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Anyone who has suffered a hernia knows that it causes almost indescribable pain. Unfortunately, countless hernia sufferers have learned that the pain can be made even more severe—by a defective hernia patch like the Composix Kugel Mesh. The mesh has a crucial design flaw and can cause life threatening harm.
If you or someone you love has suffered after having a Composix Kugel Mesh implanted, you are not alone. The corporation that made the mesh is responsible for the design flaw and liable for the consequences. John Foy & Associates can help you. Call us at 404-400-4000 and get a free consultation today.
How is the Composix Kugel Mesh supposed to work?
A hernia occurs when an organ inside the body starts to bulge out through the wall that contains it. A hernia can be very serious and without prompt treatment can be life threatening. Hernias occur for a variety of reasons but are a common complication after surgery. If there are organs underneath the surgical incision, and it does not heal properly or form thick enough scar tissue, the organs may start to push through. This is most common in surgeries involving the abdominal cavity.
This is the kind of hernia the Composix Kugel Mesh was designed to treat. The device is a type of a surgical mesh, sometimes known as a hernia repair patch. It’s a small patch of fabric-like material meant to be inserted into the body. The patch reinforces the surgical scar, stopping the hernia and strengthening the abdominal wall.
But the Composix Kugel Mesh is different from other surgical meshes. It has a small “recoil ring” built into it. This ring allows the patch to be inserted into the body in a folded up position, and then spring open once in place. It was hoped that the ring would improve the outcomes of the procedure for patients. Unfortunately, for many it has had the opposite effect—and it has been used on 350,000 patients worldwide.
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What can go wrong with the mesh and what health consequences does it have?
The recoil ring is the patch’s critical flaw. Depending on how it is placed in the body, the ring can end up breaking under pressure.
This breakage is not a minor event. Once the ring breaks inside the body, the fragments can puncture surrounding tissue and even injure the organs they were meant to protect. The results can be catastrophic.
Some of the medical problems linked to Composix Kugel Mesh include:
- Perforation of intestinal walls. The fragments can “perforate” or puncture the intestines themselves, allowing their contents to spill into the abdominal cavity.
- Migration through the abdominal wall. The ring or parts of it can actually burrow back out through the surgical scar area, working its way out of the body and further weakening the hernia site.
- Severe abdominal pain. Many patients who have had a Composix Kugel Mesh complain of persistent, sometimes severe abdominal pain. Others find the area to be tender or experience a swelling of the abdomen.
- Abdominal abscess. An abscess is a pouch of fluid that forms inside the abdomen, often from infection or a burst organ.
- FistulaeA fistula occurs when two things inside the body connect together that shouldn’t be connected—often damaging one or both of them, as well as how they function. The Composix Kugel Mesh can cause both internal and external fistulae. An internal fistula involves contact between two internal organs, while an external fistula involves contact between an internal organ and the skin.
- Infection and sepsis. Any infection in the abdomen is serious. In some cases, the infection will proceed to sepsis, a condition where the immune system attacks the body itself, potentially leading to organ failure, shock and death.
- Peritonitis occurs when the lining of the abdominal cavity itself becomes infected and inflamed.
- Pelvic Inflammatory Disease (PID). In women, a broken coil can damage the reproductive organs and cause PID. PID can lead to irreversible damage and infertility.
- Bowel complaints. Damage to the bowels can lead to ongoing problems including bowel obstruction or even bowel paralysis.
Many of these conditions can be fatal, and the Composix Kugel Mesh has been linked to multiple deaths.
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Were patients warned of these risks?
No. While all medical devices have risks, the makers of Composix Kugel Mesh did not provide sufficient warning about the risks it posed. They also did not give adequate instruction to doctors on how to deploy the repair patch.
The courts confirmed both of these failures in the 2010 case Thorpe v. Davol and Bard.
Who is responsible for this? Why wasn’t it recalled?
The device was created by Davol, Inc., a subsidiary of the company CR Bard, Inc. In the Thorpe decision, the court found that Davol and Bard did not act reasonably in how they designed the patch. Their negligence in its design led directly to the injuries it causes, and the courts have consistently found the two companies liable for the harm they caused.
The flaw in the patch’s design was discovered as early as 2005, and Davol began select recalls by the end of that year. The recall was expanded continuously during 2006 and 2007, and the FDA classified all of these recalls as “Class 1”—the highest level of recall used for items that could be potentially deadly.
Nonetheless, Bard funded a study that declared the Composix Kugel Mesh to be safe and effective, even as patients were hospitalized from broken rings.
For a free legal consultation with a lawyer serving Medical Device, call 404-400-4000
What can I do if I was harmed by a Composix Kugel Mesh?
If you experienced complications from a Composix Kugel Mesh, you hold Bard and Davol accountable. You could receive a financial recovery, which can help pay for your medical costs as well as pain and lost wages. However, you need to act as quickly as possible. Every state has its own time limits on medical cases, and they are often much, much shorter than they should be.
John Foy & Associates can help. Our team consists of some of the best lawyers in the country, with a strong track record of championing the rights of patients against big medical corporations. We have experience working on Composix Kugel Mesh cases. Give us a call. We offer a FREE consultation and we charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your free consultation today.