The Food and Drug Administration (FDA) and Davol, Inc., have again expanded the existing recall of the Bard Composix Kugel Mesh Patch. The patch is used in hernia repair surgery. Recalls of the device began in 2005, were expanded in 2006, and have been further expanded on January 10, 2007.
Ventral (incisional) hernias
A ventral hernia is a gap or tear which forms in the abdominal wall, due to thinning or stretching of scar tissue after surgery. Typically they are very painful, but sometimes they present no symptoms. They can be dangerous or even deadly. Internal organs can protrude through this gap, in come cases cutting off the blood supply and requiring emergency surgery.
How the Kugel Mesh Patch is used in hernia repair
The mesh patch is used to reinforce the weakened tissue and prevent recurrence of the hernia. During hernia repair surgery, the patch is folded, inserted through a small incision, and placed behind the weakened tissue. Once the patch is positioned a plastic ring called the “memory recall ring” opens the patch and keeps it open.
Memory Recall rings may break
The defect is in the memory recall ring. The welds of this plastic ring can break when the ring is under stress during placement. When the ring breaks the exposed, broken ends can tear through the mesh causing serious internal injuries including bowel perforations and/or chronic enteric fistulae, a condition involving abnormal connections or passageways between the intestines and other organs. Both can result in serious or deadly infections, and other complications.
According to the FDA, symptoms which may indicate the presence of a broken memory recall ring include:
- Persistent abdominal pain
- Tenderness at the implant site
- Other unusual symptoms
If you experience any of these symptoms following hernia surgery, you should seek immediate medical attention.
The recall began in 2005, after 24 reports of broken rings, even though Davol had been receiving complaints about the patches in 2002. Since the initial recall announcement, the list of recalled products has been expanded twice. The entire recall includes:
- Extra Large Oval, 8.7″ x 10.7″ (product code 0010206), recalled in December, 2005
- Extra Large Oval, 10.8″ x 13.7″ (product code 0010207), recalled in December, 2005
- Extra Large Oval, 7.7″ x 9.7″ (product code 0010208), recalled in December, 2005
- Oval, 6.3″ x 12.3″ (product code 0010209), recalled in March, 2006
- Large Oval, 5.4″ x 7.0″ (product code 0010202), recalled in January, 2007
- Large Circle, 4.5″ (product code 0010204), recalled in January, 2007
It is possible that patches which have not yet been recalled may be defective as well. In fact there have been reports of several cases of hernia patches which have not been recalled failing and causing injury and sometimes death. If you have had, or are planning to have, hernia repair surgery be sure to get the name of the manufacturer and make of the patch used in your surgery from your doctor, in case you begin to experience symptoms of a defective patch.
If you have a recalled patch
In some cases replacement surgery is necessary, if you have a recalled patch. However, replacement surgery carries risks, and for some patients who do not show symptoms of ring breakage, it may be safer to leave the ring in place. If the ring is broken, it may be possible to remove only the ring and leave the original patch.
If you experience symptoms of hernia patch failure, seek immediate medical attention, even if your patch has not been recalled or if you don’t know which patch was used in your surgery. Time is of the essence and complications ca be fatal.
If you or a loved one has been injured or killed by a defective hernia patch,contact an experienced personal injury attorney today.