| Ilena Rose 2004-09-26, 4:07 am |
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http://www.fda.gov/fdac/features/2004/504_implants.html
Making an Informed Decision About Breast Implants
By Carol Rados
Despite more than a decade of controversy over their safety, breast
implants are more popular than ever among women who want to build upon
what nature gave them or who want to restore what disease has taken
away. Whatever the reason, opting for breast implants is a personal
decision that should be made only after a woman fully understands and
accepts the potential risks of the devices and the importance of
follow-up evaluations with her physician.
Some people see an enormous benefit to getting implants and are
willing to accept associated risks. They say that using breast
implants to rebuild the breast (reconstruction), or change its size
and shape (augmentation), significantly improves the quality of life
for many women. Advocates of breast implants also say that a woman's
consent to the surgery should be considered valid as long as she
weighs the risks and benefits of the procedure.
While every surgical procedure has potential risks, such as infection,
bleeding, and scarring, there are risks that are specific to breast
implants. Learning about them is key to being properly informed about
the procedure.
A Primer on Breast Implants
According to the American Society of Plastic Surgeons (ASPS), there
were nearly 255,000 breast enhancement implant surgeries in 2003,
nearly twice the number done in 1998. Another 68,000 women received
breast implants for reconstruction following mastectomy due to cancer
or other disease.
But also in 2003, 45,000 augmentation patients and 17,000
reconstruction patients had their breast implants removed. The medical
community and others, including the Food and Drug Administration,
would like to better understand why.
Breast implants are designed for augmentation, a cosmetic procedure;
reconstruction; and replacement of existing implants, called revision.
There are two primary types: saline-filled and silicone gel-filled.
Depending on the type of implant, the shell is either pre-filled with
a fixed volume of solution or filled through a valve during the
surgery to the desired size. Some allow for adjustments of the filler
volume after surgery. Breast implants vary in shape, size, and shell
texture.
At this time, there are two manufacturers with approved saline-filled
breast implants. No manufacturer has yet received FDA approval to
market a silicone gel-filled breast implant.
The Silicone Controversy
Breast implants were first marketed in the early 1960s, before the
1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic
Act required a reasonable assurance of safety and effectiveness to be
shown for certain medical devices. The 1976 law gave the FDA authority
over such devices, but breast implants were "grandfathered" into the
regulatory scheme, meaning that manufacturers were not required to
provide the agency with scientific evidence of product safety unless
questions arose about the safety and effectiveness of these
already-marketed devices. Silicone was initially assumed by
manufacturers to be biologically inactive and, therefore, to have no
harmful effects.
But over the years, questions did arise about the effects of silicone
on the body. In 1991, the FDA published a regulation that required
manufacturers of silicone gel-filled breast implants to submit
premarket approval applications (PMAs). This requirement meant that
the FDA needed to agree that the manufacturer has presented data
showing a reasonable assurance of safety and effectiveness in order
for the devices to remain on the market.
In January 1992, the FDA called for a voluntary moratorium--a delay on
the use of these implants--until new safety information could be
thoroughly reviewed. The moratorium was not intended to "ban" the
implants, but instead to allow time to review the new safety
information.
In April 1992, the agency decided that no PMA yet submitted contained
sufficient safety and effectiveness data to support approval. However,
access to these silicone gel-filled breast implants would continue for
women enrolled in certain clinical studies.
In the years that followed that decision, thousands of women filed
lawsuits against the manufacturers of silicone gel-filled implants,
claiming the devices had caused serious ailments, such as connective
tissue diseases, neurological diseases, and cancer. Consumer groups
repeatedly filed petitions urging more studies on the implants. But
many women said they were pleased with their implants, including
cancer patients who had pleaded for the opportunity to choose silicone
gel-filled implants for reconstruction.
A Turn of Events
In October 2003, the FDA held a two-day advisory panel meeting to
discuss a manufacturer's PMA for a silicone gel-filled breast implant.
Some people complained that the meeting was premature in light of the
fact that long-term studies had not been completed, but the FDA
proceeded because the agency was required by law to consider the
pending PMA within a specified time frame. The meeting also provided
patients and others with timely access to information and expert
analyses on the issue. The issues before the panel reflected much of
the decades-long debate over the implants. Moreover, the meeting
provided a valuable public forum for discussing the issue from many
diverse perspectives and for raising important additional questions.
As a panel member, Benjamin O. Anderson, M.D., voted with the majority
to recommend that the FDA approve the new PMA, but only with specific
conditions. Anderson says he wants to avoid getting into the business
of determining how a woman defines the value of breast reconstruction
or augmentation.
"The use of implants and augmentation conjures up some social
judgments that may well be unfair," says Anderson, a professor of
surgery and director of the university of Washington's Breast Health
Center. Rather than deciding that no woman can have access to silicone
gel-filled implants because a small number may be at risk for certain
illnesses, he says, "I believe the better approach is to make the
devices available and inform all women of the degree of risk
involved."
That, according to Anderson, "is reasonable informed consent."
