Kugel Hernia Patch

The Bard� Composix� Kugel� Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a �memory recoil ring� that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Davol, Inc. started recalling the Kugel Hernia Patch in December of 2005 for all lots manufactured before 2006. Six different products in the patch line have been recalled. The reason for the recall is that the "memory recoil ring" that opens the Bard� Composix� Kugel� Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Kugel Hernia Patch Side Effects

persistent dominal pain

fever

tenderness at the implant site

other unusual symptoms

Kugel Hernia Patch History

Davol, Inc. reportedly received complaints as early as 2002. The company took no action at that time and asserted that the number of complaints was very small and didn't require public notification. In 2005, Davol received 10 reports of ring breakage within a 3 month time frame. At this time Davol did not take responsibility and instead laid the responsibility with the doctors who didn't implant the patch correctly. The FDA began an inspection of the Kugel Hernia Patch in the beginning of 2007, after the Kugel Hernia Patch recall.

In April of 2007, the FDA sent a warning letter to Davol citing several "serious regulatory problems" and that these problems directly contributed to the delay of addressing the problems with the Kugel Hernia Patch. These violations included:

Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).

Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.

Failure to document the implementation of corrective and preventive actions, as required by 21 CFR 820.100(b). For example, CAPA #Q6023, (opened on April 28, 2006 and closed on June 13, 2006), was initiated as a result of your class 1 recall of the Composix Kugel Hernia Patch due to ring weld breaks. This CAPA included the following specific action to be taken, "... establish complaint threshold limits for recoil ring break complaints & continue to monitor trends." During the inspection, no documentation could be provided to our Investigator that demonstrated these limits had been established prior to closing of the CAPA.

Failure to validate your device's design to ensure that the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g). For example, there was no documentation to demonstrate that design validation was performed on your Salute Reusable Fixation device. During the inspection, we observed a performance specification for your Salute Reusable Fixation device which states, ". . .the reusable assembly shall be capable of producing [redacted] Q Rings without compromising performance". There was no documentation available to demonstrate that any testing was performed to ensure that the Salute Fixation device met this specification.

Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).

Products liability lawyers & attorneys: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts. Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Washington D.C., West Virginia, Wisconsin, Wyoming