[Congressional Record (Bound Edition), Volume 146 (2000), Part 10]
[House]
[Pages 13808-13809]
[From the U.S. Government Publishing Office, www.gpo.gov]



     IN SUPPORT OF H.R. 1323, SILICONE BREAST IMPLANT RESEARCH AND 
                            INFORMATION ACT

  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, the reason this evening that I am 
asking for a 5-minute special order is to talk about some legislation 
that I have been working on and we have a great many cosponsors, H.R. 
1323. As I begin to talk about it, Members need to understand when I 
first was brought to the problem's attention by some constituents of 
mine, I realized the first issue we need to deal with is what I call 
the candy effect, we need to get over the snicker factor and then 
really get on to dealing with the problems that some women in our 
country are having.
  H.R. 1323 deals with breast implants, an issue that has been the 
subject of court cases. But my concern, Mr. Speaker, is that the 
Federal Food and Drug Administration, who is supposed to be America's 
watchdog, our protector, to make sure that we are not harmed by faulty 
drugs or medical devices. In fact, the FDA's own Web site calls itself 
the Nation's foremost consumer protection agency, and we pour millions 
and millions of Federal tax dollars into this agency every year. 
Unfortunately, when it comes to medical devices, the FDA is neither our 
watchdog nor our protector.
  In May, I was disappointed to learn that the FDA approved saline 
breast implants for the general market. The FDA approved these breast 
implants despite data presented by the manufacturers showing that three 
out of four mastectomy patients who opt for saline breast implant 
reconstruction experience painful local complications.
  The FDA approved breast implants despite the fact that the majority 
of implants rupture within the first 3 to 4 years. The FDA's own 
scientists concluded that the manufacturers have incorrectly carried 
out their statistical analyses and therefore determined that the 
complication rates were as high as 84 percent with mastectomy patients 
within the first 3 to 4 years. These complication rates continue to 
increase over time.

                              {time}  1745

  But, now with the FDA approval, the two leading manufacturers are 
able to market their saline breast implants. In fact, one of the 
manufacturers even has a pending FDA criminal investigation regarding 
its breast implant production and testing hanging over its head, and it 
still received approval by the FDA.
  My concern for women who opt for a saline breast implant stems from 
hundreds of women who have contacted me with their experience, and I 
have heard from my own constituents and women from across the country 
who have suffered from the long-term consequences of reconstruction and 
cosmetic surgery, including infections, deformity and rupture.
  These women also have suffered from inaccurate mammogram readings due 
to implants concealing breast tissue which is critical in detecting a 
reoccurrence of cancer. Studies show that up to 35 percent of the 
breast tissue can be obscured by these implants.
  In addition, these women are experiencing difficulties with health 
insurance coverage to pay for the high cost of repeated surgeries and 
examinations. The cost of faulty implants is paid for by all of us. 
Just consider the number of women who have had breast implants. The 
Institute of Medicine estimated by 1997, 1.5 to 1.8 million American 
women had breast implants, with nearly one-third of these women being 
breast cancer survivors.
  The American Society of Plastic and Reconstructive Surgeons cites 
breast augmentation as the most popular procedure for women ages 19 to 
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 these escalating numbers, very little is known about the 
long-term effects of the silicone of these breast implants on the body. 
Few patients understand that even when they opt for the saline breast 
implants, the envelope of the implant is made of the silicone.
  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.
  So, now with the FDA approval process behind us, the only course of 
action to safeguard future women is an informed consent document. 
Somehow, a

