If you or a loved one has received a kugel mesh patch via hernia treatment, it is important to see a qualified health care provider at the earliest sign of unusual symptoms. Kugel technique of groin hernia repair basicmedical key. Symptoms include a burning sensation at the surgery site, swelling and pain during intercourse, and the pain may be caused by nerve damage or a reaction to the mesh. Kugel repair might be expected to have a lower incidence of chronic pain as the incision is much higher. The percentage of chronic pain in adults having inguinal hernia repair is 535%. Kugel as an alternative treatment for hernia repair. The pain subsides over time, reports the american college of surgeons. Although the difference was not significant, female patients seemed to be more prone to develop chronic pain. Preperitoneal repair surgery has played a large role in the management of inguinal hernia with few complications and less postoperative chronic pain in recent. The recurrence of hernias after open hernia repair surgery is low, between 17% for an indirect hernia and between 410% for a direct hernia. Chronic pain that typically follows primary inguinal hernia repair can be. This study assesses the incidence and degree of chronic pain and discomfort after primary. Immediate complications were similar in both groups.
Doctors may remove hernia mesh by open abdominal surgery, laparoscopic surgery or robotic surgery. Aug 02, 2016 the kugel technique for groin hernia repair is a tensionfree, minimally invasive, yet open, preperitoneal or posterior abdominal wall groin hernia repair. Up to 30% of patients have longterm chronic pain or restricted movement after hernia repair surgery. The products were commonly used to repair incisional hernias in the abdomen. Furthermore, if you or a loved one has been harmed due to kugel hernia mesh patch side effects, it is important to inquire about your legal rights and options. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. Chronic groin pain is defined as pain that is present for more than 3 months after inguinal hernia surgery. The kugel mesh patch was hailed as a costeffective breakthrough in hernia repair. Inguinal hernia repair with the kugel patch inguinal hernia repair with the kugel patch reddy, k.
The aim of the present study is to report an initial experience of a cohort of patients with inguinal hernias undergoing repair using this technique. Hernia mesh can irritate or damage nerves and cause severe, chronic pain. Jun, 2016 the kugel technique for groin hernia repair is a tensionfree minimally invasive, yet open, preperitoneal or posterior abdominal wall groin hernia repair. The problems led to several recalls and thousands of lawsuits. What are some common longterm problems after mesh inguinal. R bard for injuries and complications caused by bard hernia mesh. Placing the patch on the inside of the abdomen utilizes the natural outward pressure of the abdomen to secure the patch in place, making the repair stronger.
Information re the bard kugel patch hernia mesh device, failure rates, recalls. If you or a loved one is suffering from bowel perforation or chronic enteric fistulae, due to a failed kugel mesh patch, you have the right to seek compensation for your medical expenses, injuries, loss of productive and social time. Initial experience with application of single layer. Citeseerx paper immediate and longterm outcomes of. It had a defective ring that could break and puncture organs.
The minimally invasive preperitoneal approach of the kugel technique probably. The patch was used to help eliminate the tension and strain on surrounding. Underlay mesh for hernia repair yields better postop pain outcomes. Inguinal hernia repair has a long history dating back to as early as the 19th.
Surgeons perform hernia mesh removal surgery, also called hernia mesh revision surgery, in patients who experience chronic pain, infections or other serious meshrelated. Symptoms include pain and a burning sensation in the area of the surgery. Although it has vastly improved the quality of life of many people in the united states, the implant procedures and design aspects of the device have lead to serious complications in some patients. Hernia mesh pain causes, symptoms and treatment options. Assessment of the incidence of chronic pain and discomfort. The lawsuits involving the hernia mesh medical devices that are being filed in 2018 claim the products are failing at a rate higher than expected, and causing. As the technique and technologies evolved over time, the era. Inguinal hernia repair with the kugel patch reddy 2005. Chronic herniorrhaphy pain after lichtenstein repair has been reported to be as high. Kugel patch hernia mesh complications and legal claims. Barddavol composix kugel hernia mesh patch due to serious safety risks.
