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Composix Kugel Mesh Patch

The Kugel Mesh patch was first recalled in 2005, after the FDA received reports that the Composix Kugel Mesh patch had caused many severe injuries. Two more Kugel Mesh recalls followed. Since that time, thousands of Kugel Mesh lawsuits have been filed against Davol, Inc. and its parent company Bard, and many more hernia patients with Composix Kugel Mesh may be entitled to file a Kugel Mesh lawsuit.

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Kugel Mesh Patch

The US Food and Drug Administration first approved the Kugel Mesh Patch in 1996. The Composix Kugel Mesh patch is surgically implanted via a small incision, positioned behind the hernia, and its ‘memory coil ring’ opens the patch behind the herniated area. The mesh patch is then supposed to repair the hernia.

The memory ring is designed to aid in deployment of the patch, but it can break when increased stress is placed on it during certain surgical placement techniques. If the ring should break, the broken ends could poke through the mesh and create bowel perforations and/or a condition called "chronic enteric fistulae."

Kugel Mesh Recalls

kugel meshThe first Kugel Mesh recall occurred in 2005. It was recalled again in 2006 and 2007, both times to recall several other sizes of the device. The FDA, along with Davol, Inc., a subsidiary of C.R. Bard, Inc., recalled certain models of the Bard Composix Kugel Mesh Patch (below) after reports that the memory ring had broken, causing a number of painful and serious injuries in hernia patients.

Because the reports of side effects were so severe, the FDA designated specific lots of the Kugel Mesh X-Large Patch as a Class I recall.  This level of recall is defined as a product that is dangerous or defective and could cause serious health problems or death.

According to the FDA Recall Notice, "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include the following:
  • unexplained or persistent abdominal pain
  • fever
  • tenderness at the surgery site or other unusual symptoms
In a March 24, 2006 recall notice, Bard recommended that health care professionals "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall."

The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:

PC#0010206 Bard Composix Kugel Extra Large Oval 8.7" x 10.7"
PC#0010207 Bard Composix Kugel Extra Large Oval 10.8" x 13.7"
PC#0010208 Bard Composix Kugel Extra Large Oval 7.7" x 9.7"
PC#0010209 Bard Composix Kugel Oval 6.3" x 12.3"
PC#0010202 Bard Composix Kugel Large Oval 5.4" x 7"
PC#0010204 Bard Composix Kugel Large Circle 4.5"


Kugel Mesh attorneys are also investigating the following hernia mesh patches manufactured by Davol and Bard that have not been recalled, but defects have been reported.

0010203 Bard ® Composix ® Kugel Small Circle 7.6 cm
0010201 Bard ® Composix ® Kugel Small Oval 8 cm x 12 cm
0010205 Bard ® Composix ® Kugel Medium Oval 11 cm x 14 cm
Bard® Kugel® Hernia Patch All sizes
Bard® VentraleX® Hernia Patch All sizes
Bard® Modified Kugel™ Patch All sizes
Bard® Composix® E/X Mesh All sizes


For further information on the three recalls, visit the FDA website.

Kugel Mesh Lawsuits

In its second-quarter filings, C.R. Bard reported it settled some lawsuits related to use of the Composix Kugel Mesh Patch. According to The Providence Journal (07/06/11), Bard will pay $184 million to settle 2,600 of approximately 3,600 lawsuits filed against the company to date. The lawsuits claimed that the company's Composix Kugel Mesh hernia patch caused serious medical complications including bowel perforation, sepsis, intestinal fistulas and abdominal abscess formation.

In 2010 a jury in the U.S. District Court for the District of Rhode Island found Davol and Bard liable for injuries suffered by plaintiffs Christopher Thorpe and Laure Thorpe. The drug device company was also found liable for the failure to warn of dangers associated with the patch. The Thorpe case resulted in a $1.5 million verdict for the plaintiffs. Christopher Thorpe’s attorneys claimed that he suffered severe internal injuries caused by a broken plastic ring on the hernia repair mesh, which included an abdominal wall abscess and fistula and resulted in him undergoing a number of surgeries to repair the damage. The jury award $1.3 million by the jury for personal injury damages and $200,000 for loss of consortium.

