FDA Issues Warning Letter to Mesh Manufacturer ENDO for Federal Regulation Violations

Endo International PLC, a subsidiary of American Medical Systems, Inc. was recently issued a warning letter by the FDA for violating three federal regulations relating to how the Minnesota company facility manufactures its urological devices. Click here to read the full article: Inspection Triggers FDA Warning for Mesh Manufacturer While the warnings does not pertain [...]

April 25th, 2014|Drug and Medical Device Litigation, Transvaginal Mesh|0 Comments

3,697 da Vinci Adverse-Events Reported – Doubling Reported Events in 2012

According to the FDA, Intuitive Surgical’s da Vinci Robot system has received 3,697 adverse reports through November 3, 2013.  This number is more than double of the number of adverse events Intuitive Surgical received last year at this time.  Last year, the da Vinci robot only received 1,595 complaints through the FDA. Click here to [...]

November 13th, 2013|Da Vinci Robot Surgery, Drug and Medical Device Litigation|0 Comments