Davol Inc., maker of the Bard Composix Kugel Mesh Patch, was issued a warning letter in 2006 from the FDA about serious problems the product has.
The FDA mentioned that these problems needed to be taken care of or there would be consequences. The warning was issued because of numerous cases involving the Kugel Mesh Patch that needed to be addressed. Deaths had been reported although there is no hard evidence supporting the fact that the patch had everything to do with it. One patient died during emergency surgery after developing a fistula. Another patient had hernia repair surgery and returned a year later because of a painful lump. The surgeon found plastic wire over the mesh and a lab investigation discovered that the memory ring was broken.
One patient returned after hernia surgery with “bowel obstruction and recurrent hernia.” The surgeon found the Kugel Mesh ring was exposed. It was two-and-a-half years between the time the patient had the hernia surgery and the time he or she returned with serious problems. This is extremely disturbing to think about.
Even though all these incidents sound so negative, there is still hope. In some cases, patients were fine even a year or two after the mesh patch was implanted. It totally depends on the individual and how each person’s body responds to the patch.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.