The strom law firm, llc is currently investigating and evaluating cases against the makers of kugel mesh. Hernia mesh cases set for trial nationwide mass tort nexus. Hernia mesh patch patients implanted with a hernia mesh patch are advised to find out if their hernia mesh patch is one of the recalled bard composix kugel mesh hernia patches. The smaller the polypropylene mesh gets, the more force the ring must sustain. Jul 12, 2011 in response to a groundswell of kugel mesh hernia patch lawsuits, c. Attorneys working with are currently speaking with patients who experienced complications following hernia mesh surgery, including severe pain, dangerous infections and other serious problems that led to second surgeries to remove or replace the mesh. The compsix kugel mesh hernia patch is manufactured by davol, inc. Once in place, a memory recoil ring springs the patch open to its full size so it can lay flat over the affected site. Fda recalls additional bard composix kugel hernia patches medscape apr 03, 2006. Healthcare professionals are encouraged to report adverse events related to use of the ventral hernia repair patches to the fdas medwatch reporting program by phone at. If you have experienced adverse side effects after receiving a composix kugel mesh hernia patch, contact our attorneys to find out if you have a hernia mesh lawsuit that entitles you to compensation.
Composix kugel hernia mesh lawsuit filed over implant failure. C today at 855 topfirm or simply fill out the free kugel mesh recall case evaluation form. Defects in the composix ex and composix kugel implants. Legal help for victims of bard composix kugel mesh patch. This synthetic mesh is designed for use in hernia repair surgeries. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and later spring open and lay flat once it is in place. If you believe that you may have a claim, consider contacting an attorney as soon as possible. Composix kugel mesh patches composix kugel mesh patches are primarily used to repair ventral hernias.
The coil portion of the kugel mesh patch, according to one kugel mesh patch attorney, was meant to snap back into place so the herniated area would flatten and the hernia could heal appropriately without further strain on the weakened muscles that caused the problem in the first place. There are thousands of cases in state litigation in rhode island about ventralex and composix ex. Composix kugel mesh patches lawsuit hernia mesh lawsuit. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. Bard recalled several lots of the composix kugel hernia patch in 2005, 2006 and 2007. One of the options available to doctors in the surgical treatment of hernias is the use of mesh patches.
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. Three years later, the hernia was repaired at the time of a second colectomy using a composix kugel patch. Between 2007 and 2008, he underwent multiple surgeries to remove infection and a fistula resulting from the repair. The lawsuit notes that prior to sanders hernia surgery in march 2008, the manufacturers were aware of defects with the patch and had issued composix kugel hernia mesh recalls for several. This recall and the subsequent recalls followed alarming reports that the hernia patchs memory recoil ring can break under stress. Although the composix kugel mesh hernia patch was recalled in 2005, and in its wake the manufacturer offered settlements in about 2,600 lawsuits, claims are still being filed. The visceral side of the bard composix ex mesh features a permanent submicronic eptfe barrier, which minimizes adhesions to the prosthesis. See what the composix kugel hernia mesh looks like and understand its defects.
The composix kugel mesh implant is now considered a dangerous and defective product because of the serious medical risks associated with the patch. A hernia occurs when an organ inside the body starts to bulge out through the wall that contains it. Mesh lawsuits for kugel hernia mesh recall saunders. Surgery is the only cure for a hernia and over 750,000. Bard hernia mesh products, like other surgical mesh products, are classified as class ii medical devices which means that most of the. Bard, but was phased out during the 2000s with the introduction of the bard modified kugel patch, which was also known as the mk patch. The aim of this retrospective study is to compare the immediate and longterm postoperative outcomes of lichtenstein and kugel repair of inguinal hernia. However, many hernia repair patients are still experiencing problems. In many cases, doctors surgically insert hernia repair mesh which lays flat, preventing the hernia from pushing through any holes in the abdominal tissue.
The patch is folded before being inserted into a small abdominal incision. Composix kugel mesh patch was recalled due to faulty memory. Bard composix hernia mesh encompasses several types of composite surgical mesh indicated for use in the reconstruction of soft tissue deficiencies in hernia repair surgeries. Unfortunately, the advertisements failed to mention the implants major side effects. 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 hernia mesh problems resulted in revision. The device is a type of a surgical mesh, sometimes known as a hernia repair patch. The kugel mesh patch is used to repair ventral hernias. Bard manufacturers many different types of medical and surgical products but their surgical mesh has a particularly poor safety record. The kugel mesh patch was approved for use by the u. Kugel as an alternative treatment for hernia repair. Hernias are painful and require treatment to prevent further medical harm. The bard composix kugel device is no longer sold in the united states after being recalled in 2007 3. Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. Christopher thorpe underwent hernia repair with a kugel patch in 2005. Immediate and longterm outcomes of lichtenstein and kugel.
