In December 2005, Davol, Inc., a subsidiary of CR Bard, recalled certain models of the Bard Composix Kugel® Mesh Patch – a hernia repair device that it manufactures. Shortly after, in 2006, the U.S. Food and Drug Administration (FDA) also issued a warning on the product, and advised patients to look out for patch failure symptoms, and seek immediate medical attention, if any occurred.
What are Mesh Patches?
Mesh patches are used in hernia surgery procedures to help stop the thinning or stretching of scar tissue following surgery. The mesh patches help to repair the tissue surface and are typically deployed in hernia surgeries, conducted as laparoscopic procedures. The patches are placed inside the abdominal cavity of the patient and positioned behind the hernia, during surgery. Once placed inside the patient’s abdomen, the patch is unfolded and opened by a plastic "memory recoil ring.”
Reports indicate that the memory recoil ring can break in some surgeries, creating several health complications for the patients. When the ring breaks, the broken ends tend to poke through the mesh causing bowel perforations and/or a condition called "chronic enteric fistulae." While the ring is designed to help secure the patch, when placed in the abdomen, it can break if increased stress were placed on it at the time of surgery.
A Life Altering Condition
One of the key challenges in early detection of ring breakage / malfunction is that the condition is hard to diagnose. Usually, hernia surgery is followed by residual pain, a condition that both doctors and patients expect and are prepared for. Besides, reactions to ring breakage are manifested in many ways such as infections, bowel obstructions, constipation, diarrhea, internal organ complications etc., which often prevent early detection.
Being difficult to diagnose, doctors use a range of diagnostics tests to determine the condition. These include:
- A lower plate X-Ray
- Barium fluid test—either swallowed or taken as an enema
- Reverse Imaging CT scan
Health professionals warn that in general, if the pain were accompanied by constant diarrhea, excessive seeping or constipation, it is an indication that things may be going wrong.
While issuing its warning on the Composix Kugel® Mesh Hernia Repair Patch Recall, the FDA advised that “Patients who have been implanted with a Composix Kugel® Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include: unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms."
The worst “side effect” from a Composix Kugel® Mesh patch malfunction is that patients are left dealing with problems that isolates them from society. A malfunctioning hernia repair patch causes injuries that are often perceived as undignified, causing much embarrassment and discomfort to patients. Often, patients feel uncomfortable discussing their injuries such as constipation, diarrhea, open wounds that are continuously seeping, with others.
In effect, a simple laparoscopic hernia surgery that would have been quick and almost pain-free, confounds patients with a life altering condition, that causes immense physical and emotional suffering, and takes multiple surgeries over several years, to heal.
Kugel Hernia Mesh Lawsuit
If you or a loved one is suffering from bowel perforation or chronic enteric fistulae, due to a failed Kugel® Mesh patch, you have the right to seek compensation for your medical expenses, injuries, loss of productive and social time. Please contact our San Antonio Kugel Mesh lawyers for a free review and consultation.
Our experienced attorneys will offer you all the professional inputs and legal counsel you need to pursue a Kugel Hernia Mesh lawsuit. Call us today at 210-888-888.