FDA Injecting Liquid Silicone Illegal!

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P92-5                                       Food and Drug Administration
FOR IMMEDIATE RELEASE                       Sharon Snider- (301) 443-3285


    The Food and Drug Administration announced today that three New York      
physicians have signed consent decrees agreeing to stop injecting liquid      
silicone into patients to correct wrinkles and acne scars.  The physicians    
will no longer be allowed to use injectable silicone for cosmetic treatment   
unless the product is approved by FDA either for marketing or for             
investigational studies.
    Also today, the Department of Justice filed an injunction on behalf of    
FDA against a California physician to stop him from using injectable liquid   
silicone.
    "Consumers should know that liquid silicone injections have never been    
scientifically evaluated for safety and effectiveness," said FDA              
Commissioner David A. Kessler, M.D.  "People who undergo these injections     
are exposing themselves to unknown, potentially dangerous risks." 
    Adverse reactions to the injections may include swelling, reddening of    
the skin, lumpiness of the face and development of soft tissue tumors.
    The consent decrees, signed by Drs. Norman and David S. Orentreich and    
Michael A. Kalman of the Orentreich Medical Group and filed in the U.S.       
District Court in Manhattan, prohibit the physicians and anyone working in    
their clinic from using or promoting injectable silicone.
                                   -MORE-

                                          Page 2, P92-5, Injectable Silicone
    The injunction was filed in the U.S. District Court in Los Angeles        
against Dr. James E. Fulton and two clinics owned by Fulton, Vivant (also     
known as Fulton Pharma-Cal Inc.) and Acne Research Institute, Inc.
    FDA considers liquid silicone injections to be adulterated because the    
product does not have an approved application for marketing or an approved    
investigational exemption to permit scientific study of the device.  The      
product has been regulated as a device by FDA since l976.  It was previously  
regulated as a drug.
    Actions to prevent the physicians and their clinics from using liquid     
injectable silicone were begun after they failed to heed warnings by FDA and  
the Justice Department that their use of injectable silicone is illegal and   
that the product is adulterated.
    The doctors had been purchasing silicone, then injecting it into          
patients to treat such conditions as wrinkles and acne scars and to enlarge   
lips.  Orentreich bought industrial grade silicone which he processed before  
using.
    FDA inspection of Orentreich's clinic in July and September 1991          
revealed that Orentreich's medical group was continuing to openly use and     
promote liquid silicone for the treatment of facial defects.  On Nov. 12,     
1991, FDA notified Orentreich that unless he took prompt action to correct    
the violation, FDA could take regulatory action against him.
    In June 1991, FDA investigators attended a seminar where Fulton           
described and promoted his use of liquid silicone injections.  An inspection  
of his clinics in August 1991 confirmed that he was openly promoting and      
using the product.  On Sept. 23, 1991, the U.S. Attorney's office in Los      
Angeles notified Fulton that the use and promotion of liquid silicone is      
illegal.
    FDA is one of the eight Public Health Service agencies in HHS.
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