Composix Kugel Mesh Recall Lawsuits
The Strom Law Firm, LLC is currently investigating and evaluating cases against the makers of Kugel Mesh. The Composix Kugel Mesh Hernia Patch is a medical device surgeons use to repair ventrical hernias, which may develop at previous surgery sites or scars. The mesh is supposed to be able to fold and lay flat, the design causes the device’s memory recoil ring to break resulting in severe intestional issues, future surgeries, and sometimes death. There have been several national recalls. Give us a call today for a free consultation. 803.252.4800.
Kugel Mesh Patches
The Food and Drug Administration (FDA) reported that Kugel Mesh Patches are used in approximately 750,000 hernia repair surgeries every year. Several lawsuits claim that the manufacturer had reason to know of the Kugel Mesh problems and still allowed thousands of individuals to have defective devices implanted.
As a result, many patients experienced:
- Bowel Perforation
- Severe Tenderness at surgery site
- Extreme Abdominal Pain
- High Fever, and sometimes
Kugel Mesh Defects
The problems with the Composix Kugel mesh patch started to come about in 2002, right after Davol Inc. produced the large hernia patch units. Reports surfaced that the rings in certain devices were breaking, leading to injuries to patients’ internal organs and tissue from hernia patch side effects, including bowel perforations, bowel obstructions and chronic enteric fistulas.
The Kugel mesh patch was intended to make hernia operations go more smoothly. The patch also aimed to lower patients’ post-surgical pain. It won approval from the Food and Drug Administration in 1996. The patch consists of two layers of synthetic mesh enclosed by a flexible plastic “memory-recoil ring,” which is implanted at the site of a hernia. The ring then springs into place, allowing the hernia to heal and re-grow around the compressed patch.
Kugel Mesh Investigation
Davol first attributed the broken rings to mistakes made by doctors while performing hernia-repair surgery. Later, however, company studies revealed that the failures almost always took place at the spot where the ring was fused together. In December 2005, as a result of the design and manufacturing flaws uncovered in its tests, Davol issued a hernia patch recall for the extra-large model of the Kugel mesh hernia patch. Shortly after, Davol issued two more Kugel mesh hernia patch recalls (March 2006 and January 2007) as a result of FDA reports which connected the hernia patch to quite a few fatalities and more than 80 injuries and other problems.
In early 2006, the FDA performed an inspection at Davol’s manufacturing plant. The administration found major defects in the system for tracking and reporting patients’ complaints about the Kugel mesh hernia patch’s unwanted side effects. FDA officials found that Davol had been downplaying the significance of injuries related to the Kugel hernia patch, including the fact that one person may have passed away.
Call the Strom Law Firm, LLC For a FREE Kugel Mesh Case Evaluation
If you or a loved one received a Kugel mesh hernia patch and suffered injuries as a result, you could be entitled to compensation. Give us a call today to schedule a free consultation at 803.252.4800. Don’t suffer through the pain. It is important to understand that you have rights. Let us help you and your family.