Ventralex st hernia patch the michael brady lynch firm. Bard announced the recalls after it became known that certain batches of. However, the mesh has been shown to cause significant medical issues for those who. Some were recalled by the food and drug administration fda, although most were voluntarily recalled by the hernia mesh manufacturers after several patients reported injuries from having hernia mesh. It is intended for use in all forms of hernia repair requiring reinforcement with a nonabsorbable support material. Ventralex hernia patch is a selfexpanding, nonabsorbable.
On september 14, 2017 julio nunez of randolph county, north carolina filed a ventralight st hernia patch lawsuit against c. Hernia mesh lawsuits stem from device complications like infection, pain, bowel obstruction, organ or tissue perforation and adhesion. The mesh was approved using bards ventralex hernia patch, a hernia mesh approved by the fda in 2002, as a predicate device. Ventralex st medium circle with strap hernia patch. The fda later updated the degree of its warning, as the products defects have potential to result in serious and adverse health consequences, including death. This synthetic mesh is designed for use in hernia repair surgeries. Bard hernia mesh linked to injuries drug and device watch. Ventralex hernia patch is a selfexpanding, nonabsorbable, sterile prosthesis.
According to kamps lawsuit, he underwent laparoscopic umbilical hernia repair surgery in february 2016. 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. Class 2 device recall bard ventralex st medium circle with strap. Within months, it was clear that the hernia mesh had failed when kamp began to suffer debilitating pain. This time it is the ventralex hernia patch, a mesh developed by bard subsidiary davol. There is currently no ventralex mesh recall by the fda. The ventralex hernia patch is designed for umbilical and epigastric hernia repair. Dec 03, 2018 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.
Ventralex hernia mesh lawsuit 2017 hernia mesh settlement 2018. Bard, were granted regulatory clearance under the u. Because the mesh is designed to create scar tissue and ingrowth, when it shrinks. The attorney alleges the patient experienced infection, additional surgery, adhesions, permanent injury, defective mesh and explant. According to allegations raised in a product liability lawsuit filed over complications from bard ventralex hernia mesh, a silent recall was issued by the manufacturer to address design defects. 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. The company has faced additional concerns over several of its transvaginal mesh products and surgical mesh products manufactured using the marlex plastic which had not been intended to be. Despite the known risk associated with polypropylene, bard. 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. 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 have been recalls for these bard hernia mesh devices. Physiomesh is a patch used to strengthen the abdominal wall in hernia repair surgeries.
Postop pain is supposed to be reduced because the ventralex hernia patch. Hernia mesh manufacturers have recalled more than 211,000 units of hernia mesh from 2005 to march 2018. Mesh is the preferred repair as it is supposed to minimize the possibility for infections and pain. The device classification name is mesh, surgical, polymeric. Twice in 2011, davol recalled the bard ventralex hernia patches due to labeling mixups. Bard hernia mesh lawsuit dangerous side effects reported. Polypropylene deteriorates in oxygen, and a patients blood and tissues contain oxygen. 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. Recall or not, if your hernia mesh is causing you pain and complications, please speak to a mesh attorney. Mesh breakage the ventralex st patch had a tendency to break, especially at its edges, which can lead to hernia recurrence, pain, and other serious complications. Sep 07, 2018 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. Class 2 device recall bardventralex hernia patch fda. The physician of one patient specifically reported a number of adverse events to the maude database.
Food and drug administration fda has recalled the ventralex or the ventralex st. Ventralex is a hernia mesh patch made of polyproplene. Mesh shrinkage the polypropylene material used to make ventralex st patches has been known to contract or shrink into itself in the weeks following surgery. In 2007, the fda issued a class 1 recall for the composix kugel mesh patch, a medical device inserted to repair ventral incisional hernias. Ventralex hernia patch medium circle with strap diameter 6. However, to gain approval, bard said ventralex was similar to its other mesh product, kugel.
Ventralex st hernia patch complications lawyer law offices. Bard ventralex hernia patch mesh health complications. Nov 09, 2016 bard ventralex hernia patch mesh health complications november 9 2016 by lucy campbell santa clara, ca. Dozens of defective hernia mesh medical devices have been recalled. Bard ventralex hernia mesh silent recall issued due to. Ventralex hernia patch lawsuit and settlement cases potentially being investigated include claims of patients who had a davol bard ventralex hernia patch surgically implanted during a hernia repair surgery and who claim to have subsequently suffered serious hernia mesh problems, injuries, sideeffects or complications including, among other. The table below provides the hernia mesh recall list updated for 2019. Ventralex st umbilical hernia mesh deployment dr pradeep. Not surprisingly, bards transvaginal mesh and bladder sling products also are made using polypropylene mesh. Ventralex mesh is a patch composed of polyproplene.
