public meeting was important and justified the effort to ensure ample space to accommodate all who wanted to attend.
The IOM prepared a public announcement of the meeting that was posted on the IOM website and mailed on May 1, 1998, to approximately 300 individuals and organizations. These included consumer groups identified from the Food and Drug Administration's (FDA's) mailing list, as well as professional organizations, industry contacts, clinicians, academicians, scientists, and legal contacts identified through review of the literature, Internet searches, and other sources. The public meeting announcement provided background on the IOM study and requested that those who wanted to give an oral statement, provide a written statement, or simply attend the public meeting as observers, register and submit certain information prior to specified deadlines. Reporters who wanted to attend were asked to register with the Office of News and Public Information.
This public participatory event was an opportunity for those with relevant information about the safety of silicone breast implants to advise and inform the committee. The IOM defined relevant information to include evidence on the strengths or validity of the science associating silicone breast implants with local or systemic health effects. Seven questions were included in the notice to provide a common framework for the oral and written statements. However, the IOM did not require that statements be limited to scientific evidence alone, since one of the primary intentions was to provide a forum for women with implants to share their personal stories. This inclusive effort resulted in many individuals providing both oral and written testimony on their own behalf or on behalf of special interest groups and organizations. All of those who presented written or oral statements were advised that the information presented at or submitted for the meeting would become part of the public record and be accessible through the NAS Public Access Records Office.
There were approximately 175 written statements from the various individuals and organizations, including those submitted to the committee before, at the time of, or subsequent to the public meeting. As specified in the notice, these statements were limited to five pages or less via electronic mail, telefax, or regular postal mail, submitted by the August 28, 1998, deadline. Some statements were submitted after August 28; they also were accepted. The written statements were distributed to each of the committee members at three separate meetings.