Answers
12/23/1994

<TITLE>SALINE-FILLED BREAST IMPLANT UPDATE</TITLE>
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T94-61                                             Susan Cruzan
Dec. 23, 1994                                      (301) 443-3285

                           Talk Paper

               SALINE-FILLED BREAST IMPLANT UPDATE

      FDA is receiving inquiries about its decision to require
manufacturers of saline-filled breast implants to proceed in
conducting studies to demonstrate the safety and effectiveness of
these devices. The companies will be required to enroll patients
promptly in clinical trials, report the data in stages and
disseminate revised patient information.  The saline implants may
remain on the market while these studies are conducted.  
     The following may be used to respond to inquiries.
     Saline-filled breast implants are silicone envelopes filled
with salt water.  These devices were on the market prior to the
Medical Device Amendments of l976, which gave FDA regulatory
authority over these products.  Like many other pre-amendment
devices, saline-filled implants have been allowed, under the law,
to remain on the market until FDA systematically requires
manufacturers to demonstrate their safety and effectiveness. 
     Saline implants currently are the only product generally
available to women who seek breast implants.  Although they have
silicone rubber envelopes like silicone gel-filled implants, FDA
believes that saline implants present a lower degree of risk than 
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                                  Page 2, T94-61, Saline Implants
gel-filled implants because leakage or rupture would release only
salt water into the body.  Since 1992, gel-filled implants for
breast reconstruction have been available only for women who could
not use saline-filled implants, and who agreed to participate in
clinical studies.
     The two manufacturers of the saline-filled implants -- McGhan
Medical Inc. and Mentor Corp, both of Santa Barbara, Calif. -- have
agreed to conduct studies and submit data, as follows:

          TYPE OF STUDY                            STUDY COMPLETED

Preclinical testing (short-term)                         1995

10-year retrospective epidemiological study              1996
     -- rupture/failure rate

1-year large, simple clinical trial                      1997
     -- short-term complications
     -- peri-operative infections, deflation and
        capsular contracture

3-year prospective clinical study                        1998
     -- augmentation and reconstruction patients
     -- full clinical profile
     -- quality of life


     FDA is also requiring the companies to submit a complete
battery of preclinical data.  The first set of these data will be
submitted in the first quarter of l995.  
     The agency will review the new studies as they become
available, and will make public any significant new health
information derived from these studies.  Manufacturers will use the
information to update labeling as appropriate.  
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                                 Page 3, T94-61, Saline Implants
     The agency plans to issue a final rule calling for the
submission of premarket approval applications in 1998.  By that
time the manufacturers will have submitted all preclinical data, as
well as the results of both the epidemiology study on rupture rates
and the large simple trial on complication rates.  The remaining
three-year clinical data and quality of life assessment will be
required as part of the marketing application.  
     FDA has called on the American Society of Plastic and
Reconstructive Surgeons to assist the manufacturers in recruiting
the clinical investigators and patients needed to conduct these
studies in a timely manner.   
      The manufacturers have also agreed to disseminate, through
surgeons, updated patient information to prospective patients.  FDA
is in the process of updating the patient information sheet, with
the assistance of health professional groups, consumer groups and
the manufacturers.
     Women considering implants should carefully read these patient
information sheets, as well as the informed consent form, and
discuss the risks with their doctors before undergoing implant
surgery.  Known risks include rupture, capsular contracture and
infection.  Saline implants are also known to interfere with
mammography.  Special radiographic techniques need to be used on
women with implants in order to minimize interference. 
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