Although hernia treatments have always posed some degree of difficulty and risk for patients, it was always considered safer to have the painful problem corrected due to potential complications, such as gangrene, that occur if left untreated. However, due to some defective hernia patch side effects some patients may be rethinking the wisdom of that approach. In fact, some suffered more as a result of the hernia repair surgery complications than they did from the hernia itself.



When Davol Inc. received FDA approval for their Composix Kugel mesh patch in 1996, it was hailed as a revolutionary example of new hernia treatments that would be less invasive, less costly, and less difficult for the patient. All was going well with the product until 2002 when the company started releasing two larger size patches. Around the same time complaints about hernia repair surgery complications began pouring in from patients around the country.

The complaints of defective hernia patch side effects centered around the units breaking while they were inside the patients. The components ended up floating around the patient’s body, usually the abdomen, and possibly doing additional damage. Punctures to the bowels, internal organs, and tissue were common problems. Bowel obstructions and other complications were also a problem for patients.

Initially, Davol blamed the surgeons for the defective hernia patch side effects. The company claimed surgeons were making errors while inserting the devices into patients and this was causing them to break. However, when the devices were examined more thoroughly by inspectors it was determined that the problem actually kept occurring at a point where the pieces had been welded together.

After the determination that the hernia repair surgery complications were not being caused by the surgeons but by the device itself, the FDA asked Davol to pull it from the market. However, that move has done little to compensate the thousands of people who had been seeking hernia treatments only to have their conditions made worse and increasingly painful through the use of a malfunctioning device. Despite the recall, a countless number of patients still contains the product and could still be affected by these defective hernia patch side effects. Lawsuits have been filed by many patients in an attempt to receive compensation for their added suffering.