News & Resources
Archive by Year: 2016 - Page 5
At last, the FDA has finalized its proposals from April of 2014 to reclassify certain transvaginal mesh implant devices from Class II medical devices to Class III devices. Class III medical products are “high risk” devices that require pre-market approval. This is a process that requires manufacturers to provide the FDA with clinical data to demonstrate safety and efficacy of a product before it can be sold. The reclassification only applies to transvaginal mesh used to treat pelvic organ prolapse (POP) and does not include transvaginal mesh sling products implanted for the treatment of stress urinary incontinence.
Radiology is a discipline that involves the use of various imaging techniques to diagnose and treat disease. Radiology techniques include X-rays, ultrasound, CT scans, PET scans and MRIs. Radiology errors hurt or kill thousands of people every year and the resulting harm can be difficult to trace back to the error itself. In such cases, the assistance of an experienced Tampa medical malpractice lawyer can be invaluable.