In January 2004--contrary to the recommendation of the agency's
advisory panel--the FDA determined that the new silicone gel-filled
breast implant PMA was "not approvable" at that time. This meant that
the implants were not approved for marketing pending additional
information, but that women would continue to have limited access to
them by enrolling in clinical studies.
"The public scientific process that has been used to consider these
devices is fully consistent with the FDA's mission--to use the best
available science to protect and promote the public health interests
of the American people," says Linda Kahan, deputy director of the
FDA's Center for Devices and Radiological Health (CDRH).
Also in January 2004, the agency released a draft of its new
guidelines for companies submitting breast implant PMAs, explaining
the scientific issues that the FDA recommends be addressed as part of
their applications. The guidance document reflects the FDA's current
thinking about new scientific information that the agency,
manufacturers, and the clinical community have gained over the last 10
years, including information learned at the October 2003 advisory
panel meeting. Consistent with the FDA's good guidance practices, the
agency has asked for public comments on the breast implant guidance.
The guidance is not intended for implementation until it is finalized.
"Current testing doesn't reflect reality," says Michael A. Choti,
M.D., an associate professor of surgery and oncology at the Johns
Hopkins university School of Medicine in Baltimore, and also an FDA
advisory panel member. The implants, he says, are extremely durable
when tested outside the body. "You can virtually run a truck over them
and they'll hold up. But the question is, what happens when implanted
long-term in a woman's body?"
The FDA's draft guidance document says that two to three years of
follow-up data may not be enough to allow the agency to evaluate the
safety and effectiveness of breast implants. The agency recommends the
use of tests that can predict clinical outcomes, such as how long
breast implants will last before rupturing in the body, as well as
tests that explain how and why the breast implants rupture. In
addition, the agency recommends that more data be gathered regarding
the rate of rupture over time, as well as the health consequences of
rupture.
Breast Implant Risks
In 1999, the Institute of Medicine (IOM) issued a report on a review
of information related to health effects associated with silicone
breast implants, both gel-filled and saline-filled, in humans. An
important goal of the IOM was to provide women with detailed
information about the potential risks of silicone breast implants.
One risk is capsular contracture, which is a tightening and squeezing
of the scar tissue that naturally forms around the implant. This
contracture may result in hardening of the breast tissue, rippling of
the skin, and changes in breast shape. It also may cause pain, which,
if severe, can require surgery to remove the scar tissue or replace
the implant.
In addition, a rupture can occur at any time. While saline-filled
breast implants leak only salt water when they rupture, the health
effects of leaking silicone gel-filled implants remain controversial.
Women sense a change more easily when saline-filled breast implants
rupture. But the silicone gel-filled implants are more likely to
maintain their shape after they rupture, which can make it more
difficult to detect a break.
Called "silent ruptures," these breaks involving silicone gel implants
may occur without a visible change. And a woman may not feel any
sensation, says Sahar M. Dawisha, M.D., a medical officer in CDRH who
has reviewed data submitted by implant manufacturers. Magnetic
resonance imaging (MRI) with equipment specifically designed for
imaging the breast may be used for evaluating women with suspected
rupture of their silicone gel-filled implant. The FDA considers MRI to
be the best method at this time. There are no standards on how often
to screen for silent rupture with MRI, and the costs of this procedure
must be considered when choosing a silicone gel-filled breast implant.
Physicians usually recommend removal of the implant if it has
ruptured, regardless of whether it is saline-filled or silicone
gel-filled.
Another potential complication of implant surgery is nerve damage,
which can cause some women to experience a loss or increase in
sensation in their nipples and breast tissue. These symptoms may
disappear eventually, but can be permanent in some cases. It is
unclear at this time whether insufficient milk production to
breast-feed--another reported problem--is due to damaged nerves or to
other reasons.
Women should know that, regardless of the type of implant, it is
likely they will need to have one or more additional surgeries
(reoperations) over the course of their lives, because of
complications from breast implants. Reasons for reoperations include
any of the potential complications, such as capsular contracture,
wrinkling, asymmetry, rupture, or implant malposition.
The IOM committee also found that women with silicone breast implants
are no more likely than women without implants to develop the
life-threatening systemic illnesses that some people have claimed
might be related to the implants.
But many women disagree. They have reported health problems related to
their immune systems or neurological symptoms that they believe are
caused by ruptured or intact breast implants. And some women who have
received breast implants claim they weren't fully informed of the
risks.
Lynda Roth, who was diagnosed with breast cancer in 1990, says she was
forced to make a quick decision, based on very little information,
about getting breast implants following a mastectomy.
"I trusted what my highly respected doctors were telling me was true,"
says the 63-year-old social worker in central Colorado. "You're in
shock, you think you're going to die, so what kind of informed
decision can you possibly make about what you want your breasts to
look like if you're lucky enough to survive?"
Roth did survive--both breast cancer and two silicone breast implants
gone bad. But the ruptured devices, she believes, caused her to lose
her good health, her job, and eventually her health insurance over the
next 11 years. "I found out the hard way," she says. "There were many
risks with the implants that I didn't know about."
Other women are pleased with their implants. Clara Filion underwent
reconstruction in 1993 after having a breast removal that included the
lymph nodes under the arm (modified radical mastectomy) due to cancer.
