Aaron Menendez endured two years following implantation of a Bard Composix Kugel mesh hernia patch before he suffered a serious infection and died this past September.  Soon after his implantation, the patch was recalled.  Menendez’s autopsy results confirm that the Bard Composix Kugel mesh was the cause of death.  Now, Menendez’s family want others to know about this potentially fatal medical device.

Over 700,000 hernia repair surgeries are performed in the U.S. annually.  Hernias are areas where an organ breaks through weakened or torn tissue.  Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery, which could cause problems if muscle tissue re-tore.  The patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring.  The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia. (more…)

The defective Kugel Mesh Hernia Patch – recalled several years ago – was mistakenly implanted in seven patients at two Virginia hospitals.  At least one woman who received a recalled Kugel Mesh Hernia Patch at one of the two hospitals owned by Sentara Health Systems says she has been living in excruciating pain since her surgery, and is worried that the medical device might be putting her life in danger.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quit using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice – in 2006 and 2007 – to include several other sizes of the device. (more…)

The maker of the defective Kugel Mesh Hernia Patch will now have to face even more lawsuits over faulty hernia patches.  Earlier this month, a Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall.

When it was first introduced, the Kugel Mesh Hernia Patch was heralded as an innovation in hernia treatment. Unfortunately, by 2005, the Food & Drug Administration (FDA) was receiving more and more reports of failure with the Kugel Patch. The reports were so alarming that the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. A Class I recall means that the recalled product poses a serious danger to patients still using it. The FDA warned doctors to quite using the patch. The FDA also warned patients who received the patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

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An Arkansas man is suing the makers of the Kugel Mesh Hernia Patch, alleging  that a hernia patch made by Davol and its parent company Bard caused a massive infection that forced him to undergo surgery to have the patch replaced.   Though the complaint does not say if the hernia patch responsible for his injuries was one of the recalled Davol patches, Marion Teague’s story is consistent with others who have been harmed by the faulty Kugel Mesh Hernia Patch.

The Kugel Mesh Hernia Patch was supposed to offer hernia patients relief from an extremely painful condition. But by 2005, it was evident that something had gone terribly wrong with the device. Apparently, the recoil ring that opened the patch could break. When the ring broke, patients experienced bowel perforations and other serious problems. The reports were so alarming that the Food & Drug Administration (FDA) issued a Class I recall, its most serious type of recall, of the Bard Composix Kugel Mesh X-Large Patch. Doctors where warned to stop using that version of the Kugel Mesh Hernia Patch, and patients who received the patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to several other sizes of the device.

(more…)

The recalled Kugel Mesh Hernia Patch was supposed to eliminate dangerous complications from hernia surgeries. Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery, which could cause problems if muscle tissue re-tore. Unfortunately, design flaws inherent in the defective Kugel Mesh Hernia Patch led to even more serious complications and injuries for many patients.

Over 700,000 hernia repair surgeries are performed in the U.S. annually. Hernias are areas where an organ breaks through weakened or torn tissue. The Kugel Mesh Hernia Patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring. The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the Kugel Mesh Hernia Patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia.

(more…)