Kugel Hernia Patch Lawyer
Hernia Patch Recalls
Information regarding hernia patch recalls, product numbers, and news regarding recalled hernia mesh patches.
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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney
Your Rights: Kugel Hernia Mesh Patch
Category: Hernia Patch Recalls
If you have undergone hernia repair surgery that utilized a Kugel Hernia Mesh Patch, you are urged to contact your hernia surgeon for a copy of your medical records.
Kugel Mesh Maker's Poor Quality Control Helps Prompt FDA Reform
Category: Hernia Patch Recalls
The FDA recalled the Kugel Mesh Hernia Patch after it was discovered that the patch's memory recoil ring was predisposed to breakage. The post approval adverse event reporting system used by the manufacturers was cited as being in adequate and resulted in a delayed response because the FDA was unaware of complications with patches. This in addition to the controversy surrounding prescription medications has prompted a new bill that has already been passed by both houses of Congress, and will hopefully give the FDA a much better opportunity to make sure that events like this are not soon repeated.
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Overview: Kugel Hernia Mesh Patch Recalls
Category: Hernia Patch Recalls
Problems stemming from the Composix Kugel Mesh Hernia Patch started to surface as far back as 2002, shortly after Davol Inc., first introduced the large and extra-large models of the hernia patch.
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Kugel Mesh Inferior Quality Control Methods Cited
Category: Hernia Patch Recalls
Following the initial recall of the Kugel Mesh Hernia Patch, the FDA issued a warning letter citing poor quality control maintenance as a major reason for the defects resulting in the recall. The FDA only issues these warning letters in cases where they have found significant problems in the methods or facilities that are part of the manufacturing process.
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Kugel Hernia Patch Recall
Category: Hernia Patch Recalls
The U.S. Food and Drug Administration (FDA) recalled several hernia patches in January 2006. The hernia patch recall was classified as a "Class 1" recall by the FDA because they believe the defect associated with the use or exposure to the Kugel Mesh Large Patch has reasonable probability to cause serious and sometimes fatal adverse health effects.
Hernia Patch Left on Market After Davol Knew of Health Risks
Category: Hernia Patch Recalls
Davol, the maker of Bard Composix Kugel Hernia Mesh Patches, are used to treat hernias that usually occur where a previous incision was made in the body.
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Expanded Hernia Patch Recall
Category: Hernia Patch Recalls
In March, Davol Inc expanded their earlier recall of the Composix Kugel Patch that is used when repairing ventral hernias that can appear at the site of a prior surgical incision.
FDA Issues Class 1 Recall of Hernia Patch
Category: Hernia Patch Recalls
The U.S. Food and Drug Administration (FDA) urges patient's to determine if they have a Bard Composix Kugel Mesh Hernia Patch that is included in the hernia patch recall. The FDA recently issued a "Class 1" recall of the hernia mesh repair patch due to a defect in the "memory coil ring."
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Kugel Hernia Patch Recall Recap
Category: Hernia Patch Recalls
In three different product recalls that date back to 2005, C.R. Bard Inc. and its subsidiary Davol Inc. in association with the Food and Drug Administration had initiated voluntary recalls of the Kugel patch.
Makers of Kugel Patch did not Accurately Report Severe Side Effects
Category: Hernia Patch Recalls
The New York Times recently obtained documents under the Freedom of Information Act that indicates the manufacturers of the Kugel Hernia Patch did not accurately report possibly severity and complaints to the FDA.
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Kugel Mesh Patch Recall
Category: Hernia Patch Recalls
A hernia is described by doctors as a defect of gap in the abdominal muscle wall through which an intra-abdominal organ can protrude. Weakness or a small tear can cause this gap in the muscle. Ventral hernias usually occur in an area where surgery has previously been performed and are on the abdominal surface.
Hernia Repair Warning
Category: Hernia Patch Recalls
The Bard Composix Kugel Hernia Patch, manufactured by Daval, is a medical device that has commonly been used to repair Insicional & Umbilical Hernias, and has recently been recalled due to reported complications from patients.
Bard Composix Kugel Mesh Patch Recall
Category: Hernia Patch Recalls
On March 31, 2006, the FDA announced a second recall of Davol, Inc.'s Bard Composix Kugel Mesh Patch.
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 springs open and lays flat once it is in place. The FDA issued a Class 1 Recall of certain lot numbers of the Composix Kugel Mesh Patch because the "memory recoil ring" that opens the Composix Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae. The FDA notice contains all of the product codes and lot numbers affected by the recall.
Hernia Patch Patients
Category: Hernia Patch Recalls
Patients that have had hernia surgery that utilized a mesh patch are urged to contact their hernia surgeon or the hospital where the surgery took place to find out if a recalled Composix Kugel Hernia Mesh Patch was used in their hernia surgery. The FDA has a list of all the recalled hernia patches.
Kugel Mesh Hernia Patch Recall
Category: Hernia Patch Recalls
The Bard Composix Kugel Mesh Patch was originally designed by Dr. Robert Kugel as a way to repair ventral (incisional) hernias, which are caused by the stretching or thinning of scar tissue formed after surgery. While older hernia repair methods may require several weeks of patient recovery time, the Bard Composix Kugal Mesh Patch was created to minimize recovery time and pain, typically allowing patients to return to normal activities soon after surgery. Since the Bard Composix Kugel Patch was first manufactured in 2001, thousands of Americans have been implanted with it. The patch, which is positioned behind the hernia injury through an incision, is held open by a 'memory recoil ring' that allows it to be folded for insertion then spring open and lay flat once it is in place. The 'memory recoil ring' is designed to keep the patch closed until after it has been inserted in the body. Then, the primary purpose of the patch is to stop the hernia from breaking through weakened tissue walls, specifically in instances when stomach muscles are very fragile. In recent years, defects in the Bard Composix Kugel Patch's 'memory recoil rings' have been the source of several injuries and lawsuits, as well as product recalls.
Kugel Mesh Hernia Patch
Category: Kugel Hernia Patch
The Bard Composix Kugel Mesh Patch was created to repair ventral hernias. The Patch was to be placed behind the hernia surgery and then held open by a "memory recoil ring." It is this memory coil ring that caused the Bard Composix Kugel Mesh patch recall.