The minimally invasive preperitoneal approach of the kugel technique probably causes less nerve damage and subsequent neuropathic pain. Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. In other instances, defective hernia mesh may have caused an injury that entitles the patient to compensation. Chronic pain at sixmonth followup was present in 89 patients constituting 39. Citeseerx document details isaac councill, lee giles, pradeep teregowda. The kugel inguinal hernia repair is associated with a low rate of postoperative. Mesh hernia surgery is complicated by abnormal chronic pain in 20% of patients. Sublay repair for primary superior lumbar hernia with the. Immediate and longterm outcomes of lichtenstein and kugel patch. Tipp repair using kugel mesh is a feasible and effective method for giant. 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. The kugel technique for groin hernia repair is a tensionfree minimally invasive, yet open, preperitoneal or posterior abdominal wall groin hernia repair.
Nerve management and chronic pain after open inguinal hernia repair. The patch was used to help eliminate the tension and strain on surrounding muscles and ligaments which reduced discomfort after surgery. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. Although this pain is thought to be related to some reasons, there is not an exact conclusion about this. 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. Pain is one of the most common complications after. The kugel hernia patch was developed to treat ventral or incisional hernias, which are caused by a stretching or thinning of scar tissue that forms after abdominal. Hernia relapse or recurrence chronic pain chronic infection mesh migration into nearby organs and tissues mesh. Although it has vastly improved the quality of life of many people in the united states, the implant. Open hernia repair surgeries are normally done to eliminate the pain of a hernia, prevent the symptoms of a hernia from interfering with daily activities, to prevent the hernia form becoming a greater health risk, and when the hernia restricts blood flow or causes a blocked intestine. Causes of postoperative pain following inguinal hernia repair. Hernia mesh increases the risk of infection compared to nonmesh repair.
Nov 20, 2007 the incidence of chronic pain after kugel herniorrhaphy is not well documented, since it was not used as a primary outcome measure in studies reporting on the kugel technique. 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 eliminate the pain caused by the hernia. The severe abdominal pain which can be one of the kugel mesh side effects when the patch adheres to the bowels or the bowels become perforated has resulted in some patients requiring bowel dissection surgery so that the patch can be removed and the bowels repaired. Kugel hernia patch lawsuits beginning in court next week. Nov 22, 2012 oblique inginal hernia associated with lipoma of the cord. Mesh lawsuits for kugel hernia mesh recall saunders. 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. It is applicable to the treatment of indirect and direct inguinal hernias as well as femoral hernias.
Repairs not using prosthetic mesh are preferable options in patients with an. This study assesses the incidence and degree of chronic pain and discomfort after primary inguinal hernia repair performed in our hospital and aims to clarify its relationship to the type of mesh placement. Hernia mesh failure symptoms can appear long after surgery. The author has significant experience with laparoscopic inguinal hernia repair, but now routinely performs the kugel or open preperitoneal repair because of the faster recovery and decreased postoperative pain.
Mar 16, 2007 the kugel hernia patch problems are so severe that the fda classified the recall as class i in january 2007, since the defect has a reasonable probability of causing serious adverse health consequences, including death. It was for this reason that we wished to explore the role of the kugel patch technique. They are actively investigating all hernia mesh cases. Bard, were granted regulatory clearance under the u. Minimally invasive open preperitoneal inguinal hernia repair.
The kugel hernia patch problems are so severe that the fda classified the recall as class i in january 2007, since the defect has a reasonable probability of causing serious. The kugel patch is designed to be inserted through a small incision. The kugel inguinal hernia repair is associated with a low rate of postoperative chronic pain. Nienhuijs s, staal e, strobbe l, rosman c, groenewoud h, bleichrodt r. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. For more serious cases, doctors may recommend surgery to remove the mesh or the nerve causing the pain. Inguinal hernia repair has a long history dating back to as early as the 19 th century, the era of tension repair. While the symptoms may indicate hernia mesh failure, imaging tests and xrays can confirm that the mesh has fallen apart. As the technique and technologies evolved over time, the era of tensionfree repair was ushered in with the discovery of synthetic polymers in 1935. This erosion shrunk the patch, causing medical complications and chronic pain. Treatments include pain medications and nerve blocks.
The pain subsides over time, reports the american college of. Initial experience with application of single layer modified kugel. Dec 20, 2016 kang repair meshlessno mesh hernia repair. Individuals who have had a hernia repair surgery and suffer severe abdominal pain, high fever, tenderness at the site of the. Many hernia mesh products, including some of those marketed by ethicon, atrium medical, and c.
