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When you are injured it’s a stressful time, especially when the injuries are the result of another person’s negligence or actions. At Hughes and Coleman, our job is to help those who have been injured in Kentucky or Tennessee.
With more than a million people residing in the two states, residents of Kentucky and Tennessee are exposed to a multitude of potential accidents. Freeways, highways, and city streets pose a daily threat to residents. As the traffic grows so do the number of motor vehicle accidents.
The following is a list of practice areas in which the attorneys at Hughes and Coleman are experienced and proven. Click on an area to discover a wealth of information on each topic. If you have been affected by any of the following, contact Hughes and Coleman Injury Lawyers today for a free consultation.
The Bard® Composix® Kugel™ Mesh Hernia Patch is used to repair incisional hernias (ventral hernias), which are usually the result of the thinning or stretching of scar tissue that forms after a person has undergone surgery. A hernia occurs when part of an internal organ pushes through an opening in the organ’s wall.
Symptons of Mesh Patch Failure
Patients who have been implanted with the recalled mess patch should immediate seek medical attention if they experience:
|• Severe pain||• Nausea||• Vomiting||• Large bulge at the surgery site||• Death||• Fever|
|• Tenderness at implant site||• Persistent or unexplained abdominal pain||• Any unusual symptoms|
The problem with the Bard® Composix® Kugel™ mesh patch began in 2002, shortly after the introduction of the large and extra large hernia patch models were introduced by Davol Inc. Reports began to surface that some of these devices were breaking and causing patient injuries to internal organs and tissues including bowel obstructions, bowel perforations, and chronic enteric fistulas.
The Bard® Composix® Kugel™ mesh patch received FDA approval in 1996. The mesh patch was created to make the hernia operation easier for surgeons, and to reduce post-surgical pain. The patch was made of two layers of synthetic mesh then surrounded by a flexible plastic called a “memory-recoil ring," which is implanted by the surgeon at the hernia site. The ring then springs into place, and the hernia grows around the flattened patch and heals.
When the device first began to fail Davol® was quick to pass blame onto the surgeons. However, testing soon showed that in the majority of cases the failure occurred at the weld point where the ring was attached. As a result, Davol issued a hernia patch recall for the extra-large model of the Kugel mesh hernia patch in December 2005.
At the prompting of the In March 2006 and January 2007 Davol® issued two more Kugel mesh hernia patch recalls linked the hernia patch to several fatalities and more than 80 injuries or other concerns.
FDA Inpsection lEads to Lawsuits against Davol
In 2006, the Davol’s manufacturing plant was inspected by the FDA. The FDA found significant flaws in the patient tracking and reporting system in addition to the complaints about the Bard® Composix® Kugel™ mesh patch side effects. The FDA inspectors determined Davol® had downplayed the severity of the injuries linked to the Kugel hernia patch, including the omission of the death of one person.
The first Bard® Composix® Kugel™ mesh patch was filed in Rhode Island in December 2006. Since then a significant number of other patients have filed hernia patch lawsuits.
Update #1 – Hughes and Coleman Injury Attorneys are examining all hernia patch cases and have uncovered evidence of ring breakage in the non Bard® Composix® Kugel™ mesh patch. As a result our law office has decided to look at ALL Bard® Composix® Kugel™ mesh patch cases that have caused harm, regardless of the FDA recall.
Update #2 – The FDA issued a safety alert on Feb, 01, 2007. The defect associated with the using the Bard® Composix® Kugel™ has a reasonable likelihood it may cause serious adverse health effects, including death. As a result it has been classified as a Class I.
Our Defective Medical Device Lawyers Can Help
If you or someone you know has been affected by a faulty medical device, Hughes & Coleman wants to help. We help people nationwide get the compensation they deserve. Contact us today.
Cases likely to be referred.