Device manufacturers must comply with the Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. ( Review these sources and checklists for case evaluation and product identification)
Hernia Surgical Mesh Implants- Reporting of Adverse Events to the FDA The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their s urgeons THE BARD MDL 2846 POLYPROPYLENE HERNIA MESH PRODUCTSįDA Hernia Surgical Mesh Implants Information and LinksįDA describes hernias, the different treatment options to repair hernias and recommendations for patients that are considering surgery for their hernias. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position. Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum.Inlay– The hernia mesh is placed between layers of the rectus abdominis.
Mesh is easiest to remove when it is placed in the overlay position. Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis.In fact, I would advise purchasing the resign through a third party, not the resin supplier, to avoid a supply issue once the medical application is discovered” Please do NOT mention Davol’s name in any discussions with these manufacturers. “Thus, it is likely that they do not know of our implant application. In an email, CR Bard vice president Roger Darois said “We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers,” he said. In 2004, formal warning notices were sent stating that Marlex was “not for human implantation” and told medical mesh companies that they did not want their custom mesh products used “at any price.” Marlex, the Bard supplier of the synthetics resins, said repeatedly that they were afraid of being sued if the product was used in implants. Court filings and other sources reveal that manufacturers were warned decades ago that plastic should not be used to make implants.ĬR Bard and its subsidiary Davol were allegedly warned that they should discontinue their use of polypropylene resin back in 1997. The history of synthetic mesh failures and formal warnings being raised can be traced back more than 20 years, after news broke that mesh firms were warned 21 years ago about the risks of the device’s material.
We have observed that these devastating injuries are occurring all across the United States.įor additional case related information or potential case referrals, please contact Kelsey Stokes at WARNINGS OFFERED LONG AGO Stokes of Fleming, Nolen & Jez, L.L.P., Houston, Texas, co-lead counsel, who commented “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. 24, 2017ĭiscussions on the Bard Hernia Mesh MDL 2846 took place with Kelsey L. Overall, patients with complex ventral hernias (a bulge in the abdominal wall which can include incisional hernias) have a recurrence rate of approximately 30-40% nationally.Īdditional synthetic mesh failure data : “Hernia Reoperation Rate Underestimates Real Recurrence Numbers”. National Library of Medicine reports that incisional hernia repair involving mesh has a recurrence rate of 20-45%. Using the same figures reflects over 42,000 potentially new failures per year, and accordingly the number of potential cases.įor real time case docket information see the Mass Tort Nexus briefcase: BARD-DAVOL-Hernia-Mesh-MDL-2846-(Polypropylene-Mesh)-USDC-Southern-District-of-Ohio With more than 300,000 surgical mesh implant procedures per year, and a conservative failure rate of 20% and Bard’s 70% market share, the numbers for just the last 5 years would exceed 200,000 potential cases. Bard/Davol controls close to 70 percent of the hernia mesh implant market in the United States and have for close to 10 years, and by simply doing the math you can calculate the number of cases that will be filed into the MDL. Sargus, US District Court, Southern District of Ohio). Bard/ Davol, Polypropylene Hernia Mesh Products Liability Litigation, MDL No. (MASS TORT NEXUS MEDIA) One of the fastest growing emerging mass torts is the C.R. IS YOUR FIRM LOOKING AT THE BARD HERNIA MESH LITIGATION?