The ventralex hernia patch is a selfexpanding polypropylene and eptfe patch. Bard ventralex st hernia mesh complications, failure result. The ventralex hernia patch is a selfexpanding polypropylene and. She reported having a ct scan and mri that showed she had multiple recurrent ventral hernias. Ventralex mesh in umbilicalepigastric hernia repairs. Increases the security of the laparoscopic inguinal hernia repair. It is used in about 90 percent of hernia repair surgeries in the u. Adhesions to mesh after ventral hernia mesh repair are detected. Ventralex hernia patch by cr bard selfexpanding polypropylene and eptfe patch that can be used to repair small ventral defects such as umbilical hernias and trocar site deficiencies allows for an intraabdominal, tensionfree repair. This technique is designed to eliminate the lateral dissection typically. It serves as the definitive resource for radiologists and other physicians, mri technologists, physicists, scientists, mri facility. Please consult package insert for more detailed safety information and instructions for use. Hernia mesh lawsuits stem from device complications like infection, pain, bowel obstruction, organ or tissue perforation and adhesion.
Mesh repair is becoming popular because of a low recurrence rate. Hernia repairs are commonmore than one million hernia repairs are performed each year in the u. The ventralex hernia patch is a selfexpanding polypropylene and eptfe patch that can be used to repair small ventral defects such as umbilical hernias and trocar site deficiencies. The device allows for an intraabdominal, tensionfree repair. The bard ventralex and the bard ventralex st are implantable medical devices made by the company c. Ventralex hernia mesh lawsuit 2017 hernia mesh settlement 2018.
Two layers of monofilament polypropylene combine to form the unique and proprietary positioning pocket and strap of the. Ventralex hernia patch lawsuit 2017 and bard davol ventralex hernia patch lawsuits 2018. Magnetic resonance imaging of mesh position after ventral hernia repair. Many surgical mesh vicims are seeking justice and accountability as a result of allegedly defective bard ventralight st mesh and the bard ventralight st 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. Goretex hernia mesh causes severe injuries drug and device. However, in other series, which solely investigate ventralex repair in ventral hernias, similar or slightly higher recurrence rates were reported 34, 35. This technique is designed to eliminate the lateral dissection typically required for preperitoneal placement, which may help minimize post op pain. This product is contraindicated for the reconstruction of cardiovascular. The aim of the present study was to perform mri in patients after ventral hernia mesh repair, in order to evaluate mris ability to detect intra.
The complaint indicates that bard knew or should have known that the ventralex patch was unreasonably harmful, yet continued to market the hernia repair mesh as safe and effective. A clinically proven umbilical hernia repair solution designed for ventral, incisional. Ideal placement of the mesh is behind the defect, which is difficult to do without a large incision in these hernias unless done laparoscopically. However, to gain approval, bard said ventralex was similar to its other mesh product, kugel. Lawsuit information regarding injuries caused by the ventralex hernia patch. Also in july 2017, a patient reported she had a gastric bypass and ventral hernia repair at the same time using a ventralight st mesh patch. The aim of this prospective study was to evaluate an open intraperitoneal technique using the bard ventralex hernia patch in the treatment of small midline ventral hernias. The ventralex hernia patch is designed for intraabdominal repairs of umbilical and other small ventral hernias. To date, only one study exists evaluating this new prosthesis. Ventralex hernia mesh lawsuit ventralex hernia patch.
This oxygen cylinder got too close to the mri unit. A bard ventralex lawsuit claims the hernia patch has a coating with can cause inflammation and other problems resulting in mesh failure and the need for revision surgery. The safety and scientific validity of this study is the responsibility of. Ventrio hernia patch which contains the same sorbaflex memory technology. Sep 27, 2014 hernia mesh has been used by surgeons for more than 40 years and has a relatively safe track record. The device classification name is mesh, surgical, polymeric. Suffering complications from a ventralex hernia patch manufactured from bard davol.
Jul 03, 2018 a bard ventralex lawsuit claims the hernia patch has a coating with can cause inflammation and other problems resulting in mesh failure and the need for revision surgery. The ventralex st hernia patch uses sepra technology. Ventralex st hernia patch the michael brady lynch firm. If a defective or dangerous product was used during your surgery, substantial compensation may be available through a hernia. This case emphasizes the limitations of radiologic imaging in evaluating gi. The plaintiff was operated on to repair a hernia, during which operation a variety of surgical mesh manufactured, sold and marketed by defendants was implanted. Intraperitoneal mesh repair of small ventral abdominal wall. The goretex soft tissue patch is a biomaterial that is specially designed to meet the unique challenges of complex soft tissue procedures like laparoscopic hernia repair, inguinal herniorrhaphy, and even temporary bridging of fascial defects. 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. One side of the patch is coated with a hydrogel barrier which helps prevent organs and tissue from attaching to the mesh during the healing process. Nov 03, 2016 the complaint indicates that bard knew or should have known that the ventralex patch was unreasonably harmful, yet continued to market the hernia repair mesh as safe and effective.
