Hernia repair is a very common surgery in the US. In fact, around 10 million hernia repairs have been performed in operating rooms across the country over the past decade. About 500,000 ventral (or abdominal) hernia repairs and 500,000 inguinal (or groin repairs), are conducted each year. Oftentimes these hernias are repaired using a product called surgical mesh, which prevents the organ from pushing through the weakened tissue that helps hold the organ in place. While hernia mesh is generally successful in preventing recurrent hernias, some complications have been attributed to two types of mesh devices: Physiomesh and C-QUR mesh.
ATTENTION: HEALTH WARNING
This is an important health alert for anyone who has received a laparoscopic hernia repair in the past 6 years.
The Ruth Law Team is currently investigating Physiomesh and C-QUR cases. The following symptoms are common in patients with failed mesh devices:
- Need for Revision Surgery
- Removal of the Mesh Device
- Severe Abdominal or Groin Pain
- Extrusion of the Mesh Device
- Chronic Open Wound
- Delayed Wound Closure
- Hardening of the Mesh Device
- Bowel Obstruction
- Seroma (fluid buildup under skin)
- Bowel Perforation
- Failure to Adhere to Damaged Tissue
- Mesh Folding
- External Skin Rash
What is a Hernia?
A hernia occurs when an organ bulges through weakened tissue or abdominal opening, and it can be caused by a number of different things. These ruptures often develop after surgery, where the tissue is in a weakened state and susceptible to damage. Hernias may occur in the abdomen, upper thigh, groin, and/or belly button, and can affect both men and women alike. They generally cause pain and discomfort and may even cause cosmetic issues.
How is a Hernia Mesh Used?
Surgical mesh is a medical device attached to the weakened tissue, or hernia, to provide support and prevent the organ from continuing to push through the wall.
Three different types of mesh may be used for hernia repair:
- Synthetic, which is generally made of polyester and polypropylene.
- Biologic, which is made of biological material such as human or pig skin, pig intestines, or cow heart.
- Composite, which is a combination of the two types of materials listed above.
Surgical mesh can be inserted into the body through two different types of procedures: open repair and laparoscopic repair. An open repair surgery takes place when a surgeon opens up the body to implant the mesh device. On the other hand, a laparoscopic repair is completed by poking holes into the area surrounding the hernia, using cameras to guide the surgeon in implanting the mesh and repairing the hernia. In both cases, the mesh is designed to prevent the intestine or other organ from continuing to push through the weakened tissue while simultaneously integrating itself into the damaged wall.
What Is The Problem With Physiomesh and C-QUR?
Manufactured by Ethicon, the Physiomesh product was cleared through the FDA 510(K) approval process in 2010. The FDA 510(K) approval process is used when a product is modeled after a device that has been fully approved by the FDA, and it requires less testing than the FDA requires for new medical devices on the market. Using the FDA 510(K), Ethicon conducted minimal testing on mesh devices. In tests that were conducted, most patients experienced some type of issue with the product. Furthermore, Ethicon may have concealed unfavorable results and failed to conduct any clinical trials on the product, ensuring the product entered the market as quickly as possible. In May 2016, Ethicon voluntarily withdrew the device from the market.
Similarly, the C-QUR product (manufactured by Atrium) has a history of defective design and deceptive marketing tactics. In fact, the FDA issued several warnings to Atrium, yet the company failed to improve the design and cease its deceptive marketing promises. Evidence also suggests that general surgeons who conduct mesh surgeries were promised impossible results and given false or misleading information about the device. At least one clinical trial is known to have been terminated due to concerns with the product.
What Other Mesh Products Are Being Investigated?
In addition to Ethicon Physiomesh and Atrium C-QUR, we are also investigating the following mesh products:
- Covidien meshes
- Gore Dualmesh
- Gore Dualmesh Plus
- Ventralex ST
- Sepramesh IP Composite
- Ethicon Prolene Hernia System
- Ethicon Prolene 3D Plug
- Ethicon Proceed
How Can You Tell If a Mesh Implant Has Failed?
Patients with a failed Physiomesh or C-QUR mesh may experience the following complications:
- Severe Pain
- Recurrent Hernias
- Contraction of the Mesh
- Adhesion to the Intestine
- Bowel Blockage
How Can I File a Hernia Mesh Lawsuit?
We are now accepting cases on behalf of those who were injured due to failed hernia mesh. If you believe you have experienced complications due to a defective mesh device, call the product liability attorneys at The Ruth Law Team. We have 35 years of experience helping those who have been injured through no fault of their own, including by products that are unsafe. As always, your call is free, and there are no fees or costs to you unless we win your case.
We are also investigating defective transvaginal mesh products.