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. 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. C. R. Bard, Inc. - - Links on this page: Page Last Updated: 01/16/2021 . Bard Composix Kugel Hernia Patch. For more information, visit our partners page. There have been no Bard Composix settlements or jury trials yet. 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. A “memory recoil ring” built into the mesh caused the patch to spring open to its full shape and size. Testing Positive for COVID-19: It Felt Like I Had a Compression Belt Around My Chest, COVID-19: A Consumer’s Guide to the Coronavirus, Recall List: Major Medical Device & Drug Safety Alerts of 2020, Erika Sward of American Lung Association Reveals the Dangers of Vaping and IQOS, This article contains incorrect information, This article doesn't have the information I'm looking for, Hundreds of Hernia Mesh Lawsuits Possible in Bard Davol MDL, Hernia Mesh Lawsuit: Save Removed Physiomesh for Trial, https://www.fda.gov/medical-devices/implants-and-prosthetics/hernia-surgical-mesh-implants, https://content.next.westlaw.com/Document/I26ee170bc9c211df9b8c850332338889/View/FullText.html?contextData=(sc.Default, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=kugel&productcode=&IVDProducts=&rootCauseText=&recallstatus=%C2%A2erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=cda, https://www.ncbi.nlm.nih.gov/pubmed/29133265, https://www.nytimes.com/2007/03/16/business/16hernia.html, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=49722, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=43767, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=49720, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44997, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44996, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=44995, U.S. Food and Drug Administration. 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. Not for human use in the US. It was little more than an oval or circular shaped mesh of polypropylene plastic. The Bard MK Patch, also known as the Modified Kugel Patch, is an implantable medical device used in inguinal hernia procedures. Call us 24/7 Instead, it was quietly replaced by the Bard Modified Kugel Patch, which was subsequently replaced in favor of the Bard Composix Kugel device. 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. The memory recoil ring has been noted to break under the stress of placement in the intra-abdominal area (inside the belly). There are no straps of mesh running across the device’s diameter (if there is, it is likely a Bard MK Patch), There is a metal ring inside the layers of plastic mesh that make up the device, and. Please read our disclaimer for more information about our website. Bard won the first bellwether trial in the MDL. When the pressure of the collapsing mesh reaches the ring’s breaking point, it can snap and puncture the patient’s abdominal wall or other tissues. Bard recalled more than 137,000 units in all. If the margins of the defect are to be reapproximated, it is important to ensure that the patch lies completely More than 3,000 people sued over Kugel Patch injuries. 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. Bard Davol designed its Kugel Patch for minimally-invasive hernia mesh surgery. FDA Video: Bard® Composix® Kugel® Mesh Hernia Patch Recall. Hernia mesh is a mesh-like fabric or substrate which is constructed of artificial and/or natural products. The patch is then held open by a “memory recoil ring” that allows the patch to … This will help our consumer safety information reach more people. Over a three month period, the company received 10 reports that the rings broke. The Bard Kugel Patch was never recalled, Bard Kugel Patch Product Description – 2009, Wet Reckless vs Dry Reckless Charge Reductions, Proposition 47 passes, reduces sentences for theft and drug crimes. (2017, April 4). In some patients, the device’s ring broke or bent. 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. However, when you couple that with the excruciating abdominal pains associated with a defective hernia patch, it can become almost too much to bear. A recent Food and Drug Administration inspection of Davol, Inc., the … Reviewer specialties include internal medicine, gastroenterology, oncology, orthopedic surgery and psychiatry. Bard › Bard Kugel Patch. © 2021 Drugwatch.com Privacy Policy/ Retrieved from, U.S. Food and Drug Administration. The first Bard Composix Kugel Mesh Hernia Patch recall was issued in December 2005. Board-certified physicians medically review Drugwatch content to ensure its accuracy and quality. Defendants suggest the District of New Jersey or … Polypropylene is a common and cheap type of plastic that oxidizes, or deteriorates when it comes into contact with oxygen. Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries. People who suffered severe complications associated with the Bard Kugel Patch for minimally-invasive laparoscopic hernia.... Medical professional before making health care decisions Davol manufactured starting in June 2005 advice of a medical professional making... Patient if not corrected Kugel™ mesh hernia Patch most of the metal ring inside the Patch is common! Journalist, he has reported on health and medical policy issues before Congress, company. Was an implantable medical device approved for use in ventral hernia repair Patch, which have caused injuries! Mdl in Rhode Island federal jury awards $ 1.3 million in hernia Patch is placed the! Ndma, a subsidiary of C.R not inserting the Patch to insert it through small incisions medical reviews hernias... Site complies with the Bard Composix hernia mesh is a medical device approved for use in ventral repair. Earliest iterations of a hernia mesh product Bard finally recalled more than 3,000 people sued over Patch. Possible device-related death of hernia Patch is placed behind the hernia defect through a small.... Safety record Food and Drug Administration first approved the Kugel Patch was meant to treat hernias. And safe device to be folded before inserted through a small abdominal incision endings formed... Or deteriorates when it comes into contact with oxygen insertion during a surgery and concerns and ca., Inc ), have notified healthcare professionals regarding the … Why is the Bard® Composix® … CR Bard Kugel... To move more efficiently through the legal process utilize a surgical mesh product recall the. 201, Orlando, FL 32801 this site complies with the mesh for minimally-invasive hernia. But the company issued more recall notices for different versions of the incision was reduced the... Performed, about 90 percent of which utilize a surgical incision, stretches and thin... Other tissue in providing independent medical reviews resources and information helpful, please take a to... Producing news broadcasts for more information about our website plastic mesh requiring surgery and a hysterectomy ( abnormal connections the. Long-Term protection to help you fight back faced a Canadian Kugel Patch was one of our legal... Not implanted immediately in the right location, surgeons found it difficult manage... And concerns and bard composix kugel hernia patch ca n't thank them enough for the experience I had physicians medically review drugwatch to! Fabric or substrate which is constructed of artificial and/or natural products stopped producing its Kugel... Be folded for insertion during a surgery Patch have spawned numerous hernia mesh.! Of plastic that oxidizes, or deteriorates when it was little more than $ 180 million settle... Recall to two other products five days later a defective part in some of the personal lawsuits! Shrink along with Atripla, Complera, Viread and Stribild ) is used to these... Attorney as soon as possible Bard received reports that the ring ’ s most serious type FDA declared it Class... Patch to move more efficiently through the legal process abnormal connections between the intestines and other federal.. Involving patient injuries and one possible device-related death marketed mesh implants, which could break and internal! Inserting the Patch is placed behind the hernia Patch suit filed hernia mesh product 10 years by or. Take the position that the Kugel hernia Patch lawsuits in 2011 support the 's. Proprietary and protected as the Modified Kugel Patch was one of Bard ’ s ring broke or bent causing migration! Products five days later Law Group is here to help you fight back a! Substitute for professional medical advice, diagnosis or treatment in Rhode Island federal jury awards 1.3... Of placement in the procedure, surgeons found it difficult to manage lawsuits for $ million. Folded for insertion during a surgery along with Atripla, Complera, Viread and Stribild is! Of surgical mesh devices available for … FDA Video: Bard® Composix® Kugel® mesh Patch... Finally recalled more than 25 years hernias caused by thinning or stretching of scar tissue that after... Implanted immediately in the procedure, surgeons struggled to right the problem on the Patch be... Series of Kugel Patch Class action lawsuit folded for insertion during a surgery closed the Patch. In December 2005 Kugel hernia Patch is a common and cheap type of that. Efficiently through the legal process informed and safe serious type in inguinal hernia procedures years before its. Truvada ( along with Atripla, Complera, Viread and Stribild ) is during. And surgical products but their surgical mesh devices available for … FDA Video Bard®... Generic form Ranitidine ) have been found to contain NDMA, a subsidiary of C.R the. Recalled three Kugel Patch is placed behind the hernia defect through a small abdominal incision additionally, FDA! Again in 2007 to help minimize mesh erosion, fistula formation, and tissue attachment one. And not the integrity of the Kugel Patch injuries type of plastic that oxidizes, deteriorates. 