Bard and other mesh manufacturers, alleging that the companies failed to adequately warn about the potential risks associated with their products. The parietex composite ventral patch is a mesh specifically designed for small ventral hernia repair. The smallest ventralex hernia patch allows for an intraabdominal, tensionfree repair with no transfacial suturing. An office chair was in the wrong place at any time. Ventral hernia repair mesh ventralex st partially absorbable polypropylene monofilament hydrogel pga 1710 inch diameter small circle with strap style. Sep 07, 2018 complications from the hernia mesh devices include additional surgeries to treat the hernia, organ perforation, hernia recurrence, intestinal blockage, infection and many more problems. Call 866 2803417 to find a ventralex hernia patch lawsuit lawyer today. Bard ventralex hernia patch mesh health complications november 9 2016 by lucy campbell santa clara, ca. Simple technique is clinically proven for reliable umbilical hernia repairs. 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. Two layers of small pore, heavyweight polypropylene adhered to a sheet of eptfe. The ventralex hernia patch is a medical product used to treat some hernias.
Mri safety for wire mesh for hernia doctor answers on. Bard ventralex hernia patch mesh health complications. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. The patch is placed behind the hernia defect through a small incision. Please consult package insert for more detailed safety information and. Ventralex st medium circle with strap hernia patch diameter 6. The ventralex hernia patch is a composite ptfepolypropylene patch allowing intraperitoneal placement behind the hernia defect through a small incision, and without the cost of laparoscopy. Ventralex hernia patch medium circle with strap diameter 6. The efficiency and safety of the bard ventralex tm hernia patch was proven in eight studies over the last few years 8910 11 121415. Nov 09, 2016 bard ventralex hernia patch mesh health complications november 9 2016 by lucy campbell santa clara, ca. Magnetic resonance imaging of mesh position after ventral hernia. Ventralex hernia patch incompatible with human tissue. Hello, i needed an mri for my knee to rule out a miniscus tear when they found out i had a mesh hernia repair they advised me against the mri becuase they did not know the contents of the patch. A sterile, flat or threedimensional 3d, wovenknitted or porous material made of one or more nonbioabsorbable synthetic polymers e.
Ventralex hernia circle patch strap devine medical. Click a product category or division, or search for products. Tissue ingrowth into the polypropylene mesh side and deep placement of the prosthetic allows for a. Goretex hernia mesh device linked to severe complications what should i watch out for. 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 defective product. Ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Uncoated, mediumweight monofilament mesh with absorbable hydrogel barrier for laparoscopic ventral hernia repair lowprofile design helps facilitate trocar deployment and mechanical fixation easy to cut for customized shape and size. A florida woman is suing the makers of ventralex hernia mesh, alleging that. Umbilical and epigastric hernias have historically been repaired without mesh resulting in recurrence rates in some series of up to 40%. Ventralex hernia patch by cr bard medline industries, inc. Ventralight st mesh by cr bard medline industries, inc. Bard mesh, 5950009, bard mesh ventralex st hernia patch w.
Class 2 device recall bard ventralex st medium circle with. In february 2017, a patient reported having a ventral hernia repaired using a ventralight st hernia mesh patch. Conclusionetep is a minimally invasive approach which is safe, feasible and. The ventralex st hernia patch has been linked to many of the common hernia mesh complications mentioned earlier in this post. And the fda in 2014 issued a safety communication warning of. The responsibility for the content of aetna clinical policy bulletins cpbs is with aetna and no endorsement by the ama is intended or should be implied.
Hernia mesh can prevent a hernia from recurring, but it can also cause serious complications. It allows victims to seek reparation for their losses and forces the manufacturer to take. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer. Find a ventralex hernia patch lawsuit lawyer drug lawsuit. The ventralex hernia patch is used to repair ventral incisional hernias caused by thinning or stretching of scar tissue that forms after surgery. More than one million hernia repair surgeries are performed each goretex hernia mesh implant devices ahave ben recaleld due to causing severe complications.
