[Congressional Record (Bound Edition), Volume 145 (1999), Part 10]
[House]
[Page 13871]
[From the U.S. Government Publishing Office, www.gpo.gov]



                 IOM REPORT ON SILICONE BREAST IMPLANTS

  The SPEAKER pro tempore. Under a previous order of the House, the 
gentleman from Texas (Mr. Green) is recognized for 5 minutes.
  Mr. GREEN of Texas. Mr. Speaker, yesterday, the Institute of Medicine 
released its report on silicone breast implant research. It evaluated 
past studies on the association between silicone implants and diseases 
as well as considering the frequency of complications including 
rupture, the need for additional surgeries, and problems with 
contraction.
  Perhaps the Institute of Medicine's most important directive was to 
recommend areas of future research concerning silicone breast implants.
  The IOM, the Institute of Medicine, report points to the undeniable 
need for additional scientific research on the long-term outcomes and 
local complications of silicone breast implants. In fact, the report 
states these complications occur frequently enough to be a cause for 
concern and to justify the conclusion that they are the primary safety 
issue with silicone breast implants.
  Although the rate of implant rupture and silicone leakage has not 
been definitively established, a recent analysis of implant failure 
conducted by the University of Florida found silicone breast implant 
rupture at a rate of 30 percent at 5 years, 50 percent at 10 years, and 
70 percent at 17 years.
  However, in information sent to women considering implants, 
manufacturers currently are grossly underestimating the rupture rate at 
1 percent.
  The Institute of Medicine, the IOM, also concluded that the 
information concerning the nature and relatively high frequency of 
local complications and reoperations is an essential element of 
adequate informed consent for women undergoing breast implantation.
  Therefore, the IOM recommends the development of national model of 
informed consent of women undergoing breast implantation to ensure 
women fully understand the risks associated with silicone implants.
  Women have the right to choose to get breast implants, but Congress 
has the responsibility to make sure that they are fully aware of the 
risks associated with these products.
  For these reasons, I, along with the gentlewoman from New Mexico 
(Mrs. Wilson) and nearly 45 cosponsors have introduced H.R. 1323, the 
Silicone Breast Implant Research and Information Act.
  This bill promotes independent research at NIH in order to ensure 
impartial, scientifically sound studies on silicone breast implants. To 
date, there have been no National Institutes of Health, NIH, clinical 
studies of mastectomy patients who have had implants.
  With the level of attention and controversy on this issue, supporters 
of H.R. 1323 believe leadership from NIH is critically important.
  Our legislation would also require the FDA to strengthen informed 
consent procedures in clinical trials and institute better follow-up 
mechanisms for consumer complaints. Because the FDA has never approved 
silicone breast implants for the market, it is crucial that women and 
their doctors have access to accurate information concerning the 
possible risks.
  Finally, the Institute of Medicine, the IOM, recommends additional 
research to determine safe levels of silicone in the human body. 
Everyone has some level of silicone in their body. However, there has 
never been any research to establish a safe level of silicone. How can 
scientists be expected to determine whether silicone is causing 
diseases if we do not know what is the safe level?
  Mr. Speaker, I urge my colleagues to look at H.R. 1323.

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