The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. The fda announces the nationwide recall of certain kugel mesh hernia patches. Z052506 bard composix kugel mesh xlarge patch oval with eptfe, 10. Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the fdas medwatch reporting program. The strom law firm, llc is currently investigating and evaluating cases against the makers of kugel mesh. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. This synthetic mesh is designed for use in hernia repair surgeries. More than 78,000 bard composix hernia patches were distributed by davol between 20012006. The kugel mesh patch was originally recalled in 2005 with an expanded recall in 2007. The ring allows the patch to be folded for insertion and later, once the patch is in place, to spring open and lay flat. After insertion through a small incision, the patch is placed behind the hernia defect. Instead of experiencing relief from their hernia, many have had to undergo multiple followup surgeries to remove the defective hernia patch as well as complications caused by the broken kugel mesh patch. The recall was due to the discovery that the memory recoil ring, which opens the patch, can break under the pressure of placement in the intraabdominal space and lead to severe intestinal conditions.
But the company waited almost three years before recalling its mesh. Gary sharp had a composix kugel mesh patch implanted in december, 2004, to repair a hernia. The kugel mesh is a circular patch featuring an innovative springloaded ring. The kugel mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. Although it is started out as a simple singlelayer mesh, it became progressively more intricate in order to make the performance of the. Food and drug administration fda approved the kugel mesh patch in 1996. Kugel as an alternative treatment for hernia repair. Z052406 bard composix kugel mesh xlarge patch oval with eptfe, 8. If you have questions about the composix kugel mesh hernia repair patch.
The fda has issued the following hernia mesh recallsaccounting for hundreds of thousands of implanted devices since 2005. 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. Kugel mesh hernia patch chicago product liability lawyer. 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. The composix kugel hernia mesh patch has a ring in the middle of the mesh to help it keep its shape. A mesh patch used to repair ventral hernias has been recalled by the fda. Lots of proceed surgical mesh may delaminate from the polypropylene mesh during certain hernia repairs. Both of these products have resulted in problems in the testicular area for men, causing pain or, in the perfix plugs case, removal of the testicles. One of the first surgical meshes to be recalled was the kugel hernia mesh, manufactured by c. The wellknow patch has received several recalls on their product leading to users filing. Bard recalled several lots of the composix kugel hernia patch in 2005, 2006 and 2007.
Between 2005 and 2007, three separate recalls were issued for the c. Barddavol composix kugel hernia mesh patch due to serious safety risks. Composix kugel mesh xlarge patch recalling company. The bard composix kugel mesh patch, more often simply referred to as the kugel mesh or kugel hernia patch, is manufactured by davol, inc. Additionally, ethicon, the maker of physiomesh voluntarily pulled their product from the market in 2016. Food and drug administration blamed recalled mesh for some of the worst complications.
Kugel mesh recalls unexplained or persistent abdominal pain. An article in todays new york times suggests that the recent kugel hernia patch recall could have occurred sooner. As of january 2007, the number of recalled composix kugel mesh products. 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. Many hernia mesh products, including some of those marketed by ethicon, atrium medical, and c. Bard composix kugel hernia patch large oval with eptfe, 5. However, if youve had hernia repair surgery using the kugel mesh hernia patch, you may still be suffering from complications due to the implantation of the defective patch. Over a million kugel patches have been implanted nationwide. The bard composix kugel mesh hernia repair patch, manufactured by davol inc. It is used primarily for hernia surgery, particularly for laparoscopic ventral.
The table below provides the hernia mesh recall list updated for 2019. The first of the two kugel mesh hernia patch lawsuits brought to trial ended in a victory for the defense last april. There were two more recalls following in 2006 and 2007. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar. The manufacturer of the popular kugel hernia mesh patch, c. If you believe that you may have a claim, consider contacting an attorney as soon as possible. It is usually placed, through a small incision, behind the hernia defect. Between december 2005 and march 2006, davol recalled specific lot numbers of composix kugel mesh hernia repair patches. Most hernia mesh recalls have been designated with class ii status. Bard hernia mesh linked to injuries drug and device watch. Many of these hernia repair patches have been recalled after reports of. Top product liability lawyers across the united states are filing hernia mesh lawsuits. Canadian patients join classaction suit over recalled.
