Six different products in the patch line have been recalled. 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. More than 78,000 bard composix hernia patches were distributed by davol between 20012006. On the inner side of the pad is plastic mesh made of polypropylene. The bard composix kugel mesh hernia repair patch, manufactured by davol inc. Composix kugel mesh patch was recalled due to faulty memory. Bard, manufacturer of the defective kugel mesh hernia patch, has received an 11page warning letter from the us fda. Davol noted that the newer hernia meshes utilize a lighterweight mesh and absorbable materials, which leave less implant material behind in. On the outer side of the pad is a plastic fiber cloth. Composix kugel mesh patches are manufactured by davol, a subsidiary of parent company c.
The recall notice warned that the ring defect could cause bowel perforations and fistulas. The patch is then held open by its memory recoil ring, a thin ring that allows the patch to be folded for insertion and spring open, laying flat, once the patch is in place. The poor design of the kugel mesh hernia patch has resulted in painful and sometimes life threatening injuries, including bowel perforations. 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 bard composix ex mesh, combines two clinically proven biomaterials, bard polypropylene mesh and eptfe, into one product. The bard kugel patch was one of bard s earliest iterations of a hernia mesh product. Hernia patch recallbard composix kugel mesh patch injury. 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. Bard is now known as bard medical which is a division of bd. The products were commonly used to repair incisional hernias in the abdomen. If you or a loved one is a victim of a defective bard davol composix hernia product, fill out the form below for a free legal consultation. The bard composix kugel mesh patch is placed behind the hernia during surgery and is held open by a memory recoil ring. The kugel hernia patch is one of bards earliest and most problematic mesh products.
As of march 31, 2012, davol discontinued the composix kugel patch and suggested replacing the product with the ventrio or ventrio st hernia patch products. Jul 30, 2018 problems with a bard composix kugel hernia patch caused a texas man to suffer devastating complications about ten years after it was implanted, resulting in emergency surgery that discovered the. Problems with a bard composix kugel hernia patch caused a texas man to suffer devastating complications about ten years after it was implanted, resulting. This synthetic mesh is designed for use in hernia repair surgeries. After insertion through a small incision, the patch is placed behind the hernia defect. R kugelr mesh xlarge patch intended for ventral hernia. The hollis law firm will be unboxing the composix kugel hernia mesh. By the time problems surfaced, however, it had already been implanted over a million times. This patch however was recalled by bard as a result of reports of various complications arising from its use. Bard davol, which produces the composix, ventralex, kugel patch, perfix, and. 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. A lowprofile, easy to use mesh with the effectiveness.
Mesh lawsuits for kugel hernia mesh recall saunders. Cr bard composix kugel mesh hernia patch is a dangerous hernia patch used during hernia repair surgery. The composix kugel is made by davol, a subsidiary of c. Bard kugel hernia mesh patch was one of the first mesh implants to be recalled. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. If you have already received one of these recalled medical devices in a hernia repair operation, you should contact your. It is used primarily for hernia surgery, particularly for laparoscopic ventral hernia repair. The fda has instructed surgeons and hospitals to immediately stop using the patch.
The bard composix hernia mesh is a medical product used to treat some hernias. The recall, issued by the food and drug administration fda was a class 1 recall, the highest level of concern and had to be issued twice in 2005 and 2007. Bard announces recall of composixr kugelr mesh xlarge. After a trial that lasted four weeks, the nineperson jury unanimously found that the composix kugel hernia patch, which was placed in over 100,000 patients, was. Davol noted that the newer hernia meshes utilize a lighterweight mesh and absorbable materials, which leave less implant material behind in patients.
Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. This recall and the subsequent recalls followed alarming reports that the hernia patchs memory recoil ring can break under stress. For example, bard recalled its kugel patch hernia mesh in 2005. Nov 29, 2016 the hollis law firm will be unboxing the composix kugel hernia mesh. Composix kugel patch side effects parker waichman llp. Bard issued the first in its series of kugel patch recalls in december 2005. Davol, a subsidiary of bard, manufactures this product. Composix kugel mesh patches hernia mesh lawsuit attorney. The ring allows the product to spring open once implanted, adding structural support and stability. Patients with the bard davol composix hernia patch who have experienced infection, mesh erosion, severe pain, and revision surgery may be eligible for financial compensation for injuries. The kugel mesh patch is used to repair ventral hernias. Bard davol hernia mesh mess hernia mesh lawsuit update.
Aug 09, 2014 after a trial that lasted four weeks, the nineperson jury unanimously found that the composix kugel hernia patch, which was placed in over 100,000 patients, was defective and unreasonably. Composix kugel mesh patches lawsuit hernia mesh lawsuit. Barddavol composix kugel hernia mesh patch due to serious safety risks. But it wasnt until 2010 that the first bellwether trials occurred. Recall classified as class i because the defect associated with the use or exposure to the bard composix kugel mesh large patch has a reasonable probability to cause serious. Bard composix hernia mesh lawsuit bard composix hernia mesh. This recall and the subsequent recalls followed alarming reports that the hernia patchs memory recoil ring can break under. The kugel patch was a line of hernia mesh products bard davol manufactured starting in the 1990s. Z052406 bard composix kugel mesh xlarge patch oval with eptfe. The bard kugel patch was one of bards earliest iterations of a hernia mesh product. The first kugel hernia patch was approved in the 1990s. A surgeon folded the kugel patch to insert it through small incisions.
