Adverse Event

/Tag: Adverse Event

FDA: Lapdog Enforcement on Reporting Adverse Events

Lapdog, Portrait of Woman in Red, Agnolo Bronzino, 1532, Tuscan School, WikiCommons Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it's not legally [...]

By |2017-03-07T10:44:31-04:00March 7th, 2017|FDA News|7 Comments

FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent

March 29, 2013 ~ In September 2011, the U.S. Food and Drug Administration convened a panel of experts to try and get a handle on the concerning number of complications the agency was receiving about surgical mesh used to treat pelvic organ prolapse (POP)  and stress urinary incontinence (SUI).  The experts  [...]

By |2018-07-10T13:10:44-04:00March 29th, 2013|FDA News|13 Comments