On December 22, 2005, the Food and Drug Administration (FDA) issued a nationwide Bard Composix Kugel Mesh Patch recall due to findings that this medical device had design flaws that were causing malfunctions, severe patient injuries, and patient fatalities. This initial recall was followed up by recalls of six other models of the hernia patch.
First approved by the FDA in 1996, the Kugel Mesh Patch was used to facilitate recovery from ventral hernias by surgically implanting the patch behind the hernia. The Kugel Mesh Patch then opened via a “memory recoil ring.” Although Davol, Inc. (the maker of the Bard Composix Kugel Mesh Patch) initially blamed patient injuries on doctors’ mistakes, it soon came to light that malfunctions with the device’s memory recoil rings were causing serious, life-threatening injuries.
Side Effects Spark Kugel Mesh Patch Recall
Some of the serious injuries caused by defective Kugel Mesh Patches include:
- chronic enteric fistulas (abnormal connections that develop between two parts of the intestines)
- bowel obstructions
- bowel perforations
- intestinal perforations
- severe infections that can be fatal if they spread to the blood (i.e., cause sepsis).
Kugel Mesh Patch patients who begin to develop any of the following symptoms should seek emergency medical attention to prevent potentially fatal side effects from arising:
- persistent abdominal pain
- tenderness at implant site
- vomiting and nausea
Kugel Mesh Patch Recall Lawsuits
An estimated 75,000 patients have had the Bard Composix Kugel Mesh Patch implanted. Of these patients, those who sustain any serious injury due to malfunctions of their hernia mesh patch will have a strong legal case against Davol, Inc. They may also be entitled to compensation for their medical bills, lost wages, permanent disabilities, ongoing treatment costs, pain, and suffering. Prospective plaintiffs can learn more about their legal rights and receive a thorough assessment of their case by attending a free, no obligations initial consult with a skilled products liability lawyer.
If you or a loved one have used the Kugel Mesh Hernia Patch and suffered from any side effect including bowel obstructions, intestinal perforations, or sepsis you should contact us immediately for a free and confidential case review. You may be entitled to compensation and we can help.