However, to gain approval, bard said ventralex was similar to its other mesh product, kugel. Patch, hernia, ventralex, 0010301, davol, bard, repair. Ventralex st umbilical hernia mesh deployment dr pradeep. Bard hernia mesh lawsuit dangerous side effects reported. Doctors use ventralex st hernia patches in several types of hernia repair, according to the manufacturer, davol inc. Bard, the manufacturer of the ventralex hernia patch, knew of the unreasonable harm the surgical patches could pose when used to repair a hernia. His surgeons implanted him with the defective bard ventralex st mesh at this time. Ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite.
What she does have is the bard ventralex hernia patch, which according to her doctor is a cousin to the kugel mesh patch. Class 2 device recall bard ventralex st medium circle. Bard ventralex hernia patch mesh health complications. Ventralex hernia mesh lawsuit joining thousands of others. Bard mesh, 5950009, bard mesh ventralex st hernia patch w. The ventralex hernia patch is a selfexpanding polypropylene and. 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.
The table below provides the hernia mesh recall list updated for 2019. 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. 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. 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. According to allegations raised in a product liability lawsuit filed over complications from bard ventralex hernia mesh, a silent recall was. Similar to other hernia mesh devices, ventralex was approved under the fdas 510k clearance. Defects in the design of the hernia repair patches caused some of the plastic rings to break. Bard may be defectively designed, making it be incompatible with human tissue causing health complications in people who have is surgically implanted. The ventralex is a hernia mesh patch made from polypropylene.
Reviewing your ventralex st hernia patch complications case. Ventralex mesh is a patch composed of polyproplene. 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. In the 510k application, bard described the ventralex st hernia patch as being composed of a top layer of polypropylene 0. Ventralex st medium circle with strap hernia patch diameter 6. The fda granted bard 510k clearance for then ventralex st on march 23, 2011. The closest thing to recall has been bards decision to replace the plastic ring with sorbaflex memory material.
This synthetic mesh is designed for use in hernia repair surgeries. An fda class 1 recall is the most urgent type of recall. Another barddavol hernia mesh product is ventralex, approved in 2002. Hernia surgery is one of the most common types of surgeries that are performed. The kugel mesh is a circular patch featuring an innovative springloaded ring. Ventralex st hernia patch the michael brady lynch firm.
Bard then further expanded the st product line by applying the st coating to its ventralex patch. Hernia mesh recall list a current list of recalled hernia mesh devices. 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. Free consultation hernia mesh recall list according to the us food and drug administration fda the following recalls. No recall has been announced by the fda and nor has there been a ventralex mesh. The ventralex hernia mesh lawsuit is against bard and its subsidiary davol inc. Unfortunately, thousands of patients had already felt the impact of these complications by the time the product was recalled. Class 2 device recall bardventralex hernia patch fda. 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. Bard then developed its ventralex st hernia mesh by combining the sepramesh with its kugel mesh patch.
There have been recalls for these bard hernia mesh devices. There may be large cash claims from settlements in these bard ventralex st hernia patch lawsuits. According to kamps lawsuit, he underwent laparoscopic umbilical hernia repair surgery in february 2016. Bard surgical mesh lawsuit hernia complications drug dangers. Bard hernia mesh linked to injuries drug and device watch. Hernia mesh mess bard davol hernia mesh lawsuit update. The bard ventralex and the bard ventralex st are implantable medical devices made by the company c.
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. 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. Bards ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Ventralex hernia mesh caused permanent harm within months. Ventralex hernia patch medium circle with strap diameter 6. 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. The woman filed this ventralex hernia mesh lawsuit soon after discovering the allegedly defective nature of the device. She alleges the company either knew or should have known about potential hernia mesh complications. 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. Accessgudid bard ventralex hernia patch 00801741016479 bard ventralex hernia patch medium circle with strap.
Bard, through its bard davol division, is one of the largest manufacturers of hernia mesh. 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. Bard is facing a new ventralex hernia mesh lawsuit from a tennessee woman, alleging the hernia mesh product was unreasonably dangerous. The device classification name is mesh, surgical, polymeric. Bard 3dmax mesh ventralex sepramesh ip hernia patch. This time it is the ventralex hernia patch, a mesh developed by bard subsidiary davol. Complaints regarding ventralex st hernia patch include pain and adhesions.
This technique is designed to eliminate the lateral dissection typically. It is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. Bard, davol, 0010301, ventralex, hernia, patch, repair. The mesh was approved using bards ventralex hernia patch, a hernia mesh approved by the fda in 2002, as a predicate device. 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. Ventralex st umbilical hernia mesh deployment dr pradeep sharma.
Bard kugel, 3dmax, ventralex, sepramesh kugel mesh hernia patch. Twice in 2011, davol recalled the bard ventralex hernia patches due to labeling mixups. Within months, it was clear that the hernia mesh had failed when kamp began to suffer debilitating pain. 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. Ventralex st hernia patch complications lawyer law. 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. 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. Hernia mesh manufacturers recall their products if they discover a problem. However, they have been connected to patients suffering from chronic pain and other medical complications when the. Bard acquired the license for sepramesh, which is intended to separate polypropylene from the bowel, from sanofi genzyme in 2007. Ventralex is a hernia mesh patch made of polyproplene.
This patch however was recalled by bard as a result of reports of various complications arising from its use. On april 11, 2011, a class 2 device recall was issued for a specific lot of the hernia patch medium circle with strap, a selfexpanding, nonabsorbable, sterile prosthesis used in various types of hernia repairs requiring reinforcement with a nonabsorbable. The bard ventralex hernia patch is intended for use in all forms of hernia repair requiring reinforcement with a non absorbable support material. Bard ventralex hernia patch, small circle w strap, 1. 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. Food and drug administration fda has recalled the ventralex or the ventralex st. The ring allows the product to spring open once implanted, adding structural support and stability.
It is estimated that every year as many as 750,000 people undergo hernia repair surgery. When a patient is diagnosed with a hernia surgery is the only permanent treatment possible. 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. Currency all prices are in aud currency all prices are in aud. 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.
Accessgudid bard ventralex hernia patch 0080174355 bard ventralex hernia patch small circle with strap. Ventralex hernia patch by cr bard medline industries, inc. Bard ventralex hernia mesh silent recall issued due to. It was reported the patient was implanted with a bard ventralex st hernia patch. The bardventralex hernia patch is a selfexpanding, nonabsorbable, sterile p. Ventralex hernia mesh lawsuit ventralex hernia patch. There is currently no ventralex mesh recall by the fda.
Tracy is having problems with her hernia repair patch and requires. 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. There is a bard davol multidistrict litigation, including ventralex mesh, which is. The physician of one patient specifically reported a number of adverse events to the maude database. Ventralex hernia mesh lawsuit 2017 hernia mesh settlement 2018. The kugel hernia patch is one of bards earliest and most problematic mesh products. Bard ventralex hernia patch lawsuit alleges mesh incompatible with human tissue. Bard ventralex st hernia patch bard mesh perfix plug baron and budd. We want you to tell us about the complications you experienced with the ventralex st hernia patch following your surgery. Over time, your bodys tissue grows naturally into the patch to help it stay in place and add strength to the repair. 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.
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