Generally speaking, manufacturers are required to submit individual reports to the FDA for each patient who sustains an injury or complication caused by a medical product. Established in 1997, Alternative Summary Reporting Program allowed manufacturers to bypass that standard by submitting quarterly summaries for cases that involve “well-known” complications. The FDA claims that this policy allowed the agency to “more efficiently review reports of well-known, well-understood adverse events.” However, the public was largely kept in the dark because this massive database was kept hidden, available only to the FDA – until now.