Most of these repairs have focused on tensionfree techniques. The kugel patch is manufactured by davol, inc, which is a division of c. 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 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 patch is then held open by its memory recoil ring. Inguinal hernia repair outcomes that utilized the modified kugel patch without the optional overlay patch. Prospective multicentre case series of 450 consecutive kugel patch. If you or somebody you know has been diagnosed with a. The schmidt firm, pllc is currently accepting hernia plug induced injury cases in all 50 states. The kugel patch method prevents the development of a femoral hernia after inguinal herniorrhaphy article in surgery today 451 march 2014 with 47 reads how we measure reads. The patch was used to help eliminate the tension and strain on surrounding muscles and ligaments which reduced discomfort after surgery. One of the most popular devices for open hernia repair surgery is the kugel mesh hernia patch manufactured by davol, inc. The kugel mesh hernia patch is constructed with a springlike recoil ring that opens the patch after insertion.
If you believe that you may have a claim, consider contacting an attorney as soon as possible. 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 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. In laparoscopic hernia repair, the surgeon uses a laparoscope to visualize the hernia and affix a mesh patch behind the abdominal muscle wall.
The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. With more than 50 years of clinical experience, bard mesh is the gold standard product to be used in a. Davol issued a hernia patch recall for the extralarge model of the kugel mesh hernia patch in december 2005. Plaintiffs steering committee member and chair of the law and briefing committee. Kugel mesh hernia patch dangers north carolina product. The repair of the indirect hernia was then completed with prolene mesh. The compsix kugel mesh hernia patch is manufactured by davol, inc.
Experience with direct kugel patch method for repair of. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. 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 patch is used to repair ventral, inguinal, and laparoscopic hernias. Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the fdas medwatch reporting program. 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. The kugel mesh was intended for the repair of two types of hernia. Kugel mesh hernia patch massachusetts drug and medical.
The kugel technique for groin hernia repair is a tensionfree minimally invasive, yet open, preperitoneal or posterior abdominal wall groin hernia repair. The kugel mesh hernia patch was recalled in 2005, 2006 and again in 2007 because, according to the u. Controversies in inguinal hernia repair outpatient. Kugel technique of groin hernia repair basicmedical key. The direct kugel patch method is a minimally invasive but nonlaparoscopic preperitoneal method of hernia repair which has various ideal characteristics including all the benefits of laparoscopic hernia repair without the risks of complications. In recent years, thousands of injury lawsuits have been filed over severe side effects. Kugel hernia mesh recall lawyers problems with recalled. Kugel mesh hernia patch page 2 of 2 the miller firm. There were two more recalls following in 2006 and 2007. The kugel hernia patch was designed for use in open ventral hernia repair. Open hernia repair surgery and kugel patch mesh patch. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. Tensionfree repairs, when performed properly, reduce the.
Wexler wallace represented individuals who had defective composix kugel mesh. False reduction of an inguinal hernia treated by kugel. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. Hernia plugs and surgical mesh patches are commonly used to repair groin, femoral, umbilical, and inguinal 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. Open, preperitoneal hernia repair with the kugel patch. 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. 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 kugel patch method prevents the development of a. Broken kugel hernia patch lawsuit set for trial to begin. From 1996 to 2006, 219 consecutive patients underwent inguinal hernia repair 92 using a standard lichtenstein repair and 127 with a kugel patch. Hernia patch is a selfexpanding polypropylene and eptfe patch that allows for an intraabdominal, tensionfree repair.
The most commonly used open approaches include the lichtenstein repair. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. 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. The kugel mesh patch has been linked to bowel perforations. Early experience of performing a modified kugel hernia repair with local anesthesia. A sterile, flat or threedimensional 3d, wovenknitted or porous material made of one or more nonbioabsorbable synthetic polymers e. Kugel mesh hernia patch chicago product liability lawyer. Chronic pain after kugel inguinal hernia repair springerlink. After insertion through a small incision, the patch is placed behind the hernia defect. The kugel patch inguinal hernia repair is a relatively new, open, minimally invasive procedure using a preperitoneal approach. A hernia occurs when the patients stomach muscles become weakened and as such are unable to properly contain the intestines. 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. The relatively high risk of hernia recurrence associated with pure tissue repairs, as reported in the literature, has prompted a significant increase in the use of.
Immediate and longterm outcomes of lichtenstein and kugel. With the hernia patch, of course, the leaving of something inside is the whole ideaa patch that remains with you to properly treat and control. Deep placement of the prosthetic also allows for a strong repair and less. The products were commonly used to repair incisional hernias in the abdomen.
Expansive literature has been produced demonstrating benefits associated with a large number of repairs. The open peritoneal repair of an inguinal hernia was first described in the late 1990s, and kugel patch inguinal hernia repair is one of the established treatment now, since it is less invasive with a relatively low recurrence rate, satisfactory patient comfort, and various ideal characteristics 911. The kugel patch is designed to be inserted through a small incision. The dissection proceeded all the way down to the hernia contents and circumferentially around the hernia through a combination of blunt and sharp dissection with the scalpel. Bard modified kugel selfexpanding mesh patch w strap for anterior approach to preperitoneal hernia repair.
Immediate and longterm outcomes of lichtenstein and kugel patch operations for inguinal hernia repair bobby dasari, lorraine grant, and terry irwin dept of colorectal surgery, royal victoria hospital, belfast hsc trust, grosvenor road, belfast, bt12 6ba, united kingdom. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias. 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. This technique is designed to eliminate the lateral dissection typically required for preperitoneal placement, which may help minimize post op pain. Fda recalls additional bard composix kugel hernia patches. Inguinal hernia repair with the kugel patch reddy 2005. Bard medical is at it again with defective hernia patches. In this retrospective study, we report our experience with this method for adult inguinal hernia repair. Class 1 device recall davol composix kugel hernia patch. Many techniques have been used, and these can be categorized as tensionfree repairs that typically use mesh, and primary tissue approximation repairs that do not use mesh. The second bellwether trial in the kugel hernia patch litigation is scheduled to begin later this summer, involving a case where the plaintiff suffered severe internal injuries from a broken rin.
In re kugel mesh hernia patch products liability litigation, case no mdl no. Bard received reports that the kugel patch was failing as early as 2002. Composix kugel mesh patches, manufactured by davol, inc. New york kugel mesh attorneys medical device litigation. This was brought up on the table, cut to size, and was sutured to coopers ligament inferior and medially, the shelving edge of the inguinal ligament, then laterally. Between 2005 and 2007, three separate recalls were issued for the c. Inguinal hernia repair is among the most common procedures performed by general surgeons. Although it is started out as a simple singlelayer mesh, it became progressively more intricate in order to make the performance of the. Moore introduction hernia repair constitutes a major part of the typical general surgical practice. 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.
It is applicable to the treatment of indirect and direct inguinal hernias as well as femoral hernias. Swing mesh versus modified kugel mesh for primary inguinal. Dissection extended down to the fascial defect, which was circumferentially dissected, incising all attachments between the incarcerated hernia and the adjacent fascial. Barddavol composix kugel hernia mesh patch due to serious safety risks.
Indirect inguinal hernia repair transcription sample report. Hernia repair inguinal laparoscopic preop patient education medical hd duration. Kugel mesh dangerous implant litigation wexler wallace llp. Umbilical hernia mesh repair transcription sample report.
605 1104 747 586 1078 352 742 1253 1081 851 1570 555 1166 1263 1084 531 8 16 865 116 1167 613 1233 1186 485 259 423 613 710 896 748 927 1057 274 625 514 977 1424 802 1461 19