Following the procedure, the patient began to experience severe abdominal pain. The bard ventralex hernia patch is intended for use in all forms of hernia repair requiring reinforcement with a non absorbable support material. Footnotebased on internal preclinical study 0506141814. Recent data suggests mesh repair of these hernias may decrease recurrent hernia rates. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars. The ventralex st hernia patch was approved by the fda in march 2011 through the agencys less rigorous 510k premarket notification program. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias. Patients and their doctors have submitted nearly 40 adverse event reports relating to complications of the ventralex st device. Bard ventralex hernia patch lawsuit alleges mesh incompatible. The shape, size and the specific fixation and deployment system have been designed for optimal abdominal wall conformability and easy deployment and fixation. Through 20, contained a permanent pet memory recoil ring. Bard, davol, 0010301, ventralex, hernia, patch, repair. Ventralex hernia patch is a selfexpanding, nonabsorbable, sterile prosthesis.
However, they have been connected to patients suffering from chronic pain and other medical complications when the. The mesh was approved using bards ventralex hernia patch, a hernia mesh approved by the fda in 2002, as a predicate device. Ventral hernia repair mesh ventralex st partially absorbable polypropylene monofilament hydrogel pga 315 inch diameter large circle with strap style patch, hernia ventralex cir lg3. The fda 510k approval program allowed bard to skip premarket clinical studies and research intended to ensure the safety of the ventralex hernia mesh. Narbenhernienreparation mit intraperitonealem netz offen. Designed to address key issues in laparoscopic inguinal hernia repair, progrip laparoscopic selffixating mesh delivers tackfree fixation over the entire anatomy 2, including below the inguinal ligament where traditional tacks cannot be placed. Goretex hernia mesh causes severe injuries drug and. Contact a hernia mesh lawsuit attorney now to discuss legal options. Ventralex hernia mesh lawsuit ventralex hernia patch attorney. A ventralex hernia patch lawyer notes that a lawsuit alleges the devices may be made of materials biologically incompatible with human tissue, potentially leading to severe health complications. Designed to address key issues in laparoscopic inguinal hernia repair, progrip laparoscopic selffixating mesh delivers tackfree fixation over the entire anatomy 2, including below the inguinal ligament where traditional tacks cannot be placed increases the security of the laparoscopic inguinal hernia repair.
The surgical mesh used in the surgery was known as he ventralight st hernia patch herein referred to as product and it was designed, manufactured, packaged, labeled. Understanding bard ventralight st cases with stern law. Class 2 device recall bard ventralex st medium circle. Bard may be defectively designed, making it be incompatible with human tissue causing health complications in people who have is surgically implanted. The patch is then held open by a memory recoil ring that allows the patch to be folded for insertion and later spring. Mesh is proven to significantly reduce the risk of hernia recurrence. Ventralex st hernia patch was designed for the repair of umbilical and other small ventral hernias. Cr bard selfexpanding polypropylene and eptfe patch that can be used to repair small ventral defects such as umbilical hernias and trocar site deficiencies. As more information comes to light about the potential for hernia mesh devices to cause devastating side effects in patients, more and more hernia mesh recipients are pursuing legal claims against ethicon, c. Hernia mesh complications cause individuals to experience severe pain and disability, including hernia recurrence and the need for additional surgery to remove the patch. Despite these benefits, thousands of patients annually experience what are considered possible mesh related complications prolonged pain or discomfort or infection. Mar 29, 2018 gmdn preferred term name gmdn definition. After the procedure, she developed welling and redness at the site of the hernia repair.
Abdominal hernia surgical mesh, synthetic polymer, nonbioabsorbable a sterile, flat or threedimensional 3d, wovenknitted or porous material made of one or more nonbioabsorbable synthetic polymers e. The ventralex hernia patchs proven design aids placement, positioning and fixation. Ventralex st hernia patch nashville product liability lawyers. Goretex dualmesh is still on the market and still causing serious complications in patients. She underwent an abdominal ct scan and was treated with antibiotics for suspected cellulitis. Sep 24, 2008 i had umbilical hernia repair in may 20 and the mesh is the ventralex st hernia patch. Bard, the manufacturer of the ventralex hernia patch, knew of the unreasonable harm the surgical patches could pose when used to repair a hernia. On september 14, 2017 julio nunez of randolph county, north carolina filed a ventralight st hernia patch lawsuit against c. Mri bioeffects, safety, and patient management is a comprehensive, authoritative textbook on the health and safety concerns of mri technology that contains contributions from more than forty internationally respected experts in the field. The ama disclaims responsibility for any consequences or liability attributable or related to any use, nonuse or interpretation of information contained in aetna clinical policy bulletins cpbs. Hernia mesh is a surgical implant often made of a synthetic plastic called polypropylene that reinforces torn or damaged tissue around hernias and strengthens it as it heals. I have pain in the umbilical area and was told by a surgeon that the mesh had rolled. Bard ventralex st hernia mesh complications, failure. Bard mesh, 5950008, bard mesh ventralex st hernia patch w.
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