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The FDA says that the manufacturer of the composix kugel mesh patch (Davol, Inc.), is said to have known of the dangers of the product and the several injuries liked with the patch, including one fatality, and still kept it on the market. . The FDA documents also say that Davol underreported the number of device-related complaints it received from doctors about injuries stemming from the Kugel mesh hernia patch.

The reports suggested that hernia patch patients could experience severe injuries as a result of breaks in the “memory-recoil ring” that surrounds the patch. Over a three-month period, the company received 10 reports of ring breaks, including at least one possible fatality. However, Davol did not issue the first hernia patch recall until December 2005. Two subsequent hernia patch recalls for smaller models of the Kugel mesh patch were issued in March 2006 and January 2007.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

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