Tragically, some medications and devices used to treat patients are found to be unsafe after they have already been widely implemented. The defects and side effects associated with the Kugel Mesh Hernia Patch are no exception.

While Davol, Inc. first introduced the Kugel Mesh Hernia Patch for the treatment of ventral hernias in 1997, by 2002, the company was starting to receive complaints about the potentially deadly side effects of Kugel Mesh Hernia Patches.

Kugel Mesh Hernia Patch Recalls

Initial patient complaints issued to Davol, Inc. were attributed to improper patch placement and surgeon errors. However, after holding special training sessions for doctors on how to implant Kugel Mesh Hernia Patches, patient complaints persisted, and Davol realized that the patch itself was flawed.

This triggered a series of FDA recalls:

  • the first in December 2005
  • the second in January 2006
  • the final one in January 2007

With the final Kugel Mesh Hernia Patch recall, the FDA had effectively recalled six different models of the hernia patch and had elevated the recall to a Class I status, indicating that patients still using these devices are at a high risk of developing potentially fatal side effects.

The Investigation of Davol

In the midst of these recalls, the FDA also performed a thorough investigation of Davol’s facilities, products and methods. Shockingly, the inspection found that:

  • Davol lacked any system for recording, investigating and generally managing patient complaints.
  • Davol didn’t test all of the products it made, meaning that the company wasn’t following or standing up to its own quality and safety standards.
  • Davol’s facilities were in violation of a number of safety and health regulations regarding the production and storage of the devices it made.

These findings of Davol’s gross negligence have been crucial evidence in many personal injury lawsuits over Kugel Mesh Hernia Patch defects and side effects.

Starting a Kugel Mesh Hernia Patch Lawsuit

If you or a loved one have used a Kugel Mesh Hernia Patch and have experienced related health problems, you may be eligible to file a Kugel Mesh Hernia Patch lawsuit to recover money for your:

  • Medical costs
  • Pain and suffering
  • Lost wages or loss of earning capacity
  • More

To learn more about filing a Kugel Mesh Hernia Patch lawsuit, contact us today. We’ll be happy to evaluate your case and inform you of your legal options.

Published November 17, 2011 by