Answers
06/01/1994

<TITLE>BREAST IMPLANT UPDATE</TITLE>
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T94-27                                         Susan Cruzan
June 1, l994                                   (301) 443-3285 

                      BREAST IMPLANT UPDATE

      FDA has been receiving inquiries in advance of its June 2
public hearing on a proposal to require manufacturers of saline-
filled breast implants to submit data showing safety and
effectiveness before the products can continue to be marketed.  The
hearing will focus on the status of the manufacturers' studies,
reports of independent research, consumer and professional
concerns, and the timing of the requirement for submission of the
data.  FDA has also received inquiries on the status of silicone
gel-filled breast implants.  The following is a summary of the main
issues and may be useful in responding to inquiries.  
     Saline-filled and silicone gel-filled breast implants were 
already on the market when FDA began regulating medical devices in
l976.  Like other devices that were grandfathered under the Medical
Device Amendments of l976, breast implants were allowed to remain
in use with the understanding that FDA would later require
manufacturers to submit evidence of product safety and
effectiveness. 
     Saline-filled breast implants are silicone envelopes filled
with salt water.  Currently, only saline-filled breast implants are
commercially available for both breast augmentation and
reconstruction.  
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     The short and long-term safety of saline implants has not been
established.  It is known that the implants can leak or rupture,
requiring further surgery for replacement.  Other known risks
include infection, capsular contracture, interference with
mammography, and altered breast sensation.  In addition, because
the envelope is made of a silicone elastomer, there is concern
about any systemic problems that may be related to exposure to
silicone.  
      In a January l993 proposed rule, FDA notified manufacturers
of saline-filled implants that the agency intended to require
submission of data demonstrating product safety and effectiveness,
and that each company's products would have to receive agency
approval to allow continued marketing.  
     At its June 2 public hearing, FDA will solicit public comment
on the timing of this requirement, which could affect availability
of the products.  The agency will consider this testimony in
determining when to promulgate the final rule.  
     FDA also has asked the manufacturers to present testimony on
the status of their clinical studies on saline implants, including
patient enrollment. 
     In regard to silicone gel-filled implants, none are available
commercially.  This type of implant is available only as part of a
clinical study, and currently only for breast reconstruction. 
Mentor Corp. of Santa Barbara, Calif., is at this time the only 
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                        Page 3, T94-27, Breast Implant Update
manufacturer allowed to conduct clinical studies of silicone gel-
filled implants.  
     Manufacturers currently are gathering data on women who 
already have breast implants in order to provide important
information about long-term effects of the implants. 
     The agency advises potential implant recipients to discuss
risks with their doctors before undergoing implant surgery, and
to read carefully the patient information that accompanies the
products.
     The record of hearing will remain open until July 5, l994. 
Written comments may be submitted to the Dockets Management Branch
(HFA-305), Food and Drug Administration, Room. 1-23, 12420 Parklawn
Drive, Rockville, MD 20857.  
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