[[Page 13809]]

piece of paper is supposed to make up for the manufacturer's 
insufficient mechanical testing, revision data and retrieval analysis. 
It is supposed to make up for inaccurate labeling and risk estimates. 
It is supposed to make up for the plastic surgeon's obligation to fully 
inform their patients of the potential complications and reoperations 
and the doctor's chosen surgical procedures.
  There is so much we don't know, and yet the one government agency 
mandated to safeguard the public's food, drug and medical devices is 
willing to jeopardize women with a medical device that has alarmingly 
high failure rights.
  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. I highly 
doubt the post-market studies will be conducted in a meaningful and 
timely manner, and I doubt that the FDA has the ability to properly 
oversee these studies anyway. One of the manufacturers is already 
predicting to its stockholders it will have FDA's approval of its 
silicone breast implants in a couple of years, and I believe the need 
for more research is especially compelling in light of the FDA's own 
study on the rupture of saline breast implants.
  Mr. Speaker, I include for the Record two articles from The 
Washington Post and the Los Angeles Times.
  On May 18 of this year, Dr. S. Lori Brown's research was presented. 
The study examined women through the use of MRIs in order to detect 
whether their implants had ruptured and concluded that 69 percent of 
the women had at least one ruptured breast implant.
  The FDA concluded that rupture of silicone breast implants is the 
primary concern although ``the relationship of free silicone to 
development or progression of disease is unknown.''
  My colleagues have joined me in trying to get some critically needed 
independent research into silicone breast implants. We have sponsored 
``The Silicone Breast Implant Research and Information Act,'' H.R. 
1323, which calls upon the National Institutes of Health to conduct 
clinical research on women with silicone breast implants.
  Our bill places a special emphasis upon mastectomy women, who are 
adversely affected at a much higher rate than women receiving implants 
for cosmetic reasons.
  While that research is being conducted, the bill would also bolster 
the informed consent procedures and information given to women when 
they consider breast reconstructive surgery or breast augmentation.
  I urge my colleagues to join me in sponsoring this bill, and ensuring 
the health and well-being of American women. Since the FDA won't do 
it's job, we'll have to.
  Mr. Speaker, I include the following articles from the Washington 
Post and the Los Angeles Times for the Record.

                [From the Washington Post, May 21, 2000]

                           How Safe Is Safe?

       The Food and Drug Administration ruled last week that 
     saline-filled breast implants, the only kind still available, 
     can remain on the market. They had been in regulatory limbo; 
     a 1976 law allowed medical devices then available to continue 
     to be sold pending further testing, only now completed. But 
     for those who hoped the long-awaited FDA ruling would give a 
     firm yes or no on safety, the agency's judgment is less than 
     definitive.
       Saline implants may be sold, the agency ruled, but women 
     must be made aware of their many potential complications, 
     including pain, infection, cosmetic problems and a 20 to 40 
     percent chance they will need replacing by another operation 
     within three years. A serious effort needs to be mounted to 
     warn women of these risks, the agency believes. Not exactly a 
     ringing endorsement.
       Why, then, approve at all? Critics accuse the FDA of 
     diluting the meaning of its seal of approval. Many products 
     legally on the market carry risks. Drugs commonly come with 
     warnings of side effects. But the critics argue that the 
     agency should take a harder line toward optional cosmetic 
     products and procedures. And in fact, most optional devices 
     with complication rates this high have been kept from the 
     market.
       The FDA says it is trying to draw difficult lines between 
     protecting people and allowing them to weigh their own risks 
     at a time when both demand for ``lifestyle products'' like 
     cosmetic surgery and the variety available are skyrocketing. 
     Should people be protected from liposuction and laser eye 
     surgery? From cosmetic procedures with a remote risk of 
     serious harm but a high risk of moderate harm?
       The implant ruling reflects an FDA choice to become, at 
     least for cosmetic surgery, less a goalie and more a 
     disseminator of information. It's a defensible but risky 
     approach that can only work if accompanied by close 
     oversight, especially of the implant manufacturers and 
     plastic surgeons who benefit financially from use of these 
     products. For most consumers, the FDA's stamp of approval 
     still speaks more loudly than any warnings it may tack on.
                                  ____


              [From the Los Angeles Times, June 15, 2000]

                      Women Can't Count on the FDA

                        (By Patricia Lieberman)

