In the NetFlix "The Bleeding Edge" documentary, there is an excerpt of an FDA Pre-market Approval Hearing
recording (July 22, 2002) for the permanent birth control device.
In the Netflix Documentary, the FDA review panel raised several "open" questions to the manufacturer before
determining that “The device clearly makes the criteria for safety and effectiveness required for pre-market
approval”.
Examine two of the "open" questions by conducting searches in relevant databases (since 2002) and
synopsizing the findings.
Investigate the issue of migration highlighted in the 2014 Ricci et al publication (provided in Additional
Resources) by conducting searches in the relevant databases (since 2002) and synopsizing the findings
With the information gathered from your research, in your opinion, if the FDA pre-market approval review board
that approved the Essure permanent birth control device knew then
in 2002 what we now know about the potential risks and adverse events would they still have approved the
device.
Sample Solution