Composix Kugel Mesh
Motley Rice continues to litigate cases involving patients who suffered injuries or complications related to manufacturer Davol, Inc.'s Composix® Kugel® Mesh hernia repair patch, including:
- abdominal abscess formation
- abdominal tenderness
- bowel paralysis
- corrective surgery
- distended abdomen
- external fistulas
- fluid in abdomen
- internal fistulas
- intestinal or bowel perforation
- pelvic inflammatory disease
- persistent surgical site drainage
- severe persistent abdominal pain
If you have questions about the Composix Kugel Mesh hernia repair patch litigation, contact medical device lawyers Don Migliori or Leah Donaldson by email or call 1.800.768.4026.
Don Migliori serves as the co-lead plaintiffs' counsel and liaison counsel for the Composix Kugel Mesh multidistrict litigation in federal Rhode Island court on behalf of thousands of individuals alleging injury by the hernia repair patch. He additionally serves as liaison counsel for the nearly 2, 000 Composix Kugel Mesh lawsuits consolidated in Rhode Island state court.
Read complete Composix Kugel Mesh trial updates.
Composix Kugel Mesh Recall
The Composix Kugel Mesh hernia repair patch is used to repair abdominal hernias. It is folded and inserted into the abdomen through a small incision. Once inside the abdomen, the mesh springs open and lays flat as a result of a hard memory recoil ring contained within it.
Specific lots of the Composix Kugel Mesh patch were initially recalled in December 2005 by manufacturer Davol, Inc., a subsidiary of C.R. Bard, Inc., after it was discovered that the memory recoil ring, which opens the device, can buckle or break under the stress of placement in the intra-abdominal space. Between December 2005 and March 2006, and again in January 2007, the recall notice was updated to include additional product codes and lot numbers.
These specific lot numbers of the Composix Kugel Mesh patch are subject to a Class 1 recall by the FDA, the highest level of recall that is made when the FDA believes a medical product is dangerous or defective and predictably could cause serious health problems or death. Review a detailed list of lot numbers and product codes affected by the recall.
Dangers Associated with Composix Kugel Mesh Failure
As of January 2007, the number of recalled Composix Kugel Mesh products exceeded 100,000 units. Of these, the FDA received 34 reports of ring breakage, 21 of which caused serious patient injury and one resulted in death.
If the Composix Kugel Mesh hernia patch fails as a result of the memory recoil ring buckling or breaking inside the abdomen, it can cause perforation of the intestines, ring migration through the abdominal wall, fistulae (an abnormal connection or passageway between organs or vessels that normally do not connect), abscesses, bowel obstruction and sepsis. The symptoms one could expect to experience include fever, abdominal tenderness, nausea, diarrhea, abnormal bowel movements and abdominal distention.