Since the FDA issued a recall of the Kugel mesh patch, patients have been looking for relief from medical issues, uncertainty and injustice.

Kugel Mesh Patch

The Kugel patch was originally introduced in 1996 as a device to help repair and prevent hernias. The patch was comprised of two pieces of mesh that were connected by a hard plastic ring that sprung open to hold the patch in place. During hernia surgery, the patch was placed over the weakened area of the abdominal wall to keep organs from protruding through the wall.

Without the repair, an organ, such as the intestine, could push through the wall and collect bacteria, leading to infection, or could become stuck, which could result in even more serious consequences including gangrene.

In most cases, surgeries that repaired this type of hernia included repositioning any protruding organs and inserting the patch as an additional barrier.

Hernia Mesh Recall

Starting in 2002, patients began to have problems with the Kugel Mesh Patch. Upon closer inspection, doctors realized that the plastic ring was breaking. Initially, the Kugel manufacturers believed that the problem lay with surgical techniques used in implanting the device, however, they began to realize that the rings were breaking at the same site—the place where the ring was joined together by the manufacturer.

When the ring broke, the sharp plastic edge could puncture soft internal organs. If the ring punctured the stomach or intestine, bowel material could leak into the abdominal cavity, resulting in an infection. Other infections could occur, leading to chronic fistulas, which are abnormal connections within the intestine. A hernia patch failure can cause serious, sometimes life-threatening, complications.

The FDA issued a hernia mesh recall of the  Kugel patch in 2005, and eventually updated patches were introduced to the market.

Kugel Mesh Lawsuit

Although the recall has been issued, many patients still have the original Kugel mesh patch. The manufacturer has recommended that the patch remain in place unless it is presenting problems. For these patients, this means they must live with a potentially defective device that at any moment could lead to a medical emergency.

Concerned with this, as well as the knowledge that the manufacturer may not have been diligent in tracking and reporting patient complaints, numerous patients have filed a Kugel mesh lawsuit to seek legal reparations for their suffering.

If you have a Kugel mesh patch and are concerned about your legal options, please call us for a free, no-obligation consultation. We are currently representing patients throughout the United States in filing a hernia mesh lawsuit.

What does a hernia repair mesh patch do?
A hernia repair mesh is a patch that is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

What problems are associated with hernia repair mesh patches?
The hernia patches that have been recalled were manufactured by Davol, Inc., and released under the brand names Bard, Composix, and Kugel. In some cases, the ring in these hernia repair mesh patches has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Davol initially blamed the surgeons who installed the hernia repair mesh patch for the broken rings. Davol claimed that the doctors made mistakes which caused the breaks in the rings. However, tests conducted by Davol revealed that the failure almost always occurred at the spot where the ring was welded together, which was done by the company.

What recalls have been issued?
On December 22, 2005, Davol, Inc. recalled its extra large mesh patch. In March 2006, the recall was expanded. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March 2006 recall expansion, Davol received four confirmed complaints of recoil ring breakage from one of their product codes manufactured between January 2004 and September 2005.

Davol notified U.S. customers of the initial Kugel patch recall by letter on December 27, 2005, which it sent via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information.

On January 10, 2007, Davol, Inc. issued another hernia mesh recall for patches that were manufactured before October 2005. Davol sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots Bard, Composix, and Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

It should be noted that Davol also decided to withdraw from the market specific lots of mesh patches that were manufactured from October 2005 to October 2006. Please contact us for a free no-obligation consultation to discuss your legal options including filing a hernia mesh lawsuit.

In a May trial, the U.S. District Court for the District of Rhode Island determined that although the mesh patch design was defective, the patient bringing the lawsuit, John Whitfield, had not proven that the design directly caused his problems of bowel obstructions, abdominal pain or permanent bowel disfigurement.

Patients who are still suffering from repercussions from the mesh patch continue to believe that future hernia mesh lawsuits will see different outcomes, delivering justice for their situations.

Background on the Kugel Hernia Mesh Patch

A hernia is an opening that develops, often in a weakened area of the abdominal wall. When a person with this weak area puts stress on it through coughing, sneezing, or straining from bowel movements, the intestines can push through that weak area. A patch that adds strength to the weakened abdominal wall is the traditional way to treat the condition.

The Kugel patch was made of two mesh segments, connected by a hard plastic ring that acted as a spring, holding the device in place.

Approved by the FDA in 1996, the mesh patch was used on thousands of patients worldwide. As early as 2002, doctors began to discover that patients were being injured when the hard plastic ring began to break. The hard plastic edges at the break site could puncture internal organs, causing pain and serious consequences including bowel perforations and fistulas.

When the hernia mesh manufacturers, C.R. Bard and its subsidiary Davol, were told of the complications in 2002, they blamed the doctors for improperly inserting the device.

