News
09/25/1991

<TITLE>FDA Advises Doctors to Provide Risk Information on Breast Implants</TITLE>
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FDA Advises Doctors to Provide Risk Information on Breast Implants

P91-22                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285 

    The Food and Drug Administration today told doctors and breast implant
manufacturers that they should advise patients who are considering breast 
implant surgery about the risks of having these products implanted. 
    FDA said in today's Federal Register that breast implant manufacturers
must provide doctors with information for patients on the risks, written in 
easily understandable language, so that the doctors can pass on this
information to their patients.
    The risks include hardening of tissue surrounding the implant, rupturing
of the implant and interference with mammography. 
    HHS Assistant Secretary for Health James O. Mason, M.D., said, "We
believe it is vital that women be informed -- well before implant surgery --
of the known and potential risks."  Dr. Mason heads the Public Health 
Service, which includes FDA.
    About 150,000 women a year have this surgery, about 80 percent for
augmentation and the remainder for reconstruction following mastectomy. 
    FDA Commissioner David A. Kessler, M.D., said, "We took this action 
after discussions with doctors and consumer health advocates, and we believe
it is the best way to make sure women who are considering this surgery have 
an opportunity to weigh the risks as well as the benefits.  The information 
on risks should be provided to patients prior to scheduling implant surgery,
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                                        Page 2, P91-22, Breast Implant PPI's
so that patients have sufficient time to review it and discuss it with their
physicians. 
    "This action will also help to enhance the dialogue between these 
patients and their doctors, which I believe is very important and should
occur," he continued. 
    Since the 1960s breast implants have been used to enlarge women's 
breasts or reconstruct them after breast cancer surgery.  Besides risks of
tissue hardening, rupturing, and problems with cancer detection through 
mammography, questions have been raised about the health effects of leakage 
of silicone from an implant, such as increased risks of autoimmune diseases 
or cancer.
    Recently, FDA told manufacturers of silicone gel filled implants -- the 
majority of breast implants on the market -- that they had to submit safety 
and efficacy data or remove the products from the market.  Manufacturers of 
the remaining implants, filled with a saline solution, will be required to
submit these data in the near future. 
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