Bard, were granted regulatory clearance under the u. Kugel hernia patch recall could have occurred earlier. 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. Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. The kugel mesh patches were first approved by the fda in 1996 and were marketed as an effective repair for hernias. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. Soon after its release, it was discovered that the kugel mesh hernia patches resulted in an extraordinarily high rate of bowel infections and other gastrointestinal disorders. Medical device recalls food and drug administration.
Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. The bard composix kugel mesh xlarge oval with eptfe was issued a class i recall because the memory recoil ring that opens the patch after it has been inserted into the intraabdominal space can break. The kugel hernia patch is one of bards earliest and most problematic mesh products. Mesh lawsuits for kugel hernia mesh recall saunders. Hernia mesh lawsuit recalls, hernia repair complications. It is used to strengthen the abdominal wall and repair incisional hernias caused by the stretching or thinning of scar tissue that form after surgery. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. There have been issues with the kugel hernia patch since its. Kugel hernia mesh patch recalls recalls of certain sizes of the kugel hernia mesh patch were issued in 2005, 2006, and 2007. Kugel mesh recall lawsuit kugel mesh recall lawyers. 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 implanted. The first kugel hernia patch was approved in the 1990s.
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. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. The compsix kugel mesh hernia patch is manufactured by davol, inc. Under this designation, the company whose product is recalled must notify customers and advise them. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches. Some canadian hernia surgery patients have launched a classaction lawsuit against the maker of a nowrecalled surgical mesh, claiming they werent warned of its dangers. These hernia mesh lawsuits have been filed on behalf of aggrieved victims suffering from injuries caused by defective hernia mesh medical devices. Bard and davol recalled composix kugel mesh products from the market starting in 2005. Like so many of their products, however, they are causing more problems than they are solving.
While the jury in that case did find that the composix kugel patch was defective, the plaintiff was unable to prove that his hernia repair problems were the. Surgery is the only cure for a hernia and over 750,000 hernia repair surgeries are performed in the us each year, mainly to prevent the hernia from becoming a serious health risk and. The patch is then held open by its memory recoil ring. Here are some of the hernia mesh recalls since 2005. Composix kugel mesh patch was recalled due to faulty memory. If they received the kugel hernia patch in their hernia repair surgery, the nightmare was just beginning. Z052406 bard composix kugel mesh xlarge patch oval with. Bard received reports that the kugel patch was failing as early as 2002. A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines. The kugel hernia mesh was one of the earliest and most used hernia meshes in the united states. It had a defective ring that could break and puncture organs. Composix kugel mesh patches are primarily used to repair ventral hernias.
Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Kugel mesh hernia patch recalls and patient safety st. The products were commonly used to repair incisional hernias in the abdomen. Recalled kugel mesh patches drug and medical device. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. The composix kugel hernia mesh was one of first and most well known hernia meshes to be recalled. Fda recalls additional bard composix kugel hernia patches. The device, which consists of a plastic memory recoil ring surrounding two mesh layers, is folded and inserted through a small incision in the abdomengroin. The ring allows the product to spring open once implanted, adding structural support and stability. Davol, a subsidiary of bard, manufactures this product. Manufacturers recalled the hernia mesh after people reported failures and organ injuries following surgery. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.
The composix kugel mesh hernia patch is a device used to repair. Kugel hernia mesh is used primarily for hernia surgery, particularly for. Kugel hernia mesh recall lawyers problems with recalled hernia. Lucky for patients preparing for a hernia repair surgery with a kugel mesh patch, all defective hernias have been removed from the market and were no longer used in surgery after 2007. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain lot numbers of the defective medical device. Hernias are painful and require treatment to prevent further medical harm. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. Each year, there are approximately 500,000 hernia repair surgeries performed in the united states. The patch is used to repair ventral, inguinal, and laparoscopic hernias. This patch however was recalled by bard as a result of reports of various complications arising from its use. Hernia mesh recalls have been issued over a number of brands of this surgical mesh over potential serious complications after surgery.
The recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed. Bard, issued eight recalls for various hernia mesh models between 2006 and 2007 alone. Bard has also been sued over their perfix plug mesh implant and the 3dmax mesh implant. 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. Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. Hernia mesh manufacturers have recalled more than 211,000 units of hernia mesh from 2005 to march 2018. Cqur vpack mesh made by atrium medical corporation was.
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