Paul street suite 700, dallas, tx 75201 who associates. Davol noted that the newer hernia meshes utilize a lighterweight mesh and absorbable materials, which leave less implant material behind in. The composix kugel patches unknown bard mesh perfix plug and ventralex hernia patch used in patients hernia repair surgery failed, resulting in patients suffering pain and harm. Another barddavol hernia mesh product is ventralex, approved in 2002. Like the kugel mesh, the ventralex is a polypropylene mesh patch that contains a springloaded memory coil. Composix kugel mesh patch marlex mesh bard ventralex st hernia patch bard mesh perfix plug baron and budd. Suffering complications from a ventralex hernia patch manufactured from bard davol.
Many patients who have been implanted with hernia mesh may have serious postsurgical complications, some of which may. Complaints regarding ventralex st hernia patch include pain and adhesions. While the jury in that case did find that the composix kugel patch was defective, the plaintiff was unable to prove that his hernia repair problems were the. 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. It is estimated that every year as many as 750,000 people undergo hernia repair surgery. Ventral hernias occur when scar tissue, caused by a surgical incision, stretches and becomes thin. The physician of one patient specifically reported a number of adverse events to the maude database. 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.
A ventralex hernia patch lawsuit is a civil claim filed on behalf of an individual or the family of an individual who has suffered injury or death as a result of the. In 2015 patient had abdominal pain, nausea and vomiting and she was admitted to. Bard 3dmax mesh ventralex sepramesh ip hernia patch. Bard hernia mesh linked to injuries drug and device watch. Bard composix hernia mesh lawsuit bard composix hernia mesh. Both products are laminate meshes comprised of a nonabsorbable polypropylene mesh prolene encapsulated by a polydioxanone polymer and a layer of absorbable oxidized regenerated cellulose orc. The first of the two kugel mesh hernia patch lawsuits brought to trial ended in a victory for the defense last april.
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. Those techniques include the use of sutures, the use of organic material from the patient, from a cadaver or from an animal, and the use of synthetic meshes. Composix kugel mesh by bard davol specifically designed to prevent the occurrence of incisional hernias, the composix mesh was designed with a recoil ring built in that allowed the mesh patch to be inserted into. Bard davol hernia mesh mess hernia mesh lawsuit update. The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a substantive equivalent to a product or products already approved by the fda. Tissue ingrowth into polypropylene mesh side and deep placement of prosthetic allows for a strong repair and reduced chance of recurrence. In 2010, the patient underwent surgery with implant of a bard ventralex hernia patch for the repair of an incisional ventral hernia. This synthetic mesh is designed for use in hernia repair surgeries. Composix kugel mesh patches are primarily used to repair ventral hernias.
In october 2011, bard issued an urgent class 2 fda recall of the ventralex st medium circle with strap hernia patch. If you have been injured by a mesh implant used for your hernia repair surgery. The shape, size and the specific fixation and deployment system have been designed for optimal abdominal wall conformability and easy deployment and fixation. Intraperitoneal tensionfree repair of a small midline ventral abdominal wall hernia. Ventralex mesh is a patch composed of polyproplene. According to the lawsuits, plaintiffs who received bards polypropylene mesh devices allege they were seriously injured by mesh failures and were forced to have additional, unplanned surgeries to have the mesh removed from their bodies and internal injuries repaired. There are a variety of techniques that surgeons can employ to repair a hernia. Several plaintiffs claim they have suffered injuries after being implanted with bard ventralex hernia mesh devices, causing various internal injuries and serious pain. Fda class 1 device recall davol composix hernia patch. One of those products, the kugel hernia patch, was never fda approved for effectiveness and safety. The fda has issued the following hernia mesh recallsaccounting for hundreds of thousands of implanted devices since 2005. A clinically proven umbilical hernia repair solution designed for ventral. Many victims who were implanted by surgeons with ventralex hernia mesh medical devices are now pursuing mesh lawsuits against bard and bards subsidiary, davol inc.
Bard mesh devices have been recalled in recent years, including the ventralex, 3d max, sepramesh, composix, perfix plug, ventralight, marlex, visilex and kugel patch models. While the jury in that case did find that the composix kugel patch was defective, the plaintiff was unable to prove that his hernia repair problems were the direct result of the negligent design. 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. Ventralex hernia mesh lawsuit ventralex hernia patch. Hernia mesh lawsuits filed against manufacturers claim serious injuries as a result of mesh failure. There are already thousands of hernia mesh lawsuits filed against the manufacturers of various hernia mesh products for the injuries they have allegedly caused. 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. Jan 30, 2018 composix kugel mesh patches are primarily used to repair ventral hernias. Bard hernia mesh lawsuit dangerous side effects reported. Retrospective analysis of umbilical, epigastric, and small incisional hernia repair using the ventralex hernia patch. Bard is facing more than 2,000 hernia mesh lawsuits for complications caused by several bard and davol hernia repair mesh products. The composix lp mesh is a lightweight, low profile prosthesis that. But the company waited almost three years before recalling its mesh.
Ventralex hernia mesh lawsuits 2020 hernia mesh settlement. 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. Ethicon created two different proceed hernia mesh products, the proceed surgical mesh proceed sm and the proceed ventral patch proceed vp. 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. Complications of bard hernia mesh surgery may include. The bard composix hernia mesh is a medical product used to treat some hernias. Hernia mesh lawsuits in arizona and throughout the country. Cr bard selfexpanding polypropylene and eptfe patch that can be used to repair small ventral defects such as umbilical hernias and trocar site deficiencies. The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant. Bard hernia mesh hernia mesh products manufactured by c.
