Bard then further expanded the st product line by applying the st coating to its ventralex patch. The bard ventralex hernia patch is intended for use in all forms of hernia repair requiring reinforcement with a non absorbable support material. Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. It is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. Bard kugel, 3dmax, ventralex, sepramesh kugel mesh 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.
This technique is designed to eliminate the lateral dissection typically. Bard ventralex hernia mesh silent recall issued due to. The bard ventralex and the bard ventralex st are implantable medical devices made by the company c. The ventralex st hernia patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias and deficiencies caused by trocars. Ventralex hernia mesh caused permanent harm within months. The fda granted bard 510k clearance for then ventralex st on march 23, 2011. If you had surgery to repair a hernia and developed a subsequent complication or injury, contact stern law today to find out if you could be eligible to file a lawsuit for damages against the manufacturer.
Since october 2005, there have been three separate recalls involving different sizes of davol bard composix kugel hernia mesh, which contain a memory recoil ring. There have been recalls for these bard hernia mesh devices. People who suffered complications from bard ventralex st hernia patch products are seeking lawyers for filing lawsuits against the manufacturers, claiming the devices were defectively designed and caused them serious injuries. Bard is facing a new ventralex hernia mesh lawsuit from a tennessee woman, alleging the hernia mesh product was unreasonably dangerous. If you or a loved one suffered complications or injuries from a davol bard ventralex hernia patch or ventralex st patch implanted during a hernia repair surgery, you may be entitled to recover compensation from a ventralex hernia patch lawsuit or settlement a team of medical device injury lawyers and class action attorneys is investigating injury lawsuit cases and settlement claims of. 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.
Hernia surgery is one of the most common types of surgeries that are performed. Free consultation hernia mesh recall list according to the us food and drug administration fda the following recalls. 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. Bards ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Hernia mesh mess bard davol hernia mesh lawsuit update. The ventralex hernia mesh lawsuit is against bard and its subsidiary davol inc. Currency all prices are in aud currency all prices are in aud. According to allegations raised in a product liability lawsuit filed over complications from bard ventralex hernia mesh, a silent recall was.
Ventralex hernia mesh lawsuit joining thousands of others. His surgeons implanted him with the defective bard ventralex st mesh at this time. Ventralex is a hernia mesh patch made of polyproplene. According to kamps lawsuit, he underwent laparoscopic umbilical hernia repair surgery in february 2016. Ventralex hernia mesh lawsuit ventralex hernia patch. This time it is the ventralex hernia patch, a mesh developed by bard subsidiary davol.
Ventralex st umbilical hernia mesh deployment dr pradeep sharma. The closest thing to recall has been bards decision to replace the plastic ring with sorbaflex memory material. Ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Within months, it was clear that the hernia mesh had failed when kamp began to suffer debilitating pain. Bard ventralex st hernia patch bard mesh perfix plug baron and budd. Food and drug administration fda has recalled the ventralex or the ventralex st. It was reported the patient was implanted with a bard ventralex st hernia patch. Ventralex hernia mesh lawsuit 2017 hernia mesh settlement 2018. This patch however was recalled by bard as a result of reports of various complications arising from its use. Ventralex hernia patch by cr bard medline industries, inc. Bard ventralex hernia patch lawsuit alleges mesh incompatible with human tissue. Accessgudid bard ventralex hernia patch 0080174355 bard ventralex hernia patch small circle with strap.
Bard hernia mesh lawsuit dangerous side effects reported. The mesh was approved using bards ventralex hernia patch, a hernia mesh approved by the fda in 2002, as a predicate device. Bard hernia mesh linked to injuries drug and device watch. Bard, the company behind vaginal meshes, ivc filters, and the kugel hernia mesh is once again a named defendant in a lawsuit over one of its medical devices.
In the 510k application, bard described the ventralex st hernia patch as being composed of a top layer of polypropylene 0. After numerous hernia repair surgeries with bards ventrio and ventralex meshes, a florida man has stepped forward to take the manufacturers to task for knowingly concealing serious design defects to boost profits, resulting in permanently debilitating injuries from the popular hernia patch products. Bard may be defectively designed, making it be incompatible with human tissue causing health complications in people who have is surgically implanted. There is currently no ventralex mesh recall by the fda. Class 2 device recall bard ventralex st medium circle. Patch, hernia, ventralex, 0010301, davol, bard, repair. Ventralex st umbilical hernia mesh deployment dr pradeep. Ventralex st medium circle with strap hernia patch diameter 6. However, to gain approval, bard said ventralex was similar to its other mesh product, kugel. 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.
