An additional composix kugel mesh was used to repair the recurrent left inguinal hernia. Keyport, nj if you thought you were safe from hernia repair problems because you do not have a kugel mesh patch implanted, you may want to think again. It is used primarily for hernia surgery, particularly for laparoscopic ventral. Although hernia mesh implants have helped improve the quality of life in many patients, there have been serious complications and adverse. Like many other people, ryan and sophia are upset that they were never warned about the possibility of the kugel mesh patch breaking. The hollis law firm will be unboxing the composix kugel hernia mesh. Like patients with kugel mesh patches, tracy is having problems with her hernia repair patch and requires surgery to have it taken out. These meshes are used to assist the recovery of the hernia, but remain in your body for the rest of your life. Hernia mesh lawsuit recalls, hernia repair complications. Sep 24, 2008 keyport, nj if you thought you were safe from hernia repair problems because you do not have a kugel mesh patch implanted, you may want to think again. Composix kugel mesh patches are manufactured by davol, a subsidiary of parent company c. A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines.
Nov 09, 2007 but sophias patch broke, causing her to experience severe pain and other serious problems. A selfexpanding twolayered mesh with an extruded monofilament polymer ring is then placed in properitoneal space, deep to the transversalis fascia covering the inguinal and femoral hernial orifices from the inside fig 1. Kugel mesh hernia patch dangers north carolina product defect. The kugel mesh patch has been linked to bowel perforations. Apr 09, 2020 sometimes referred to as hernia mesh, the hernia patch is a device used to surgically create a substrate at the site of the hernia. The difficult recovery associated with traditional inguinal hernia repair, where the inguinal canal is opened, has driven interest in less invasive. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. By 2018, bard had stopped marketing the kugel hernia patch in the u. The transversalis fascia is usually closed with a single interrupted stitch that also includes the anterior layer of the mesh to prevent its migration. Motley rice continues to litigate cases involving patients who suffered injuries or complications related to the composix kugel mesh hernia repair patch. The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects.
The patch then lays flat against the inner body cavity, preventing the hernia from pushing through the weakened tissue wall. Nov 22, 2012 mesh free inguinal hernia repair by desarda technique duration. See what the composix kugel hernia mesh looks like and understand its defects. Minimally invasive open preperitoneal inguinal hernia repair. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. Composix kugel mesh patches, manufactured by davol, inc. The bard composix kugel mesh patch is inserted into the body through a small incision made by the doctor and placed behind the hernia. The patches are designed so that they can be folded when inserted and. People who were implanted with a hernia mesh and experienced complications following surgery. Kugel patch hernia mesh complications and legal claims.
Incisional hernias are usually caused by the thinning or stretching. The kugel hernia patch davol, cranston, ri, usa for treatment of inguinal hernias is a minimal access technique of inguinal herniorrhaphy. 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. Both were treated by operative hernial repair with the composix kugel patch c. Bard kugel hernia mesh patch was one of the first mesh implants to be recalled. The memory recoil ring opens the patch after it has been inserted into the body. Composed of a mesh body that features a plastic ring, the purpose of the patch is to contain the hernia and allow the bodys natural healing processes to grow tissue and eventually heal the hernia. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches. Composix kugel mesh patches are primarily used to repair ventral hernias. But sophias patch broke, causing her to experience severe pain and other serious problems. But as far as i can remember, the brand had started manufacturing larger hernia patches and it was these large sized ones that were causing problems. 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. 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. While there have been no jury verdicts or major settlements in the current round of bard hernia mesh litigation, the company did settle lawsuits over its kugel patch in 2011.
The patch is placed behind the hernia through a small incision. The recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed. Composix kugel mesh patches lawsuit hernia mesh lawsuit. Abdominal incisional hernia repair using the composix kugel patch. In the spring of 2003, sophia had a hernia operation in which the doctor used a kugel mesh patch to repair the hernia. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. The compsix kugel mesh hernia patch is manufactured by davol, inc. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. Kugel mesh hernia patch page 2 of 2 the miller firm. It is used primarily for hernia surgery, particularly for. The kugel hernia patch davol, cranston, ri, usa for treatment of inguinal hernias is a minimal access technique of inguinal herniorrhaphy, which aims to combine the utility of the open operation with the advantages of the laparoscopic procedures. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias.
Mesh patches are used in hernia surgery procedures to help stop the thinning or. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. 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. Inguinal hernia repair with the kugel patch request pdf. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. By the time problems surfaced, however, it had already been implanted over a million times. What she does have is the bard ventralex hernia patch, which according to her doctor is a cousin to the kugel mesh patch. But as far as i can remember, the brand had started.
