Answers
07/11/1991

<TITLE>Manufacturers of Breast Implants Submit Data for Review </TITLE>
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           Manufacturers of Breast Implants Submit Data For Review

    Six manufacturers of silicone-gel filled breast implants have submitted 
applications to FDA under a deadline imposed by a regulation requiring them 
to prove that their products are safe and effective.  The following may be
used to respond to questions. 
    On April 10, l990, FDA published a regulation requiring manufacturers to
submit, by July 9, Premarket Approval applications (PMA's) demonstrating the
safety and effectiveness of these devices, as a condition for keeping them
on the market.  The PMA's must include all preclinical, clinical and
manufacturing data for the products.  FDA has also asked manufacturers to 
address the severity and incidence of existing or potential problems
associated with breast implants such as infection, pain, hardening of 
surrounding breast tissue, silicone leakage and implant failure, as well as 
carcinogenicity and autoimmune diseases.
    In a July 5 letter to breast implant manufacturers, FDA reiterated that 
any implants without applications may no longer be used after July 9 under
the law.  FDA asked the firms to take immediate action to ensure that those 
implants for which no applications were submitted are not implanted.
    This does not mean that the implants without applications are 
necessarily less safe than the others.  FDA's action reflects the agency's
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                                            Page 2, T91-35, Breast Implants 

belief that, in the interest of the public health, implants for which the 
agency cannot assess safety and effectiveness should not continue to be 
implanted.
    Implants for which applications have been received may stay on the
market until FDA determines whether the applications are complete enough to 
review.  Under the law, FDA has 45 days to determine whether an application 
contains enough information on which to base a decision.  If the application
meets this criterion, the agency will conduct a full review to determine
whether the data supports the safety and effectiveness of the implants. 
    The following manufacturers of silicone gel-filled breast implants have 
submitted PMAs for at least some of their implant models:  Dow Corning
Wright; Mentor Corp.; Surgitek; Bioplasty, Inc.; McGhan Medical Corp. and 
Joseph F. Cavon.  Several small manufacturers have not submitted any PMA's. 
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