How the FDA approved power morcellators over the years
Power morcellators are devices used to remove uterine masses by breaking up the growths and vacuuming them out of the uterus. This controversial device was cited by the U.S. Food and Drug Administration (FDA) in April 2014 for increasing the risk of uterine cancer among women.
Over the years, several types of power morcellators have become available on the market through previously approved devices cited as their precedent. Here are the generations of FDA-approved morcellator devices and the succeeding devices they have ‘grandfathered’ in:
- Cook tissue morcellator – Approved in 1991, this was the first ever FDA approved power morcellator that has taken its precedent on Dyonics (joint device), Storz (tissue punch), Wolf (manual morcellator), and Wisap (tissue punches)
- Karl Storz – Cited Cook tissue morcellator as its antecedent. Approved in 1995
- FemRx/Johnson & Johnson – Approved in 1997, cited Karl Storz as its precedent
- Gyrus/Olympus – Approved in 2008, cited FemRx/Johnson & Johnson as its precedent
- Nouvag – Approved in 2009, cited FemRx/Johnson & Johnson as its precedent
- Trokamed – Approved in 2011, cited FemRx/Johnson & Johnson as its precedent
- LiNA Medical – Approved in 2011, cited FemRx/Johnson & Johnson as its precedent
If you believe your condition has resulted from a uterine surgery involving a power morcellator, do not hesitate to seek compensation through a lawsuit. The team at Williams Kherkher might be able to help you. Call us at (800) 220-9341 today.