Drs. Amy Reed and Hooman Noorchashm put a public face on the failures of the U.S. Food and Drug Administrations lacking oversight over medical devices, until she lost her life due to a morecellation.
Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancers, many hospitals and doctors are still using them.
Two days before an advisory panel was gathered to look at the controversial medical device called a morcellator, a gynecologist stepped down due to conflict of interest.
Dr. Amy Reed was scheduled to undergo a common surgery to remove fibroids. Little did her doctor know hidden cancer would be released by the medical device, which eventually killed her.
Hernia mesh trials have not moved forward because of COVID and closed courtrooms. Optimistically, those will begin with bellwether trials in the new year.
The Food and Drug Administration's 510(k) clearance process for medical devices has been called a fast-track clearance for medical devices bypassing assurances of safety and efficacy.
ABC News on Mesh Class Action October 15, 2012 ~ It could become the largest class action product liability lawsuit in Australian history. Julie Dav...
SEPTEMBER 16, 2011 - Editors Note: I attended the Food and Drug Administration expert panel convened on September 8 & 9, 2011 to listen to patients ...