Ventralex mesh is a patch composed of polyproplene. Bard ventralex hernia patch, small circle w strap, 1. The ventralex is a hernia mesh patch made from polypropylene. The ring allows the product to spring open once implanted, adding structural support and stability. An fda class 1 recall is the most urgent type of recall. 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 2 device recall bardventralex hernia patch fda. The table below provides the hernia mesh recall list updated for 2019. Bard 3dmax mesh ventralex sepramesh ip hernia patch. The closest thing to recall has been bards decision to replace the plastic ring with sorbaflex memory material a decision that has been referred to as a silent recall that acknowledges the dangers presented by the products earlier design. It is estimated that every year as many as 750,000 people undergo hernia repair surgery. Although hernia mesh implants have helped improve the quality of life in many patients, there have been serious complications and adverse side effects associated with these devices. The bard ventralex hernia patch is the first prosthesis specifically designed for small ventral, umbilical, and epigastric hernia repairs positioning straps to facilitate placement and suturing the polypropylene mesh side encourages tissue ingrowth into the abdominal wall while the eptfe layer, with submicronal porosity, minimizes tissue. The kugel mesh is a circular patch featuring an innovative springloaded ring. The ventralex hernia patch, manufactured by barddavol, has been linked to a number of serious side effects including bowel perforation, bowel obstruction, chronic intestinal fistula, and serious infection.
Tracy is having problems with her hernia repair patch and requires. The physician of one patient specifically reported a number of adverse events to the maude database. Hernia mesh recall list a current list of recalled hernia mesh devices. Complaints regarding ventralex st hernia patch include pain and adhesions. Bard, through its bard davol division, is one of the largest manufacturers of hernia mesh. Bard surgical mesh lawsuit hernia complications drug dangers. No recall has been announced by the fda and nor has there been a ventralex mesh. When a patient is diagnosed with a hernia surgery is the only permanent treatment possible. Bard then developed its ventralex st hernia mesh by combining the sepramesh with its kugel mesh patch. A bard ventralex lawsuit indicates the manufacturer knew there were problems with the hernia patch and issued a silent recall in december 20 to address them but did not tell the medical. There is a bard davol multidistrict litigation, including ventralex mesh, which is.
She alleges the company either knew or should have known about potential hernia mesh complications. Bard ventralex hernia patch mesh health complications. We want you to tell us about the complications you experienced with the ventralex st hernia patch following your surgery. The woman filed this ventralex hernia mesh lawsuit soon after discovering the allegedly defective nature of the device. Over the course of bards involvement in hernia mesh manufacturing, the company has raised serious concerns and been subject to multiple fda warnings and recalls for safety infractions and reports of complications caused by its hernia mesh products. Defects in the design of the hernia repair patches caused some of the plastic rings to break.
The device classification name is mesh, surgical, polymeric. Accessgudid bard ventralex hernia patch 00801741016479 bard ventralex hernia patch medium circle with strap. A class 1 recall means there is a reasonable probability of a person experiencing serious adverse health consequences or death if that person uses or is exposed to the product in its current. Ventralex st hernia patch the michael brady lynch firm. What she does have is the bard ventralex hernia patch, which according to her doctor is a cousin to the kugel mesh patch. Hernia mesh manufacturers recall their products if they discover a problem. Ventralex st hernia patch complications lawyer law.
Reviewing your ventralex st hernia patch complications case. Bard acquired the license for sepramesh, which is intended to separate polypropylene from the bowel, from sanofi genzyme in 2007. Twice in 2011, davol recalled the bard ventralex hernia patches due to labeling mixups. Bard, davol, 0010301, ventralex, hernia, patch, repair. This synthetic mesh is designed for use in hernia repair surgeries. Another barddavol hernia mesh product is ventralex, approved in 2002. Hernia mesh manufacturers recalled more than 211,000 units of hernia mesh from 2005 to march 2018 at least one manufacturer pulled a brand off the market after high failure rates. Over time, your bodys tissue grows naturally into the patch to help it stay in place and add strength to the repair. The skilled defective medical device lawyers at stern law, pllc, are currently litigating cases involving hernia repair with bard ventralex st mesh. Over the course of bard s involvement in hernia mesh manufacturing, the company has raised serious concerns and been subject to multiple fda warnings and recalls for safety infractions and reports of complications caused by its hernia mesh products.
The kugel hernia patch is one of bards earliest and most problematic mesh products. There may be large cash claims from settlements in these bard ventralex st hernia patch lawsuits. Bard mesh, 5950009, bard mesh ventralex st hernia patch w. Similar to other hernia mesh devices, ventralex was approved under the fdas 510k clearance.
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