The lawsuit alleged that christopher thorpe suffered severe internal injuries and a sepsis infection when the hernia patch broke inside of him. Bard composix hernia mesh lawsuit bard composix hernia. The patch is placed behind the hernia defect through a small incision. The recall previously affected only the extralarge oval patch. A collapsible metal ring was sewn between two of the layers of the plastic mesh.
Composix kugel mesh patch columbia, sc personal injury. Call 877 2883241 if you suffered complications after receiving a hernia mesh patch compensation for a hernia mesh lawsuit. If you have been harmed by a composix kugel mesh patch, or lost a loved one to hernia repair complications, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation. Composix kugel mesh patches, manufactured by davol, inc. If you have already received one of these recalled medical devices in a hernia repair operation, you should contact your. Kugel patch hernia mesh complications and legal claims. Jan 29, 2012 hernia mesh patch patients implanted with a hernia mesh patch are advised to find out if their hernia mesh patch is one of the recalled bard composix kugel mesh hernia patches. The composix kugel mesh hernia patch is a medical device surgeons use to repair ventrical hernias, which may develop at previous surgery sites or scars. Six years later, the composix kugel mesh patch made by davol hit the market. If you or a loved one has been harmed by a composix kugel mesh patch, please contact our office to discuss your rights. 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 patient, a 70yearold man, had a history of a hemicolectomy for a perforating colon cancer, complicated by a large incisional hernia that was closed primarily but recurred. If you have questions about the composix kugel mesh hernia repair patch litigation, contact medical device lawyer don migliori by email or call 1. Strouss or call our toll free number 18883411405 to speak directly with an attorney.
Both the composix ex and composix kugel hernia mesh implants use polypropylene plastic threads to form the mesh. Polypropylene and permanent eptfe barrier designed for ventral hernia repair. Lawsuits, settlements, case results there have been no bard composix settlements or jury trials yet. Kugel mesh hernia patch products liability litigation, mdl docket no. The hernia mesh lawsuit was filed by mesh victim norma olmo who alleged thatextralarge composix kugel hernia patch ck patch manufactured by c. The recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed. Composix composix kugel hernia patch marlex bard hernia mesh and the fda. More than 78,000 bard composix hernia patches were distributed by davol between 20012006. The kugel mesh patch also known as the bard composix kugel hernia patch was designed and marketed as a patch used to repair ventral hernias. 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 scars.
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. Between 2005 and 2007, three separate recalls were issued for the c. The composix lp mesh is a lightweight, low profile prosthesis that fits more. Since october 2005, there have been several davol bard composix kugel hernia mesh recall for certain patches containing a design defects which may result in serious and potentially fatal injuries. Kugel in order to reduce the recovery time of hernia repair surgery and decrease the number of hernias that reappear. Nov 29, 2016 see what the composix kugel hernia mesh looks like and understand its defects. Many patients and physicians have reported the internal ring of the kugel breaking and perforating the bowel or other organs. Kugel mesh hernia patch massachusetts drug and medical. This recall and the subsequent recalls followed alarming reports that the hernia patch s memory recoil ring can break under stress. The bard kugel patch was an implantable medical device that used to be used to treat inguinal hernias. Composix kugel mesh patch columbia, sc personal injury lawyers.
Kugel hernia repair patch recall approximately 750,000 kugel mesh patches were implanted each year to repair hernias. Our law firm is accepting clients who received a hernia mesh and have experienced additional surgeries, infections, bowel obstruction, organ damage, and chronic pain. Yet despite the massive payout, the settlement still leaves nearly 1,000 kugel mesh hernia patch lawsuits unresolved. A lowprofile, large pore polypropyleneeptfe prosthesis for laparoscopic ventral hernia repair. Bards composix ex and composix kugel products are implantable hernia mesh devices made by c. It has a specially designed memory coil ring that opens the patch after it is placed behind the area of the hernia. Bard hernia mesh lawsuit dangerous side effects reported. Its a small patch of fabriclike material meant to be inserted into the body. The composix kugel hernia mesh was one of first and most well known hernia meshes to be recalled. From 1996 to 2006, 219 consecutive patients underwent inguinal hernia repair 92 using a standard. They are designed to treat incisional hernias as well as inguinal hernias, and to minimize the consequences of the contact between the implant and the tissues it touches. Once the kugel mesh is implanted, the body begins to attack and break down the polypropylene.
