Kugel Mesh Patch
GALVESTON – Complaining that an implanted Composix Kugel Mesh Patch caused abdominal problems, Bay City resident Frank Larry Spalek has pursued legal action against the patch's manufacturer and distributor.
Spalek's lawsuit filed in the Galveston Division of the Southern District of Texas against maker Davol Inc. and distributor C.R. Bard Inc. alleges the product used to repair his hernia almost seven years ago was mired in defects.
The plaintiff underwent abdominal surgery in which physicians embedded the device on July 14, 2004.
According to the original petition, Spalek did not know about the complaints, known complications and risks associated with the Kugel Patch nor was he notified that the one implanted in his body was to be recalled.
The complaint claims the Kugel Patch was the subject of increased negative feedback during the early part of the last decade, prompting the defendants to initiate a recall.
Spalek alleges he experienced fever and nausea as well as abdominal pain, tenderness,distention and soreness in March 2008. He claims he sought medical treatment, but efforts to diagnose the cause of his symptoms were unsuccessful.
Spalek's physicians, however, attributed the problems to the hernia procedure, the suit says.
The further explains that the plaintiff's suffering worsened progressively, until part of the Kugel Patch had to be removed.
"Mr. Spalek was eventually informed by his treating physicians that some, if not all, of his complaints were due to the Kugel Patch adhering to his intestinal wall, causing him great discomfort and further treatment," the suit says.
The defendants face eight counts of alleged wrongdoing.
Spalek seeks unspecified monetary damages and a jury trial.
He is represented by Matthews & Forester.
The case has been assigned U.S. District Judge Kenneth M. Hoyt.
Case No. 3:11-cv-00127