FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued: October 20, 2008 Dear Healthcare Practitioner: This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). [...]
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Clinical Trial Fraud Exposed by Coast IRB
Colorado Springs, CO (March 11, 2009) – On Friday, March 6, 2009, Coast IRB notified Criminal Fraud unit of the U.S. Department of Justice, the FBI, the FDA, and the Commonwealth of Virginia Department of Health Professions of a fraudulent clinical test. Coast Independent Review Board discovered that a protocol submitted for review of a [...]