Implant Veterans of Toxic Exposure

Dr. Henry Jenny

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Dr Jenny warns FDA regarding liquid silicone

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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