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.
Bard, Davol’s parent company, knew about severe injuries caused by the device although they claim they acted responsibly and didn’t take the product off the market because the number of complaints were small given the number of patches sold and problems cited were too random. In all, patches were recalled three times by the US Food and Drug Administration (FDA) who received nearly 100 reports of problems related to the patch, several involving death. Davol, received reports of up to 10 complications from the patches, with one possible fatality, yet Davol 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 patches, trained German doctors, revised physician instructions, and continued distributing other patches. Davol was wrong; problems continued.
The problem was not with a doctor but is in the Bard Composix Kugel mesh hernia patch ring. Tests run on a failed patch indicated a ring weld defect, meaning 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 despite 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 FDA ordered Davol to investigate and correct procedures and accused Davol of knowingly keeping defective patches on the market and understating their severe and dangerous complications. An 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.
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