Kugel Mesh Patches, Used in Hernia Surgery, Caused Painful Internal Injuries
The Kugel Mesh Patch, a medical device that was commonly used in surgeries to repair hernias, was recalled in 2005, 2006, and again in 2007 after patients suffered painful bowel perforations and other chronic injuries. The patch, placed inside the body following hernia-repair surgery to prevent tearing or the formation of scar tissue, had a tendency to break or move around inside the body, causing tears between the intestines and other digestive organs, such as the bladder and rectum.
The Kugel Mesh Patch injuries were caused when the “memory recoil ring,” which opened the oval patch so it could lay flat after it was inserted into the body through a narrow incision, broke.
FDA Announces Class I Recall
As far back as 2002, the Food and Drug Administration was receiving complaints about the Kugel Mesh devices breaking inside patients, causing serious injuries. Davol Bard, which makes the patches, initially blamed the problems on surgeons incorrectly inserting the patches into patients, but in 2005, the manufacturer admitted that faulty welding on the plastic rings caused them to break after they were sprung open inside patients. The devices also were shown to move around, or migrate, inside the body, causing further injury and requiring surgery to remove or relocate them.
In December 2005, the FDA announced a Class I nationwide recall of Kugel Mesh patches and expanded the recall to include additional types of patches in 2006 and again in 2007. In all, six types of Kugel Mesh patches have been recalled since the patient injuries were first reported.
Kugel Mesh Injury Symptoms
If you have been injured by a defective Kugel Mesh Patch used during your hernia surgery, you may experience one or more of the following symptoms:
- Persistent abdominal pain
- Fever
- Sensitivity or tenderness in the surgical area
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Permalink Tags: hernia surgery, Kugel Hernia Mesh, mesh patch