       The Food and Drug Administration is known worldwide for 
     having the most rigorous safety standards. Unfortunately, it 
     lowered its standard last month when it approved saline-
     filled silicone breast implants. That decision will have an 
     impact on the lives of as many as 150,000 women and teenage 
     girls who get those implants each year. And if implant makers 
     have their way, the FDA will approve even riskier silicone 
     gel-filled implants next.
       To win approval of their saline implants, two Santa 
     Barbara-based corporations presented the FDA with results of 
     their studies of women who get saline implants three to four 
     years ago. They claimed their patients were satisfied. but 
     reported serious problems such as broken implants, breast 
     pain, infection, deformity and additional surgeries to fix 
     those problems.
       The manufacturers touted their implants safety, and they 
     were backed up by plastic surgeons, who told the FDA about 
     the wonderful successes in their practices. Like the children 
     of Garrison Keillor's mythical Lake Wobegon, the surgeons all 
     seemed to be ``better than average,'' with complication rates 
     that were much lower than the research found and patients 
     more enthusiastic about the changes implants made.
       Yet analysis by FDA scientists showed that the 
     manufacturers and physicians had underestimated the true 
     rates of complications. Using data gathered by the 
     manufactures, the FDA calculated that for one manufacture, 
     Mentor Corp., 43% of women who got implants for augmentation 
     had at least one complication within three years. For 
     mastectomy patients, it was even worse: Within three years, 
     73% of women who got implants had at least one complication, 
     and 27% had their implants removed. The statistics were even 
     more troubling for the implants made by McGhan Medical. For 
     both brands, the FDA explained that the complication rates 
     were still rising when the studies were completed, so the 
     long-term health risks are unknown.
       The FDA also heard heart-wrenching testimony from women 
     with health problems due to saline breast implants. They 
     heard from women who got sick but are too poor because of 
     extensive medical bills to have the implants removed. They 
     heard from women who were denied health insurance because 
     they were considered highrisk due to their implants and 
     subsequent complications. They heard from women whose 
     symptoms did not improve until after their implants were 
     removed. The FDA utterly ignored these devastating stories.
       The FDA also heard a radiology expert testify that breast 
     implants can interfere with mammography. Failure to detect 
     cancer is twice as likely for women with implants. Of the 1.5 
     million to 2 million women with implants, it is likely that 
     the breast cancer diagnosis of 20,000 to 40,000 if them could 
     be delayed because their implants obscured a tumor. Such a 
     delay can be deadly. When breast cancer is detected and 
     treated in its earliest stages, 90% to 95% of those women are 
     healthy 10 years later. Only 40% live 10 years if the cancer 
     is more advanced.
       Although the health risks clearly outweigh the cosmetic 
     benefits for most women and teenage girls, the FDA approved 
     saline implants anyway. The FDA will require that 
     manufacturers provide detailed information about the risks to 
     patients, but what does that mean? Will companies that 
     misrepresented their data to the agency realistically portray 
     the risks to their potential customers? It doesn't look 
     likely.
       Instead, the manufacturers are looking for more business. 
     After the FDA announced its approval of saline implants, 
     McGhan boasted that it would seek FDA approval for silicone-
     gel implants. The FDA's own research proves that this would 
     be a tragic mistake. Scientists found that even among women 
     who had not sought medical treatment for implant problems, 
     almost 80% had at least one broken implant after 10 to 15 
     years. Even more worrisome, the silicone was migrating away 
     from the implants in 21% of those women.
       The FDA made no effort to publicize those results. Instead, 
     it issues no warnings and still permits unapproved silicone-
     gel implants to be sold.
       Consumers should have the peace of mind that the term ``FDA 
     approved'' means that a product has been thoroughly tested 
     and proved safe. Unfortunately, when it comes to breast 
     implants, the FDA has placed the burden on women instead. 
     Women will have to sift through the plastic surgeons' and 
     manufacturers' glossy promotional brochures to seek the 
     information they need because we can no longer rely on the 
     FDA to look out for us.





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