Hernia Patch Has Faulty Recoil Device Which May Perforate The Bowel
C.R. Bard, Inc., and their subsidiary, Davol, Inc., issued the first recall of their Composix Kugel Mesh hernia patch in December 2005. The recall was prompted by reports that the memory recoil rings in the devices were breaking and leading to serious abdominal injuries.
The Kugel patch is a mesh product that is used to repair various types of abdominal hernias. The mesh allows for the repair of the opening without unduly stressing the fragile tissue around it. The Davol product consists of two layers of mesh surrounded by a flexible memory recoil ring. The ring is supposed to allow the patch to be folded for insertion at the hernia site, and then to flatten back into the proper position on the back side of the opening.
Although Davol initially attributed the problems to improper use on the part of surgeons, subsequent testing showed that there was, indeed, a defect in the memory recoil ring. Since the claims of injury seemed to be most closely linked to the use of the large and extra-large models of the Kugel patch, those were the only devices included in the December 2005 recall.
The FDA, which has the authority to mandate medical device recalls, inspected the Davol manufacturing facility for the Composix mesh patch, and found that the company did not have an adequate system in place to track complaints related to the hernia patch. Soon thereafter, the recall was twice expanded to include additional models. Those recalls were issued in March 2006 and January 2007.
Since that time, hernia patch lawyers have filed suit on behalf of patients who were injured by the defective medical device. Many of these individuals have suffered bowel obstruction, bowel perforations, or chronic enteric fistulas (abnormal connections between two sections of the intestines) due to broken patches. Some of these complications resulted in death. Their attorneys allege, among other things, that Davol, Inc., showed negligence in failing to recall the malfunctioning patches in a timely manner, and that it downplayed the problems associated with its use.
To date, more than 2,000 lawsuits have been filed against the maker of the Kugel patch. As is often the case is this type of litigation, the lawsuits have been consolidated as part of a federal procedure known as multidistrict litigation (MDL). The Kugel Mesh cases are currently being litigated in the U.S. District Court in the District of Rhode Island.
In January of 2008, the federal judge overseeing the hernia patch cases expanded the scope of the litigation to include other medical devices which contain similar technology. Some of the products which have been the subject of litigation include:
- Ventralex Hernia Patch
- CK Parastomal Hernia Patch
- CruraSoft Patch
- Composix Mesh
- Composix L/P Mesh
- Composix E/X Hernia Mesh
- Other Kugel products that have not been recalled
If you have suffered injury due to these defective patches, you may desire additional information about the legal alternatives available to you. Often, the verdicts awarded in drug and product liability cases total millions of dollars. This compensation is awarded by the courts to pay for the medical care, pain and suffering, and other damages claimed by injured parties. Legal Tube has access to attorneys who specialize in defective product cases, and can help you get the answers you need.