in several instances, Davol also did not accurately report the possible severity of complaints to the agency
Austin, TX (PRWEB) March 22, 2007
Dallas-Fort Worth, TX (PRWeb) March 22, 2007 -- The Johnson Law Firm has launched an informational webpage to provide patients with recalled Kugel hernia mesh patch devices with the current recall information and free claim evaluations.
The recalled Bard Composix Kugel Hernia Mesh Patch remained on market long after injuries due to defects in the hernia patch were known to the manufacturer according to documents recently obtained from the U. S. Food and Drug Administration and published in a recent New York Times article by Barry Meier.
A recent Food and Drug Administration inspection of Davol, Inc., the manufacturer of the recalled Bard Composix Kugel Hernia Mesh Patch, has revealed "discrepancies" and "inconsistencies" in how Davol tracked and analyzed device-related complaints. An FDA inspection report shows, "in several instances, Davol also 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,"
Hernia mesh patch patients are urged to determine if they are affected by the hernia mesh recall of the Bard Composix Kugel Mesh Hernia Patches. The U. S. Food and Drug Administration recently issued a "Class 1" recall of these hernia mesh repair patches because the defect associated with the use or exposure to the Bard Composix Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death, according to the FDA.
Patients can view the complete hernia mesh patch recall list by going to http://www.lawyersforclients.com/kugel-mesh-patch-2.html or by calling toll free 1-866-374-0338 and requesting a copy of the FDA Recall Notice.
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.
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 dangerous and defective device has not only put patients at risk by allowing this device on the market without adequate testing, they have also failed to provide adequate recall information to the patients who were implanted with the device and their doctors after the dangers of the device were well known to the company, " according to Johnson Law Firm attorney Steven Johnson.
Many of the surgeons who used the device are concerned that they may wind up as defendants in the lawsuits brought by patients who have been injured by the defective devices. "Our law firm will not sue the surgeons in these cases, they are also victims of this company's inadequate testing and its practice of putting profits before patients' health. Several surgeons have contacted us about helping their patients and we are pleased to do so. The surgeons are blameless in these cases we intend to seek compensation for our clients only from the manufacturer," say attorney Johnson.
The Kugel Patch is a hernia repair mesh 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.