Composix Kugel mesh patches are primarily used to repair ventral hernias. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. The U.S. Food and Drug Administration (FDA) approved the Kugel mesh patch in 1996. It is made by Davol, Inc., a subsidiary of C.R. Bard. Because a part of the patch called the memory recoil ring can break causing serious injuries, certain sizes of the patch were recalled in 2005 – 2007. More than 100,000 units were recalled by January 2007 and the FDA received 34 reports of ring breakage, at least one resulting in death.
The memory coil ring allows the Kugel mesh patch to be placed through a very small incision in a type of procedure refer to as laparoscopic surgery. The patch is folded up so it fits through the small incision, then it pops open inside the body and will lie flat once it is placed. The advantage of laparoscopic surgery is less trauma to the tissues resulting in a shorter and easier recovery. But, the memory coil ring can bend or break. If it breaks the end can poke out of the patch causing very serious injuries. Complications may arise immediately or later down the road.
Kugel Mesh Patch Injuries
Harm caused by a defective Kugel mesh patch can include:
- Abdominal abscess
- Fluid in the abdomen
- Perforation of the intestinal wall
- Migration of the ring through the abdominal wall
- Bowel perforation
- Bowel paralysis
- Bowel obstruction
- Internal and external fistulas
- Peritonitis – potentially fatal inflammation of the lining of the abdomen
- Pelvic inflammatory disease
- Hernia recurrence
Symptoms of Kugel hernia mesh complications include:
- Tenderness in the abdomen
- Distended abdomen
- Abnormal bowel movements
- Persistent drainage at the surgical site
- Severe abdominal pain
Kugel Hernia Mesh Patch Recalls
Recalls of certain sizes of the Kugel hernia mesh patch were issued in 2005, 2006, and 2007. The FDA issued a warning announcement advising patients who already had the recalled units in their bodies to be on alert for signs of device failure and seek immediate medical attention if they experience symptoms.
In 2011, Bard offered to pay $184 million to Kugel mesh patch victims and their families to settle about 2,600 lawsuits. However, many hernia repair patients are still experiencing problems.
If you have been harmed by a Composix Kugel mesh patch, or lost a loved one to hernia repair complications, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.