company officials had also understated in several reports to the agency the potential severity of device-related injuries
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Dallas/Fort Worth, TX (PRWEB) September 4, 2007
The Hernia Patch Recall of the Bard Composix Kugel Hernia Mesh Patch that was issued by the FDA has resulted in numerous lawsuits and The Judicial Panel on Multidistrict Litigation of the United States Courts has created Master Docket No. 1:07-md-01842-ML-LDA and transferred all federal cases for pretrial proceedings to the District of Rhode Island, according to lawyers familiar with the litigation at The Johnson Law Firm.
The U.S. Food and Drug Administration recalled many of the hernia patches recently. The hernia patch recall was classified as a "Class 1" recall by the FDA because it considers the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch as having a reasonable probability to cause serious adverse health consequences, including death, according to the FDA Recall Notice of January 2006.
The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
A recent inspection by the FDA of Davol, Inc., the manufacturer of the recalled Bard Composix Kugel Mesh Hernia Patch, found the company "did not accurately report the possible severity of complaints to the agency" and that " company officials had also understated in several reports to the agency the potential severity of device-related injuries," according to The New York Times article by Barry Meier of March 16, 2007.
The Johnson Law Firm, a national law firm representing a large number of patients who have been injured by the Bard Composix Kugel Hernia Mesh Patch, is providing recall information and claims evaluations at no cost to affected patients on their website at http://www.lawyersforclients.com/kugel-mesh-patch-2.html and toll free at 1-866-374-0338.
"Davol, the manufacturer of this recalled hernia patch, has marketed a product that the FDA considers as 'probable to cause serious adverse health consequences and death' and 'did not accurately report the severity of complaints' about the device to the FDA according to the New York Times. We will seek the greatest amount of compensation allowed by law for our clients who have been injured as a result" according to Johnson Law Firm attorney Steven Johnson.
The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
The "memory recoil ring" can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to numerous complications including infections, bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The recently updated FDA Recall Notice and a list of the recalled devices is available at http://www.lawyersforclients.com/kugel-mesh-patch-2.html or patients can call 1-866-374-0338 for a list of the recalled devices and a claims evaluation packet.
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