Kugel Mesh Hernia Patch Defects Put Patients at Risk, Yet Davol Waited Before Issuing RecallNov 14, 2007 | Parker Waichman LLP
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.
Bard, Davol’s parent company, knew about severe injuries caused by the device. Although they claim they acted responsibly, the Kugel Mesh Hernia Patch was not taken off the market because Bard felt the number of complaints were small given the number of patches sold and problems cited were too random.
The company received reports of up to 10 complications from the patches, with one possible fatality. The company delayed reporting a massive recall for months because initial complaints all came from Germany, with three from one doctor. Davol concluded ring breaks were due to physician error, halted production of some Kugel Mesh Hernia patches, trained German doctors, revised physician instructions, and continued distributing other patches. Davol was wrong; problems continued.
The problem with the Kugel Mesh Hernia Patch is in the ring. Tests run on a failed patch indicated a ring weld defect. This means that the ring can break, exposing shards that have caused bowel perforations and obstructions, serious infections, and chronic fistulae (abnormal connections between intestines and organs). Despite this and Class I recalls (indicating a serious danger), Davol recommended that products continuing to function properly should not be replaced as there could be greater risk in removing a properly functioning device. Requesting replacement surgery is not an option.
The Food and Drug Administration (FDA) ordered Davol to investigate and correct procedures and accused Davol of knowingly keeping defective Kugel Mesh Hernia Patches on the market and understating their severe and dangerous complications. An FDA inspection at Davol unearthed other problems: serious flaws in their complaint tracking system (systems incompatibility); shoddy procedures (an inability to handle everything from complaint investigation to recall actions determination); and an absence of testing documentation on the manufacture of Salute Reusable Fixation devices (for attaching mesh in laparoscopic and open hernia repair and pelvic floor reconstruction). The FDA said Davol’s procedures were to blame for delays in dealing with the problems; that Davol did not accurately report complaint severity; and problems found during inspection could be symptomatic of serious underlying issues in their quality assurance system.
In addition to patch recalls, the FDA recalled some of the company’s Salute devices and warned that Davol was in serious violation of the law and that they could take further regulatory steps without notice, including inventory seizure, injunctions preventing product sale, or monetary penalties.
In all, Kugel Mesh Hernia Patches have been recalled three times by the FDA who received nearly 100 reports of problems related to the patch, several involving death.