Composix Kugel Mesh Hernia Repair Patches Target of Recalls
An estimated 100,000 Composix Kugel Mesh hernia repair patches have been the target of three government recalls because of dangerous failures that have put people’s lives in danger. People who have undergone surgery using these patches remain at risk.
The company that makes these patches failed to adequately test them before making them available to surgeons for use in repairing hernias. Because of this, patients who received one of the defective patches have had to undergo new surgeries to remove the patch and, in some instances, have died.
If you or a loved one has suffered consequences as a result of these defective patches, you have a right to hold the manufacturer responsible. Although a lawsuit cannot ease the pain or loss of a loved one, it can help pay medical expenses and compensate for income or other losses. An experienced Composix Kugel Mesh hernia repair patch attorney with Janet, Jenner & Suggs can review your situation and advise you. All consultations are free of charge.
Consumer Alert
If you’ve had a hernia repair using a Kugel Mesh patch and you experience any of the following symptoms, you should see your doctor immediately as this may indicate the patch has failed:
- Fever
- Abdominal tenderness
- Nausea
- Diarrhea
- Abnormal bowel movements
- Abdominal distention
More about Composix Kugel Mesh Hernia Repair Patches
The Composix Kugel Mesh Patch, manufactured by Davol, Inc., a subsidiary of C.R. Bard, is a medical device used to repair ventral hernias that may appear in the aftermath of a hernia surgery. The tissue in the area of a hernia repair is often thin and scarred, leaving the area vulnerable to a new tear. If this occurs, surgeons go in with a patch to make the repair. This mesh patch is folded and inserted into the body behind the hernia area.
The Kugel Mesh patch contains a spring-loaded plastic memory coil that, once inserted behind the hernia, pops open and lies flat, helping to strengthen the area. The problem with the defective patches is that this plastic coil has been known to buckle or break, creating serious consequences, including:
• Abdominal perforation
• Abdominal abscess formation
• Abdominal tenderness
• Bowel paralysis
• Corrective surgery
• Distended abdomen
• External fistulas (abnormal connections of tissue)
• Fluid in abdomen
• Internal fistulas
• Intestinal or bowel perforation
• Pelvic inflammatory disease
• Peritonitis
• Persistent surgical site drainage
• Sepsis (serious blood infection)
• Severe persistent abdominal pain
Defective Patches Subject to Recall
The U.S. Food and Drug Administration and the manufacturer recalled about 100,000 of these patches in three separate actions in December 2005, January 2006, and March 2006. The batch numbers included in these recalls were:
- PC#0010206 Bard Composix Kugel Extra Large Oval 8.7″ x 10.7″
- PC#0010207 Bard Composix Kugel Extra Large Oval 10.8″ x 13.7″
- PC#0010208 Bard Composix Kugel Extra Large Oval 7.7″ x 9.7″
- PC#0010209 Bard Composix Kugel Oval 6.3″ x 12.3″
- PC#0010202 Bard Composix Kugel Large Oval 5.4″ x 7″
- PC#0010204 Bard Composix Kugel Large Circle 4.5″
Doctors Ordered to Discontinue Patch Use
A recall notice issued in 2007, updated the batch numbers recalled. As of 2006, the FDA has ordered doctors and healthcare professionals to immediately discontinue use of recalled patches.
Legal Help for Victims of Composix Kugel Mesh Hernia Repair Patch
If you or a loved one were treated with a Composix Kugel Mesh hernia repair patch and suffered any of the above injuries, you may have valuable legal rights. Please fill out our online form, or call us toll-free at 1-877-My-Advocates (1-877-692-3862) to discuss your case with one of our pharmaceutical injury lawyers today.
