No recurrences occurred in the present study, which demonstrates the reliability of this technique. Ethicon physiomesh hernia lawsuits 2020 update personal. Composix kugel mesh patches lawsuit hernia mesh lawsuit. In conclusion, open repair of ventral hernia by placing the selfexpanding kugel patch in the submuscular plane is highly effective, safe, and is an easy technique to perform, with low recurrence, and complication rates. One of the most popular devices for open hernia repair surgery is the kugel mesh hernia patch manufactured by davol, inc. Information re the bard kugel patch hernia mesh device, failure rates, recalls.
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. Composix kugel mesh patches are manufactured by davol, a subsidiary of parent company c. 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. Hernias are painful and require treatment to prevent further medical harm. If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a defective products lawyer who may evaluate your kugel mesh hernia patch. Bard received reports that the kugel patch was failing as early as 2002. The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects. A defect of the abdominal wall with intestinal fistulas after. As in a laparoscopic tep repair, the preperitoneal space is accessed using digital dissection instead of a balloon dissection.
Like many other people, ryan and sophia are upset that they were never warned about the possibility of the kugel mesh patch breaking. Initial experience with application of single layer modified kugel. 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. Open hernia repair surgery and kugel patch mesh patch. 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. The bard composix kugel mesh patch is used to repair hernias caused by thinning or stretching of scar tissue that forms after surgery. It is used primarily for hernia surgery, particularly for laparoscopic ventral.
It is vital to know the signs of possible hernia mesh rejection as a precursor to surgical hernia repair with mesh. Most of these repairs have focused on tensionfree techniques. The problem with the kugel hernia patch was that the plastic component could break and cut through a patients internal organs and tissue. Expansive literature has been produced demonstrating benefits associated with a large number of repairs. The bard composix kugel mesh hernia patch is used to repair ventral incisional hernias. Kugel technique of groin hernia repair basicmedical key. 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. The kugel mesh patch has been linked to bowel perforations.
From 1996 to 2006, 219 consecutive patients underwent inguinal hernia repair 92 using a standard lichtenstein repair and 127 with a kugel patch. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. 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 recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed. In many cases, the memory recoil ring can break while being inserted. After incision and dissection, hernia was found behind the latissimus dorsi muscle. Journal article false reduction of an inguinal hernia treated by kugel patch repair via an anterior. Complications the devices ring broke or bent causing device migration, bowel obstruction, bowel puncture.
If you believe that you may have a claim, consider contacting an attorney as soon as possible. The compsix kugel mesh hernia patch is manufactured by davol, inc. Jun, 2016 the bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair. Different types may be recommended based on the patients individual situation, the location of the hernia and the type of repair needed. Experience with direct kugel patch method for repair of adult inguinal hernia. To introduce a surgical technique for repairing grynfeltt hernia using a bard kugel patch mesh. The patient was eventually discharged from the hospital with a 20 cm abdominal incisional hernia. Kugel mesh hernia repair now find kugel mesh hernia repair and get helpful answers about kugel mesh hernia repair.
Hernia mesh chicago personal injury attorney thomas plouff. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. Moore introduction hernia repair constitutes a major part of the typical general surgical practice. Inguinal hernia repair with the kugel patch request pdf. The device comprises a plastic memory recoil ring surrounding two mesh layers. Open hernia repair surgery and kugel patch mesh patch attorney. Nov 22, 2012 oblique inginal hernia associated with lipoma of the cord. Approximately 750,000 kugel mesh patches were implanted each year to repair hernias.
Kugel mesh patch a terrible ordeal beasley allen law firm. It is used in about 90 percent of hernia repair surgeries in the u. Inguinal hernia repair has a long history dating back to as early as the 19th. Surgery is the only cure for a hernia and over 750,000. Fda recalls additional bard composix kugel hernia patches. 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.
