In response to a groundswell of Kugel mesh hernia patch lawsuits, C.M. Bard has reportedly reached an agreement to settle about 2,600 cases with an average payout of roughly $70,000 for each plaintiff. Yet despite the massive payout, the settlement still leaves nearly 1,000 Kugel mesh hernia patch lawsuits unresolved. Claims against Bard began piling up in 2005, when various sizes and shapes of the patch were found to have design defects that could increase the risk of side effects after hernia repair surgery.
What’s the problem?
July 12, 2011 - News of the settlement deal was announced last month by Bard in its second-quarter earning report, coming after just two bellwether trials out of an estimated 3,600 claims made it to court. A total of approximately $184 million will be paid to resolve the lawsuits, the majority of which claim that a defective ‘memory recoil ring’ contained in the patch broke in the patient, resulting in serious intestinal injuries.
The first of the two Kugel mesh hernia patch lawsuits brought to trial ended in a victory for the defense last April. While the jury in that case did find that the Composix Kugel patch was defective, the plaintiff was unable to prove that his hernia repair problems were the direct result of the negligent design. In the second case, a different plaintiff was awarded $1.5 million in damages caused by the hernia patch. According to the claim, the plaintiff suffered severe internal injuries and a sepsis infection when the hernia patch broke inside him.
Kugel Mesh Hernia Patch Side Effects
The Bard Kugel mesh hernia patch is used to repair ventral hernias, which are typically caused by the thinning or stretching of scar tissue that forms after surgery. A hernia occurs when part of an internal organ pushes through an opening in the organ’s wall, which then presents itself as a painful lump in the abdomen or groin. The Bard Composix Kugel hernia patch was originally marketed as the first self expanding patch designed to address both sides of open ventral hernia repair.
The Kugel mesh hernia patch includes a ‘memory recoil ring‘ that allows it to be folded over during surgery and subsequently deployed in the abdomen once it is in place. Unfortunately, a large number of these memory recoil rings have been reported to be defective and have broken after being implanted in patients. According to the U.S. Food & Drug Administration (FDA), “The 'memory recoil ring' that opens the Kugel Mesh Hernia Patch can break under the stress of placement of the large sized products in the intra-abdominal space.” Once a memory recoil ring breaks, it can lead to the following catastrophic side effects:
- severe bowel perforation
- bowel obstruction
- chronic intestinal fistulae
- tenderness at the implant site
- abdominal pain / distention
In addition to these injuries, defects in the Kugel mesh hernia patch can also cause serious infections and even death. To date, the patch has reportedly caused at least one death. According to a wrongful death lawsuit filed against Bard, a 63-year-old woman died after sustaining a serious infection caused by a Kugel mesh hernia patch. Doctors attempted to treat the woman with antibiotics, but the infection only got worse. Finally, after several trips to the hospital, the infection led to her death.
Hernia Mesh Recalls
Since 2005, the following Davol / Bard Kugel hernia mesh products have been recalled:
Bard Compsix Kugel Extra Large Oval (All lots manufactured before January 2006)
- 8.7” x 10.7” Product Code 0010206
- 10.8” x 13.7” Product Code 0010207
- 7.7” x 9.7” Product Code 0010208
Bard Composex Kugel Oval (All lots manufactured before March 2006)
- 6.3” x 12.3” Product Code 0010209
Bard Composix Kugal Large Oval (Certain lots manufactured before October 2005)
- 5.4” x 7.0” Product Code 0010202
Bard Composix Kugel Large Circle (Certain lots manufactured before October 2005)
- 4.5” Product Code 0010204
The FDA warns that “Patients who have who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.” More information on these recalls can be found by clicking on the following links:
If you believe you may have been implanted with a Kugel mesh patch during hernia surgery, seek immediate medical attention if you experience symptoms that could be associated with hernia mesh patch memory recoil ring breakage. These symptoms may include (but are not limited to):
- unexplained or persistent abdominal pain
- tenderness at the implant site
- other unusual symptoms