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HENRY JENNY, M.D.
HENRY JENNY M.D., INC.
PLASTIC AND COSMETIC SURGERY
TELEPHONE: 714.327.1117
12
December, 1977
Mr. Rudolf Apodaca HFD-316
Compliance Evaluation Branch
Bureau or Drugs
5600 Fishers Lane
Rockville,
MD 20852
Dear Mr. Apodaca:
On October 31, 1974 I sent to you a scientific paper with photographs and slides
on the harmful effects of liquid silicone injected into the human body.
I then asked you to please review the paper
and the slides and send them to Mr. Harry E. Butts, HFX-100 Division of Compliance, Bureau of Medical Devices and Diagnostic
Products, 5600 Fishers Lane, Rockville, MD 20852. As of this date, I have not heard from you nor from Mr. Harry Butts.
I
think that I might expect the courtesy of a response as well as return of my work.
Since that date I have collected
further information on the transgression of liquid silicone particles through the gel-filled prosthetic shell into surrounding
tissues and some of my observations have been confirmed by a Doctor Shamel who is a
scientific worker at the University
of Zurixh, Switzerland.
I am amazed that no action has been taken, nationwide, against the injection of liquid silicone
and I am also amazed that you have not taken a closer look at the possible dangerous effects of the liquid silicone portions
of the gel transgressing through the shell and then being absorbed into the human body.
Yours Sincerely,
Henry
Jenny, M.D.
HENRY JENNY, M.D., INC
HJ:LM
CC: Mr. Harry Butts
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