The kugel mesh patch used in hernia repair was originally recalled in december 2005. Recall of certain composix kugel mesh patches used in hernia repair. Each year, there are approximately 500,000 hernia repair surgeries performed in the united states. There are over 750,000 hernia operations each year in the u. Hernia mesh is a simple medical device that is used to repair hernias, which occur when intestines or other tissue protrude through weak areas of muscle. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Bard received reports that the kugel patch was failing as early as 2002. Composix kugel hernia mesh patches have been used for years to repair ventral hernias. If youve recently had hernia repair surgery, your health may be at risk.
Kugel mesh hernia patch dangers north carolina product. Composix kugel mesh patches lawsuit hernia mesh lawsuit. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. It was meant to support the weakened abdominal wall until the patients own tissues can grow and heal a hernia. Bard, inc, have notified healthcare professionals regarding the expansion of a class 1 recall for a ventral hernia repair device bard composix kugel mesh patch. Dozens of defective hernia mesh medical devices have been recalled. If you have questions about the composix kugel mesh hernia repair patch litigation.
The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. The fda originally approved the composix kugel hernia mesh patches. Kugel hernia mesh is used primarily for hernia surgery, particularly for. Kugel hernia patch recall could have occurred earlier.
The products were commonly used to repair incisional hernias in the abdomen. The kugel hernia mesh patch patch is used to repair ventral hernias. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. Bard assured the fda and the public that the problem was limited to a few defective rings inside of a limited number of kugel hernia patches. On march 31, 2006, the fda expanded the original hernia mesh patch recall to include oval, large oval and large circle kugel hernia mesh patches. Bard and its subsidiary davol recalled limited lots of the kugel hernia patch in 2005, 2006 and again in 2007. An article in todays new york times suggests that the recent kugel hernia patch recall could have occurred sooner. If the maker of the hernia repair mesh had taken quicker actions to notify physicians of problems with the patch and remove it from the market, it is possible serious injuries could have been avoided for many who had the mesh. Recall classified as class i because the defect associated with the use or exposure to the bard composix kugel mesh large patch. The devices have a memory recoil ring that allows the patch to fold for insertion into the abdomen, then it springs open to finish the repair. But the company waited almost three years before recalling its mesh.
Mesh lawsuits for kugel hernia mesh recall saunders. The manufacturer of the popular kugel hernia mesh patch, c. The fda issued a warning announcement advising patients who already had the recalled. Bard composix kugel hernia patch large oval with eptfe, 5. There were two more recalls following in 2006 and 2007.
Kugel mesh side effects such as bowel perforations can be caused by the memory coil ring that open the kugel mesh patch. Here are some of the hernia mesh recalls since 2005. It had a defective ring that could break and puncture organs. Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the fdas medwatch reporting program by phone at 1800fda1088. Kugel hernia mesh recall lawyers problems with recalled hernia. Review a detailed list of lot numbers and product codes affected by the recall. The hernia mesh patch recall was further updated on january 24, 2007, to include additional product codes 0010202 and 0010204 and lot numbers recalled by davolbard since the first recall. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization. Kugel mesh patch is a type of prosthetic intended to treat the ventral hernia, a condition in which an organ in the abdomen pushes through a weakened abdominal wall. One of the most popular devices for open hernia repair surgery is the kugel mesh hernia patch manufactured by davol, inc. Bard, issued eight recalls for various hernia mesh models between 2006 and 2007 alone. Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. Fda recalls additional bard composix kugel hernia patches.
Some were recalled by the food and drug administration fda, although most were voluntarily recalled by the hernia mesh manufacturers after several patients reported injuries from having hernia mesh. However, no recall was ever issued for the ventralex st. If you have questions about the composix kugel mesh hernia repair patch. A class 1 recall for a ventral hernia repair device. Barddavol composix kugel hernia mesh patch due to serious safety risks. Kugel mesh patches, used to repair ventral incisional hernias caused by thinning and stretching of scar tissue postsurgery, were recalled. Bard then developed its ventralex st hernia mesh by combining the sepramesh with its kugel mesh patch. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. The kugel hernia mesh patch comprises two pieces of mesh. One of the first hernia mesh implants to be recalled was c. The kugel mesh patch was first recalled in 2005, after the fda received reports that the composix kugel mesh patch had caused many severe injuries.
