Bard Kugel Mesh Lawsuit
Bard Medical has been around a long time. Their latest product, the Kugel Hernia Patch, is being used to repair painful, potentially fatal tears in the abdominal wall. Like so many of their products, however, they are causing more problems than they are solving. Bard’s long history of creating defective products and sending them out to the public is well known. They are the makers of the Avulta pelvic mesh, the Vena Tech LP IVC filter, and are facing lawsuits over these and a host of others including:
- Bard PerFix Plug
- Bard Ventrio ST
- Bard Ventralex ST
- Bard Ventralight ST
- Bard Supramesh
After being approved in the 1990s, the C.R. Bard Kugel hernia mesh patch was one of the first mesh implants to be recalled. By the time problems surfaced, however, it had already been implanted over a million times. The issue was a polypropylene ring the mesh contained, which could shrink and/or break after implantation, leading to bowel and other organ perforations.
These mesh implants were recalled by Davol, a subsidiary of Bard, in 2005, 2006, and 2007, but complications due to the devices and their design defects continue to impact the lives of those who had them implanted before their recall, and lawsuits continue to move forward. Delayed complication include pain, infection, hernia recurrence, internal scarring, and bowel obstruction.
In addition to the above recalls, Bard has a long, involved history with the FDA, including:
- In July of 2015, C.R. Bard, Inc. was issued a Warning Letter by the FDA for adulteration/misbranding violations at their Tempe, AZ, facility, for quality system violations and for quality system regulation violations at Tempe, AZ, and Queensbury, NY, facilities, and for MDR violations at their Tempe facility.
- In 2012 the FDA issued a Class II Device Recall on Bard’s Ventralight ST Mesh.
- In 2010 the FDA issued a Class I Device Recall on the Bard Mesh Monofilament Knitted Polyprophlene Flat Mesh.
Along with the hernia mesh, Bard Kugel products have resulted in testicular problems for males, causing pain, or worse. Other complaints such as those from the Ventralex ST hernia mesh implant, also named in lawsuits, include severe inflammatory reactions to these products.
Bard Kugel Mesh patches were designed with a “memory recoil ring” that was made to allow the patch to be folded and inserted through a small abdominal incision and, once in place, spring open and lie flat over the area that’s affected. However, recent cases filed show that the ring can buckle or break under the stress of placement. This results in a number of painful, life-threatening and potentially fatal complications.
Warning signs of hernia mesh failure include:
- Abdominal tenderness
- Abnormal bowel movements
- Abdominal distention
If you have experienced any of these symptoms, call our Bard Kugel lawsuit lawyers now.
Each year, far too many of these meshes are being placed on the market for use that are causing irreparable harm to patients. If you have been harmed by a Bard or some other defective medical device, you should file a MAUDE Adverse Event Report as soon as possible, or call our office today for help and guidance through the process. We serve hernia mesh victims in almost every city nationwide including Colorado, Arizona, Georgia and more!