The Kugel Mesh manufactured by Davol Inc. and offered under the brand name of Bard and Composix was developed for the repair of ventral hernias which occur at natural weak points in the muscle wall. The Kugel Mesh Patch was engineered to brace weakened or torn muscle tissue and be much less invasive as compared to older, more traditional methods of hernia surgery.
In 1997, Dr. Robert D. Kugel filed a patent for his specialized hernia mesh patch which incorporated a non-invasive laparoscopic operative process which no longer required the surgeon to make an excessive incisions triggering increased post operative pain. As an alternative, several little incisions were made whereby the surgeon may create little incisions to introduce devices and a camera. During the process, doctors launch a “folded” Kugel hernia patch into the repair site which consisted of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring”. Once insertion, the special welded, outer ring is designed to release to its original shape and act as a flat underlying supporting layer.
Issues with the use of the Composix Kugel mesh patch began to become apparent in 2002 soon after Davol Inc. launched the large and extra large hernia patch. The plastic part of the memory recoil commenced to malfunction due to flaws in its manufacture. Defects in these larger patches occurred when the weld came apart on the thin and flexible plastic rod which was developed to form a loop. Doing so caused the ends of the plastic material rod to spring apart and become injurous to individual patients inserted with these defective patches.
Issues with these larger patches were initially attributed to surgical mistakes made by medical doctors while doing the hernia-repair surgery. However, manufacturer inspection quickly uncovered that the design flaws almost always transpired at the spot where the ring was welded together. Eventually Davol acknowledged that there were issues with the design of some patches. As a result, Davol commenced recalling particular models of the patch in 2005; recalls of other models were launched in 2006 and 2007 respectively. Once this defect was known, Davol revised the hazardous recoil ring.This new ring featured better weld strength for the ring assigned to the Composix XL size mesh.
Davol recalled these faulty medical devices due to patients undergoing painful issues like infections or much more extreme injuries such as bowel obstructions, holes and constrictions resulting from the migrating patch wrapping around the bowel. Additional injuries involve persistent enteric fistulas, which relates to an irregular connection between two epithelialized surfaces such as the gut and hollow organs, such as the bladder, vagina, or other regions of the GI tract.
If you or a loved one have been injured by a defective Kugel Hernia Mesh patch, contact Hummer Law Offices at www.hummerlaw.com or call them at 1-800-433-8420 for a free initial consultation regarding your potential claim.