Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study
Sports Betting Addiction Lawsuit Sports betting addiction lawsuits are being investigated for college students and young adults who developed gambling problems after using apps like FanDuel and DraftKings, alleging that the platforms failed to warn about the addictive nature of their features and marketing practices.
Nitrous Oxide Lawsuit Individuals who suffered harm, or families who lost a loved one after using nitrous oxide products may be eligible for financial compensation through a nitrous oxide lawsuit.
Hair Relaxer Lawsuit Regular exposure to chemicals in hair relaxer may cause uterine cancer, ovarian cancer and other injuries. Women diagnosed with cancer may be eligible for settlement benefits.
Depo-Provera Lawsuit Depo-Provera lawsuits are being investigated for women who developed meningioma brain tumors after receiving Depo-Provera birth control shots, claiming that Pfizer failed to adequately disclose side effects.
Ozempic Lawsuit Lawyers are pursuing Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits over gastroparesis or stomach paralysis, which can leave users with long-term gastrointestinal side effects
Suboxone Tooth Decay Lawsuit Lawsuits are being pursued by users of Suboxone who experienced tooth loss, broken teeth or required dental extractions. Settlement benefits may be available.
Change Healthcare Lawsuit Lawyers are reviewing Change Healthcare class action lawsuits for individuals who had their personal information stolen due to the data breach.
Bard PowerPort Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
AngioDynamics Port Catheter Lawsuit Serious and life-threatening injuries have been linked to problems with Bard PowerPort. Lawsuits are now being pursued by individuals who suffered injuries from the implantable port catheter fracturing or migrating.
Processed Food Lawsuit Lawsuits are being pursued against the food industry over their manufacturing and advertising of ultra-processed foods, which have caused a generation of children to face an increased risk of developing childhood diabetes and other chronic illnesses.
FDA Still Feels Transvaginal Mesh Products Too Risky After Final Postmarketing Study Mesh exposure and erosion problems still make transvaginal mesh products not worth the potential risks, FDA determined October 20, 2022 Irvin Jackson Add Your Comments Following years of concerns about the risk of painful and debilitating transvaginal mesh complications suffered by women who received products sold by a number of companies for use during pelvic repair surgery, federal regulators have concluded from a final post-marketing surveillance study conducted by Coloplat that the mesh is no better than native tissue repair, but carries far more risks. Over the past decade, manufacturers have faced tens of thousands of transvaginal mesh lawsuits brought by women, alleging that the products are unreasonably dangerous and defective, and billions in mesh settlements have been paid by C.R. Bard, Boston Scientific, American Medical Systems (AMS), Coloplast and other manufacturers. Postmarketing Transvaginal Mesh Studies Ordered To Evaluate Risks Following years of aggressive marketing and promotion by manufacturers, transvaginal mesh was widely used throughout the U.S. for treatment of pelvic organ prolapse or female stress urinary incontinence, involving the use of synthetic mesh to reinforce a weakened vaginal wall, or support the bladder. Most of the products were introduced under a controversial FDA “fast track” approval process, which allowed manufacturers to introduce new products based on the design of prior mesh products, without conducting thorough research to evaluate the safety or effectiveness of the specific designs before they were widely used by the medical community. In 2012, the FDA ordered 33 different manufacturers to conduct long-term postmarketing studies on transvaginal mesh, after the agency issued warnings about problems women were experiencing when the mesh eroded into the vagina, contracted or shrinked, caused infections, pelvic pain, urinary problems, vaginal scarring and other complications. While a number of the manufacturers voluntarily chose to stop selling the products, studies conducted by Boston Scientific and Coloplast failed to provide sufficient support to justify continued use of the mesh, leading the FDA to announce that it was removing transvaginal mesh from the U.S. market in 2019. In August 2021, the FDA announced the results of federally mandated studies involving Boston Scientific transvaginal mesh, concluding that the products fared no better than native tissue repair, while adding health risks, such as mesh exposure and erosion. The agency has now released similar findings from the last postmarketing studies pending, involving Coloplast transvaginal mesh products, which seem to confirm that the FDA has no intention of changing its opinion on the risks and benefits at this point. Share Your Story If you continue to experience problems with transvaginal mesh, share your comments with the AboutLawsuits.com community or submit information to a lawyer to determine if you may be eligible for a transvaginal mesh settlement. Add Comments In an update on its urogynecologic surgical mesh investigation published on October 17, the FDA looked at the latest results of a postmarketing surveillance study involving Coloplast transvaginal mesh used for pelvic organ prolapse. “The study results showed Coloplast transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months,” the FDA noted. “The FDA continues to believe that devices of this type for transvaginal POP mesh repair present potential additional risks compared to native tissue repair, including mesh exposure and erosion. Therefore, the FDA maintains that these devices do not have a favorable benefit-risk profile.” Although the transvaginal mesh products are no longer commercially available, they remain implanted in the bodies of tens of thousands of women throughout the United States, and continue to cause complications and the need for risky surgery to try to remove the mesh when it fails. 2022 Transvaginal Mesh Lawsuit Update At one time, there were more than 100,000 lawsuits filed against Boston Scientific, Coloplast, Bard, AMS, Ethicon and other manufacturers. While transvaginal mesh settlements have been reached to resolve most of those claims, new lawsuit continue to be filed as women experience problems. Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Learn More About Vaginal Mesh / Bladder Sling Lawsuits Complications from transvaginal mesh may cause severe injuries. Learn More SEE IF YOU QUALIFY FOR COMPENSATION Over the past few years, a steady stream of mesh lawsuits have gone to trial, with juries routinely awarding millions in damages after seeing evidence about how long the companies knew their products were unfit for use during pelvic repair surgery. Companies have also paid hundreds of millions in mesh settlements brought by state attorneys general, to resolve claims that they placed a desire for profits before the health and safety of women. In the coming years, it is expected that additional transvaginal mesh lawsuits will be filed against companies who manufactured products that continue to fail, and the end of the postmarketing surveillance studies does not conclude the liability the companies face for selling these dangerous and defective products. Tags: Coloplast, Pelvic Organ Prolapse, Transvaginal Mesh Image Credit: | More Vaginal Mesh Lawsuit Stories Study Finds Some Transvaginal Mesh Degrades Within 2 Months After It Is Implanted October 29, 2024 Supreme Court Rejects J&J Bid to Overturn $302M Vaginal Mesh Lawsuit Award February 23, 2023 Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study January 16, 2023 1 Comments Dina November 2, 2022 Do y’all have any cases for iud implant because I had one in the 80’s in I could never have more kids Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA TermCommentsThis field is for validation purposes and should be left unchanged. Δ MORE TOP STORIES Hair Color Lawsuit Alleges Bladder Cancer Caused by Salon Dye (Posted: 2 days ago) Following 52 years as a cosmetologist, a New Jersey woman says she developed bladder cancer due to routine exposure to hair color chemicals. 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Recalled Medical Devices Fast-Tracked Through FDA Approval Process Were Often Based on Flawed, Older Designs: Study January 16, 2023
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