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 mesh hernia patch lawsuits head to court, lawyers. Kugel mesh hernia patch dangers north carolina product. Fda recalls additional bard composix kugel hernia patches. There were two more recalls following in 2006 and 2007. Kugel mesh hernia patch lawsuit hernia mesh recall. It is used in about 90 percent of hernia repair surgeries in the u. The bard composix kugel mesh hernia patch is used to repair ventral. The schmidt firm, pllc is currently accepting ethicon physiomesh, atrium cqur mesh, and other hernia mesh injury cases in all 50 states. The defect in the patch concerns the memory recoil ring which has a tendency to collapse upon insertion into the abdominal wall. 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.
There is growing concern over the number of recalls of hernia mesh in canada, as patients speak out about complications they believe. Learn more about the most dangerous types of hernia mesh. Kugel hernia mesh lawsuit bard kugel hernia patch recall. The first hernia mesh recall was issued in late 2005 by davol inc. Kugel mesh means perforation, infection, and additional.
Bard received reports that the kugel patch was failing as early as 2002. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. The problems led to several recalls and thousands of lawsuits. But the company waited almost three years before recalling its mesh. 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.
Medical device recalls food and drug administration. An article in todays new york times suggests that the recent kugel hernia patch recall could have occurred sooner. Kugel mesh hernia patches come with scary, painful. By 2018, bard had stopped marketing the kugel hernia patch in the u. It is used to strengthen the abdominal wall and repair incisional hernias caused by the. Canadian patients join classaction suit over recalled hernia mesh. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. By the time problems surfaced, however, it had already been implanted over a million times. The fda has recalled the composix kugel mesh patch, used to repair ventral incisional hernias caused by thinning or stretching of scar. The recall previously affected only the extralarge oval patch. Composix kugel mesh patches are manufactured by davol, a subsidiary of parent company c. Hernia mesh is a surgical implant often made of a synthetic plastic called polypropylene that reinforces torn or damaged tissue around hernias and strengthens it as it heals.
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. 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. Ethicon proceed hernia mesh lawsuit filed over infection. The patch is then held open by its memory recoil ring. The kugel mesh hernia patch is used to repair ventral hernias. Canadian patients join classaction suit over recalled. Scary and painful complications from composix kugel mesh hernia patches posted on march 26, 20 january 17, 2019 if you or someone you love suffered injuries after being treated with composix kugel mesh patch products, youre not alone. Hernias are usually repaired by a simple operation in which a surgeon stitches the stomach muscles back together, but this is not always possible because the stomach muscles are often too weak or thin for the surgery, in which case a bard composix kugel mesh patch may be used. The bard composix kugel mesh patch, more often simply referred to as the kugel mesh or kugel hernia patch, is manufactured by davol, inc. Wexler wallace represented individuals who had defective composix kugel mesh. After insertion through a small incision, the patch is placed behind the hernia defect.
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. One of the first hernia mesh implants to be recalled was c. In re kugel mesh hernia patch products liability litigation, case no mdl no. Kugel hernia mesh lawsuit attorneys note that thousands of lawsuits have been filed against c. Growing concerns in canada over surgical mesh usage, recalls. The fda announces the nationwide recall of certain kugel mesh hernia patches. Kugel hernia mesh recall lawyers problems with recalled hernia. If you or a loved one has been harmed by a composix kugel mesh patch, please contact our office to discuss your rights. Rhode island has many cases of defective kugel hernia 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. Kugel mesh hernia patch chicago product liability lawyer. We are now investigating all hernia mesh claims, even if you dont know what hernia mesh was implanted.
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. Had colon cancer in 2001 and had to get a hernia repair in. Imagine having a hernia repair, only to find a lump develop in your abdomen. The kugel hernia patch was designed for use in open ventral hernia repair.
You can start a hernia mesh lawsuit today by contacting us today and we will help you find the right attorney. Mesh lawsuits for kugel hernia mesh recall saunders. Related medical device recalls results per page 5 10 25 50 100 500 new search export to excel help. Hernia mesh can prevent a hernia from recurring, but it can also cause serious complications. The kugel patch is manufactured by davol, inc, which is a division of c. 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. Many patients received the patch long after davol received the first reports of patch failure.
