Defective Medical Device From Davol Prompts FDA Recall
The introduction of mesh patches to aid in hernia repair surgery was initially a welcome development, both for physicians and patients. These patches were designed to allow the surgeon to repair the opening through which a hernia had protruded without stressing the already-weakened muscles and tissues surrounding it. The reality for some patients, however, has been that their hernia patch was defective and led to serious internal injuries.
The products at the center of this controversy are the Bard Composix Kugel Mesh Patches which were manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc. The company received FDA approval for smaller versions of the hernia patch in 2001, and went on to introduce larger oval patches in 2002. Shortly thereafter, reports began to surface that patients who received the larger patches were suffering serious health problems as a result.
The product defect seems to stem from the memory recoil ring which surrounds the patch. The flexible ring was designed to allow the device to be folded for insertion into the hernia site. Once situated behind the abdominal wall, the ring should help the hernia patch flatten into its proper position, effectively covering the opening and holding protruding tissues in place.
However, these rings broke after the patches were implanted in some patients, resulting in bowel obstructions, bowel perforations, and chronic enteric fistulas (abnormal connections between two parts of the intestine). In some cases, these injuries and their subsequent complications led to death.
Davol blamed the broken memory recoil rings on surgeon error at first, but their own testing later confirmed that the breakages were almost always occurring in the spot where the rings were welded together. This finding led the company to recall the large and extra large oval patches in December 2005. Further FDA investigation and reports of device defects led to the expansion of the recall to include other sizes and version of the mesh patches in March 2006 and January 2007.
If you received a Kugel Hernia Patch as part of a hernia repair procedure and have symptoms such as abdominal pain and fever, constipation, diarrhea, and bloating, immediate medical care maybe needed. These symptoms may indicate serious side effects associated with a defective patch. Untreated, these abdominal injuries can lead to serious health consequences, including death.
Many of the individuals who have been injured as a result of a receiving a defective hernia patch are pursuing legal action against the manufacturer. To date, over 2,000 lawsuits have been filed by patients who suffered illness or injury believed to be caused by breakages in the mesh patches. These injured parties are seeking compensation for a variety of things, including medical expenses, pain and suffering, and in some cases, wrongful death.
If you have questions or concerns related to the Kugel Mesh patch, or similar products, see your doctor for an evaluation of your symptoms and prompt care. If you want more information about your legal rights and the compensation which may be recovered for injuries caused by the device, an attorney with expertise in drug and product liability can help you.
The attorneys available to you through Legal Tube are specialists in a number of areas of litigation, and some even concentrate specifically on cases related to particular medical products. An experienced lawyer can evaluate your case, and help you choose a legal course of action that’s right for you.