Amswers
08/03/1992

<TITLE>FDA APPROVES CLINICAL STUDIES OF SILICONE BREAST IMPLANTS</TITLE>
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T92-35                                                Sharon Snider
Aug. 3, 1992                                          (301) 443-3285

          FDA APPROVES CLINICAL STUDIES OF SILICONE BREAST IMPLANTS
    We have been receiving inquiries about the status of silicone gel-filled  
breast implants.  On July 24, FDA granted approval to Mentor Corporation of   
Santa Barbara, Calif., to begin clinical studies of these implants.
    The agency's action will provide access to silicone gel implants, via     
participation in the studies, to all women who desire them for                
reconstruction after mastectomy or serious injury and who meet certain        
criteria.  It may be several weeks, however, before the implants are          
actually available, due to final preparations for the studies by Mentor.
    The following can be used to answer public inquiries.
    On Jan. 6, 1992, FDA called for a moratorium on the use of silicone gel   
breast implants until new information on their safety could be reviewed by    
an advisory panel (see P92-1).  On Feb. 20, the panel recommended that        
breast implants be made available only on a limited basis under carefully     
controlled clinical studies (see T92-9).  On April 16, FDA Commissioner       
David A. Kessler, M.D., adopted that recommendation, stating that more        
studies were needed to answer basic questions about the safety of silicone    
gel breast implants before they could be commercially marketed (see P92-11).
    Mentor's studies will attempt to find answers to some of these            
questions, including the rate of rupture, infection and contracture.
Participants will be watched closely by their doctors after surgery and will  
be required to have periodic checkups for five years.
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                                            Page 2, T92-35, Mentor Corp.
    To be eligible, women must be 18 years old, have a medical need for       
breast reconstruction for which saline-filled implants are not suitable and   
be willing to provide basic personal information for the study.
    Participants may include:
    * Women who need reconstruction after mastectomy or other treatments for  
cancer, or after mastectomy for other medical reasons.  This includes cancer  
patients who previously had breast reconstruction with saline implants or     
their own tissue with unsatisfactory results.
    * Women who need reconstruction because of other severe breast or chest   
deformities, such as those resulting from congenital or developmental         
problems or medical-surgical complications.  (Because "severe" is a           
subjective assessment, the physician must judge the severity of the           
deformity and certify that there is a medical need for corrective surgery.)
    * Women who have or have had silicone gel implants and for whom           
replacement is medically necessary.
    The studies exclude women who are pregnant or nursing; have an abscess    
or infection; have been diagnosed with lupus or scleroderma; have             
uncontrolled diabetes or other disease which affects healing; have            
incompatible tissue characteristics; or who are an unwarranted surgical risk.
    In order to enroll in the studies, women must agree to read and sign a    
detailed informed consent form, get follow-up examinations after surgery and  
periodically for five years and consider enrolling in a patient registry.
    At least 3,000 surgeons are expected to participate as clinical           
investigators in the study.  These surgeons must provide a special consent    
form to each patient, certify that the patient meets all the criteria and     
that saline implants are not a viable alternative, notify Mentor of all       
breast implants implanted and provide information needed for the patient      
registry.  They must also keep comprehensive records of the patient's health 
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                                            Page 3, T92-35, Mentor Corp.
prior to the operation and details of the surgery and results of follow-up    
checkups, including any complications.
    In addition, surgeons must give each patient a record of the implants     
she received, including the brand and model, identifying characteristics and  
implant placement.
    Each surgeon's participation must be approved by an institutional review  
board.
    At this time, Mentor is the only firm that has received FDA approval to   
conduct clinical studies of silicone breast implants.  Other manufacturers    
may have similar clinical studies approved at a later date.
    Also at a later date, silicone gel-filled breast implants will be         
available in other studies that will include a limited number of women who    
desire implants for breast enlargement as well as those who need them for     
reconstruction.  The studies will focus on additional safety questions and    
on the psychological benefits of implants.  Only enough women to answer the   
scientific questions posed will be allowed to enroll in these studies.
    Women who want to enroll in the current studies should contact their      
doctor.  Physicians can obtain a list of participating investigators or       
additional information from the Mentor Corporation.  They may write or call   
Mentor at:
                       Mentor Corporation
                       Clinical Studies Monitor
                       5425 Hollister Ave.
                       Santa Barbara, CA. 93411
                       1-800-525-6747

    Saline breast implants are still on the market and are not part of the    
current studies.  FDA will soon be notifying manufacturers that they will be  
required to submit safety and effectiveness information for these products.
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