The problems with the Composix Kugel mesh patch began to surface in 2002, shortly after Davol Inc. introduced the large and extra-large models of the hernia patch.
Reports came in that the rings in some of those devices were breaking, causing injury to patients’ internal organs and tissue from hernia patch side effects, including bowel perforations, bowel obstructions and chronic enteric fistulas.
The Kugel mesh patch, designed to make hernia operations easier and to reduce patients’ post-surgical pain, won FDA approval in 1996.
The patch, consisting of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring,” is implanted at the site of a hernia. The ring then springs into place, allowing the hernia to heal and regrow around the flattened patch.
Davol Blames the Doctors
Davol initially attributed the broken rings to mistakes made by doctors while performing hernia-repair surgery. However, company tests soon revealed that the failures nearly always occurred at the spot where the ring was welded together.
In response to the design and manufacturing flaws uncovered in its tests, Davol issued a hernia patch recall for the extra-large model of the Kugel mesh hernia patch in December 2005.
Davol then issued two more Kugel mesh hernia patch recalls (March 2006 and January 2007) at the prompting of the FDA after reports had linked the hernia patch to several fatalities and more than 80 injuries or other problems.
In early 2006, the FDA carried out an inspection of Davol’s manufacturing plant. The agency found major flaws in the system for tracking and reporting patients’ complaints about the Kugel mesh hernia patch side effects .
FDA inspectors determined that Davol had been downplaying the severity of injuries related to the Kugel hernia patch, including the fact that one person may have died.
The first Kugel mesh hernia patch lawsuit was filed in Rhode Island in December 2006. Kugel patch attorneys alleged that their client suffered severe pain and had to undergo bowel dissection surgery. Many other patients have filed hernia patch lawsuits since then.
The Composix Kugel mesh patch has been the subject of three hernia patch recalls by its maker, Davol, and the Food and Drug Administration since December 2005.
Davol has conducted studies indicating that the “memory-recoil ring” which surrounds the mesh patch in larger models has a tendency to break. When this happens, a number of serious hernia patch side effects can result, including bowel obstruction, bowel perforation and chronic enteric fistulas.
A bowel obstruction is a partial or complete blockage in the intestines. This does not allow the intestinal contents to pass through normally. Blockages of this kind can be caused by several conditions, including hernias, medication, scar tissue, tumors, twisted intestines, gallstones or foreign objects such as the Kugel mesh hernia patch.
Patients suffering bowel obstruction may have abdominal pain, constipation, bloating, vomiting or diarrhea. If it is not treated, a bowel obstruction can lead to infection, gangrene or bowel perforation.
When an opening forms in the intestinal wall, its contents may flow into the abdominal cavity. This condition is known as a bowel perforation. Injury, illness and bowel obstruction have been known to cause bowel perforations.
Some of the early symptoms of bowel perforations include high fever, abdominal pain, nausea and vomiting. If left untreated, a bowel perforation can lead to sepsis, an potentially fatal blood infection.
So far, at least seven Kugel mesh hernia patch patients have suffered a bowel perforation. Eleven Kugel mesh hernia patch patients have experienced breakage of the memory-recoil ring, which then migrated through the abdominal wall.
A chronic enteric fistula is an abnormal connection that forms between two parts of the intestine. Some patients with enteric fistulas may have few serious symptoms, but in others this condition can cause major abdominal pain.
Sometimes, one fistula opening closes while the other remains open. This results in an accumulation of bowel contents in this cavity. An abscess or infection may develop which, in some cases, can spread to the bloodstream.
Several Kugel mesh patch patients have suffered chronic enteric fistulas after receiving the patch. One of them died of septic shock and heart attack after an operation to repair the intestinal fistulas. number of these patients have also filed hernia patch lawsuits against the manufacturers of the Composix Kugel mesh patch, alleging that their injuries were caused by defects in the device’s memory recoil ring.
Several patients who were injured after using the Composix Kugel mesh patch have filed hernia patch lawsuits against the manufacturer, Davol Inc., and its parent company, C.R. Bard Inc.
These lawsuits allege that the two companies were aware of manufacturing and design problems that existed in the Kugel hernia patch, but failed to inform patients, doctors or health officials of the health risks posed by the Kugel mesh patch.
Since December 2005, Davol has issued three hernia patch recalls after problems were detected in certain models of the Kugel mesh patch.
The company found that the “memory-recoil ring” which surrounds the patch and holds it in place has a tendency to break after it is implanted.
This can lead to severe hernia patch side effects, including bowel obstruction, bowel perforation and chronic enteric fistulas (abnormal connections between the intestines).
An inspection by the Food and Drug Administration revealed that Davol failed to accurately report a number of complaints it received about injuries or deaths related to the Kugel mesh patch.
Soon after the hernia patch was released in 2002, Davol began receiving a disproportionately high number of reports of broken patches from doctors.
However, the company continued selling the hernia patch without informing the FDA of the increase in complaints. It was only after the first hernia patch recall in December 2005 that the design and manufacturing problems associated with the hernia patch became widely known.
In addition to allegations that Davol and Bard were aware of the problems with the Kugel mesh patch, the hernia patch lawsuits which have been filed against the two companies accuse them of negligence, deceptive trade practices, fraud and wrongful death.
Many of these patients believe that if Davol had acted faster to issue the hernia patch recall, they might have been saved from serious hernia patch side effects.
Davol Inc. has issued a total of three hernia patch recalls for the Composix Kugel mesh patch since the first was announced in December 2005. Tests have shown that the “memory recoil ring” which surrounds the Kugel mesh hernia patch can break after it is implanted.
When this happens, the broken patch may cause severe health problems, including bowel perforation, bowel obstruction and chronic enteric fistulas—abnormal connections between two parts of the intestines.
In some cases, these hernia patch side effects can be fatal.
Many patients who were injured after using the Kugel patch have filed hernia patch lawsuits against Davol and its parent company, C.R. Bard Inc.
These lawsuits have alleged that the two companies knew of design flaws in the device which could cause hernia patch side effects.
If you have suffered hernia patch side effects and are considering filing a lawsuit, contacting an attorney is the first step in receiving compensation for your injuries.
An experienced lawyer understands the complexities of filing a Kugel lawsuit and can give you the advice you need to proceed with your case.
An attorney can also help you to gather the medical and other information to prove your case.
LAW OFFICE OF MICHAEL C. EUBANK
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Atlanta, Georgia 30303