The products were commonly used to repair incisional hernias in the abdomen. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Kugel mesh side effects such as bowel perforations can be caused by the memory coil ring that open the kugel mesh patch. The kugel patch contains a memory recoil ring around the perimeter of the mesh, which allows the doctor to fold it during the hernia repair. The compsix kugel mesh hernia patch is manufactured by davol, inc. The mesh patch is then supposed to repair the hernia. Open hernia repair surgery and kugel patch mesh patch attorney. The patch is used to repair ventral, inguinal, and laparoscopic hernias. Although it is started out as a simple singlelayer mesh, it became progressively more intricate in order to make the performance of the procedure easier and the repair.
For many patients without insurance or a steady income, medical bills from hernia mesh complications can be costly. Bard faced a class action lawsuit against the kugel hernia mesh patch, which led to the company paying out hundreds of millions of dollars in settlements. Kugel hernia mesh lawsuit bard kugel hernia patch recall. The problems led to several recalls and thousands of lawsuits. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. Federal court expands scope of kugel mesh hernia patch. When marlex mesh erosion appears as irritable bowel syndrome. Jul 20, 2012 july 20, 2012 in this published report in the journal of the american board of family medicine, janfeb 2012, doctors from dewitt amy hospital, fort belvoir, va, determined irritable bowel syndrome ibs can be caused by a mesh complication. The latest product in this grim parade is the kugel patch, which has been used to repair painful and potentially fatal tears in the.
The kugel mesh patches were first approved by the fda in 1996 and were marketed as an effective repair for hernias. Stories from the fight against transvaginal and hernia mesh. But the recoil rings design was defective, and has caused serious and painful injuries to thousands who have suffered bowel perforations, chronic enteric fistulae and infections. The recall is due to the potential for breakage of the memory recoil ring under the stress of placement into the intraabdominal. Strouss or call our toll free number 18883411405 to speak directly with an attorney. After insertion through a small incision, the patch is placed behind the hernia defect. A surgeon can typically repair a hernia without the use of a mesh product andor the surgeon can use a material, such as a biologic mesh, that poses less risks than many synthetic products that are currently on the market. In december of 2005, at the direction of the fda, c. Kugel hernia mesh lawsuit attorneys note that thousands of lawsuits have been filed against c. Kugel mesh hernia patch chicago product liability lawyer. Symptoms of problems with the kugel hernia mesh mcgartland. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. Surgery is the only cure for a hernia and over 750,000.
Kugel hernia mesh recall lawyers problems with recalled. Hernia mesh recalls have been issued over a number of brands of this surgical mesh over potential serious complications after surgery. On december 22, 2006, davol announced a massive recall of the kugel mesh patch. St hernia mesh by combining the sepramesh with its kugel mesh patch. But the company waited almost three years before recalling its mesh. The fda has received reports of approximately 80 serious adverse events caused by the kugel mesh patch, including numerous deaths. Manufacturers recalled the hernia mesh after people reported failures and organ injuries following surgery. Kugel mesh hernia patch massachusetts drug and medical. 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. One of the most popular devices for open hernia repair surgery is the kugel mesh hernia patch manufactured by davol, inc.
The collagen layer of the parietex composite hernia mesh is very thin and delicate. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. 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. A class i recall is the most severe type of recall. The kugel mesh was intended for the repair of two types of hernia. In 2005, the fda announced a class i recall of eight different composix kugel mesh hernia patch models that included more than 31,000 units. Related medical device recalls results per page 5 10 25 50 100 500 new search export to excel help. The kugel mesh hernia patch is constructed with a springlike recoil ring that opens the patch after insertion. The kugel hernia mesh was one of the earliest and most used hernia meshes in the united states. The kugel hernia patch is a medical product used to treat some hernias. Different types may be recommended based on the patients individual situation, the location of the hernia and the type of repair needed.
Kugel mesh hernia patch lawsuit hernia patch injury lawyers. However, it is alleged that the collagen barrier is thin and delicate. Kugel mesh hernia patch dangers north carolina product defect. In this case a 50yearold woman had marlex hernia mesh. Bard received reports that the kugel patch was failing as early as 2002. Bard medical is at it again with defective hernia patches. Kugel hernia mesh is a common alternative used to patch holes in. 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. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. The recall previously affected only the extralarge oval patch. The recent composix kugel hernia mesh recalls were issued as a result of a. Bard composix kugel mesh xlarge patch oval with eptfe, 8.
Like so many of their products, however, they are causing more problems than they are solving. The fda issued the following kugel mesh hernia patch safety alert on 2107. Bard and davol announced a recall of the large and extra large varieties of their surgically implanted hernia repair patches, known as. I just recently underwent a hernia surgery and had a mesh patch used. The firm has established a toll free number 18663740338 for patients to report claims, get additional information and register for compensation claims. Had colon cancer in 2001 and had to get a hernia repair in 2005. If you or somebody you know was injured by a recalled hernia patch, you should contact our lawyers immediately for a free case consultation. Canadian patients join classaction suit over recalled hernia. Specific lot numbers of composix kugel mesh patches were recalled by manufacturer davol, inc. 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. More than 78,000 bard composix hernia patches were distributed by davol between 20012006. Endless claims against kugel mesh hernia patch youtube. Composix kugel mesh patches are primarily used to repair ventral hernias. Kugel as an alternative treatment for hernia repair.
