Why is the Bard® Composix® Kugel® Mesh Patch dangerous? Davol Bard) or product (e.g., Composix, Composix E/X, Composix L/P, and Composix Kugel Hernia Patch) is not meant to state or imply that the company acted illegally or improperly or that the product is unsafe or defective; rather only that an investigation may be, is or was being conducted to determine whether legal rights have been violated. Please attach copies of any medical records. Bard Composix Kugel Mesh Patch I have suffered unspeakable injuries potentially as a result of the Bard Composix Kugel Mesh Patch. The Bard Composix Kugel Mesh Patch (aka the Bard Hernia Patch) is manufactured by (Davol, Inc., a subsidiary of C.R. Bard’s Modified Kugel device – the hernia mesh product that replaced the Bard Kugel Patch – came equipped with mesh straps on its backside that allowed surgeons to move it and manipulate it after implantation through the incision. Defendants C.R. (2006, February 22). In spite of the numerous issues with the Bard Kugel Patch and the hundreds of patients who have been hurt by it, neither Bard nor the U.S. Food and Drug Administration (FDA) have recalled the device. Incisional hernias are usually caused by the thinning or stretching of scar tissue that forms after surgery. Drugwatch.com partners with law firms. It was made by C.R. For more information, visit our partners page. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. (2017, October). Additionally, the shrinkage of the Bard Kugel Patch strains the metal rings that is sewn inside of it. This erosion shrunk the patch, causing medical complications and chronic pain. Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries. Expiration dates have mostly to do with sterilization and not the integrity of the product. It was manufactured by C.R. Composix® Kugel® Mesh patches, manufactured by C.R. Bard Composix Kugel Hernia Patch. The FDA declared it a Class I recall – the agency’s most serious type. Hernia Repair Using The Ventrio ™ Keeps the patch flat and from buckling Hernia Patch or Composix™ Kugel ™ Patch 1 The patch should be fixated in a way that: • around the edges. Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of the nationwide recall of Composix Kugel mesh hernia patches and provides information about the defective memory recoil ring and possible side effects from ring breakage. A federal panel combined them into a multidistrict litigation (MDL). This metal ring allowed the device to be folded for insertion during a … Learn more. Medical device recalls. Join our newsletter to stay up to date on dangerous drugs and devices, keep up on lawsuit and settlement news, learn about FDA recalls, and more. 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. Class 1 Device Recall Davol Composix Kugel Hernia Patch. As a NJ injury lawyer can explain, the Bard Composix Kugel Mesh Patch has allegedly caused extremely painful and difficult infections in thousands of patients. This website and its content may be deemed attorney advertising. This breakage can lead to bowel perforations and recurring intestinal fistulae (abnormal connections between the intestines and other organs). Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries. © 2021 Drugwatch.com Privacy Policy/ This averaged $70,000 for each plaintiff. Retrieved from, Thomson Reuters. In 2005, Bard issued the first in its series of Kugel Patch recalls. The device gained FDA approval in 1996, but when the company began introducing larger versions of the patch in 2002, reports of problems with the mesh material and memory recoil ring began to pour in. What Charges Can I Face for Credit Card “Skimming” in Orange County? Bard Composix meshes offer long-term protection to help minimize mesh erosion, fistula formation, and tissue attachment. Class 1 Device Recall Bard. Bard reported it settled some lawsuits related to use of the Composix Kugel Mesh Patch. The three products recalled in 2005 had accounted for $11 million in sales for Bard that year. It is made by Davol, Inc., a subsidiary of C.R. Six of the reports came from Germany. Nearly six years after the first Composix Kugel Mesh Hernia Patch recall was announced by the U.S. Food & Drug Administration (FDA), C.R. In its second-quarter filings, C.R. The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. Device makers must report complaints about their products to the FDA. But the jury in the second trial found that the Kugel Patch was