In 2007, the first lawsuits were consolidated into an mdl a large group of lawsuits with similar injuries and claims. Z052406 bard composix kugel mesh xlarge patch oval with eptfe, 8. Bard composix hernia mesh lawsuit bard composix hernia. The patch is used to repair ventral, inguinal, and laparoscopic hernias. The kugel hernia mesh was one of the earliest and most used hernia meshes in the united states. The kugel mesh is a circular patch featuring an innovative springloaded ring. The composix kugel mesh patch was recalled in the united states by the fda. 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 patch is surgically implanted via a small incision, positioned behind the hernia, and its. 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.
It was little more than an oval or circular shaped mesh of polypropylene plastic. If you or a loved one is a victim of a defective bard davol composix hernia product, fill out the form below for a. But the company waited almost three years before recalling its mesh. Unfortunately, the advertisements failed to mention the implants major side effects. The kugel mesh hernia patch injury lawyers at our firm are working hard to make sure that victims of the defective bard composix kugel mesh hernia patch receive just compensation for their injuries.
The patch consists of two layers of synthetic mesh enclosed by a flexible plastic memoryrecoil ring. Kugel as an alternative treatment for hernia repair. Jun 05, 2012 longlasting statute of limitations in bard hernia mesh lawsuits in rhode island. Attorney wins verdicts and loses one for kugel mesh plaintiffs. The bard composix kugel mesh patch is used to repair ventral incisional hernias caused by thinning or 2 of 4 10172007 9.
A collapsible metal ring was sewn between two of the layers of the plastic mesh. Designed to make hernia operations easier and to decrease postsurgical pain, the kugel mesh patch gained u. Medical device recalls food and drug administration. Contraindications literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera. Food and drug administration fda approved the kugel mesh patch in 1996. Jul 28, 2011 the kugel mesh hernia patch injury lawyers at our firm are working hard to make sure that victims of the defective bard composix kugel mesh hernia patch receive just compensation for their injuries. The device, which consists of a plastic memory recoil ring surrounding two mesh layers, is folded and inserted through a small incision in the abdomengroin. Victims have been reporting dozens ofhernia mesh patch recall symptoms. The reason for the recall was that the memory recoil ring was frequently breaking. If you or someone you know has had hernia surgery and received davolbard composix kugel mesh patch please complete the free case evaluation form or call toll free at 888 5840411. The mesh has a crucial design flaw and can cause life threatening harm. Fda recalls additional bard composix kugel hernia patches. Although surgical mesh devices are one of the most commonly used treatments for hernia repair, some devices may lead to serious adverse health events, including infection, pain, adhesion, fluid buildup and hernia. Composix kugel mesh patches are primarily used to repair ventral hernias.
Bard reported it settled some lawsuits related to use of the composix kugel mesh patch. Bcr today announced that it is voluntarily recalling its bardr composixr kugelr mesh. Bard was subject to recalls for composix kugel mesh products due to safety concerns about the plastic which would splinter and migrate away from the surgical site. Bard composix kugel mesh xlarge patch oval with eptfe, 8. A memory recoil ring built into the mesh caused the patch to spring open to its full shape and size. The strongly worded letter cites the puerto rican manufacturing plant that makes the kugel mesh hernia patch for manufacturing and operational defects. The bard composix ex and the bard composix kugel devices are hernia mesh implants.
Between the two sides of the composix kugel device is a circular metal ring that allows the device to. Composix kugel hernia mesh lawsuit filed over implant failure. Bard hernia patch lawsuit kugel hernia mesh lawsuit the kugel hernia mesh was one of the earliest and most used hernia meshes in the united states. Jan 30, 2018 composix kugel mesh patches are primarily used to repair ventral hernias. Composix kugel mesh patch lawsuit seeger weiss llp. 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. Bard composix kugel hernia mesh recall between 2005 and 2007, three separate recalls were issued for the c. C today at 855 topfirm or simply fill out the free kugel mesh recall case evaluation form. 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.
The parietal side of the composix lp mesh features large pore, lightweight polypropylene bard soft mesh which encourages rapid tissue ingrowth for a strong. Hernia patch makers appeal decision in composix kugel lawsuit. Kugel patch hernia mesh complications and legal claims. Bard hernia mesh lawsuit dangerous side effects reported.
Bard composix kugel mesh hernia patch recall below is an excellent video produced by the u. Z052506 bard composix kugel mesh xlarge patch oval with eptfe, 10. The kugel mesh patch was approved for use by the u. Davol combined two of its previous hernia meshes, the composix. The compsix kugel mesh hernia patch is manufactured by davol, inc. Six years later, the composix kugel mesh patch made by davol hit the market. Food and drug administration approved the kugel hernia patch in 1996. Legal help for victims of bard composix kugel mesh patch. A bard composix hernia mesh lawsuit may be an option for people who suffered severe complications associated with the devices.
The bard composix kugel hernia patch is manufactured by davol, a subsidiary of c. Bard davol composix kugel hernia mesh patch due to serious safety risks. Unfortunately, countless hernia sufferers have learned that the pain can be made even more severeby a defective hernia patch like the composix kugel mesh. The fda issued the following kugel mesh hernia patch safety alert on 2107. Bard composix ex mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The kugel patch is manufactured by davol, inc, which is a division of c. The us food and drug administration first approved the kugel mesh patch in 1996. Class 1 device recall davol composix kugel hernia patch. This patch was manufactured to be used for ventral or incisional hernias. The hernia patch is a device intended to repair ventral hernias.
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