Thanks to Pam Dowd for sending us the following letter from Dr. Jenny
to the FDA regarding liquid silicone. This letter was part of the
evidentiary files of breast implant litigation. . .Myrl
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 ****tions 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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