FDA Still Feels Transvaginal Mesh Products Too Risky After Final Postmarketing Study
After reviewing the final postmarketing study on Coloplast transvaginal mesh, the FDA has determined the risks still outweigh the potential benefits.
Tag Archives: Coloplast
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FDA Releases Final Result of Boston Scientific Transvaginal Mesh Studies
New postmarketing surveillance studies show Boston Scientific transvaginal mesh increase the risk of health complications for pelvic organ prolapse patients, without adding any additional effectiveness or safety over traditional surgical…
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Transvaginal Mesh Removed From Market Following Years of Lawsuits, Thousands of Devastating Problems
The FDA has banned the sale and distribution of transvaginal mesh products in the United States, saying they cannot guarantee the devices are safe or effective for women.
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Vaginal Mesh Implants Reclassified As High Risk, Must Go Through Tougher Approval Process
The FDA has announce new rules that reclassify transvaginal mesh products as high-risk medical devices and will require them to go through a more stringent approval process showing safety and…
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Joint Status Conference Scheduled in All Transvaginal Mesh MDLs With Settlement Counsel
Another group status conference has been ordered for all vaginal mesh lawsuits in an effort to reach a settlement that would avoid tens of thousands of trials.
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Vaginal Mesh Settlements Encouraged by Judge in Joint MDL Meeting
A judge is pushing parties to settlement vaginal mesh lawsuits to avoid tens of thousands of cases going to trial.
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Progress Continues Toward Settling Coloplast Mesh Lawsuits: Report
Coloplast and plaintiffs continue to move toward a vaginal mesh settlement according to a federal judge.
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Vaginal Mesh, Bladder Sling Lawsuits in MDLs Approach 60,000
Nearly 60,000 lawsuits involving vaginal mesh and bladder sling products are currently pending in federal MDLs.
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Transvaginal Mesh Health Risks Require Reclassification of Devices: FDA
The FDA has proposed reclassifying transvaginal mesh products as high-risk medical devices.
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Coloplast Mesh Settlement Reached To Resolve 400 Lawsuits: Report
About 400 Coloplast vaginal mesh lawsuits have reportedly been settled for $16 million.
