Buy this domain.
Defective Kugel Mesh Hernia Patch maker Davol Inc. Ignored Problems Leaving Many Patients at Risk for Serious Injury and Untimely Death | cialis online

Defective Kugel Mesh Hernia Patch maker Davol Inc. Ignored Problems Leaving Many Patients at Risk for Serious Injury and Untimely Death

AddThis Social Bookmark Button

Despite knowing of problems with the Bard Composix Kugel Mesh Hernia Patch as far back as the summer of 2005, Davol Inc. allowed its defective product to remain on the market for months. Even when it issued a recall for the extra-large size Kugel Mesh Patch in December 2005, other versions were still being used in hernia surgeries. As a result, thousands of people may have been exposed to serious injury. In the end, it would take two more Food & Drug Administration (FDA)-ordered recalls to warn doctors and their patients about other defective Kugel Mesh Hernia Patches.

By the summer of 2005, Davol Inc. had plenty of evidence that the recoil ring that opened the hernia patch could break, leading to serious problems like bowel perforations. By then, the company had reports of at least 10 injuries – one of them fatal – linked to the Kugel Mesh Patch. Still, it took until December for the FDA to order a Class I recall of the Bard Composix Kugel Mesh X-Large Hernia Patch. A Class I recall means that a device runs the risk of causing serious injury in patients using it. Doctors were advised to stop using the device, and patients were told to seek medical attention if they experienced symptoms like unexplained fever, abdominal pain and tenderness at the incision site. The recall would need to be expanded twice – once in April 2006 for the mid-line size of the patch, and again this past January for the large patch. The FDA has accused Davol of understating the problems with the patch.

In April 2007, the FDA issued a warning to Davol after an inspection of its Rhode Island headquarters uncovered serious problems with the quality assurance programs used in the manufacture of the Kugel Mesh Patch. Among the problems cited during the inspection where those found in the system Davol used to track complaints. The FDA said that the system was so inadequate that Davol was unable to conduct timely complaint investigations. The FDA said that the lack of these procedures was to blame for Davol’s delays in dealing with the Kugel Mesh Patch’s problems.

Davol Inc. has been criticized for a lack of quality assurance procedures with some of its other devices. Some versions of the company’s Salute Reusable Fixation devices were also recalled by the FDA in 2006. This device is used to attach mesh during hernia repair. The FDA’s investigation into the Salute device found that Davol had no documentation of any testing done on the device to insure that it performed to specifications.

Because Davol chose to ignore concerns about the safety of the Kugel Mesh Patch, thousands of people who received the device run a very high risk of serious injury. Hundreds have had to undergo painful and traumatic medical procedures to have their devices replaced. Much of this misery could have been avoided had Davol acted on the reports it received during the summer of 2005.

« »

Comments are closed.




Defective Johnson & Johnson Depuy ASR Hip Implants

The Johnson & Johnson Depuy ASR Hip Implant is suppose to last 15 years, but can fail in only a few years after surgery. Victims with faulty hip implants endure excruciating pain, pain in the groin, death of tissue in the hip joint and loss of surrounding bone. GET ALL THE FACTS NOW! CLICK HERE!

CAT Scans Radiation Exposure

If you had a CT or CAT scan and now have a band of missing hair, skin reddening or any other problems possibly related to a radiation overdose, you may have been exposed to much radiation due to incorrect settings on these machines. CONTACT US TODAY!

Water Contamination From Fracking

Hydraulic Fracturing of Fracking a way to extract natural gas from shale is contaminating water supplies across the country. Get the facts to keep your drinking water safe for your family.

Overexposure to PCBs

Many people unknowingly have been exposed to high levels of PCBs. Recently 3 schools in NY City were found to have dangerous levels of PCBs throughout. Many workers for Monsanto, General Electric, and Westinghouse were exposed to high levels of PCBs. PCBs are a dangerous toxic substance that doesn't break down easily and can cause chloracne, bleeding and neurological disorders, liver damage, spontaneous abortions, malformed babies, cancer, and death. GET THE FACTS!
Overexposure to

Great Photography

Tallis Photo, the number one photographer for great corporate, wedding, and special occasion photos. CONTACT US TODAY!

Poligrip Lawsuit

Super Poligrip or Fixodent May Cause Nerve Damage. 800-LAW-INFO

Personal Injury Lawyer Nassau County

If you or someone you love was injured CONTACT US TODAY!

Nursing Home Blog

When a loved one is abused at a nursing home, it is time to take action. STOP nursing home abuse!

Car Accident Lawyer Nassau County

If you or someone you love was injured in an auto accident CONTACT US TODAY!

Suffolk County Auto Accident Lawyer

If you or someone you love was injured in an auto accident in Suffolk County, NY CONTACT US TODAY!

Don't Be Denied Veterans Benefits

If you or someone you love was denied veterans benefits CONTACT US TODAY!

Oil Rig Spills Lawyer

Oil Rig Spills harm the environment and cause heavy losses to coastal game and fishing industries, as well as a loss of waterway usage, resulting in a loss of income to individuals and businesses, and a loss of beach front usage. Don't let a spill cause you harm, CONTACT US TODAY!

Whistle Blower

Stand up and say what you think is right. See something, say something.