The 67-year-old Bedias, Texas, resident says she's thrilled with the
outcome of her saline-filled implant, as well as with her surgeon,
even though her original implant will need replacing soon due to scar
tissue--a local complication that Filion says she always knew could
occur. Filion has experienced no other complications related to the
implant in 11 years.
Other Considerations
"My doctor told me that these implants would go with me to my grave,"
says 44-year-old Patty Faussett of Henderson, Nev., who chose to
augment her breasts with saline breast implants in 1997, after years
of breast-feeding distorted their shape.
Faussett had her implants removed a year after implantation because
she believes they caused a mixed bag of health problems, including
disturbed vision, heart palpitations, muscle twitching, and an
autoimmune thyroid disease. She says, "The risks were much greater
than my surgeon led me to believe."
Experts caution that breast implants do not last a lifetime. Women
should be prepared for long-term follow-up and additional surgeries to
treat complications. They also should be prepared for the accompanying
additional costs. One of the biggest problems Faussett says she hears
from women in her breast implant support group is that "most don't
plan for the money it takes to fix what goes wrong."
In addition, women should be aware that hard pressure on the breast
(compression) during mammography may cause implant rupture. Breast
implants also can interfere with finding breast cancer during
mammography. Doctors say the implant can hide breast tissue and, as a
result, hide lesions as well. Extensive scarring and calcium deposits
in tissue surrounding an implant can mimic the appearance of cancer,
making the deposits difficult to distinguish from tumors on a
mammogram.
Another consideration is the choice of a surgeon. Patient advocates,
professional groups, and others agree that it's important to choose a
plastic surgeon who has been trained in breast implant surgery and who
has performed it successfully on many women.
After switching to a new, firmer silicone gel-filled implant through a
clinical study only a year after experiencing rippling with her saline
implants, Kathy Bracy says it's important that women who are
considering breast implants do their homework.
"I love my breast implants, but I also spent six months researching
the devices, which included picking the best doctor for me," says
Bracy, a 38-year-old self-employed bookkeeper from Tampa, Fla. "It's
not necessarily the product, but who is doing the surgery." The key to
breast implant satisfaction, she says, is to "find a doctor who is
willing to answer all your questions and take all your concerns
seriously. And the relationship with your doctor doesn't end after the
surgery."
Experts also advise women to have realistic expectations about breast
implants. There is no guarantee that the results will match those of
other women. Overall health, age, chest structure, the shape and
position of the breast and nipple, skin texture, the tendency to
bleed, prior breast surgeries, and the surgical team's skill and
experience all figure into the outcome of breast implant surgeries.
The Teen Scene
In addition to safety issues, there is concern about the growing use
of breast implants among teen-agers. Health officials worry that
teen-agers and their parents may not realize the relative permanence
of the changes caused by the devices. They also want to be sure that
teens are physically ready--that is, they're finished developing--and
that they are psychologically mature enough to handle the outcome of
surgery.
"I didn't know my breasts were still growing when I signed up for the
surgery," admits Kacey Long, who got saline-filled breast implants in
July 2001, when she was 19. Prior to her surgery, the college student
from Ennis, Texas, was a 34B--a breast size she thought would be with
her for life.
Teen-agers who are dissatisfied with their bodies see breast implants
as a harmless--and, according to Long, "fun"--thing to do to improve
their self-image. Long says she felt that her body was too "bottom
heavy" for her breasts and wanted to "even out" her figure. "But I
never thought about my implants being dangerous," she says. A friend's
mother worked for a plastic surgeon for 12 years and told Long she
knew of no problems with patients who had gotten the implants. "I
really thought that I had inside information, and that these devices
were completely safe and maintenance-free."
Following implantation, Long went to a 34D. But complications
convinced her to have the implants removed a short time later. "I had
shooting pains in my arms, excruciating pain in every joint, bone, and
muscle of my body, I was exhausted all the time, had no energy, lost
my hair, and had pains in my chest, heart, and ribs. I had trouble
remembering things and thinking clearly, and the list goes on," she
says. "Before the implants, all I had was allergies."
Many of the changes to the breast that occur with an implant cannot be
undone. If a teen chooses to have her implants removed, she may
experience dimpling, puckering, wrinkling, or other cosmetic changes.
Three years later, Long's breasts measure 36C--one size larger than
before she was implanted--suggesting that her own breasts continued to
develop even after the implants were removed. "When you're making a
decision that can impact your life at 19," Long advises other young
women, "you need to research the subject like you're 50 years old."
Ongoing clinical studies for unapproved saline-filled and silicone
gel-filled breast implants do not allow for those younger than 18 to
receive the implants for augmentation purposes. Some of these clinical
studies even limit reconstruction and revision uses to women 18 and
over.
Consumers can get a copy of the "FDA Breast Implant Consumer Handbook
2004," which provides in-depth information on both saline and silicone
breast implants, by visiting www.fda.gov/cdrh/breastimplants/, or by
writing to: FDA, Office of Device Evaluation, Division of General,
Restorative, and Neurological Devices, 9200 Corporate Blvd., HFZ-410,
Rockville, MD 20850.
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