FDA calls for a Moratorium on the use of Silicone Gel Breast Implants

News 01/06/1992 FDA calls for a Moratorium on the use of Silicone Gel Breast Implants
P92-1                                      FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                      Susan Cruzan -- (301) 443-3285

     The Food and Drug Administration today called for a moratorium on the use  
of silicone gel breast implants until new information on their safety can be    
thoroughly reviewed by an independent advisory panel and the agency can make a  
final decision in light of the panel's review.
     FDA Commissioner David A. Kessler, M.D., said, "We want surgeons to stop   
using these implants in patients until this new information can be thoroughly   
evaluated.
     "Women considering breast implants deserve to know whether these products  
are safe enough for use.  I'm calling for a delay in the use of these products  
until our advisory panel can meet to consider new information which was not     
available when it met in November," Dr. Kessler said.
     The advisory panel -- the General and Plastic Surgery Devices Panel --     
will reconvene within 45 days to evaluate the new data and make new             
recommendations on the use of these products.  Some panel members have asked    
that the panel's recommendations be revisited.  Dr. Kessler said the agency     
would make its decision on whether silicone gel implants should continue to be  
available after receiving the panel's advice.
     Saline filled implants will not be affected by today's action and will     
remain available to patients.
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                                  Page 2, P92-1, breast implant moratorium
     "Much of the new information provides additional evidence that implants    
could possibly cause autoimmune or connective tissue disorders.  The panel      
looked at this issue in November; however, the new information seems to         
underscore safety concerns in this area," said Dr. Kessler.
       Breast implant manufacturers were required to submit scientific data     
demonstrating that the implants are safe and effective by July 9, 1991, and     
under its regulations FDA had 180 days -- until January 6, 1992 -- to evaluate  
the data and decide whether the implants could be approved for marketing.  FDA  
had been prepared to make a decision, but it recently learned that some         
relevant documents that could have a bearing may not have been submitted to     
the agency.
     "Because of these unanswered questions, we believe the products should     
not continue to be marketed until this new information is reviewed.  Unless a   
woman is having problems with her implants, we are not recommending that she    
have them removed.  On the other hand, if a woman is having symptoms she        
thinks may be related to her implants, she should see her doctor for advice     
about what to do," said Dr. Kessler.
     In November 1991, FDA's advisory panel met to consider the data submitted  
by four manufacturers of silicone gel breast implants.  The panel said that,    
despite the lack of sufficient data on safety and effectiveness to approve the  
implants, these devices serve a public health need and should continue to be    
available under certain conditions.
     Approximately one million women in the United States have breast           
implants, and they have been used on about 150,000 women each year.             
Approximately 80 percent of the implants are used for augmentation and 20       
percent for breast reconstruction following cancer surgery.
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