The fda issued hernia mesh patch recall affects the composix kugel hernia mesh patch. Hernia mesh mess bard davol hernia mesh lawsuit update. A defect of the abdominal wall with intestinal fistulas. The first kugel hernia patch was approved in the 1990s. It is used primarily for hernia surgery, particularly for. Many patients and physicians have reported the internal ring of the kugel breaking and. Kugel patches were doublelayer polypropylene hernia meshes. 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. Composix kugel mesh patches are manufactured by davol, a subsidiary of parent company c. The bard kugel patch was one of bards earliest iterations of a hernia mesh product. Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. But the company waited almost three years before recalling its mesh. The product is inserted into place through a small incision in the abdomen and is meant to remain in place as a permanent repair. The composix lp mesh is a lightweight, low profile prosthesis that fits easily through a trocar and offers a permanent barrier that is designed to minimize visceral attachment.
The patch consists of two layers of synthetic mesh enclosed by a flexible plastic memoryrecoil ring. The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c. Composix kugel mesh patches lawsuit individual claims hernia. Bard composix meshes offer longterm protection to help minimize mesh erosion, fistula formation, and tissue attachment. Recall of certain composix kugel mesh patches used in hernia repair. The polypropylene side of the bard composix ex mesh promotes tissue ingrowth into the abdominal wall over time and eliminates the need for transfixation sutures.
The composix kugel mesh patch is supposed to fix a ventral or incisional hernia that may develop following surgery due. Hernia patch makers appeal decision in composix kugel lawsuit. Jan 30, 2018 composix kugel mesh patches are primarily used to repair ventral hernias. This metal ring allowed the device to be folded for insertion during a surgery. Kugel mesh recall lawsuit kugel mesh recall lawyers. This website provides the details of the hernia mesh lawsuits, settlements and recalls. The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects. It is used primarily for hernia surgery, particularly for laparoscopic ventral hernia repair.
Designed to make hernia operations easier and to decrease postsurgical pain, the kugel mesh patch gained u. Bard received reports that the kugel patch was failing as early as 2002. It was little more than an oval or circular shaped mesh of polypropylene plastic. There have been issues with the kugel hernia patch since its inception. Barddavol composix kugel hernia mesh patch due to serious safety risks. Food and drug administration fda approved the kugel mesh patch in 1996. Motley rice continues to litigate cases involving patients who suffered injuries or complications related to the composix kugel mesh hernia repair patch. While the litigation focused on the composix kugel hernia patch, some cases involved other bard hernia products such as the composix ex mesh, ventralex hernia patch, composix hernia patch, kugel hernia patch, ck parastomal patch and modified kugel patch. Kugel mesh hernia patch lawsuit hernia mesh recall. Many patients and physicians have reported the internal ring of the kugel.
Class 1 device recall davol composix kugel hernia patch. This patch however was recalled by bard as a result of reports of various complications arising from its use. The 10yearold kugel mesh hernia patch multidistrict litigation was marked closed sept. The patches are designed so that they can be folded when inserted and then spring open to lay flat once in place. The hollis law firm will be unboxing the composix kugel. Over a million kugel patches have been implanted nationwide. The composix kugel mesh patch is supposed to fix a ventral or incisional hernia that may develop following surgery due to the thinning or stretching of scar tissue. The bard composix kugel hernia patch was originally marketed as the first self expanding patch designed to address both sides of open ventral hernia repair.
This is the kind of hernia the composix kugel mesh was designed to treat. Hernia mesh lawsuits claim mesh manufactured by bard davol, ethicon and atrium failed and led to serious injuries. On december 22, 2005, the fda and davolbard notified healthcare professionals of a class 1 recall of the bard composix kugel hernia mesh patch xlarge patch oval with eptfe. More patients who have hernia surgery complications look. The plastic mesh that made up the older bard kugel patch was known to erode after implantation in a patient. The composix kugel mesh hernia patch is designed to provide extra support while repairing tissue damaged or weakened by a hernia.
The kugel mesh hernia patch includes a memory recoil ring that allows it to be folded over during surgery and subsequently deployed in the abdomen once it is in place. A hernia can be very serious and without prompt treatment can be life threatening. The products were commonly used to repair incisional hernias in the abdomen. Warning signs of hernia mesh failure include fever, abdominal tenderness, nausea, diarrhea, abnormal bowel movements and. The hollis law firm will be unboxing the composix kugel hernia mesh. The real defect of the kugel hernia patch is that the ring is inside of a polypropylene mesh. Z052406 bard composix kugel mesh xlarge patch oval with eptfe.
With more than 50 years of clinical experience, bard mesh is the gold standard. Composix lp composix ex kugel hernia patch modified kugel hernia patch sepramesh ip seprmatex visilex 3d light mesh allomax surgical graft bard mesh bard mesh preshaped dulex mesh perfix light plug perfix plug ventralight ventralex hernia patch ventralex st patch ventralight st patch ventrio st ventrio patch composix composix kugel hernia. The memory recoil ring that opens the bard composix kugel hernia mesh patch can break under the stress of. 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. A lowprofile, easy to use mesh with the effectiveness.
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