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Transvaginal Mesh Manufacturers Tell Advisory Committee They Agree to the Need for More Studies

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

The Food & Drug Administration (FDA) began Advisory Committee hearings yesterday to address concerns regarding vaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. The Advisory Committee is being asked whether the manufacturer’s transvaginal mesh notification about risks and warnings are adequate. This same panel of physicians is being asked to determine whether the use…
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Consumer and Manufacturer Costs for Surgical Mesh and Metal-on-Metal Hip FDA Clearance

January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.

When a physician tells you that a medical device can improve your life, most people assume that the device has been tested for safety and effectiveness. However, this is rarely the case. In fact, most medical devices on the market have received clearance from the Food and Drug Administration (FDA) by merely filing paperwork and paying about $4,000 for a…
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