ANSWERS
08/01/1991    

<TITLE>FDA Advisory Committee Meeting on Polyurethane-Coated Breast Implants </TITLE>
<PRE>


    FDA ADVISORY COMMITTEE MEETING ON POLYURETHANE-COATED BREAST IMPLANTS 
    An FDA advisory panel which met July 31 to consider polyurethane-coated,
silicone gel-filled breast implants said that removing the implants at this 
time because of concerns about cancer is not warranted.  The panel said the 
risk of cancer, if any, appears minimal and would very likely be outweighed 
by the surgical risk involved in removing them.  About 10 percent of breast 
implant patients, or about 200,000 women, have polyurethane-coated implants.
    The following may be used to answer questions.
    This recommendation applies only to polyurethane-coated implants.  The
polyurethane coating may break down into a chemical called TDA (2, 4
toluenediamine), which has been linked to cancer in laboratory animals. 
    The General and Plastic Surgery Devices Panel, a group of outside 
experts that advises FDA in its decision making, met in Gaithersburg, Md.,
to review an FDA risk assessment on polyurethane foam and to provide advice 
to physicians and to women who have the polyurethane-coated implants. 
    The panel accepted earlier estimates that, even for a woman with two
breast implants, the lifetime cancer risk from the TDA is likely to be very 
small.  However, it said more study is needed to assess the risk with 
                                   -MORE- 

                                            Page 2, T91-47, Breast Implants 
certainty.  The panel called for a breast implant registry to track data on 
women with implants.
    Surgitek, a subsidiary of Bristol-Myers Squibb, the sole manufacturer of
polyurethane-coated breast implants, voluntarily suspended shipments of 
these implants, sold under the brand names Meme and Replicon, in April after
questions about possible cancer risk arose. 
    FDA is requiring the firm to conduct further studies on its product to
assess the risk from TDA. 
    In his opening remarks to the advisory panel, FDA Commissioner David A. 
Kessler, M.D., commented on silicone breast implants in general.  He advised
women who are considering getting implants to obtain information on what is 
known at present about the risks involved.  He also advised them to discuss 
the risks and unanswered questions with their doctors and ask to see the
package insert that comes with the implants.  He advised that they could
also write the FDA for information on breast implant risks. 
    Meanwhile, the FDA has required all manufacturers of silicone gel-filled
breast implants to submit data proving their products are safe and
effective, as a condition for keeping them on the market.  The deadline for 
submission of data was July 9.  Six manufacturers submitted data for 10 
products by the deadline.  A special team of FDA scientists has been set up 
to review the data within the six-month time frame required by law.  The
agency will conduct a full review to determine whether the data show the
implants are safe and effective.
    Several smaller manufacturers did not submit data.  The FDA is checking 
to ensure that they have taken their products off the market and stopped
distribution. 
                                   -MORE- 


                                            Page 3, T91-47, Breast Implants 
    The FDA will soon require manufacturers of saline-filled breast implants
to submit safety and effectiveness data for these devices as well.
Approximately 10 percent of women with implants have this type. 
</PRE>