As of 2019, thousands of new lawsuits had been filed against mesh manufacturers bard davol, ethicon and atrium. To fix the mesh against the abdominal wall the 4 quadrants of the patch were. Severe or chronic pain serious infection mesh shrinkage. At least one patient allegedly had numerous adverse reactions to composix ex mesh. Polypropylene hernia mesh products liability litigation. Hernias occur when underlying tissue or organs squeeze through weak spots in the abdominal wall. Open intraperitoneal mesh repair for umbilical hernias. 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. In 2015, manufacturing of atrium medicals cqur mesh was temporarily halted after the fda had issued numerous warning letters regarding sterility and. Bard composix hernia mesh lawsuit bard composix hernia. Hernia mesh lawsuits stem from device complications like infection, pain, bowel obstruction, organ or tissue perforation and adhesion. Mesh is the preferred repair as it is supposed to minimize the possibility for infections and pain. The ventralex hernia patch is a composite ptfepolypropylene.
Like many other mesh products, it was approved via the 510k program. What you need to know before you file a hernia mesh lawsuit below is a list of these manufacturers and their mesh products, many of which have been subject to fda or voluntary recalls. Food and drug administration fda approved the kugel mesh patch in 1996. Bard and subsidiary, may have been responsible for thousands of serious medical injuries. This patch however was recalled by bard as a result of reports of. A lowprofile, easy to use mesh with the effectiveness. The parietex composite ventral patch is a mesh specifically designed for small ventral hernia repair. Ventralex hernia mesh lawsuit ventralex hernia patch attorney. Attorneys from seeger weiss are part of the executive committee that will lead the mdl2846 cases against c. Ventralex mesh in umbilicalepigastric hernia repairs. Patients patch migrated from its original position to just under the skin. Bard davol, which produces the composix, ventralex, kugel patch, perfix, and. Ventralex hernia patch and ventralex st hernia patch.
Additionally, she suffered omental adhesions as a result of the failed bard ventralex hernia patch. Physiomesh is a patch used to strengthen the abdominal wall in hernia repair surgeries. A bard composix hernia mesh lawsuit may be an option for people who suffered severe complications associated with the devices. The ventralex patch including ventralex st was a very common mesh product that has been alleged to cause significant problems. Recent data suggests mesh repair of these hernias may decrease recurrent. Many patients who have been implanted with hernia mesh may have serious postsurgical complications, some of which may take years to become evident but may also be fatal. Hernia repair surgeries are an everyday occurrence. R bard for injuries and complications caused by bard hernia mesh. There have been reports of complications arising from the use of davol c. Perfix plug ventralight ventralex hernia patch ventralex st patch ventralight st patch ventrio st ventrio patch composix composix kugel hernia patch. At this surgery, a bard composix kugel hernia patch was used to replace the bard ventralex hernia patch that was removed. A 2006 class i recalls was issued due to threat of severe injury that could be caused by the composix kugel patch, manufactured by c. Bard surgical mesh lawsuit hernia complications drug dangers. Hernia mesh lawsuits hernia repair products causing injuries.
Jul 12, 2011 the first of the two kugel mesh hernia patch lawsuits brought to trial ended in a victory for the defense last april. And like the kugel mesh products, the memory coil caused a number of serious injuries to patients implanted with ventralex. Surgical hernia mesh is most often used in hernia repair surgery to increase patient outcomes and provide longterm support for the injured area, usually the abdomen. They are actively investigating all hernia mesh cases.
Polypropylene and permanent eptfe barrier designed for ventral hernia repair. Read a lawsuit filed in maryland alleging the defendants ventralex hernia mesh patch was defectively designed and caused the plaintiff severe pain and bowel problems, which will likely require surgery to remove the mesh. Hernia surgery is one of the most common types of surgeries that are performed. The mesh was approved using bards ventralex hernia patch, a hernia mesh approved by the fda in 2002, as a predicate device. Bard received reports that the kugel patch was failing as early as 2002. Ventralex is a hernia mesh patch made of polyproplene. Fda class 1 device recall davol composix kugel hernia patch. A clinically proven umbilical hernia repair solution designed for ventral, incisional, umbilical and epigastric hernia repair as well as trocar site closure, with an absorbable barrier featuring sepra technology. Hernia mesh is a mesh like substrate which is implanted during a surgical procedure to stabilize abdominal tissue for hernia repair. Ventralex hernia mesh lawsuit 2017 hernia mesh settlement 2018. Ventralex hernia patch by cr bard medline industries, inc. Through late last year, more than 2,700 plaintiffs had.
A ventralex hernia mesh lawsuit may be an option for hernia repair patients who suffered severe complications associated with the devices after hernia repair surgery. Ventralex hernia mesh patch may lead to patient 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. There were several recalls issued in 2005 and 2006, and then another wave of recalls occurred in 2007. The ventralex hernia patch 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. Bards ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. 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. Hernia mesh is a meshlike substrate which is implanted during a surgical procedure to stabilize abdominal tissue for hernia repair. The fda sent a recall letter regarding the composix kugel mesh patch in march 2006 to physicians and patients advising patients implanted with a recalled device to seek immediate medical attention. Feb 20, 2018 the first ventralex patch was approved in 2002.