-Cur and C.R. Bard. W.L. Gore also entered the ill-fated pelvic organ prolapse mesh market, but its product, along with those from all other device makers, was pulled from the market after women suffered serious side effects. W.L. Gore has faced numerous lawsuits relating to its pelvic organ prolapse mesh.
There Was No FDA Testing of W.L. Gore Hernia Mesh
In 2017, W.L. Gore received FDA approval to sell a Biomaterial hernia repair device. While the name makes these products sound safer, the reality is that many of the reports of adverse events filed with the FDA have involved the Biomaterial hernia repair device.
BIO-A hernia mesh lawsuit
W.L. Gore’s hernia mesh was approved by the FDA without any testing whatsoever. The FDA allowed W.L. Gore to start selling hernia mesh through a process called the 510(k) process. When a product is substantially similar to another product that is already on the market and has been approved, the FDA allows a device maker to sell after they have notified the FDA. This is how many different hernia mesh products have been permitted to hit the market.
W.L. Gore Adverse Event Reports to the FDA
Patients are encouraged to report to the FDA when they have experienced an adverse event with a medical device. Their reports are found in the FDA’s MAUDE database and are publicly available. A recent search of the MAUDE database shows that adverse event reports are still coming in at a steady pace.
Many of the adverse event reports in MAUDE detail situations in which the Dual Pro mesh was explanted. This means that the patient needed surgery to remove the mesh because it was causing serious side effects. A review of the adverse event reports reveals that many of these patients were suffering life threatening complications that required one or more surgeries to address.
Side Effects of Gore-Tex Hernia Mesh
Some patients reported that the hernia mesh was causing bowel obstruction. This is when hernia mesh can turn fatal. Many patients reported that the Gore mesh was causing serious infections, while some patients suffered from a fistula. In all of these events, the patient was in significant discomfort and pain before the surgery with dramatic side effects. Specifically, these are the type of complications associated with Gore-Tex hernia mesh:
- Serious pain
- The mesh may become infected, possible causing sepsis
- Obstruction of the bowels
- Mesh migration causing it to impact other nearby organs
- Mesh shrinkage, which may cause the need for further hernia surgeries
- Mesh failure
- Fistulas and seromas
- Mesh disintegration with the pieces of the mesh causing intense pain
When a patient has these kinds of side effects, they often cannot receive a new hernia mesh. However, they are still left with a hernia that needs repair. Some patients are never able to get the hernia fixed. Not only do they have continued medical issues from the damage caused by the mesh, but they also have a hernia which may never be repaired. These patients will experience a lifetime of discomfort.
The FDA Has Done Nothing About Reports of Side Effects
However, even with the increasing number of adverse event reports, the FDA has not gotten involved and ordered the recall of any Gore products. The company still continues to sell its hernia mesh even though more patients are reporting serious injuries. The side effects from Gore hernia mesh are quite severe compared to the discomfort that many people suffer.
Some damages that people suffer when they sustain long-term injury from hernia meshes such as Gore include:
- Lost wages because the pain keeps them from working
- Medical bills and therapy costs from frequent visits to the doctor
- Pain and suffering
- Loss of enjoyment of loss
- Loss of consortium by their spouse
You Can File a Hernia Mesh Lawsuit for Gore-Tex Hernia Mesh
Hernia mesh makers such as W.L. Gore may be sued for manufacturing a defective product that causes injury to patients. You would need to file a product liability lawsuit against the company to allege that the product was defectively designed or manufactured or that the company knew of the dangers of the product and failed to warn you.
A hernia mesh lawyer could help you file your case. Hernia mesh makers have vigorously fought these cases in court and have not yet settled these claims. However, some of the first hernia mesh cases are set to go to trial in 2020, and it will give plaintiffs a picture as to the company’s liability. If you have been harmed by a Gore-Tex hernia mesh such as Bio A or Dual mesh, you can schedule a free consultation to learn of your legal rights and your ability to file a lawsuit.