October 31, 1991
David A. Kessler, M.D.
U.S. Food & Drug Administration
5700 Fishers Lane
Rockville, MD 20857
Dear Dr. Kessler,
Recently, I acquired a copy of the FDA backgrounder issued on September 5, 1991. After reading this document and
discussions with my physician, I felt a plea to your department was in order.
Health problems at an early age (not cancer) destroyed my bustline and a great deal of my self esteem. Years of barbs
and jokes added to the destruction. For sixteen years, I read every bit of information available regarding breast implants
and restorative surgery as well as discussing it with several physicians. Three years ago, a complete hysterectomy was
necessary and I elected to have breast restorative surgery at the same time. My selection of a physician was lengthy
and carful and based on my own "interviews' with several, as well as the approval of my own gynecologist of seventeen years.
I HAVE HAD NO ILL EFFECTS OF ANY KIND from that restorative surgery. The change in my self esteem and confidence has
been a 180.
Perhaps a role reversal in the vernacular will put it better. Supposing a health problem reduced the size and natural
appearance of your manhood, or maybe your development halted at age 13, and women with the occasion to do so, made cruel jokes
and laughed at you. You can certainly imagine how it would affect you mentally and emotionally. And the, technology
developed a reasonably safe procedure to correct this though there were certain POSSIBLE dangers. If you could, you
would have that surgery in a heartbeat! And you would be incensed if an agency such as the FDA took that choice away
from you by forbidding the product's use in the United States. Does this make the picture clearer?
There are many healthcare products that contain or use silicone such as artificial joints, pacemakers and artificial valves.
More than 6 million people have these types of implants. Approximately 2 million women have silicone type implants and
fewer than 100 incidents of immune-system disorders have been documented. There is no more than the generally accepted rate
of occurrence that exists in the same population of women without implants. In addition, a poll indicates that 93 percent
of the women with implants are satisfied and have had no problems, and 96 percent would have the surgery again if they had
to do it over. I am among those who have had no problems and would do it again. My only regret is that I didn't
do it sooner.
If the FDA persists and prohibits the use of implants, those of us with implants who did need "repair" or replacement would
be forced to travel outside the United States for the surgery, which in itself could pose greater hazard to our health than
the implants do.
Finally, another side, the United States was founded about 200 years ago with the concept of equality and freedom-freedom
to CHOOSE our own paths. More and more in recent years, the Government and its Agencies are whittling away at the right
to be free and the right to choose. The position of freedom and equality has been a slow and difficult battle for women
as it is. The male ideals of what constitutes a nice figure and appearance has long burdened female population to meet
the expectations and standards.
I beseech you NOT to take this choice away from us! Instead, insure that guidelines are adhered to by the manufacturers.
Insure that we are informed. Require data and studies to be continued. Accumulate data from physicians-they have
been performing the surgery for nearly 30 years AND treating health disorders.
PLEASE DO NOT TAKE THIS AWAY FROM US!
President and Mrs. Bush
Department of Health and Human Services