Kugel Hernia Mesh Patches
SEARCY DENNEY LAW FIRM PREPARED TO HOLD MANUFACTURER ACCOUNTABLE FOR INJURIES CAUSED BY FDA-RECALLED HERNIA PATCHES
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For patients who are undergoing ventral hernia repair surgery, the Kugel Composix Mesh Patch is a product often used to close the hernia and help the tissue heal. The Kugel Composix mesh patch includes a “memory recoil ring,” a small plastic ring embedded in the patch that permits it to be folded over and then deployed once in the abdomen. Sadly, a number of these memory recoil rings are breaking while the product is in patients, setting off a horrific chain reaction of consequences: bowel perforations, abdominal wall punctures or tears, adhesions, and/or abnormal connections or fistulae between intestinal organs. All of these complications may mean additional medical treatment and even more surgery for the unsuspecting patient.
Before the Kugel Mesh Patch was recalled by the FDA in 2007, patients, and some physicians, were indeed unsuspecting – but the manufacturer, Davol, had known for years that the recoil ring had a tendency to break. Patients have also been injured by other Bard/Davol hernia mesh products that include the dual mesh technology. These products can migrate within the body, which, in turn, permits the mesh to expose the bowel and other internal organs to the wrong side of the patch (the one that is supposed to only face the abdominal wall so that it can encourage the body’s tissues to grow into the patch).
In 2002, although physicians complained of dissatisfaction with the Kugel patch, there was no follow up on these complaints. Subsequent investigations indicate that by 2004, Davol was aware of a welding problem that caused the memory recoil ring defect. But Davol did not correct the defect, or notify the unsuspecting FDA, physicians, or patients.
Even when evidence accumulated over the next two years, Davol executives remained mum and continued to market the patches until the first recall notice was issued at the end of 2005. Finally, in January 2007, a Class I recall – the most serious category – was announced, and surgeons and hospitals were told to stop using certain sizes of the Kugel Mesh Patch and other hernia products that include the memory recoil ring technology.
According to the FDA, patients with a Bard Composix Kugel Mesh Patch should seek immediate medical attention if they experience any of the following symptoms:
- Persistent or unexplained abdominal pain
- Fever
- Tenderness at the implant site
- Other unusual symptoms
The law firm of Searcy Denney Scarola Barnhart & Shipley is one of the few firms in Florida with experience investigating and litigating hernia mesh cases. If you or a family member has suffered the severe consequences of a faulty hernia mesh patch such as the Kugel Composix patches that include the memory recoil ring, or other Bard/Davol products with the dual mesh design, we are prepared to help you evaluate your claim and seek justice. Please fill out our Contact Form, or call us to learn more and arrange for a confidential free consultation.