|
KUGEL MESH PATCH
The Kugel hernia patch was developed to treat ventral or incisional hernias, which are caused by a stretching or thinning of scar tissue that forms after abdominal surgery. Hernias develop in approximately 2 to 10 percent of patients who undergo abdominal surgery. The Kugel Mesh patch was designed to treat incisional hernias via a small incision. The Kugel hernia mesh patch is inserted in a small folded form, which is then opened into position by a "memory recoil ring," once in place.
Kugel Mesh Patch products were pulled from the market in December 2006 due to device defects that can cause serious side effects. The Kugel Mesh patch is manufactured by Davol Inc., a division of C.R. Bard. A recent FDA investigation has revealed that this manufacturer allowed the Kugel hernia mesh patch to remain on the market long after they learned of serious injuries caused by their product.
A recent FDA inspection of Davol, Inc. also uncovered inconsistencies and problems in how the manufacturer tracked and evaluated Kugel mesh injury complaints. According to the FDA, "in several instances, Davol did not accurately report the possible severity of complaints to the [FDA]" and that Davol company officials "had understated the potential severity of device-related injuries." Thus, it is becoming clear that this company did not adequately inform the public of the serious side effects and risks posed by the Kugel hernia mesh product.
The FDA recommends that any patients who have had Kugel Mesh used during hernia repair surgery see a medical professional immediately if any abnormal symptoms develop including, but not limited to:
- Persistent abdominal pain
- Tenderness near the implant site
- Fever
- Nausea
- Vomiting
If you or a loved one has had hernia surgery during which Kugel hernia mesh was used and you suffered injuries caused by this medical device, you may be able to seek compensation for your losses and suffering. Our qualified attorneys are prepared to evaluate your case and aggressively work to get you the compensation you deserve.
|
