Kugel hernia patch recall could have occurred earlier

Austin Kirk

By Austin Kirk
Posted March 16, 2007

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An article in today’s New York Times suggests that the recent Kugel hernia patch recall could have occurred sooner.  If the maker of the hernia repair mesh had taken quicker actions to notify physicians of problems with the patch and remove it from the market, it is possible serious injuries could have been avoided for many who had the mesh implanted.  Saiontz & Kirk, P.A. is reviewing potential hernia patch recall lawsuits nationwide.

>>INFORMATION: Kugel Hernia Mesh Problems

In 2002 Davol, Inc., a subsidiary of C.R. Bard, Inc., introduced larger versions of their Composix Kugel hernia repair mesh which are designed so that they can be folded during placement and then spring open once in place to lay flat under the hernia.  It was not long after they were introduced that the makers began to receive reports of an unusually high number of reports that the plastic memory recoil ring in the larger hernia patches was breaking, which could cause injury to internal organs and tissue.

As a result of the manufacturers failure to properly assess the hernia patch problems, they continued to manufacture the mesh and distributed it for placement inside of patients.  In December 2005, the largest of these devices, known as the Kugel Extra-Large Oval, were recalled.  However, they did not recall other potentially defective large patches.

The New York Times reports that after the initial hernia patch recall, the FDA inspected Davol and found there were inconsistencies and discrepancies in how Davol monitored hernia mesh problems and reported injuries.  According to inspection reports, Davol did not accurately report the number of problems as well as the extent of the problems with the hernia mesh.  This has led to two subsequent recalls of the Composix Kugel Large Oval and Large Circle. 

>>INFORMATION: List of Recalled Composix Kugel Hernia Patch Products

The defective hernia repair patches are used to repair ventrical hernias which may develop at the site of prior surgical incisions in the abdomen.  The patch problems could result in failure of the memory recoil ring, leading to possible bowel perforation, intestinal fistula or death.

KUGEL HERNIA PATCH RECALL LAWSUITS

The Kugel hernia patch problems are so severe that the FDA classified the recall as Class I in January 2007, since the defect has a reasonable probability of causing serious adverse health consequences, including death.  Individuals who have had a hernia repair surgery and suffer severe abdominal pain, high fever, tenderness at the site of the hernia repair or other unusual and unexplained symptoms, should consult with their doctors immediately.

The Kugal hernia patch recall lawyers at Saiontz & Kirk, P.A. provide free consultations  to help determine if you may be eligible for compensation.  Request a free claim evaluation.

8 Comments • Add Your Comments

  • michael tresco says:

    i have had this hernia mesh in me for a very long time i have had pain ,soreness,bad prostate problems,bad etching where mesh was put in,,constipation problems for the most part since i was younger when the mesh was put in ,,im 55 now had it done in 1991 and 1992 ,told my drs. through the years,but dont really remember what they said..get in contact with me if i have a case or not,like i said it is been a very long time thank you for your time

    Posted on March 30, 2007 at 1:42 am

  • VINCENT DONATELLI says:

    I HAD A HERNIA OPERATION A YEAR AND A HALF AGO. I HAVE A MESH PATCH PUT IN ME. I HAVE HAD PAINS AROUND THE AREA WHERE THEY OPERATED ON ME. THE PAIN IS CONSTENT EVERY DAY. AND I GET A SICK FEELING IN MY STOMACH. I DIDN’T KNOW WHAT IT COULD BE UNTIL I READ ABOUT THE MESH PATCH. IF I TOUCH AROUND THE AREA WHERE MY HERINA USE TO BE IT IS VERY TENDER . I DO BELIEVE I HAVE A CLAIM.
    SINCERLY VINCENT DONATELLI

    Posted on April 4, 2007 at 1:43 am

  • Steve Levy says:

    I had the mesh patch put in 13 years ago and have had problems ever since. I have tenderness in the areas involved, itching, prostate problems, nausa, constipation, chest pains, stomach aches daily, just generally feel crappy. I have seen many doctors over the years and have had many trips to the emergency room, they could never pin point what the problem is. The same company (Bard) made the patches that were put in me and I feel they could be making me ill. Pease inform me if you think I could have a claim against the company. Thank You.

    Posted on April 9, 2007 at 6:30 pm

  • Austin Kirk says:

    Steve, I am sorry to hear about your hernia repair problems. At this time, we are investigating claims for individuals who recieved specific types of hernia repair mesh manufacturered by Bard/Davol which was manufactured after 2002. Therefore, it appears that your problems would be unrelated to the design problems which led to this recall. However, you should speak with your physician if you have continuing medical concerns regarding the hernia repair.

    Posted on April 9, 2007 at 10:05 pm

  • debbie mcclai n says:

    idebra mcclain have had 4 herina operations my stomace is mune
    i have some pain and have bowl prombles today . if i dont take medicane for my bowls then istrain wich hurtsme when my bowls do move

    Posted on July 3, 2007 at 5:16 pm

  • William H. Lucas says:

    I had a herina operation about 5 years ago at the VA hospital . I had severe stomach problems 2 days after comming home I had to return to have my stomach pumped out. About six weeks later the same thing. I’ve had problems every since it seems that my stomach just shuts down and I can not pass gas or anything, and there is much more.

    I received a letter not long ago from VA asking me about the operation and I told them about the problems after the surgery but I never heard anything back from them.

    Thanks,

    William H. Lucas

    Posted on September 30, 2007 at 4:06 pm

  • Hattie Burns says:

    I had hernia repair surgery in December of 2005. I had signed up with a law firm to be a part of their class action suit and was told in October of 2007 that the patch that was used in my surgery was not one that was recalled. I haved checked the list of recalls and it seems that the patch used was among those recalled. When I contacted another law firm, I was told that I was too late because I only had two years to file a claim. Do I have any recourse? Is there any way that that time frame might be extended in some cases? I have had two surgeries and am still facing another one soon because of this unfortunate circumstance.

    Hattie

    Posted on November 8, 2007 at 4:52 pm

  • mary says:

    I had 2 hernia repair surgeries done ( 1992, 1993) I suffer from chronic pain, either constipation or diarrhea, nausea, vomiting, bleeding and intussusception in November of 2008. No doctor has been able to identifiy the cause. I am wondering if the patches used to repair the hernias may be the cause? Any similar stories?

    Posted on May 20, 2009 at 11:17 am

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