Thousands of cases are pending and underway against the Kugel Mesh manufacturer in Rhode Island federal court’s first consolidated multidistrict litigation (MDL). Almost 2,000 more cases are pending in Rhode Island Superior Court.

By the time of the first recall in December 2005, Davol had sold about 32,000 of its Kugel Mesh Patches worldwide since 2002. In 2005 alone, the device sales reached $11 million.

Kugel Mesh Legal Help

If you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please send your complaint to a Kugel Mesh attorney by clicking the link below. Your claim will be reviewed by a Kugel Mesh lawyer at no cost.

Last updated on Feb-1-12

KUGEL MESH HERNIA PATCH LEGAL ARTICLES AND INTERVIEWS

Kugel Mesh One Helluva Mess
Kugel Mesh One Helluva Mess Appleton, WI: “If I knew that some Kugel Mesh had been recalled, I would have insisted on having it taken out sooner,” says Ann. “This mesh had 10 years to seriously damage my body. [READ MORE]

Living with Hernia versus Kugel Mesh
Living with Hernia versus Kugel Mesh Los Angeles, CA: Harry wishes he had spent more time researching Kugel Mesh before having surgery to treat a hernia. After two more unsuccessful surgeries to remove the Composix Kugel Mesh patch, Harry is filing a Kugel Mesh lawsuit [READ MORE]

Kugel Mesh Victim Says She Would Rather Live with a Hernia
Kugel Mesh Victim Says She Would Rather Live with a Hernia Muskogee, OK: Mary wishes she never had a Kugel Mesh patch implanted to treat a hernia. In fact, she would rather live with a hernia than the Composix Kugel Mesh patch [READ MORE]




READER COMMENTS

Posted by
Margot Ybarra
on
I had a surgical mesh implant for an umbilical hernia in 2007. I began having problems with pain and swelling off and on for about two years now. I also get a poking sensation from time to time which really irritates me. This poking sensation is on and around the belly button area but I also get that same sensation on the left side of my belly at times. I have seen my doctor several times to voice my complaints. I explained to her the pain and swelling that I have been experiencing. I was given medication for pain and some kind of antibiotics. Well, I continue to suffer with pain and swelling. What should I do? Should I get legal advice? Any advice from you would be greatly appreciated. MCYbarra in SA,TX.

Posted by
Alabama
on
Moderate to severe groin pain, tenderness, testicular pain, ED.

Posted by
Louisiana
on
I have pain in my groin. Also I have trouble and pain when I use the bathroom. I've had this mesh for 10 years. Can some please help me?

Posted by
Missouri
on
I had it placed in December of 2014 and I'm in more pain than I was before my surgery.

Posted by
Wisconsin
on
I have severe pain constantly. Makes it hard for me to move and hurts when I stand up and go to lay down. I have been having issues with being in so much pain that it's hard for me to work. The pain makes it so hard for me to eat because I am in so much pain. It almost feels as if it has ripped inside of me.

Posted by
Wisconsin
on
I've had a hernia repair and the mesh was recalled and gave me a severe staph infection. I have had so many surgeries for this ongoing issue. My stomach lining is thinning and it's now continuing. My doctor put it in and then left it in knowing it was causing problems.

Posted by
California
on
I received my first Kugel Mesh implant in 2002 and needed surgery in 2004 due to problems with hernia popping out and in a lot of pain. Had another surgery 2007 for the same problem occurring again. I have seen the general surgeon about repair again last year and this year. They stated I should try to lose weight and maybe that will help with the hernia not bulging out. Well I have lost weight and my problem still remains. Anytime I sneeze or cough the mesh moves and the hernia pops out.

Posted by
Pennsylvania
on
I am in constant pain and my surgeon said removing the patch could kill me. It is too deeply imbedded and constantly ripping my abdomen. I am miserable and it limits what I can do. Most days I am in bed. It has my intestines a tangled mess and I have difficulty going to the bathroom. It has affected my family drastically as I am barely able to vacuum my house or cook dinner for my family. Every move I make it tears and pulls more.

Posted by
Colorado
on
I had a Bard Oval Kugel Mesh Patch PC 0010105 installed in an inguinal hernia repair in 2011. I now have chronic pain in the area. Today, a hernia doctor informed me that this product code is currently under investigation by the FDA due to reported broken memory rings. Can you help me?