It wasn’t until the 2005 FDA recall that patients began to be aware of some disturbing facts. Davol was aware of design problems with the mesh device, yet did not inform patients— and even continued to use the product for several more years. In addition, the FDA found that Davol did not accurately track patient complaints—which delayed the recognition of problems.

With 80 cases of people who have been injured and who have even died as a result of the defective device—and the potential for even more problems for those who still have the device implanted, patients are filing lawsuits in an effort to achieve justice.

If you have had hernia surgery that includes the Kugel hernia mesh patch, you may be eligible to file a hernia patch lawsuit as well. Please contact us for a free no-obligation consultation. We are currently representing patients throughout the United States who have suffered hernia mesh complications due to a defective patch.

What is a hernia mesh?
A hernia mesh is a patch designed to make hernia operations easier and reduce post-surgical pain for patients. A hernia mesh patch by the name of “Kugel” was approved by the FDA in 1996. The Kugel mesh patch consists of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring.” It is implanted at the site of a hernia. The “ring” then springs into place, which allows the hernia to heal and re-grow around the patch. The Kugel hernia mesh was introduced to the market by Davol Inc. In 2002, problems began to surface.

What has the FDA done?
In the early part of 2006, the FDA inspected Davol’s manufacturing plant. The FDA found major problems in the system for tracking and reporting patients’ complaints about the hernia mesh side effects. The FDA concluded that Davol had been downplaying the severity of the injuries associated with the Kugel mesh patch, including that one person may have died from this product. These findings by the FDA prompted two recalls.

What problems are associated with the Kugel hernia mesh?
In some cases, the ring in the Kugel Mesh patch has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Davol initially blamed the surgeons who installed the Kugel Mesh patch for the broken rings. Davol claimed that the doctors made mistakes which caused the breaks in the rings. However, tests conducted by Davol revealed that the failure almost always occurred at the spot where the ring was welded together, which was done by the company.

Where would we file the lawsuit?
A hernia mesh lawsuit can be filed in any state within the United States. The first lawsuit was filed in Rhode Island in December 2006. Since then, many other hernia mesh lawsuits have been filed. In January 2008, the U.S. District Court Judge who is overseeing the consolidated Hernia Mesh Litigation that has been centralized in Rhode Island, issued an order expanding the scope of the multidistrict litigation (MDL), to include several other products manufactured which contain similar technology. Some of the other types of hernia surgical mesh which have been associated with alleged injuries in lawsuits filed throughout the United States include:

• Ventralex Hernia Patch
• CK Parastomal Hernia Patch
• CruraSoft Patch
• Composix Mesh
• Composix L/P Mesh
• Composix E/X Hernia Mesh
• Other Kugel products that have not been recalled

If you have experienced any Kugel hernia mesh complications, you should contact an experienced hernia mesh recall attorney right away.

You may have first noticed a protrusion that may be bigger when you strain to cough, lift heavy objects or have a bowel movement. This site may also be painful. The bulge may be reducible: that is, the organ may be able to be returned to its original position. However, the organ may become stuck in the hole, which can lead to serious consequences if not treated.

Hernias may occur without symptoms, but once a protrusion or pain begins, a hernia will need to be treated, typically with surgery. Some patients who had Kugel mesh implanted have suffered from hernia mesh complications. Surgery usually consists of repositioning the organ and inserting a device that adds support to the weakened area. Two types of surgery are commonly used: open and laparoscopic.

The open surgery creates a larger incision, while the laparoscopic surgery creates smaller incisions and uses a laparoscopic camera to see inside the repair area. In both types of surgery, a device, or patch, is used in the abdominal area. Although it is considered standard procedure, occasionally even this solution can create problems.

In recent years, the FDA announced a Kugel mesh recall after discovering that the plastic ring that connects the mesh patch was prone to breaking. When this happened, the hard plastic break point of the ring could puncture internal organs. Patients experienced side effects including perforated bowels and chronic fistulas. To date, more than 80 people have had injuries, including death, as a result of hernia mesh complications from the Kugel patch.

Reports indicate that the Kugel patch manufacturer, Davol, Inc., a subsidiary of C.R. Bard Inc., was aware of defects with the ring, but may not have tracked them effectively or addressed them immediately.

As a result of the complications caused by the defective device, affected patients have initiated a Kugel mesh lawsuit seeking compensation. If you have had surgery to repair a ventral hernia in the last five to eight years, you may be included in this group. If you are unsure of the type of patch used in your surgery, we can help you identify it and determine if the defective device affects you.

Contact us today for a free consultation to discuss your legal options and the latest news on a Kugel mesh settlement. As always, there never any legal fees unless we win compensation on your case.

Depending on which organs a hernia affects, it can have different consequences. Sometimes, it can cause the organ to become infected, as it becomes irritated in the spot where it is popped through the muscle wall. Other times, the hernia can cut off blood flow to a part of the organ, causing cell death. Eventually, cell death can lead to gangrene, which can result in part of an organ needing to be removed through emergency surgery.