Kugel hernia mesh recall information added to law firm website. Beginning in 2009, kugel hernia mesh lawsuits were transferred and centralized in rhode island. If you or somebody you know was injured by a recalled hernia patch, you should contact our lawyers immediately for a free case consultation. Kugel mesh hernia patch lawsuits stemming from davol, incs 2005 recall of the defective medical device are shining a spotlight on the us district court in providence, rhode island that will decide many of the kugel patch cases recently, the judicial panel on multidistrict litigation of the united states courts consolidated all. The fda later updated the degree of its warning, as the products defects have potential to result in. The recall is due to the potential for breakage of the memory recoil ring under the stress of placement into the intraabdominal. Kugel mesh hernia patch page 2 of 2 the miller firm. Strouss or call our toll free number 18883411405 to speak directly with an attorney.
A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines. It is used primarily for hernia surgery, particularly for. Review a detailed list of lot numbers and product codes affected by the recall. Barddavol composix kugel hernia mesh patch due to serious safety risks. Approximately 170,000 people have undergone hernia repair surgeries involving mesh implants during the past six years in england. Kugel as an alternative treatment for hernia repair. 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.
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. Bard kugel hernia mesh patch was one of the first mesh implants to be recalled. The kugel mesh patch is made of two pieces of mesh that surround a flexible plastic ring. In december of 2005, at the direction of the fda, c. Then you discover that something went wrong with your kugel mesh patch, after the. Kugel hernia patch recall could have occurred earlier. Bard alleging serious complications and adverse reactions linked to its kugel hernia mesh. The firm has established a toll free number 18663740338 for patients to report claims, get additional information and register for compensation claims. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. It was approved in the 1990s and has been implanted over a. Between 2005 and 2007, three separate recalls were issued for the c. The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c. Complications from such a defect can cause extreme pain, fistula, bleeding, and infection.
Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. The products were commonly used to repair incisional hernias in the abdomen. Kugel mesh hernia patch dangers north carolina product defect. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. More than 78,000 bard composix hernia patches were distributed by davol between 20012006. From 1996 to 2006, 219 consecutive patients underwent inguinal hernia repair 92 using a standard lichtenstein repair and 127 with a kugel patch. 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. Open hernia repair surgery and kugel patch close to 750,000 hernia repair surgeries are performed in the united states annually.
Although it is started out as a simple singlelayer mesh, it became progressively more intricate in order to make the performance of the. Kugel mesh dangerous implant litigation wexler wallace llp. The first kugel mesh hernia patch recall was issued in 2005 and has been expanded several times to include more sizes of the patch. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. Some of the content may be disturbing to some viewers. A hernia occurs when part of an internal organ pushes through an opening in the organs wall and often presents itself as a painful lump in the abdomen or groin. In january 2007, the fda issued another class i recall of the bard composix kugel hernia patch due to the same recoil ring defect. Those who received the patch are left with few alternatives other than to wait to see if their patch malfunctions.
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. Bard and davol announced a recall of the large and extra large varieties of their surgically implanted hernia repair patches, known as. The kugel mesh hernia patch was recalled in 2005, 2006 and again in 2007 because, according to the u. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. Composix kugel mesh patches lawsuit hernia mesh recall attorney. Plaintiffs steering committee member and chair of the law and briefing committee. Endless claims against kugel mesh hernia patch youtube. The mesh patch recall began over 7 years ago and has been developing ever since. There are over 750,000 hernia operations each year in the u. Kugel mesh hernia patch massachusetts drug and medical. Composix kugel mesh patches are primarily used to repair ventral hernias.
A lawsuit has been filed over problems with ethicon proceed hernia mesh, alleging that the patch disintegrated inside the body of a texas woman, leading to infection and other complications. The patch is used to repair ventral, inguinal, and laparoscopic hernias. New york kugel mesh attorneys medical device litigation. The fda has approved several bard hernia mesh devices for use in hernia repair surgical procedures through the fda 510k process. The patch was used to help eliminate the tension and strain on surrounding muscles and ligaments which reduced discomfort after surgery. The compsix kugel mesh hernia patch is manufactured by davol, inc. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. Prolene hernia system, lichtenstein mesh and plugandpatch for primary inguinal hernia repair. One of the most popular devices for open hernia repair surgery is the kugel mesh hernia patch manufactured by davol, inc.
Immediate and longterm outcomes of lichtenstein and kugel. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. The kugel mesh patch was originally recalled in 2005 with an expanded recall in 2007. 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. It had a defective ring that could break and puncture organs.