[Congressional Record Volume 146, Number 107 (Wednesday, September 13, 2000)]
[House]
[Pages H7562-H7563]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                               H.R. 1323

  The SPEAKER pro tempore (Mr. Sherwood). Under a previous order of the 
House, the gentleman from Texas (Mr. Green) is recognized for 5 
minutes.
  Mr. GREEN of Texas. Mr. Speaker, today I want to talk about 
legislation that I have been working on. It is H.R. 1323. H.R. 1323 
deals with breast implants, an issue that has been the subject of many 
court cases now for a number of years.
  On Monday, the Food and Drug Administration, the FDA, hosted a 
meeting to discuss research on silicone gel-filled implants, and I am 
grateful for the FDA in their willingness not only to meet with my own 
constituents but also other people on my staff on this issue and 
hopefully will continue to dialogue with the FDA to ensure that women 
get the information they need on the safety of the implants.
  However, the research indicates that platinum salts have been 
released by silicone gel-filled implants. This is significant 
information because the platinum salt in certain form is known to be 
toxic. New technology has allowed scientists to determine that the 
platinum used as a catalyst in making the gel and the shell of the gel-
filled breast implant is being released into the body of women in a 
harmful toxic form.
  Last week, the FDA released information on their web site citing 
breast implant complications. This is a victory for the consumer 
advocates who have been working to provide more information to women 
who are considering implants. However, the information provided in this 
web site does not include the recent findings on the toxicity of 
platinum salts found in gel-filled implants.
  Women need to know how harmful the release of platinum in their body 
and to their children who may be nursing can do to them. It has come to 
my attention that children who breast-feed from mothers with silicon 
brevity implants may also experience harmful body excess from the 
toxicity symptoms of exposure of platinum salts.
  Symptoms of exposure to platinum in a reactive form can also cause 
fatigue, dry eyes, dry mouth, joint inflammation, hair loss and also 
rashes.
  As a sponsor of the Silicon Breast Implant Research and Information 
Act, I believe that the need for more research is especially compelling 
in light of the FDA's own study on the rupture of silicone breast 
implants.
  On May 18 of this year, Dr. S. Lori Brown's research showed that 69 
percent of the women with implants had at least one ruptured breast 
implant. The FDA concluded that the rupture of silicon breast implants 
is the primary concern although the relationship of the free silicon to 
the development or progression of the disease is unknown.
  We do know there is a rupture of silicon into the body, but we do not 
know the impact. That is why we need more research by the FDA.
  I heard from my own constituents over the last number of years and 
literally women across the country, Mr. Speaker, who have suffered from 
the long-term consequences of reconstruction and cosmetic surgery. They 
have experienced infections, chronic pain, deformity and implant 
rupture, inaccurate mammography readings due to

[[Page H7563]]

the implant concealing breast tissue and difficulties in getting health 
insurance to pay for the high costs of repeated surgeries. The cost of 
faulty implants is paid by all of us in the system even if it is not 
covered by insurance.
  The Institute of Medicine estimated that by 1997, 1.5 million to 1.8 
million American women had breast implants with nearly one-third of 
these women being breast cancer survivors. The American Plastic and 
Reconstruction Surgeons cited breast augmentation as the most popular 
procedure for women ages 19 through 34. In 1998, nearly 80,000 women in 
this age bracket received breast implants for purely cosmetic reasons. 
By 1999, an additional 130,000 women received saline breast implants.
  In spite of the escalating numbers, very little is known about the 
long-term effects of silicone or platinum in the body. Few patients 
understand that even when they opt for saline breast implants, the 
envelope of the implant is made of silicon.
  Following the FDA's decision to approve saline breast implants, the 
agency did warn women of the potential risk. FDA officials called upon 
implant manufacturers and plastic surgeons to ensure that thorough 
patient information is provided to women before they undergo the 
surgery.
  Mr. Speaker, with the FDA approval process behind us, the only course 
of action to safeguard the future of women is that of an informed 
consent document. Somehow, a piece of paper cannot make up for a 
manufacturer's insufficient data or the retrieval analysis. It cannot 
make up for inaccurate labeling and even risk estimates.
  There is so much we do not know, and yet the one government agency 
mandated to safeguard the public's food, drug and medical devices is 
moving so slow on this issue that could jeopardize women with a medical 
device that has alarmingly high failure rates.
  In spite of the agency's call for post-market studies, the FDA 
approval of saline breast implants provides no incentive for the 
manufacturers to make data better or a safer medical device.
  Mr. Speaker, hopefully the FDA will continue their research.

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