A ventral hernia is one that occurs at the site of a previous incision. If you’ve had a Caesarian section, for instance, you’re more likely to suffer form a ventral hernia. The abdominal wall where the incision was made is probably always going to be weaker than the rest of your abdominal muscles, putting you at risk for a hernia.

When organs in the abdomen pop through the site of a previous incision because of muscle weakness, this is a ventral hernia. Like a regular hernia, a ventral hernia is normally best treated through surgery to repair the weak spot in the muscle wall. Sometimes, a minor hernia can be fixed through non-surgical means, but more often than not, a hernia fixed in this way will simply reappear at some later date.

One modern fix for a ventral hernia is hernia mesh, the Kugel mesh being one of the most popular options. This device is made up of two pieces of medical-grade plastic mesh connected by a plastic ring that holds them together. They help strengthen the abdominal wall along the site of the previous incision, repairing a hernia and preventing later problems.

However, there have been hernia mesh problems in certain product lots. One of the most severe is that the plastic ring can break, leaving sharp edges exposed to the soft tissue of the internal organs. This can result in hernia mesh infections and other serious complications, such as perforated bowels.

Kugel Patch Lawsuit
In 2005, there was a major Kugel mesh recall because so many people had suffered from problems related to this piece of equipment. Now, though, there are still those out there who suffer Kugel mesh complications. Sometimes that tiny piece of broken plastic can cause complications that last for an entire lifetime. if you or a loved one has suffered from hernia mesh complications, you may want to look into your legal options, including filing a hernia mesh lawsuit. Please contact us for the latest Kugel mesh settlement news.

One of the things that greatly hinders the recovery process for hernia patients is the buildup of scar tissue, which is often erratic and uneven. This can leave portions of the inner wall of a patient’s abdomen weak and unhealed for months. Not too long ago, Dr. Robert Kugel developed a device that was designed to solve this problem, and get hernia patients on the mend much more quickly.

What the Kugel Hernia Mesh Patch Is

The Kugel hernia mesh patch is a surgical implant, developed by Dr. Kugel and produced and distributed by Davol, Inc., to be used following the successful removal of a hernia from a patient. The mesh patch is a polypropylene composite that is grafted into the interior wall of a patient’s abdomen, where a hernia was removed. It is used to strengthen the interior abdominal wall and help weakened areas heal evenly and quickly.

How the Patch Can Fail

At the heart of the Kugel hernia mesh implant is a memory recoil ring that allows the implant to snap itself into place following surgery, allowing for an even distribution of the polypropylene mesh over the affected inner lining of the abdominal wall. Unfortunately, this memory recoil ring was defective in a large number of the patches that were manufactured, leading to a complete rupture and failure of the hernia mesh implant.

This often pushed jagged shards of the implant into the interior of the abdominal cavity, puncturing, perforating and leaving gashes and lesions in the internal organs. Many patients who had the implants rupture on them experienced bowel perforation, internal bleeding, septic infection, and required additional surgeries to correct the complications. For many patients, they were permanently affected by the hernia mesh complications.

The Hernia Mesh Recall

Davol, Inc. was forced to issue a series of health advisories following increasing reports that their hernia mesh implants were causing injury. Once it was conclusively discovered that the mesh implants were defective, and causing serious, life-threatening complications, Davol, Inc., issued a full recall of certain lots of the Kugel hernia mesh patches. Though thousands of patients worldwide had the mesh patches implanted, the recall was primarily intended to remove unused products from circulation. Davol, Inc., advised patients who were otherwise healthy, and suffering no complications, to avoid having surgery to remove the implant. Please contact us for a free no-obligation consultation and filing deadlines for a hernia mesh lawsuit.

One type of surgical solution for hernias is the Kugel hernia mesh. This mesh is made of medical-grade materials that can stay inside the body indefinitely. It has a spring coil in it that causes it to lay flat after surgery, as it is folded to be put into place during surgery.

The solution once seemed like an innovative idea, but it went through a serious of recalls in 2005, and since then, many complications including hernia mesh infection with the Kugel patch have been reported. If you or a loved one is considering a hernia mesh or already have one in place, it’s important that you know about these complications so that you can make informed decisions about your medical and legal needs.

Bowel Perforations
The main Kugel hernia mesh problems come from the spring. Sometimes, this coil will break, exposing sharp edges to the soft tissue of internal organs like the stomach and intestines. Often times, this problem will cause bowel perforations, small holes in the bowels that can lead to any number of problems. If these holes are super small, they may heal on their own, but they often require extra surgeries to fix them.

Infection
A hernia mesh infection can also occur because of these sharp edges. The area around the edges can become irritated and infected. When an infection is settled so close to so many vital organs, it can have dire consequences for the patient.

