Answers
11/15/1991

<TITLE>PANEL ISSUES BREAST IMPLANT RECOMMENDATIONS</TITLE>
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T91-72                                                    Susan Cruzan
Nov. 15, 1991                                             (301) 443-3285

                 PANEL ISSUES BREAST IMPLANT RECOMMENDATIONS

    The General and Plastic Surgery Devices Panel, a group of outside         
experts, has advised FDA that data submitted by four manufacturers of         
silicone gel-filled breast implants do not provide reasonable assurance of    
the safety and effectiveness of these devices.  The panel chairperson, Dr.    
Elizabeth Connell of Emory University School of Medicine, emphasized that     
the group did not find evidence that the implants are unsafe, but rather      
that there was not enough information about the risks and benefits of their   
use.  
    Despite the lack of data, the panel voted unanimously to advise the       
agency that the implants serve a public health need and that they should      
continue to be available while the manufacturers collect the additional       
data.  The panel urged FDA to hold the manufacturers strictly accountable     
for providing, without delay, the needed data on safety and effectiveness.    
Although the committee's recommendation's are not binding upon FDA, they      
will be given a great deal of consideration in the agency's decisions on the  
silicone breast implant applications.
    About 2 million women in the United States have received breast implants  
for augmentation or reconstruction.  Silicone gel-filled breast implants 
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                               Page 2, T91-72, Breast Implant Recommendations
were already on the market in l976, when FDA was given authority to regulate  
medical devices.  The law provided that these breast implants could remain    
on the market until FDA, through regulation, required the submission of data  
supporting the implants' safety and effectiveness.  
    In opening the meeting of the advisory panel, FDA Commissioner David A.   
Kessler, M.D., called the breast implant issue one of the most difficult he   
has faced during his tenure as Commissioner.  He pledged that FDA would       
require manufacturers to provide the information needed to answer safety      
questions about these products, and that the agency would take into account   
the needs of women who now have the implants or who might desire them in the  
future.
    Following testimony from FDA scientists and implant manufacturers, the    
committee concluded that the four manufacturers had not provided adequate     
information concerning the chemical properties of the implant material, the   
mechanical and physical properties of the implants, the frequency of adverse  
effects such as rupture and contracture, the extent to which implants mask    
tumor detection during mammography and risks of cancer or immune disorders. 
    Under the law, the manufacturers had until July 9, l991, to submit data   
to FDA, and the agency has 180 days from then -- until early January l992 --  
to decide whether to approve silicone gel-filled breast implants for          
continued marketing.  If FDA follows the panel's advice, it could extend      
this deadline to allow the manufacturers more time to collect data.  During   
such an extension, the implants would remain on the market.  The length and   
conditions of the extension, should it be allowed, would be determined by 
the agency.  
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