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. From 1996 to 2006, 219 consecutive patients underwent inguinal hernia repair 92 using a standard lichtenstein repair and 127 with a kugel patch. 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. Hernias are painful and require treatment to prevent further medical harm. The wellknow patch has received several recalls on their product leading to users filing. The kugel mesh hernia patch is constructed with a springlike recoil ring that opens the patch after insertion. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. Kugel mesh hernia patch massachusetts drug and medical. The kugel mesh patch was approved for use by the u. The manufacturer of the popular kugel hernia mesh patch, c. Additionally, ethicon, the maker of physiomesh voluntarily pulled their product from the market in 2016.
The mesh patch is then supposed to repair the hernia. Jan 30, 2018 composix kugel mesh patches are primarily used to repair ventral hernias. 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. Surgery remains the ultimate treatment for all types of hernias as they will not get better on their own, however not all require immediate repair. 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. According to the fda recall notice, patients who have been implanted with a composix kugel mesh patch during hernia surgery should seek medical.
The bard composix kugel mesh hernia patch is used to repair ventral incisional hernias. Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. Hernia mesh lawyers filed thousands of cases due to serious complications resulting from alleged faulty mesh products used for hernia repair surgeries. The kugel mesh patches were first approved by the fda in 1996 and were marketed as an effective repair for hernias. As in a laparoscopic tep repair, the preperitoneal space is accessed using digital dissection instead of a balloon dissection.
Bard received reports that the kugel patch was failing as early as 2002. 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. Composix kugel mesh patches lawsuit individual claims hernia. This metal ring allowed the device to be folded for insertion during a surgery. Nov 29, 2016 see what the composix kugel hernia mesh looks like and understand its defects. It is used in about 90 percent of hernia repair surgeries in the u. Mesh lawsuits for kugel hernia mesh recall saunders. Kugel hernia mesh is a common alternative used to patch holes in abdominal muscles when surgery has left the muscles too thin or weak to be.
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 marketed by ethicon, inc. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the. Food and drug administration fda approved the kugel mesh patch in 1996. The us food and drug administration first approved the kugel mesh patch in 1996.
Kugel mesh patch a terrible ordeal beasley allen law firm. There have been issues with the kugel hernia patch since its inception. Kugel mesh hernia patch chicago product liability lawyer. 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. Symptoms of problems with the kugel hernia mesh mcgartland. The bard composix kugel mesh patch is used to repair hernias caused by thinning or stretching of scar tissue that forms after surgery. In hernia surgery such as is carried out in british hospitals, a plastic mesh is used during the operation as shown on the right hand side.
Lawsuits are being filed over several manufacturers hernia meshes at least one of which. It was the kugel mesh hernia patch that was recalled recently that you must have read about. Soon after its release, it was discovered that the kugel mesh hernia patches resulted in an. Like many other people, ryan and sophia are upset that they were never warned about the. There were two more recalls following in 2006 and 2007.
The kugel hernia patch davol, cranston, ri, usa for treatment of inguinal hernias is a minimal access technique of inguinal herniorrhaphy, which aims to combine the utility of the open operation. Inguinal hernia repair with the kugel patch reddy 2005. The aim of inguinal hernia surgery is to repair the structural integrity of the lower abdomen, and, in adults, placement of a mesh reduces the risk of reformation, or recurrence, of the hernia. Although it is started out as a simple singlelayer mesh, it. Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. Mesh free inguinal hernia repair by desarda technique duration. Over a million kugel patches have been implanted nationwide. If you believe that you may have a claim, consider contacting an attorney as soon as possible.
Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after. Dec 03, 2010 the kugel mesh patch has been linked to bowel perforations. Inguinal hernia surgery is an operation to repair a weakness in the abdominal wall that abnormally allows abdominal contents to slip into a narrow tube called the inguinal canal in the groin region. The first kugel hernia patch was approved in the 1990s. It had a defective ring that could break and puncture organs. The kugel hernia mesh was one of the earliest and most used hernia meshes in the united states. Defendants liable in hernia repair patch lawsuit motley rice. The kugel hernia patch davol, cranston, ri, usa for treatment of inguinal hernias is a minimal access technique of inguinal herniorrhaphy, which aims to combine the utility of the open. 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. Hernia mesh lawsuit recalls, hernia repair complications lawyer.
Previous lawsuits, starting in 2005, and finally resolved. Information re the bard kugel patch hernia mesh device, failure rates, recalls. Jun, 2016 the bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. 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. In the long run, the meshes can cause pain and discomfort. Bard composix kugel mesh hernia patch lawsuits schmidt. The bard kugel repair technique is very similar to a laparoscopic repair in that the entire groin region is potentially protected against further herniation. Immediate and longterm outcomes of lichtenstein and kugel. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. Hernia mesh can prevent a hernia from recurring, but it can also cause serious complications. 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. Bard, issued eight recalls for various hernia mesh models between 2006 and 2007 alone. The problems led to several recalls and thousands of lawsuits.
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