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Since December 2006, Bard Composite Kugel Mesh Patch products have been pulled from the market due to device defects that can cause serious side effects. The Kugel Mesh patch is manufactured by Davol Inc., a division of C.R. Bard. A recent FDA investigation has revealed that this manufacturer allowed the Kugel hernia mesh patch to remain on the market long after they learned of serious injuries caused by their product.
A recent FDA inspection of Davol, Inc. also uncovered inconsistencies and problems in how the manufacturer tracked and evaluated Kugel mesh injury complaints. According to the FDA, “in several instances, Davol did not accurately report the possible severity of complaints to the [FDA]” and that Davol company officials “had understated the potential severity of device-related injuries.” Thus, it is becoming clear that this company did not adequately inform the public of the serious side effects and risks posed by the Kugel hernia mesh product.
If you or a loved one has had hernia surgery during which Kugel hernia mesh was used and you suffered injuries caused by this medical device, you may be able to seek compensation for your losses and suffering. Our qualified attorneys are prepared to evaluate your case and aggressively work to get you the compensation you deserve. Please contact our offices today.
What is the Kugel Mesh Patch?
The Kugel hernia patch was developed to treat ventral or incisional hernias, which are caused by a stretching or thinning of scar tissue that forms after abdominal surgery. Hernias develop in approximately 2 to 10 percent of patients who undergo abdominal surgery. The Kugel Mesh patch was designed to treat incisional hernias via a small incision. The Kugel hernia mesh patch is inserted in a small folded form, which is then opened into position by a “memory recoil ring,” once in place.
Kugel Mesh Defect
The problem with the Kugel Mesh patch is that many of the devices contained a defective “memory coil ring.” This part of the medical device can break, particularly under the stress of certain surgical techniques. When this device breaks, the Kugel Mesh can cut through internal organs and other tissues, posing serious life-threatening risks to patients.
Kugel Mesh Side Effects
With this Kugel Mesh defect, patients are at an increased risk of suffering bowel perforation, bowel obstruction, infection and chronic intestinal fistulae (abnormal passageways from the intestines to another internal organ or the body surface). These are serious side effects that require immediate medical attention.
Symptoms of Kugel Mesh Side Effects
The FDA recommends that any patients who have had Kugel Mesh used during hernia repair surgery see a medical professional immediately if any abnormal symptoms develop including, but not limited to:
The FDA has received reports of approximately 80 serious adverse events caused by the Kugel Mesh patch, including numerous deaths.
Hernia Kugel Mesh Recall
On December 22, 2006, Davol announced a massive recall of the Kugel Mesh Patch. However, FDA records show that the manufacturer began receiving reports of serious injuries caused by the Kugel Mesh as early as 2002. Most of these problems were related to the extra-large sized Kugel Mesh patches.
In 2005, the company began receiving a strikingly high number of adverse event reports—10 reports in just 3 months—including one possible fatality caused by Kugel Mesh. Despite these known cases, the company continued to market this dangerous Kugel Mesh product.
Only in 2005, after tests run by the company revealed that the Kugel mesh patch’s recoil device could malfunction, did the company finally pull this dangerous medical device off the shelves. The company began by recalling only the extra large sizes of Kugel Mesh but then recalled all of the larger sizes of the product.
The recall prompted the FDA investigation, which found several inconsistencies and discrepancies in the way Davol tracked and managed Kugel Mesh injury reports.
Kugel Mesh Recall and your legal rights
If you or a loved one has received a Kugel Mesh patch via hernia treatment, it is important to see a qualified health care provider at the earliest sign of unusual symptoms. Furthermore, If you or a loved one has been harmed due to Kugel hernia mesh patch side effects, it is important to inquire about your legal rights and options. By contacting a Kugel Mesh Attorney. You may have the legal right to seek compensation for your past and future medical expenses, financial losses, pain and suffering, and more; The Kugel Mesh Lawyers at Oshman & Mirisola are experienced in handling these types of medical device cases and can counsel you to determine if you are entitled to file a Kugel Mesh lawsuit.
Please contact us today for a free no-obligation consultation, which will enable you to learn more about your legal rights and options. Our caring and competent team will work hard to ensure you receive the compensation you deserve.