Posted by
Alabama
on
My dad died when I was 16 because of that patch....he would still be here today if not for that defective medical product...I don't even care about money...I just want JUSTICE.

Posted by
Maryland
on
Had laproscopic surgery that didn't work had bad symptoms..had to go back and have another surgery that once again didn't help now I experience constant pain and problems.

Posted by
Michigan
on
I have not been able to lift nearly as much weight as I used to.I find it hard to do certain activities that were simple before my surgery.My strength in my mid section has diminished greatly.I still do drywall but in a less significant capacity due to my hurnia patch issue.

Posted by
Texas
on
Stomach extended stays swollen/ left side bigger than right side, burning pains, after I eat food won't go down, stomach protrudes from under breast to lower stomach like I am pregnant looking.

Posted by
Iowa
on
On the fifth hernia repair, I had infected mesh that had to come out. The mesh infected so bad that it opened up my incision and oozed smelly painful secretion for almost two months before I got to have it operated on.

Posted by
California
on
In all fairness, my concern is that I have had and continue to have unusual pains and sensations down around that side of my umbilical area spreading out to the abdominal area. Pains and sensations that were never present until the surgery.
I had a ventral hernia repaired with one of these patches. Is it possible that you can have complications with these things this long after surgery? I am concerned now.
What is the recommendation concerning the implant and now recall of this patch?
If I have this thing inside of me and it can break or already has broken how can they tell?

Posted by
Kansas
on
I had been having a poking sensation since the fall of 2005 and was told by two physicians there was nothing wrong with my mesh. On Sept 15, 2007 I was hospitalised with a bowel perforation and taken to surgery for a bowel resection. I had no prior diarrhea or negative health history to lead to this condition. The surgeon and resident told me they had to change gloves during the surgery due to being poked by the broken ring.

Posted by
California
on
I am 8 months post op and the pain has not gone away
This is not normal. I have sought out a new doctor and now have to have the mesh removed. This is a miserable surgery that takes many months to recover. I have no choice but to have it removed. The pain will not go away.

Posted by
California
on
I am a 24 y/o male that has suffered from a left inguinal hernia; my first operation on this hernia was performed when I was 19 y/o ; I began to feel pains coming from the area and the doctor assured me this was normal for scaring. At age 21 (roughly 18 months after surgery) the hernia was repaired again because a noticeable bulge had re-formed just above the original repair scar. The doctor was able to go in through the same scar. I still receive unexplained sharp pains that are in my abdominal area nearly 3 years after the second surgery. In some instances the pain is so great I fall to my knees. I have not been able to get a primary care physician to do further testing for me to see if my pains are affected from the mesh.

Posted by
Washington
on
Because of the pain I only get 2 to 3 hours of sleep each night and have nausea associated to the pain. At times the hernia area swells. For many years the pain has made it very hard to have sexual activity and enjoy it. I have been to the doctor many times but have not gotten any relief.

Posted by
Texas
on
Consistent bleeding of the abdomen, which has cost over $100 per month to control for the past 5 years; have actually pulled two pieces of plastic "mesh" out of the abdomen, which led to the closing of previously open wounds. Extreme heaviness in the abdominal area due to protruding intestines; permanent deformations as a result. Extreme numbness on the exterior of belly.

Posted by
Idaho
on
I developed a severe infection immediately after the mesh was put in. I never seemed to heal completely from the surgery either. For a full year I was in severe pain, my abdomen was constantly distended, I developed a large red lump on my stomach and I caught every illness that came around. I basically lost a year of my life due to pain and illness. I recently endured a very painful surgery to have the mesh removed and I can't even begin to explain how hard my recovery has been. As of this date I have not fully recovered.

Posted by
Arizona
on
Initial hernia surgery with mesh 1996, surgery and replace mesh 1/2000, another surgery for swelling and "relocating mesh" 3/2000 and a fourth surgery 5/2000. All surgeries left me in pain, fever, tendernes, swelling, fluid accumulation, nausia, vomitting, lack of energy, inability to be active and causing weight gain, depression, leaking fkuid, subacious cysts, distended abdomin, and multiple discomfort. Dr. told me to undergo a 5th surgery to ensure everthing is alright.

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