Surgical Mesh Complications Lawsuit News & Legal Information
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Abdominal Surgical Mesh
Abdominal surgical mesh is used to help repair issues in the patient’s abdomen such as hernias. Mesh is used to reinforce a hernia repair or strengthen abdominal wall tissue. The mesh is made from animal tissue or synthetic materials and can be absorbable, non-absorbable, or a combination of both.
Absorbable mesh, according to the US Food and Drug Administration (FDA) loses strength over time and is not intended as a long-term reinforcement. As the absorbable mesh, which is made from animal tissues, degrades, the patient’s new tissue growth should take over and provide strength. Non-absorbable mesh is made from synthetic materials and is considered a permanent implant.
Abdominal Surgical Mesh Complications
The FDA reports the common complications associated with hernia surgery involving hernia mesh are:
- Pain
- Infection
- Bowel obstruction
- Hernia recurrence
- Adhesion (when the mesh adheres to the patient’s tissue)
Due to serious complications, some abdominal mesh products are no longer on the market. Complications reportedly associated with recalled meshes:
- Pain
- Infection
- Obstruction
- Adhesion (when the mesh adheres to the patient’s tissue)
- Recurrence
- Perforation
“In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications,” FDA notes.
Abdominal Surgical Mesh Lawsuits
Products that have faced or could face a lawsuit concerning serious complications linked to abdominal surgical mesh:
Composix Kugel Mesh
The Composix Kugel Mesh Patch has been voluntarily recalled multiple times after concerns were raised that a component in the patch could break under stress, possibly causing bowel perforations and/or chronic enteric fistulae. C.R. Bard, parent company of Davol Inc., has faced thousands of lawsuits alleging patients suffered serious medical problems linked to the use of the Composix Kugel Mesh patch.
In 2011, Bard announced it would pay $184 million to settle the majority of lawsuits filed against it. Bard had argued that problems with the memory ring were the fault of doctors implanting it and not an issue with design of the patch.
A Kugel Mesh lawsuit was also filed in Canada, alleging Canadian patients suffered complications as a result of the Composix Kugel Mesh Patch.
Ventralex Hernia Mesh
Bard also faces allegations linked to its Ventralex hernia mesh. Ventralex, made from polypropylene, was approved by the FDA in 2002. Plaintiffs allege it has an unreasonable risk of complications because it was not properly manufactured or designed.
Ethicon Physiomesh
In 2016, Ethicon issued a voluntary withdrawal of its flexible composite physiomesh, after unpublished data from two registries suggested the product had higher than expected recurrence rates. In announcing its withdrawal, Ethicon noted that the problem could be linked to product characteristics, operative factors, and/or patient factors. Lawsuits have been filed against Ethicon, alleging patients suffered serious health complications due to use of the flexible composite physiomesh. They further allege the composite mesh has a high risk of unreasonable side effects.
Atrium C-Qur Hernia Mesh
Makers of the C-Qur Hernia Mesh face allegations that the mesh is not suitable for its intended purpose. Patients allege the mesh “folded up” and caused pain, infection, and septic shock.
Alloderm is a skin graft used in reconstructive breast surgery and hernia repair. Complications linked to Alloderm include infection, pain, abscesses, and inflammation.
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