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Kugel Mesh Hernia Patch Adverse Side Effects
The Kugel Mesh Hernia Patch is a simple medical device used in the treatment of hernias since 1997. Produced by Davol, Inc., the Kugel Mesh Hernia Patch consists of a flexible plastic ring housed between two pieces of mesh, all of which are biomaterials (materials safe for use in the human body). In ideal conditions, this device prevents internal organs from further damaging a weak abdominal wall while also allowing weak tissues to grow back and heal the hernia.
Unfortunately, defects in the Kugel Mesh Hernia Patch's plastic ring (officially known as the "memory recoil ring") have caused patients to develop a variety of mild to serious side effects, ranging from pain to death.
Health Complications from Kugel Mesh Hernia Patch Defects
The simplicity of the Kugel Hernia Patch
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- bowel obstruction: If the intestines are, for some reason, blocked, their contents can't be expelled, and a patient experiences bowel obstruction. Pain, bloating, diarrhea and/or vomiting may be symptoms of bowel obstruction. If left untreated, patients will develop further health problems, such as infection or bowel perforation.
- bowel perforation: When broken memory recoil rings tear the intestinal tissues, the contents within the intestines can spill into an otherwise sterile abdominal cavity and cause bowel perforation. High fever, vomiting and/or serious blood infection (known as sepsis) are typical symptoms of bowel perforation. Bowel perforation can result in death if left untreated.
- chronic intestinal fistulae: This Kugel Mesh Hernia Patch side effect results when two areas of the intestine form an abnormal connection. While the main symptom of chronic intestinal fistulae is abdominal pain, lack of treatment can lead to infection and/or sepsis.
To prevent serious health problems and death, the FDA has issued a series of recalls, warning patients to seek immediate medical help if they have a Kugel Mesh Hernia Patch and start experiencing fever, pain, nausea and/or vomiting.
Kugel Mesh Hernia Patch Side Effects and Related Statistics
Below are a few interesting statistics that will give you an idea of the scope and gravity of the possible hernia patch side effects:ยท The FDA has issued three different recalls of various models of the Kugel Mesh Hernia Patch.
- To date, six different models of the Kugel Mesh Hernia Patch have been recalled.
- Each year, about 750,000 patients receive hernia surgery.
- Since 2005, Bard and its subsidiary Davol, Inc. have made over $11 million selling defective Kugel Mesh Hernia Patches.
Hernia Patch Recalls and Lawsuits
While the initial FDA recall on defective Kugel Mesh Hernia Patches was issued in 2005, the latest recall in January 2007 expanded the scope of earlier recalls and upgraded them to "Class I." A Class I recall means that patients still using a device have a high risk of developing serious health problems.
This series of hernia patch recalls triggered a comprehensive FDA investigation of Davol, Inc., during which the FDA found that Davol:
- knew about patch defects before the 2005 recall
- improperly handled patient complaints regarding the Kugel Mesh Hernia Patch
- lacked a system for issuing and managing product recalls
- failed to comply with various regulations regarding the production and storage of their medical devices
Given this negligence and the inherent defects of the Kugel Mesh Hernia Patch, it's no surprise that a number of patients have sought compensation through personal injury lawsuits.
In fact, pursuing a hernia patch lawsuit is a good idea for any patient that has suffered serious Kugel Mesh Hernia Patch side effects. With an experienced personal injury lawyer, injured patients will get help proving their case and winning the money they need to pay medical bills and move on with their lives.
If you have suffered a Kugel Mesh Hernia Patch side effect, contact us today for a free case evaluation.
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