defective. Kugel Mesh Patch The US Food and Drug Administration first approved the Kugel Mesh Patch in 1996. Bard saw a flurry of complaints starting in June 2005. Bard Composix Kugel Hernia Patch Self-Expanding Polypropolene & ePTFE Patch for Soft Tissue Reconstruction 22.1 cm x 27.1 cm (8.7″ x 10.7″ ) Part # 010206 Exp 11/13. Any unauthorized or illegal use, copying or dissemination will be prosecuted. A defective part in some of the meshes could break and puncture internal organs or other tissue. The Bard Kugel Patch was an implantable medical device that used to be used to treat inguinal hernias. Thousands of people have filed lawsuits over Kugel Patch injuries that have resulted in multi-million-dollar settlements. By pushing the hernia back through the abdominal wall and then inserting the patch on the hernia location through an incision in a patient’s groin, a surgeon could induce scar tissue that, together with the mesh, supported and strengthened the muscles there. As a result, many inguinal hernia procedures using the Bard Kugel Patch were poorly done because the mesh device would be in the wrong place or were folded on itself in ways that the surgeon could not correct. Once inside and released, the metal ring would spring the device back to its original shape, covering more area. In December 2005, Bard ran tests on the rings. A “memory recoil ring” built into the mesh caused the patch to spring open to its full shape and size. The Kugel Patch was a line of hernia mesh products Bard Davol manufactured starting in the 1990s. Retrieved from. The Bard MK Patch, also known as the Modified Kugel Patch, is an implantable medical device used in inguinal hernia procedures. Each year, nearly 1 million hernia repair surgeries are performed, about 90 percent of which utilize a surgical mesh product. And the company held training sessions for surgeons. Bard also gave out a $5.5 million settlement to an individual in Bakersfield, Calif., and a $2 million settlement to an individual in Charleston, W.V., for its transvaginal mesh. Bard Composix Kugel Hernia Patch-Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202: Code Information: Recalled Lot Numbers: 43AOD 43LOD 43BOD 43APD 43COD 43BPD 43DOD 43CPD 43EOD 43DPD 43FOD 43EPD 43GOD 43FPD 43HOD 43GPD 43IOD 43HPD 43JOD 43IPD 43KOD; Market Wthdrawal Lot Numbers: 43JPD 43DQD 43KPD 43EQD 43LPD 43FQD 43AQD 43GQD 43BQD … Board-certified physicians medically review Drugwatch content to ensure its accuracy and quality. Bard received reports that the Kugel Patch was failing as early as 2002. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. Bard finally recalled more than 137,000 of the devices between 2005 and 2007. In 2014, C.R. The manufacturers sterilize the products after they are packaged and it lasts … (2007, January 30). News FDA Recalls Additional Bard Composix Kugel Hernia Patches 2001/viewarticle/844574 Journal Article False Reduction of an Inguinal Hernia Treated by Kugel Patch Repair via an Anterior Approach Benefits of Bard 0010201 Composix Kugel Hernia Patch: • Can be performed through a small 3-4cm incision • Covers the entire groin region, reducing risk of recurrent or missed hernias • Same mesh placement as in a laparoscopic repair without the potential costs and complications On December 22, 2005 the FDA issued an immediate recall of Bard Composix Kugel Mesh Hernia Repair Patches and updated the list on March 31, 2006 and again on January 24, 2007. An Emmy-winning journalist, he has reported on health and medical policy issues before Congress, the FDA and other federal agencies. We will direct you to one of our trusted legal partners for a free case review. Generally, however, large groups of settlements do not occur until such time as a few lawsuits are tried before a jury, and the manufacturer is able to more thoroughly understand its financial risk. Our attorneys are looking at all possible … The failure rate appeared higher than normal. The recalled Bard Composix Kugel Hernia Mesh Patch remained on market long after injuries due to defects in the hernia patch were known to the manufacturer according to documents recently obtained from the U. S. Food and Drug Administration and published in a recent New York Times article by Barry Meier. If you have questions about the Composix Kugel Mesh hernia repair patch litigation, contact medical device lawyer Don Migliori by email or call 1.800.768.4026. 