The kugel patch is designed to be inserted through a small incision. The mesh patch recall began over 7 years ago and has been developing ever since. Dec 03, 2010 the kugel mesh patch has been linked to bowel perforations. Many patients received the patch long after davol received the first reports of patch failure. It is designed to spring open once in place to lay flat. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain lot numbers of the defective medical device. Kugel mesh recall lawsuit kugel mesh recall lawyers. The us food and drug administration first approved the kugel mesh patch in 1996. Soon after its release, it was discovered that the kugel mesh hernia patches. Kugel hernia mesh recall information added to law firm website. Dozens of defective hernia mesh medical devices have been recalled. But as far as i can remember, the brand had started manufacturing larger hernia patches. 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. Traditionally, these surgeries are performed as an open hernia repair surgery, meaning that the abdomen is opened to allow the surgeon access to the site of the hernia.
It was the kugel mesh hernia patch that was recalled recently that you must have read about. The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a substantive equivalent to a product or products already approved by the fda. 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 implanted. The composix kugel mesh hernia patch is a medical device surgeons use to repair. Hernia mesh manufacturers recall their products if they discover a problem. Sep 08, 2009 kugel hernia mesh lawsuit settlements reported. Hernia mesh is used to repair both ventral hernias and inguinal hernias. Hernia mesh manufacturers recalled more than 211,000 units of hernia mesh from 2005 to march 2018 at least one manufacturer pulled a brand off the market after high failure rates. Recall of certain composix kugel mesh patches used in hernia repair. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. Severe hernia mesh complications are occurring even with hernia meshes that have not been recalled.
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. It is important to understand your legal rights, and the hernia patch. When it was first introduced, the kugel mesh hernia patch was heralded as an innovation in hernia treatment. Mar 16, 2007 an article in todays new york times suggests that the recent kugel hernia patch recall could have occurred sooner. Composix kugel hernia mesh problems resulted in revision. Hernia mesh manufacturers have recalled more than 211,000 units of hernia mesh from 2005 to march 2018.
Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. Hernia mesh is a simple medical device that is used to repair. The kugel mesh patch used in hernia repair was originally recalled in december 2005. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair.
The kugel mesh hernia patch was originally recalled due to defects with the memory recoil ring in 2005. Jun, 2016 the bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. Composix kugel mesh patches lawsuit hernia mesh lawsuit. However, many hernia repair patients are still experiencing problems. The mesh is a thin material that is placed over the area of muscle or tissue weakness to. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Kugel hernia patch recall could have occurred earlier. Davol did the right thing by sending out a warning but it wasnt soon enough i had the kugel mesh repair in december and the recall happened later that same month. Jun 30, 2009 the fda announces the nationwide recall of certain kugel mesh hernia patches. Class 1 device recall davol composix kugel hernia patch. Many complications related to hernia repair with surgical mesh that have. The strom law firm, llc is currently investigating and evaluating cases against the makers of kugel mesh. In december 2005, the fda issued a class i recall of a number of lots of the kugel mesh patch due to problems with the recoil ring breaking and causing bowel perforations, chronic enteric fistulas, and other injuries.
The patch was used to help eliminate the tension and strain on surrounding muscles and ligaments which reduced discomfort after surgery. The kugel mesh patch was originally recalled in 2005 with an expanded recall in 2007. It was recalled again in 2006 and 2007, both times to recall several other sizes. Hernia patch lawsuits in 2007, the fda issued a class 1 recall for the composix kugel mesh patch, a medical device inserted to repair ventral incisional hernias. According to the fda recall notice, patients who have been implanted with a composix kugel mesh patch during hernia surgery should seek medical attention immediately if they experience symptoms. Although it has vastly improved the quality of life of many people in the united states, the implant procedures and. Filing a hernia mesh lawsuit may be an option for patients who experienced severe complications, including hernia recurrence and the need for revision surgery, following implantation of hernia mesh patches. Regardless of pain levels, hernia mesh removal or revision surgeries may be recommended. Thousands of kugel hernia mesh patches have been recalled. The first kugel mesh hernia patch recall was issued in 2005 and has been expanded several times to include more sizes of the patch. Bard recalled several lots of the composix kugel hernia patch in 2005. The kugel mesh patch is made of two pieces of mesh that surround a flexible plastic ring. In many cases, doctors surgically insert hernia repair mesh which lays flat, preventing the hernia from pushing through any holes in the. Learn more about the most dangerous types of hernia mesh.
