Hollis Wright is currently reviewing cases involving complications with two types of flexible, composite surgical mesh devices. The Atrium C-Qur mesh is used in surgeries involving hernia repair, chest wall repair and surgical wound repair. Physiomesh, made by Ethicon (a Johnson & Johnson subsidiary) is used in laparoscopic surgery to repair hernias, or tissue breakthrough, in the abdominal wall.
Both meshes have been recalled by their manufacturers and are reported to be responsible for recurring hernias, revision surgery, infection, pain, bowel perforations, and a host of other medical issues.
Additionally, both meshes were introduced through the FDA’s 510(K) program, which allows the FDA to approve, without stringent pre-market testing, products that have substantially similar countertypes already on the market. The 510(K) product approval route is controversial in that it allows a product to be used in the market on patients solely based on the performance of other substantially similar products.What is Flexible, Composite Surgical Mesh?
Atrium C-Qur and Ethicon Physiomesh are both made of a synthetic resin called polypropylene. Synthetic mesh has become more common in hernia repair, as sutures are more likely to lead to infection, pain and a slower recovery. However, both are causing an increase in hernia recurrence, requiring further surgery. This defeats the purpose of mesh being safer, as many patients are facing additional surgery, missed work, and an increase in medical costs.Ethicon Physiomesh
Johnson & Johnson’s subsidiary Ethicon in 2016 recalled its surgical mesh product Physiomesh, which is used in ventral hernia repair. The device is used by surgeons to reinforce the weakened tissue through which the hernia is protruding. Surgical mesh is intended to be superior to sutures because it ideally offers a quicker and smoother recovery time. Also, because the surgery is done laparoscopically, the patient should in theory have less complications and less recovery time.
However, studies indicate a higher need for follow-up revision surgery after a hernia repair using the Ethicon Physiomesh. In other words, patients are at a substantially higher risk for a recurring hernia after a hernia repair procedure using Physiomesh. Patients who have already had surgery may need another procedure, which increases patient risk, recovery time, cost and the possibility of further damage. Patients may also incur pain and suffering, loss of wages, emotional distress and a host of other issues due to the avoidable follow-up surgery.Atrium C-Qur
Atrium recalled its mesh device C-Qur this year due to complications and possible revision surgeries for patients whose surgeons repaired a hernia, a chest wall, or a surgical wound with the C-Qur mesh. Since its introduction in 2005, patients have reported many of the following symptoms:
- Abdominal pain
- Bowel adhesions and issues
- Ulcers or perforations
- Mesh failure or erosion
- Revision surgery
As with Ethicon Physiomesh, Atrium C-Qur substantially enhances the patient’s risk of needing a revision surgery. This causes the patient to endure undue risk through another surgery, which may lead to lost wages, emotional stress, missed work, and further injuries.Hollis Wright Can Help
If you or someone you know has had complications related to surgical mesh for ventral hernia repair, chest wall repair or surgical wound repair, please know the skilled attorneys of Hollis, Wright, Clay and Vail, P.C. are able to assist in obtaining just compensation for incurred losses and hardships. Please call us at 1-844-LAW-TALK or locally at 205-324-3600 so that our experienced attorneys can review your claim. We have a proven track record for handling medical device cases. Please remember that a statute of limitations will apply to your claim or lawsuit so don’t wait to hire an attorney. Our attorneys are ready to speak with you. All of these claims or cases are handled on a contingency fee basis which means you pay nothing unless we successfully recover money on your behalf.