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. The device gained FDA approval in 1996, but when the company began introducing larger versions of the patch in 2002, reports of problems with the mesh material and memory recoil ring began to pour in. Every day innocent consumers are injured and killed by dangerous drugs and medical devices. Bard has offered a $184 million settlement to 3,000 Kugel hernia patch-implanted patients. This mesh helps healthy tissue grow … It was made by C.R. The Bard Composix Kugel Mesh Patch is used during surgery to repair ventral (incisional) hernias. Part # 0010201 Exp 8/16. The hernia patch is a device intended to repair ventral hernias. Composix Kugel mesh patches are primarily used to repair ventral hernias. A surgeon folded the Kugel Patch to insert it through small incisions. Contact a Composix Kugel Mesh Attorney. The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. According to the recall notice, the memory recoil ring on the patch could break and cause bowel perforations and fistulas. Z-0524-06 - Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206: 1 02/22/2006 Davol, Inc., Sub. Bard 0010201 Composix Kugel Hernia Patch, Small Oval 8cm x 12cm. The Kugel Mesh Patch, used to repair ventral (incisional) hernias, was recalled because the "memory recoil ring" that opens the Mesh Patch can break in the intra-abdominal (inside the belly area) space, which can lead to bowel … Calling this number connects you with a Drugwatch representative. The size of the incision was reduced by the metal ring in the Kugel Patch. Bard. Bard and its subsidiary Davol recalled limited lots of the Kugel hernia patch in 2005, 2006 and again in 2007. The FDA declared it a Class I recall — the agency’s most serious type. For these patients, there are several ways to tell if your hernia device is a Bard Kugel Patch: Depending on the size and shape of the device, Bard Kugel Patches have the following product numbers1: The reliance of the Bard Kugel Patch on polypropylene plastic is what makes it defective and prone to hurt people. Drugwatch's trusted legal partners support the organization's mission to keep people safe from dangerous drugs and medical devices. Bard won the first trial in the MDL. The problems with the Bard Kugel Patch have spawned numerous hernia mesh lawsuits. The results pinned the problem on the ring’s design. The problems led to several recalls and thousands of lawsuits. This causes chronic pain, particularly if nerve endings have formed in the ingrowth. It had a defective ring that could break and puncture organs. The patch is placed behind the hernia defect through a small incision. Not for human use in the US. The Composix Kugel Mesh patch is surgically implanted via a … Unfortunately, a large number of these memory recoil rings have … Very helpful with any questions and concerns and I can't thank them enough for the experience I had. The migrations resulted in bowel obstructions and punctures. Bard Composix, a brand of hernia mesh, is mainly used to treat a hernia, which occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Defective hernia mesh devices lead to chronic pain, constipation, bowel obstruction, bulging, sexual dysfunction and additional surgeries to remove the mesh. History of Hernia Patch Raises Questions on Implant Recalls. A hernia occurs when part of an internal organ pushes through an opening in the organ’s wall and often presents itself as a painful lump in the abdomen or groin. Bard subsidiary Davol Inc., were designed with a “memory recoil ring” that allowed the patch to be folded, inserted through a small abdominal incision and, once in place, spring open and lie flat over the affected area. “The Bard® MK™ hernia repair technique is a minimally invasive, tension-free technique that can be completed through a small 4-6 cm incision and minimal requirement of fixation. Retrieved from, U.S. Food and Drug Administration. The Bard Composix Kugel patch is specifically designed for use in open ventral hernia repair because it eliminates the tension and strain on surrounding muscles and ligaments, and therefore reduces discomfort after surgery. New York Times. The shrinkage also compromised the strength of the metal ring inside the patch, which could break and impale the patient if not corrected. The patch is placed behind the hernia defect through a small incision. What’s … C. R. Bard, Inc. 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