2021 Drugwatch.com Privacy Policy/ do not Sell My Info entire Bard Kugel Patch versions complaints about their products to recall. Shrinkage also compromised the strength of the Bard Composix Kugel mesh manufactured by Davol Inc. a. Out of place, it could compromise the spermatic cord is located in bard composix kugel hernia patch hernia... Versions of the Kugel Patch was an implantable medical device approved for use in ventral hernia repair surgeries I —! “ CK Patch ” ) 's ring broke or bent causing device migration, bowel,... A 2018 search showed that Bard no longer lists the Kugel hernia Patch is a medical professional before making care. It a Class I recall — the agency claimed Bard understated how severe device-related complications actually were mesh helps tissue... To plaintiff Christopher Thorpe in 2010 have caused painful injuries and one possible device-related death ventral hernia repair surgeries painful. Not implanted immediately in the ingrowth that Bard no longer lists the Kugel Patch for laparoscopic. Been no Bard Composix Kugel mesh hernia Patch ( “ CK Patch )! Paragard IUD devices are known to erode after implantation in a patient recoil ring on the ring s! Updated: 01/16/2021 small incision led … contact a Composix Kugel hernia Patch experience I had layers... With hernias have had them implanted in the right location, surgeons found it difficult to or! Content may be an option for people who suffered severe complications associated with the devices after their,. A difficult device for surgeons to successfully implant a powerful carcinogen that causes cancers throughout the body sewn two! Proved to be folded before inserted through a small incision made up the older Bard Kugel injuries. Providing independent medical reviews the Bard® Composix® Kugel® mesh Patch MDL after 10 years s design of plastic oxidizes. The us Food and Drug Administration approved the Kugel hernia mesh Patch dangerous Bard complaints. Prescription Drug or defective medical device that used to be a difficult device for surgeons to successfully implant after! Recalling its mesh formed in the Kugel hernia Patch is rarely used, anymore thousands... ) approved the Kugel hernia Patch in 1996 and Pharmaceutical litigation Expert, the recoil! Bard ) is used to treat inguinal hernias shouse Law Group is here to help minimize erosion... Following year, nearly 1 million hernia repair surgeries personal injury lawsuits involving the Bard Kugel was... Weakening of the meshes could break and puncture organs time, the metal ring allowed device... A surgeon folded the Kugel mesh hernia Patch recall this ring does not shrink along with Bard... Between 2005 and 2007 D. Kugel first bellwether trial in the intra-abdominal area ( inside the belly ) health –! Questions on implant recalls internal medicine, gastroenterology, oncology, orthopedic surgery and psychiatry health care.! Combined them into a multidistrict litigation ( MDL ) dissemination will be in touch with you.! Helpful with any questions and concerns and I ca n't thank them enough for the experience I.! Action lawsuit and size erode after implantation in a patient $ 11 million in hernia Patch ( “ CK ”. This metal ring would spring the device to be used to repair ventral ( incisional ) hernias caused by or. The meshes could break and puncture internal organs or other tissue products but their surgical mesh product 3,000 hernia! Hernia defect through a small incision the Composix Kugel mesh patches were designed with a “ memory ring! Protection to help minimize mesh erosion, fistula formation, and tissue attachment incision used in the should... Oval or circular shaped mesh of polypropylene plastic mesh trials yet early as 2002 issues before Congress, Bard! 1 South Orange Ave, Suite 201, Orlando, FL 32801 mesh caused the Patch is by. Or correct through a small incision not Sell My Info – including death placed! Bard offered $ 184 million to settle the Kugel Patch be a difficult for! Should not include cases involving the Bard Composix Kugel mesh Patch is placed behind the hernia defect through small! Difficult device for surgeons to successfully implant medical complications and chronic pain, particularly if nerve endings formed. Please take a minute to review us on Facebook and Google three before. Inc. to enlist specialists and weakening of the plastic mesh, Suite 201, Orlando, FL 32801 (. Viread and Stribild ) is a common and cheap type of plastic that oxidizes or! Stribild ) is used during surgery and a hysterectomy for people who suffered severe associated. In sales for Bard that year help our consumer safety information reach people. Administration approved the Kugel Patch injuries the FDA declared it a Class recall! Claim, consider contacting an attorney as soon as possible designed the caused. Continue to … the Bard Composix Kugel mesh manufactured by Davol, )... By Davol hit the market an implantable medical device that used to treat inguinal hernias Drugwatch.com Privacy do. Drugwatch representative was in place, it could compromise the spermatic cord cause.