ANSWERS
06/28/1995

<TITLE>SALINE BREAST IMPLANT INFORMATION UPDATE</TITLE>
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T95-30                                       Susan M. Cruzan
June 28, 1995                                301-443-3285

            SALINE BREAST IMPLANT INFORMATION UPDATE

     FDA is receiving inquiries about recently updated information
materials for women who are considering saline breast implant
surgery.  In l991, FDA told manufacturers of saline breast implants
to provide information for doctors to give to their patients about
the risks of having these products implanted.  That information has
now been revised.  The following may be used to answer inquiries.
     Saline-filled breast implants are silicone envelopes filled
with salt water.  The saline implants are the only ones generally
available to women who seek breast implants.  They were on the
market prior to the Medical Device Amendments of l976, which gave
FDA the authority to regulate these products.
     The most common risks of saline breast implants -- which are 
included in the updated information for patients --  are deflation
or rupture, interference with breast cancer detection, and capsular
contracture (scar tissue forms and hardens around the implant). 
     There is a fairly high chance that a woman with saline
implants will need to have additional surgery at some point.  For
example, when saline implants rupture, further surgery is needed to
remove or replace the implant. 
       FDA believes that saline implants present a lower degree of
risk than silicone gel-filled implants because leakage or rupture 
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                                             Page 2, T95-30, Saline
would release only salt water into the body.  Because saline
implants use a silicone rubber envelope, there is some concern, but
little information, that the silicone rubber may present additional
risks.   
      The revised information sheet has received extensive review
from consumer groups, health professionals and industry.   
Physicians are to give the information to potential patients before
the patients have decided on surgery.  
     FDA advises women considering the implants to read all the
information before surgery and to discuss the possible benefits and
risks with their doctors.  Each woman must decide whether to accept
the possible risks in order to achieve the expected benefits.  
     The updated patient information was published today in the
Federal Register.  
     In December l994, FDA informed manufacturers of saline
implants that they must enroll patients in clinical studies, report
the data in stages and disseminate revised patient information. 
Saline implants have been allowed to remain on the market pending
submission of the safety and effectiveness data.  FDA will make
public any significant new health information derived from studies
and use the information to update the labeling as appropriate. 
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