Answers
04/17/1990

<TITLE>Breast Implants</TITLE>
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T 
91-20                                                    Bonnie Aikman
April 17, 1991                                           Sharon Snider
                                                         (301) 443-3285 

                  POLYURETHANE FOAM-COVERED BREAST IMPLANTS 

    Recent news reports refer to preliminary data in an FDA study on
polyurethane foam, a material used as a coating for certain kinds of
silicone gel-filled breast implants.  FDA's study found that the foam might 
degrade into a substance called 2-toluene diamine (TDA), which has been 
shown to cause cancer in laboratory animals.  While agency scientists are 
still assessing the data, FDA believes the statistical values expressed in
some media accounts may have overstated the risk of cancer to women who have
these implants.  The following may be used to answer questions. 
    The agency is pleased that the manufacturer and marketer of the 
implants, Surgitek, a subsidiary of Bristol-Myers Squibb, has acted 
responsibly by voluntarily suspending the shipment of its Meme and Replicon 
polyurethane foam-coated breast implants -- and requesting that doctors 
delay implanting these devices -- while FDA continues to evaluate laboratory
and risk assessment data on a possible link between polyurethane foam and 
cancer. 
    It is unfortunate that preliminary FDA laboratory results reached the 
public before FDA's analysis of the data was complete.  This has created an 
unnecessary climate of fear in patients who have been implanted with these
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                                            T91-20 , Breast Implants, Page 2
products.  The agency is working to conclude its own analysis of the data 
and will release those results in the near future.
    At this time, FDA's best advice to patients and physicians is to delay
any new implantation procedures involving these products until the agency's 
laboratory and risk assessment analysis has been completed. 
    FDA's study was intended to answer the question of whether the breakdown
of polyurethane foam to TDA could actually occur in the human body.  Earlier
laboratory studies had shown that small amounts of TDA were released from 
the polyurethane foam, but this could have been due to manufacturing
residues of TDA.  If, however, the TDA resulted from degradation of the foam
in the body, this would imply continual and possibly increasing exposure to 
this agent as the implant aged in the body. 
    The study, which has been completed, found measurable quantities of TDA 
produced from the degradation of polyurethane foam under laboratory 
conditions of pH and temperature similar to those in the human body.  FDA 
scientists are currently analyzing the data to try to pin down the exact
magnitude of the risk which TDA might pose. 
    Although this analysis is not complete, it is clear that the cancer risk
is very small -- certainly too small to warrant removing the implants.  In
fact, the risk of removal could outweigh the risk of keeping the implant. 
    Women who have concerns about their implants despite the low risk should
discuss the situation with their physicians.  Patients and physicians with
questions can call Surgitek at 1-800-533-3398.
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