Composix kugel mesh patches, manufactured by davol, inc. This metal ring allowed the device to be folded for insertion during a surgery. 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. Kugel mesh hernia patch massachusetts drug and medical. The bard composix kugel hernia patch is manufactured. The kugel hernia patch is a medical product used to treat some hernias. The kugel hernia patch was designed for use in open ventral hernia repair.
Transinguinal preperitoneal repair of giant inguinoscrotal hernias. A prospective series of 107 inguinal hernia repairs performed between january 2000 and october 2003 in 96 patients, using the bard kugel hernia patch were entered into the study. Chronic pain after kugel inguinal hernia repair request pdf. Modified kugel versus lichtenstein operation for inguinal hernia.
Some people suffer chronic hernia mesh pain that interferes with their daily activities and can last from several months to years. The kugel mesh patch was approved for use by the u. Immediate and longterm outcomes of lichtenstein and kugel. The severe abdominal pain which can be one of the kugel mesh side effects when the patch adheres to the bowels or the bowels become perforated has resulted in some patients.
The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects. Hernia mesh removal for hernia mesh pain petersen hernia. Although recurrence and chronic groin pain rates are higher with kugel repair, this was not statistically significant. A total of 72 patients underwent anterior preperitoneal single layer mk mesh. Inguinal hernia surgery is an operation to repair a weakness in the abdominal wall that. Hernia mesh surgery causing chronic and severe pain.
Indeed, the kugel mesh patch formed the basis of, for some, years of pain. It can also promote scartissue that entraps nerves. To date, many controversies still exist regarding the indication for tensionfree repair due to the lack of a standard classi. Attorneys from seeger weiss are part of the executive committee that will lead the mdl2846 cases against c. Initial experience with application of single layer modified. Although it is started out as a simple singlelayer mesh. However, hernia mesh implant patients should talk to their surgeons about these symptomseven if it has been years since the initial hernia mesh repair. Dec 15, 2014 chronic pain at sixmonth followup was present in 89 patients constituting 39. Chronic pain after kugel inguinal hernia repair springerlink. Hernia mesh surgery complications hernia mesh patch lawsuit. 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. Top product liability lawyers across the united states are filing hernia mesh. Inguinal hernia repair with the kugel patch, anz journal.
Chronic pain in the leg or groin lasting three months or longer is reported by 7. The minimally invasive preperitoneal approach of the kugel technique probably causes less nerve. None of the patients in the lichtenstein group and 1. The aim of this retrospective study is to compare the immediate and longterm postoperative outcomes of. Chronic pain and discomfort is a notable complication after inguinal hernia repair. Kugel repair might be expected to have a lower incidence of chronic pain as the incision is much higher than conventional groin hernia incisions and the mesh is not placed on the major inguinal cutaneous nerves ilioinguinal and genitofemoral. When a hernia mesh product was either manufactured with inferior materials or according to a design that is defective. Seroma, a collection of clear or yellow fluid formed around the hernia site, effects 8 percent of mesh implant patients and usually resolves on. Moore introduction hernia repair constitutes a major part of the typical general surgical practice. Mesh hernia repair is the most popular means for repairing. In december 2005 davol issued a recall for the extralarge kugel mesh hernia patch. Treatment for chronic pain includes painkillers, mesh removal and nerve removal surgery.
Kugel hernia patch recall could have occurred earlier. The minimally invasive preperitoneal approach of the kugel technique probably causes less nerve damage. Surgeons perform hernia mesh removal surgery, also called hernia mesh revision surgery, in patients who experience chronic pain, infections or other serious meshrelated complications following hernia repair. Chronic pain after kugel inguinal hernia repair, hernia 10.
Chronic pain seems to be more common in young female patients with immediate postoperative pain. Chronic pain after kugel inguinal hernia repair, hernia. Open hernia repair surgery and kugel patch mesh patch attorney. The kugel mesh patch was granted fda approval in 1996 and was designed to make hernia operations easier and lessen postsurgical pain for patients. Defective mesh can cause severe pain as well as chronic pain. Conservative treatment for hernia mesh pain typically involves oral pain medications or painrelieving injections. Swing mesh versus modified kugel mesh for primary inguinal hernia. Inguinal hernia repair with the kugel patch request pdf. The incidence of chronic pain after kugel herniorrhaphy is not well documented, since it was not used as a primary outcome measure in studies reporting on the kugel. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. Nov 20, 2007 the kugel inguinal hernia repair is associated with a low rate of postoperative chronic pain.
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