DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD
20850
Pierre Blais, Ph.D.,F.C.I.C.
496 Westminister Avenue
Ottawa, Ontario
Canada K2A2V1
Dear Dr. Blais;
The center for Devices and Radiological Health (CDRH) of the Food and drug Administration (FDA) has received your letter dated November 18, 1999 involving comments on the 515(b) final rule for silicone inflatable (saline-filled) breast implants.
We are planning to discuss the safety and effectiveness of specific saline-filled breast implants in an upcoming advisory panel meeting on March 1-3, 2000 (look for a future FDA Federal Register notice for details). The safety discussion should include any issues raised in the clinical data regarding rupture/deflation, infection, capsular contracture, etc. Also as part of this upcoming meeting, we plan to discuss elements of patients labeling.
Additionally, we will consider suggested improvements to our draft guidance, "Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses" dated August 1999 and available at
If you have any questions, please call Mrs. Samie Allen, Breast Implant Team Leader, at 301-594-3090, ext. 139.
Sincerely yours,
James E. Dilllard III
Acting director
Division of General and Restorative Devices
Office of Devices Evaluation
Center for Devices and Radiological Health
