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Kugel Mesh Hernia Patch Defects
The Kugel Mesh Hernia Patch, a prosthetic device made by Davol, Inc., was first introduced in 1997 to treat ventral hernias, which result when an organ puts pressure on (or pushes through) a weak abdominal wall.
While the Kugel Mesh Hernia Patch was widely used after its introduction, by 2002, inherent defects with this patch had started causing serious health problems, leading to patient complaints, FDA recalls and a number of personal injury lawsuits.
What is the Kugel Mesh Hernia Patch?
The Kugel Mesh Hernia Patch is a flat, oblong device comprised of a plastic ring, referred to as the "memory recoil ring," held between two pieces of mesh cloth. Ideally, the Kugel Mesh Hernia Patch is intended to act as a support for weakened abdominal walls in that it should:
- relieve pressure caused by internal organs
- prevent internal organs from pushing on the weak abdominal wall
- allow weak abdominal wall tissues to re-grow and heal themselves
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Because the Kugel Mesh Hernia Patch is made of safe materials, it can stay in place throughout the hernia recovery process, as tissues can safely grow around and over this device.
How the Kugel Mesh Hernia Patch Malfunctions
Kugel Mesh Hernia Patch defects occur when the memory recoil ring breaks and damages surrounding tissues and/or organs. With a damaged hernia patch, a patient may experience painful and, in some cases, serious symptoms including:
- abdominal pain
- bloating
- constipation
- diarrhea
- high fever
- infections, particularly sepsis (a possibly fatal blood infection)
- nausea
- vomiting
These symptoms indicate that one (or more) of the following hernia patch side effects have occurred:
- bowel obstructions
- tears in the bowel tissues
- chronic intestinal fistulae (in which two parts of the intestines make an abnormal connection)
If left untreated, Kugel Mesh Hernia Patch side effects can cause permanent damage or death. Consequently, anyone with a mesh hernia patch should seek immediate medical care as soon as (s)he starts to experience any of the above symptoms.
Kugel Mesh Hernia Patch Recalls and Lawsuits
Initial patient complaints about Kugel Mesh Hernia Patch defects began arising in 2002. At the time, Davol, Inc. (whose parent company is Bard) refused to acknowledge the patch's inherent defects, claiming that doctors weren't implanting the devices correctly.
While Davol eventually reversed this claim and recognized the patch's defects, by 2005, the FDA had taken action, issuing a recall of specific models of the Kugel Mesh Hernia Patch.
Two years later, in 2007, the FDA:
- upgraded its 2005 recall to a "Class I" status, which is reserved for the most serious recalls (A Class I recall warns patients still using a product that they are at a high risk of developing health complications.)
- expanded the scope of the recall to include many more versions of the Kugel Mesh Hernia Patch
- initiated a thorough inspection of Davol's headquarters in Rhode Island, during which evidence of the company's negligence was found.
On the basis of this negligence and the patch's defects, many injured patients have filed personal injury lawsuits against Davol. If you or a loved one has developed a health problem resulting from a Kugel Mesh Hernia Patch defect, contact us today to learn more about your legal options.
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