The recent Composix Kugel hernia mesh recalls were issued as a result of a defective memory recoil ring which has been found to break in some cases. As a result, small needles of plastic could slice through internal organs, intestines and the bowels, causing serious and potentially fatal injuries. While the manufacturer indicates that the ring breakage is only caused by stresses associated with inserting the surgical patch, there is not sufficient information available to reach that conclusion. It is possible the hernia mesh could lead to problems in the future even if there are no complications during surgery.
>>INFORMATION: Hernia mesh recall
The unique element of the Kugel hernia patch is a hard plastic memory recoil ring which allows the surgical mesh to be folded and put in place through a small incision. The memory ring is designed to cause the mesh to spring open and lay flat once it is in place. This results in a less invasive hernia repair surgery, and the patient is able to make a much quicker recovery.
Over the past year there have been three separate recalls announced for different models of the Composix Kugel patch, manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. To date, the recalls have involved certain large and extra large models of the patch. However, there are other models which have a similar memory recoil ring and some question whether there will be additional hernia mesh recalls in the future.
The manufacturer failed to perform sufficient pre-market tests to evaluate the pressures which are placed on the plastic ring during insertion. When the makers announced the recall, they indicated that the surgical stresses which are exerted on the plastic ring are accountable for the device failure. There is no excuse for their failure to account for these stresses, especially since they are the ones who often train the physicians on how to insert the surgical mesh. As a result, the makers face thousands of lawsuits from individuals who suffered serious complications after hernia repair surgery.
>>INFORMATION: Hernia mesh lawsuits
The manufacturers have also failed to conduct appropriate testing to determine the strength of the ring when placed under the normal stresses encountered over the life of the patient. It is not well understood whether the plastics and forming techniques which lead to the weaknesses in the ring could also cause future failure or deterioration. Therefore, some believe that it is possible that some of these devices will fail in the future, even if the ring did not break immediately during insertion.
HERNIA MESH RECALL LAWYERS
The lawyers at Saiontz & Kirk, P.A. represent individuals who have suffered complications after hernia surgery which are caused by the defective Kugel hernia repair mesh. If you, a friend or family have experienced bowel perforation or intestinal problems after a hernia repair since 2002, request a free claim evaluation to determine if you may be eligible for a claim.