Hernia mesh lawsuits infections and other injuries. The recalled hernia mesh patches are bard composix kugel mesh hernia patches. Kugel mesh hernia patch massachusetts drug and medical. The fda has issued the following hernia mesh recalls accounting for hundreds of thousands of implanted devices since 2005. Kugel hernia mesh recall lawyers problems with recalled. The compsix kugel mesh hernia patch is manufactured by davol, inc. Patients who had the hernia mesh implanted prior to 2005 likely did not have it removed during the kugel mesh recalls, the first of which occurred in 2005. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar. It is usually placed, through a small incision, behind the hernia defect. It was approved in the 1990s and has been implanted over a million times. Hernia mesh recalls have been issued over a number of brands of this surgical mesh. The fda sent a recall letter regarding the composix kugel mesh patch in march 2006 to physicians and patients advising patients implanted with a recalled device to seek immediate medical attention. Z052406 bard composix kugel mesh xlarge patch oval with.
It was the kugel mesh hernia patch that was recalled recently that you must have read about. Another barddavol hernia mesh product is ventralex, approved in 2002. Composix kugel mesh patches are used specifically to repair ventral incisional hernias caused by thinning and stretching of scar tissue postsurgery. Each year, there are approximately 500,000 hernia repair. This patch however was recalled by bard as a result of reports of various complications arising from its use. Lots of proceed surgical mesh may delaminate from the polypropylene mesh during certain hernia repairs. These hernia mesh lawsuits have been filed on behalf of aggrieved victims suffering from injuries caused by defective hernia mesh medical devices.
Recalled composix kugel hernia mesh patches may harm patients. Hernia mesh lawsuit recalls, hernia repair complications. Medical device recalls food and drug administration. As a result of some of the complications arising from these surgical meshes, the fda has recalled a variety of hernia mesh implants over the years. Thousands of kugel hernia mesh patches have been recalled be the fda. This synthetic mesh is designed for use in hernia repair surgeries. The kugel mesh patch was approved for use by the u. The fda issued the following kugel mesh hernia patch safety alert on 2107. Specific lot numbers of composix kugel mesh patches were recalled by manufacturer davol, inc. The kugel mesh patch is used to repair ventral hernias. Roughly a decade ago, bard recalled several lots of the kugel mesh product.
Bard and its subsidiary davol recalled limited lots of the kugel hernia patch in. One of the first surgical meshes to be recalled was the kugel hernia mesh. The kugel mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. Recalls of certain sizes of the kugel hernia mesh patch were issued in 2005, 2006, and 2007.
The implant was made of polypropylene and contained a ring around the mesh. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. Top product liability lawyers across the united states are filing hernia mesh lawsuits. As of january 2007, the number of recalled composix kugel mesh products. Kugel mesh hernia patch chicago product liability lawyer. Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. Bard and davol recalled composix kugel mesh products from the market starting in 2005. The us food and drug administration fda and davol, inc a subsidiary of c. These hernias can occur in a patient when scar tissue, due to a surgical incision, becomes extremely thin due to stretching. Composix kugel mesh patch was recalled due to faulty memory. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain lot numbers of the defective medical device. The fda issued a warning announcement advising patients who already had the recalled units in their bodies to be on alert for signs of device failure and seek immediate medical attention if they experience symptoms. Z052406 bard composix kugel mesh xlarge patch oval with eptfe, 8.
Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. But as far as i can remember, the brand had started manufacturing larger hernia patches. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. Bard hernia mesh linked to injuries drug and device watch.
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