Three years later he underwent a sigmoidectomy and partial small bowel resection at the same hospital for a metachronous sigmoid colon cancer. Nov 09, 2007 but sophias patch broke, causing her to experience severe pain and other serious problems. In the spring of 2003, sophia had a hernia operation in which the doctor used a kugel mesh patch to repair the hernia. Mesh lawsuits for kugel hernia mesh recall saunders. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. 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 main limitation of the study is that this is a retrospective. 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. Inguinal hernia repair with the kugel patch reddy 2005. Symptoms of problems with the kugel hernia mesh mcgartland.
Fda recalls additional bard composix kugel hernia patches medscape apr 03, 2006. Kugel hernia repair is classically carried out through the posterior approach. Hernia mesh can prevent a hernia from recurring, but it can also cause serious complications. Immediate and longterm outcomes of lichtenstein and kugel. Cr bard inc first recalled their bard davols kugel patch in 2005 as it could cause fistulas and bowel perforations. The patch is placed behind the hernia through a small incision. The incisional hernia was simultaneously repaired using composix kugel patch. The bard composix kugel mesh hernia repair patch, manufactured by davol inc. The bard kugel patch davol, cranston, rhode island was developed to facilitate performance of the kugel hernia repair.
The kugel patch inguinal hernia repair is a relatively new, open, minimally invasive procedure using a preperitoneal approach. The composix kugel mesh patch is surgically implanted via a small incision, positioned behind the hernia, and its. Sublay repair for primary superior lumbar hernia with the. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches. Transinguinal preperitoneal repair of giant inguinoscrotal. Giant inguinoscrotal hernias are rarely encountered in clinical settings, and their repair is technically challenging.
Kugel patch hernia mesh complications and legal claims. Composix kugel mesh patches, manufactured by davol, inc. 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. The us food and drug administration first approved the kugel mesh patch in 1996. The bard davol kugel implant was designed in the early nineties to repair hernias, and by 2002 the first serious complications were reported. Kugel mesh hernia patch massachusetts drug and medical.
By 2018, bard had stopped marketing the kugel hernia patch in the u. The kugel hernia patch davol, cranston, ri, usa for treatment of inguinal hernias is a minimal access technique of inguinal herniorrhaphy. Bard davol designed its kugel patch for minimallyinvasive hernia mesh surgery. Open, preperitoneal hernia repair with the kugel patch. Aug 02, 2016 kugel technique of groin hernia repair robert d.
Patients who have had a previous laparoscopic posterior approach on the same side and have a recurrent hernia are not candidates for an open posterior approach. 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. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. Prospective multicentre case series of 450 consecutive kugel patch. 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. 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. It had a defective ring that could break and puncture organs. In laparoscopic hernia repair, the surgeon uses a laparoscope to visualize the hernia and affix a mesh patch behind the abdominal muscle wall. This metal ring allowed the device to be folded for insertion during a surgery. The problems led to several recalls and thousands of lawsuits. The bard kugel repair technique is very similar to a laparoscopic repair in that the entire groin region is potentially protected against further herniation. The aim of this study is to evaluate the efficacy of transinguinal preperitoneal repair tipp of giant inguinoscrotal hernias using kugel mesh. Minimally invasive open preperitoneal inguinal hernia repair. However, sublay repair using the kugel patch could provide suf.
Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. Preperitoneal groin hernia repair with a bard modified kugel patch. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. Find kugel mesh hernia repair and get helpful answers about kugel mesh hernia repair. Controversies in inguinal hernia repair outpatient surgery. Their latest product, the kugel hernia patch, is being used to repair painful, potentially fatal tears in the abdominal wall. 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. Patients who have had a radical prostatectomy are generally not candidates for laparoscopic hernia surgery, but may be eligible to undergo an open preperitoneal repair. These are severe conditions that pose a significant health risk to hernia patch patients.874 490 26 931 6 1059 943 287 668 353 1473 1096 869 408 279 895 229 120 1344 1079 1007 881 1181 1498 1092 622 499 909 1470 69 1472 1278 741 673 1045