Food and drug administration fda has recalled several types of surgical mesh implants used in hernia repair. There were two more recalls following in 2006 and 2007. Medical device recalls food and drug administration. Recall classified as class i because the defect associated with the use or exposure to the bard composix kugel mesh large patch. Beginning in 2009, kugel hernia mesh lawsuits were transferred and centralized in rhode island. It had a defective ring that could break and puncture organs. Hernia mesh lawsuit recalls, hernia repair complications. The stated reason for the recall of the composix kugel mesh patch was a failure in the memory recoil ring contained in the composix kugel patches. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. Between 2005 and 2007, three separate recalls were issued for the c. May 12, 2007 the kugel mesh hernia patch is used to repair ventral hernias. Kugel mesh hernia patch dangers north carolina product.
Hernia mesh lawsuits claim mesh manufactured by bard davol, ethicon and atrium failed and led to serious injuries. This recall and the subsequent recalls followed alarming reports that the hernia patch s memory recoil ring can break under stress. The lawsuit notes that prior to sanders hernia surgery in march 2008, the manufacturers were aware of defects with the patch and had issued composix kugel hernia mesh recalls for several. In many cases, doctors surgically insert hernia repair mesh which lays flat, preventing the hernia. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. Review a detailed list of lot numbers and product codes affected by the recall. Although it is started out as a simple singlelayer mesh, it became progressively more intricate in order to make the performance of the procedure easier and the repair more secure. Bard alleging serious complications and adverse reactions linked to its kugel hernia mesh. The fda has approved several bard hernia mesh devices for use in hernia repair surgical procedures through the fda 510k process. There have been issues with the kugel hernia patch. Each year, there are approximately 500,000 hernia repair surgeries performed in the united states.
The bard composix kugel mesh hernia patch is used to repair ventral incisional hernias. The schmidt firm, pllc is currently accepting ethicon physiomesh, atrium cqur mesh, and other hernia mesh injury cases in all 50 states. There are over 750,000 hernia operations each year in the u. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. If you have been harmed by a composix kugel mesh patch, or lost a loved one to hernia repair complications, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. The composix kugel mesh patch is surgically implanted via a small incision, positioned behind the hernia, and its memory coil ring opens the patch behind the herniated area. Bard davol composix kugel hernia meshes and patches. Hernia mesh complications can be mild, moderate or severe. Over a million kugel patches have been implanted nationwide. The kugel patch is manufactured by davol, inc, which is a division of c. Bard, issued eight recalls for various hernia mesh models between 2006 and 2007 alone. The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c.
Jul 04, 2007 hernia mesh patch patients are advised that the latest information on the kugel mesh hernia patch has been updated to include nonrecalled bard composix kugel hernia mesh patches. A class i recall is the most severe type of recall the fda issues and is only used when a drug, product or medical device may result in the users suffering serious injuries or death. Hernia mesh is a simple medical device that is used to repair hernias, which occur when. If you or a loved one has been harmed by a composix kugel mesh patch, please contact our office to discuss your rights. Barddavol composix kugel hernia mesh patch due to serious safety risks. The kugel hernia patch was designed for use in open ventral hernia repair.
We are now investigating all hernia mesh claims, even if you dont know what hernia mesh was implanted. The kugel mesh patch was approved for use by the u. By 2018, bard had stopped marketing the kugel hernia patch in the u. It is vital to know the signs of possible hernia mesh rejection as a precursor to surgical hernia repair with mesh. The mesh was subject to an fda class i recall in december 2005. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. The hernia mesh patch at the center of this latest round of litigation against the new jerseybased company was designed, manufactured and marketed by davol, a bard subsidiary since 1980. Although hernia mesh implants have helped improve the quality of life in many patients, there have been serious complications and adverse side effects associated with these devices. The reports were so alarming that the fda issued a class i recall of the bard composix kugel mesh xlarge. Graham is slim and healthy, eats organic food and drinks plenty of. The ring can break or bend when it is under pressure or when it changes position. The manufacturer of the popular kugel hernia mesh patch, c. Abdominal wall hernias often require surgical correction. An expanded recall was enacted in january 2007 after the fda warned doctors to stop using certain.
The patches are designed so that they can be folded when inserted and then spring open to lay flat. In january 2007, the fda issued another class i recall of the bard composix kugel hernia patch. Those who received the patch are left with few alternatives other than to wait to see if their patch. The first kugel hernia patch was approved in the 1990s.
Three separate kugel hernia mesh recalls were issued between 2005 and 2007 for different sizes and models of the patch, due to. A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines. Mesh lawsuits for kugel hernia mesh recall saunders. The composix kugel mesh hernia patch is a device used to repair ventrical hernias also known as incisional hernias, which may develop at the site of prior surgical scars. Since december 22, 2005, the recall has been expanded twice to include additional shapes, sizes and production lots of the composix kugel mesh patch. If you, a friend or family member have received a kugel mesh hernia patch, request a free consultation to determine if your device is included in the recall.