Intestinal Fistulae
A fistulae is basically when an abnormal passage is opened up between one organ and another or between an organ and the body’s surface. One of the hernia mesh complications is that of recurring small intestinal fistulae, where communications are opened, so to speak, between the intestines and other organs. This can cause all sorts of health problems and may require surgery to fix.
Many of the problems associated with the hernia mesh are only able to be fixed through surgery. This makes them very expensive complications, indeed. The longer the problem persists, the more expensive it will be to fix.

After 2005’s Kugel hernia patch recall, many patients underwent surgery to remove the mesh patches from their bodies. Before this, though, many patients were already irreparably damaged by the mesh inserts. These patients had often already undergone surgery to remove their patches or repair damage already done.

One problem is that people who had already had their mesh patches removed may not have known their legal rights. Those who were injured by the Kugel mesh should consult an attorney about a Kugel mesh lawsuit, which could recompense them for their financial losses and emotional suffering in connection with a defective Kugel mesh patch.

What does a hernia mesh patch do?
A hernia mesh is a patch that is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

What problems are associated with hernia mesh patches?
The hernia mesh patches that have been recalled were manufactured by Davol, Inc., and released under the brand names Bard, Composix, and Kugel. In some cases, the ring in these hernia repair mesh patches has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Davol initially blamed the surgeons who installed the hernia repair mesh patch for the broken rings. Davol claimed that the doctors made mistakes which caused the breaks in the rings. However, tests conducted by Davol revealed that the failure almost always occurred at the spot where the ring was welded together, which was done by the company.

What hernia mesh recall has been issued?
On December 22, 2005, Davol, Inc. recalled its extra large hernia mesh patch. In March 2006, the Kugel mesh recall was expanded. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March 2006 recall expansion, Davol received four confirmed complaints of recoil ring breakage from one of their product codes manufactured between January 2004 and September 2005.

Davol notified U.S. customers of the initial recall by letter on December 27, 2005, which it sent via Federal Express. On March 24, 2006, Davol issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use (“IFU”) clarifying the proper insertion technique and Supplemental Patient Management Information.

On January 10, 2007, Davol, Inc. issued another hernia patch recall for patches that were manufactured before October 2005. Davol sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard, Composix, and Kugel mesh patches. The letter stated that surgeons and hospitals should stop using the recalled product and return unused units to the company.

When should you seek medical attention?
The FDA recommends that patients who have been implanted with one of the recalled devices seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms. Please contact us for the latest information on filing a Kugel mesh lawsuit. There is never any charge to speak to one of our attorneys.

What is a hernia mesh?
A hernia mesh is a patch designed to make hernia operations easier and reduce post-surgical pain for patients. A hernia mesh patch by the name of “Kugel” was approved by the FDA in 1996. The Kugel mesh patch consists of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring.” It is implanted at the site of a hernia. The “ring” then springs into place, which allows the hernia to heal and re-grow around the patch. The Kugel hernia mesh was introduced to the market by Davol Inc. In 2002, problems began to surface.

What has the FDA done?
In the early part of 2006, the FDA inspected Davol’s manufacturing plant. The FDA found major problems in the system for tracking and reporting patients’ complaints about the hernia mesh problems. The FDA concluded that Davol had been downplaying the severity of the injuries associated with the Kugel mesh patch, including that one person may have died from this product. These findings by the FDA prompted two recalls.

What problems are associated with the Kugel hernia mesh?
In some cases, the ring in the Kugel Mesh patch has broken. This has caused severe injuries to patients’ internal organs and tissue, including bowel obstructions, bowel perforations, and chronic enteric fistulas. Davol initially blamed the surgeons who installed the Kugel Mesh patch for the broken rings. Davol claimed that the doctors made mistakes which caused the breaks in the rings. However, tests conducted by Davol revealed that the failure almost always occurred at the spot where the ring was welded together, which was done by the company.

Where would we file the hernia patch lawsuit?
A hernia mesh lawsuit can be filed in any state within the United States. The first lawsuit was filed in Rhode Island in December 2006. Since then, many other hernia mesh lawsuits have been filed. In January 2008, the U.S. District Court Judge who is overseeing the consolidated Hernia Mesh Litigation that has been centralized in Rhode Island, issued an order expanding the scope of the multidistrict litigation (MDL), to include several other products manufactured which contain similar technology. Some of the other types of hernia surgical mesh which have been associated with alleged injuries in lawsuits filed throughout the United States include:

• Ventralex Hernia Patch
• CK Parastomal Hernia Patch
• CruraSoft Patch
• Composix Mesh
• Composix L/P Mesh
• Composix E/X Hernia Mesh
• Other Kugel products that have not been recalled

If you have experienced any Kugel mesh complications, you should contact an experienced hernia mesh lawsuit attorney right away.