[Congressional Record Volume 146, Number 88 (Tuesday, July 11, 2000)]
[House]
[Pages H5814-H5815]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
[[Page H5814]]
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 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
[[Page H5815]]
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.
____________________