Did Your Kugel Hernia Mesh Fail?
McGartland Law is currently investigating possible lawsuits on behalf of patients who have experienced health problems related to hernia mesh implants. If you or someone you love required surgery due to an implant, you may be eligible to seek compensation for damages, including medical bills, lost wages, and pain and suffering.
Let the experienced team with McGartland Law help you explore your legal options. Our firm offers no-cost and no-obligation initial consultations. Contact us today to schedule an appointment to discuss the details of your case.
Kugel lawsuits are being brought by patients that have suffered complications following the use of Kugel hernia mesh to repair incisional hernias. Ventral or incisional hernias are often the result of thinned or stretched scar tissue formed following the surgery. The hernia itself occurs when part of the patient’s internal organ pushes against this scar tissue, creating an opening in the wall of the organ. When it pushes through it presents as a painful lump in the groin or abdomen.
Kugel Hernia mesh is a common alternative used to patch holes in abdominal muscles when surgery has left the muscles too thin or weak to be stitched directly to each other. The patch manufactured by Bard Composix is inserted into the body through a small incision. It is placed behind the hernia where the ‘memory recoil ring’ opens, allowing the patch to lay flat against the inner body cavity. That prevents the hernia from pushing against, and breaking through, the tissue wall where it has been weakened. However, since its approval for this procedure, the FDA has received numerous complaints from patients that have experienced pain and complications following the insertion of the mesh. These complaints have in turn led to multiple Kugel lawsuits being filed.
Bard Comosix
The Bard Composix Kugel Hernia Mesh Patches were approved by the FDA for use in 1996. The device has two layers of monofilament polypropylene plastic, surrounded by a ‘memory recoil’ ring. The plastic layers form a pocket, while the memory ring holds the device open, allowing it to retain its shape. The FDA was first made aware of difficulties with the hernia patch in 2002 after two large models were introduced onto the market. Reports were received that the device was fracturing and causing severe injuries to patients. These injuries included bowel perforations and obstructions.
Bard, and its subsidiary Davol, who manufactured the mesh, initially placed the blame for the difficulties on physician error. However, tests carried out by Davol showed a consistent failure in the device where the memory recoil ring was welded together. The mesh was subject to an FDA Class I recall in December 2005. That is the most substantial recall available to the FDA and is used only for products considered dangerous or defective enough to cause serious health problems or even result in the death of the individual. The Class I recall was updated in March 2006, to include further lots of patches considered defective. The potential dangers are recognized by the FDA to be a result of a design defect that causes the memory ring to break.
Symptoms of Problems with the Kugel Hernia Mesh
If the memory ring on the patch breaks, it can cause intestinal injuries, including perforation of the bowel and chronic intestinal fistula. Symptoms that indicate a problem with the mesh include:
- High fever
- Abdominal pain
- Tenderness over hernia site
- Unexplained and unusual intestinal symptoms
- Bowel perforation
- Intestinal fistula
- Death
Is Your Kugel Hernia Mesh Defective?
Patients who have undergone an incisional hernia repair using a Kugel Hernia Mesh should seek medical advice at the first sign of any of these symptoms. Even if patients are not experiencing symptoms, they should take steps to find out whether the mesh that was used in their surgery is included in either the 2005 or 2006 recall. Once the patient’s health and wellbeing are secured, they should seek professional legal advice and look to join others bringing Kugel lawsuits, after being put at risk through the use of a defective medical product.