Bard hernia mesh bard mesh lawsuit hernia mesh complications. Many hernia mesh products, including some of those marketed by ethicon, atrium medical, and c. Bard may be defectively designed, making it be incompatible with human tissue causing health complications in people who have is surgically implanted. Bard 3dmax mesh ventralex sepramesh ip hernia patch lawsuits. Watch umbilical hernia repair with ventralex st mesh performed meticulously by dr pradeep sharma. Complaints regarding ventralex st hernia patch include pain and adhesions.
To date, there has not been a ventralex hernia mesh recall. The 3dmax mesh features a curved design that was created fit the inguinal groin canal in men. The majority of surgical mesh devices available for use are constructed from synthetic materials. Bard ventralex hernia patch lawsuit alleges mesh incompatible. This mesh is primarily used to repair hernias in the groin area. His surgeons implanted him with the defective bard ventralex st mesh at this time. 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. This patch however was recalled by bard as a result of reports of. 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. Bards ventralex st mesh was the subject of two class ii recalls in 2011. If broken, the ring could impale or perforate tissues or organs in the patient. This technique is designed to eliminate the lateral dissection typically required for preperitoneal placement, which may help minimize post op pain. Ventralex hernia mesh lawsuit ventralex hernia patch attorney. Food and drug administration blamed recalled mesh for some of the worst complications.
Bard claims that the product is easy to position, fixationfree, and will reduce the pain in patients. Ventralex hernia mesh lawsuit ventralex hernia patch. Hernias occur when underlying tissue or organs squeeze through weak spots in the abdominal wall. Oct 27, 2017 there will likely be future adverse effects caused by the ventralex hernia mesh, the complaint continues, that will require additional treatment and surgeries to remove the hernia mesh patch. Utosuture surgipro polypropylene mesh clear 3 x 5 sterile. Bard and davol recalled composix kugel mesh products from the market starting in 2005. 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. Ventralex hernia patch by cr bard medline industries, inc. Bard has already faced thousands of lawsuits over its transvaginal mesh and bladder sling products, which are also made from polypropylene. The memory recoil ring that opens the ventralex mesh patch can break under the stress of placement of the large sized products in the intraabdominal space.
Ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Davol initially blamed the surgeons who installed the kugel mesh patch for the broken rings. 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. The ventralex is a hernia mesh patch made from polypropylene.
The ventralex hernia mesh lawsuit is against bard and its subsidiary davol inc. The patch allows for sufficient overlap beyond the hernia defect without having to perform lateral dissection to develop a preperitoneal pocket. Class 2 device recall bard ventralex st medium circle. However, other surgical mesh devices have been recalled due to serious complications and adverse reactions. Do not use the ventralex st hernia patchin infants or children, whereby future growth will be compromised by the use of such mesh material. A bard ventralex lawsuit indicates the manufacturer knew there were problems with the hernia patch and issued a silent recall in december. Manufacturers recalled the hernia mesh after people reported failures and organ injuries following surgery. Ventralex, a brand of hernia patch, is mainly used to treat a hernia, which occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Product classification, mesh, surgical, polymeric25 product code ftl. An fda class 1 recall is the most urgent type of recall. 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 kugel hernia patch is one of bards earliest and most problematic. 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. Bards ventralex st hernia patch combines the original ventralex patch with the sepramesh ip composite. Ventralex st medium circle with strap hernia patch diameter 6. The bardventralex hernia patch is a selfexpanding, nonabsorbable, sterile p. There have been reports of complications arising from the use of davol c. The bard ventralex and ventralex st devices are defective because of their reliance on a plastic mesh that is made of polypropylene. Another barddavol hernia mesh product is ventralex, approved in 2002. 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.
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. Hernia mesh recall hernia mesh manufacturers have recalled more than 211,000 units of hernia mesh from 2005 to march 2018. Class 2 device recall bard ventralex st medium circle with. Do not use the ventralex st hernia patch for the reconstruction of cardiovascular defects.
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