Truth And Consequence
Mr. Les Weinstein,
Please have my view expressed either orally, or in writing, to the committee members.
Over 40 years ago, before all of the discussions, disputes, lawsuits, and lies, the scientists and researchers for the breast implant manufacturer's raised questions, because of professional integrity, and concern, and found many of the answers to today's issues regarding breast implant safety. These observations were raised in an innocent and untainted atmosphere, not influenced by money and power, professional gain, or personal loss.
Today, 80 million documents, and answers to this committee's questions regarding the safety of breast implants are locked away in a Birmingham, Alabama bankruptcy court. The tactic used for hiding the truth behind the sealed documents in our U.S. bankruptcy court system, was nothing short of brilliant by the manufactures defense, because the truth to this issue would have been so unbearably detrimental to their clients best interest.
In today's controversial environment surrounding the breast implant issue, the consequence for finding the undisputed scientific truth, requires that these documents be unsealed, and opened. If the pure and honest aim of this panel is to resolve this dispute and find the truth, then that TRUTH lies in Birmingham, Alabama.
Sincerely,
Robert Olexa
Wife: Sue Olexa (breast implant recipient)
CC: Dr. David Feigel
Dr. Jane Henney
Dr. Diana Zuckerman
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee. General Function of the Committee To provide advice and recommendations to the agency on scientific disputes between the Center for Devices and Radiological Health and sponsors, applicants and manufacturers. Date and Time The meeting will be held on October 31, 2000, 1 p.m. to 4 p.m. Location Corporate Bldg., conference room 020B, 9200 Corporate Blvd., Rockville, MD. Hotel Information Contact Person Les Weinstein, Center for Devices and Radiological Health (HFZ-5), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, mailto:lsw@cdrh.fda.gov or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 1 0232. Please call the Information Line for up-to-date information on this meeting. The members of the newly established Medical Devices Dispute Resolution Panel will be introduced to the public and will hear presentations by FDA staff on the purpose of the committee and its role in dispute resolution.
Procedure Interested persons may present their views, orally or in writing, on issues regarding resolving scientific disputes concerning medical devices, and on the role of this committee. Written submissions may be made to the contact person by October 25, 2000. Oral presentations from the public will be scheduled between approximately 2 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 25, 2000 and submit a brief statement of the general nature of the comments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
