An interesting press release:
"Allegations continue surrounding the testing of two annuloplasty rings, invented by the chief of cardiac surgery, Dr. Patrick McCarthy at Northwestern University,
the Myxo Ring, and the IMR Ring (invented by McCarthy, and colleagues).
Both rings were implanted in patients, allegedly, without their
consent. These rings considered to be similar to the pre-existing
devices, which never underwent FDA approval or FDA registration for
legal sales on the US market according to FDA congressional letters as
reported in the Chicago Tribune, and the project of government
oversight, POGO. This line of valve rings, have resulted in over 4000
adverse events, including 645 deaths according to the FDA MAUDE
"In a letter sent to Northwestern on March 5, 2014,
the Senate Judiciary committee requests a response to documents
surrounding this unauthorized human experimentation which took place at
Northwestern Memorial Hospital. The deadline for Northwestern University to respond to this request is today March 21, 2014."