FDA warned Bard about quality control issues at plant where the Kugel Hernia Mesh is made

Harvey Kirk

By Harvey Kirk
Posted October 15, 2008


Yesterday the FDA released a letter sent to C.R. Bard, Inc. regarding a number of manufacturing problems and quality control issues at their plant where the Kugel Hernia Mesh is manufactured. Although there is no indication that the violations have anything to do with the Kugel Mesh lawsuits that are pending throughout the United States, it is a clear sign of the same types of negligence which led the company to issue three separate hernia patch recalls since 2005.

The hernia mesh lawyers at Saiontz & Kirk, P.A. have been investigating potential cases against Bard and their subsidiary Davol, Inc. involving problems with the design of several of their hernia repair products.

Design defects have caused a number of people to suffer severe complications after hernia repair surgery, such as:

  • Intestinal Pain
  • Bowel Perforation
  • Intestinal Fistula
  • Additional Hernia Surgery
  • Death

Between October 2005 and January 2007, Bard issued three separate Kugel Hernia Patch recalls involving different sizes of their mesh. However, the company has been widely criticized for failing to adequately investigate complaints received and for delaying the recalls even after they received numerous reports of problems.

The Kugel hernia mesh contains a memory recoil ring which has been found to break in some cases, resulting in small, sharp pieces of plastic cutting up the intestines. Hundreds of thousands of Kugel patches were implanted in patients throughout the United States, even though C.R. Bard and their subsidiary Davol knew about the defective ring.

Problems have also been associated with other types of hernia repair mesh made by Davol and Bard which they have not recalled. Hernia repair patches that utilize a dual-mesh technology, combining palypropylene mesh with an expanded polytetrafluorothyleen (ePTFE) layer, both with and without a memory recoil ring, have been included in the federal Kugel Hernia Patch litigation that is pending in the U.S. District Court for the District of Rhode Island.

During FDA inspections at C.R. Bard’s plant in Puerto Rico where many of these products are made, the FDA has identified a number of violations of the Good Manufacturing Practices of the Quality System regulation under the Food, Drug and Cosmetic (FD&C) Act. Bard was found to not follow up on quality control problems, mislabeled and mixed up products and even sold some Kugel patches that were labeled with the wrong size information.


Most patients who receive a hernia surgery mesh are unaware of the type of patch that was used. However, our product liability lawyers provide free consultations and claim evaluations for any individuals who have had a hernia repair and experienced unusual complaints or problems following surgery.

Cases are investigated and reviewed to determine if the hernia surgery complications may be related to the defects in Bard hernia mesh products. If you, a friend or family member think you may have a case, request a free consultation and claim evaluation.

1 Comment • Add Your Comments

  • Tammy says:

    Yes I have the bard/Kugel hernia mesh inside of me and I have had nothing but problems .I’m pretty sure the memory coil has already broke.i had a hernia surgery in 2000 to have it repaired it was 11×14 and they used a large oval patch. My incision opened up right after the operation. And it got badly infection I had to have plastic surgery to close it up but my belly button had to be removed I’m in pain constantly. Can someone help me please. I also have all of my medical records from the surgery to

    Posted on August 9, 2017 at 5:04 pm

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