kugel patch news * kugel hernia news * composix kugel patches * patch failure * hernia patch recall

 

Kugel Patch in the News October 5, 2012
Nadrich & Cohen, experienced national pharmaceutical medical device and products defects law firm, are representing victims of the Atrium C-QUR mesh.

If you or your loved one suffered the above injuries from the Atrium C-QUR mesh you have a right to financial recovery. The national products defect medical device law firm of Nadrich & Cohen has been handling lawsuits for surgical mesh victims for many years. We are already involved in over 14 different various surgical mesh defective product lawsuits.
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2007 Safety Alert: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal

IMPORTANT PATIENT MANAGEMENT INFORMATION:
Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4" x 7.0"
Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5"


January 10, 2007

This letter is intended to inform you of actions being undertaken by Davol, a subsidiary of C. R. Bard, Inc., with the Large Sized Composix® Kugel® patches referenced in the header box at the top of this letter. First, we are expanding the recall action to certain manufacturing lots of the referenced product based on having received additional complaint reports of PET recoil ring breakage. Specific information about this recall action is discussed below. Second, Davol has decided to withdraw from the market all remaining 0010202 and 0010204 product which has the same component design as the manufacturing lots being recalled. An upgraded product design for both product codes is available for replacement.
Read more here

History of Hernia Patch Raises Questions on Implant Recalls
By BARRY MEIER
Published: March 16, 2007

How do makers of implanted medical devices react when one of their products starts breaking?
One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Kugel Mesh Hernia Patch Still Has Potential to Injure Many Patients
Date Published: Wednesday, July 18th, 2007

The Kugel Mesh Hernia Patch, which has been the subject of several Food & Drug Administration (FDA) recalls, has not been removed from all the patients who received it. Patients with the device who have not experienced symptoms of patch failure still need to be aware of the problems that can occur with the Kugel Mesh patch. If a Kugel Mesh patient experiences any of those symptoms, they must seek medical attention immediately.

Hernias are an extremely painful condition where one part of the body bulges between the muscles surrounding it (for instance, the stomach could bulge through a fissure in the abdominal muscles). The extreme pain and discomfort caused from a hernia can greatly reduce a patient’s quality of life. Surgery is the only way to permanently repair a hernia. A patch, like the Kugel Mesh Patch is supposed to close the fissure and prevent the bulge.

Read rest of story here.

FDA says Davol waited too long to issue hernia patch recall
March 23, 2007

Davol, Inc., the manufacturer of the Composix Kugel mesh patch, kept the device on the market long after it learned of several injuries linked with the hernia patch, including at least one fatality, a Food and Drug Administration safety report has concluded. The FDA documents also say that Davol underreported the number of device-related complaints it received from doctors about injuries stemming from the Kugel mesh hernia patch.

Davol received the first reports of injuries among Kugel mesh patch users in 2002, soon after it released the largest model of the device. The reports suggested that hernia patch patients could experience severe injuries as a result of breaks in the “memory-recoil ring” that surrounds the patch.
Over a three-month period, the company received 10 reports of ring breaks, including at least one possible fatality. However, Davol did not issue the first hernia patch recall until December 2005. Two subsequent hernia patch recalls for smaller models of the Kugel mesh patch were issued in March 2006 and January 2007.

In its report on safety inspections conducted at the Davol plant in early 2006, the FDA says that problems with the company’s system for tracking complaints created “discrepancies” and “inconsistencies” in how they were monitored. In addition, the FDA says that officials from Davol understated the severity of injuries caused by the Kugel mesh hernia patch in its reports to the agency, including at least three cases of severe injury and one fatality.

The FDA has since released a Class 1 hernia patch recall for some models of the Kugel mesh patch, meaning that the device has a reasonable probability for causing severe injury or death.