Breast Implants | Breast Surgery
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More than 150,000 women had breast implant surgery
last year; an all-time high. At the same time, the number
of teenagers who choose breast implants has more than
doubled in the last two years.
And yet, the controversy about breast implants still
rages. As is often the case when the media covers medical
issues, there are experts on all sides of this issue,
and the consumer is left totally confused.
As a Congressional investigator in the early 1990s,
I had access to all published and unpublished studies
of breast implants, and was appalled to learn that almost
one million women had breast implants, but they had
never been objectively evaluated in either clinical
trials or epidemiological research. That situation has
changed. After the FDA started restricting access to
silicone gel breast implants, the implant manufacturers
started to fund research in an effort to prove that
they were safe.
As a scientist trained in psychology and epidemiology,
I have studied both the desire for implants and the
possible physical risks. Despite all the controversy
and media coverage about breast implants, there are
surprisingly few studies on the psychological benefits
of implants, the local complications caused by breast
implants, or the long-term risks. Instead, there is
a great deal of misinformation in the media, and many
women make the decision to get breast implants with
unrealistic expectations about how it will change their
lives, little awareness of the financial consequences,
and without the resources to cope if problems do occur.
Plastic surgeons claim that breast implants
have a very positive impact on a patient’s self-image.
It would be easy to study this objectively, by evaluating
women’s self-esteem and body image before, after,
and several years after getting breast implants. No
such study has ever been conducted.
Surveys indicate that when plastic surgeons ask their
patients if they are satisfied, most say that they are.
However, that is not an objective way to study the impact
on breast implants. There is no doubt that some women
are very satisfied with their breast implants, but any
evaluation of patient satisfaction should be conducted
by someone other than the plastic surgeons or their
staff. If you want honest and accurate answers, it is
important for patients to feel that their answers are
anonymous. Since implants are a lifetime commitment,
it is also important to study them several years later,
since that is when problems become more likely.
From a psychological point of view, improving one’s
appearance, with plastic surgery or other means, can
help a person feel better about himself or herself.
On the other hand, there are individuals who feel unattractive
because of a particular physical shortcoming, who then
“solve” that problem, and then focus on
a different shortcoming. There are other potential problems
specific to implants: a woman who changes her appearance
by getting breast implants may find that men treat her
so differently that she feels uncomfortable. If the
implants seem obvious (for example, because of the swooshing
sound of saline, hardness from capsular contracture,
or because they don’t feel the same as natural
breasts) she may become more self-conscious rather than
Implants Approved by the FDA?
FDA approval of some Mentor and McGhan saline breast
implants is based on studies that are not published.
For detailed information, check out the FDA Web site
or the summary on the Web site of the National
Center for Policy Research for Women and Families.
The manufacturers studied local complications such
as pain, implant rupture, and the rate of subsequent
surgery and implant removal. Mentor reported that 43
percent of the augmentation patients in their study
experienced local complications within the first three
- asymmetry, scarring, or wrinkling (32 percent)
- needing additional surgery (13 percent)
- severe capsular contracture (10 percent)
- implant removal (8 percent)
Even more women (60 percent) with McGhan implants reported
at least one serious complication in the almost four
years of that study. In the first three years, McGhan
patients experienced the following:
- asymmetry, scarring, or wrinkling (27 percent)
- needing additional surgery (21 percent)
- severe capsular contracture (9 percent)
- had at least one implant removed (8 percent)
The complication rates were even higher for patients
who got new breast implants to replace previous implants,
and higher still for women getting implants for reconstruction
after a mastectomy.
If these complication rates sounds very high to you,
you’re not alone. The FDA decision to approve
saline implants has been questioned by members of Congress
because one of the manufacturing companies is under
a criminal investigation and because the FDA did not
require long-term studies or studies of whether saline
breast implants cause serious diseases. Long-term research
is essential, because many of the implant patients who
have had problems, complain of systemic diseases that
developed years after getting their implants.
Instead, the FDA apparently relied on studies that
had been reviewed by the Institute of Medicine, which
did not find a significant increase in systemic diseases
among implant patients. However, the Institute of Medicine
only reviewed studies that had been conducted previously,
and these studies were not conclusive.
Silicone Gel Implants
The Institute of Medicine report primarily focused
on silicone gel breast implants, and found no statistically
significant relationship to systemic disease in most
of them. However, several studies found an increased
risk of connective tissue diseases, although the risk
was not always statistically significant. These trends
can mean several things:
- Illness could occur by chance (in other words, whether
or not the person has implants)
- The sample could be too small to detect a real risk
(this is especially likely when rare diseases like
scleroderma (connective tissue disorder) are studied)
- The study is not well designed—for example,
most of the studies include women who had implants
for a few months or years, which is probably too short
a period of time to develop connective tissue disease
Whether or not silicone gel implants cause systemic
disease, a new FDA study shows that they break more
quickly than has been acknowledged. The new FDA study,
published in September, 2000, showed that many women
with silicone gel implants walk around with broken and
leaking implants without knowing it. Using magnetic
resonance imaging (MRI), researchers determined that
almost half (48 percent) of the women who had silicone
gel-filled implants for only six to ten years had at
least one ruptured implant, even though they didn’t
know it. Even more of the women (79 percent) who had
gel-filled implants for 11 to 15 years had at least
one ruptured implant. What was surprising was that the
women had not realized the implants were broken and
had not sought any medical care. Since this study excluded
any women who had already reported implant problems
or removal, the actual breakage rate is even higher.
Even more worrisome is that more than one in five of
women had silicone gel “migrating” away
from the broken implant capsule. The long-term risks
of migrating silicone are unknown, but there are studies
documenting serious health risks and fatalities when
liquid silicone migrates to vital organs. Since silicone
gel can break down to liquid form, this is a serious
concern, especially since these women were not aware
of what was happening and only found out because they
were randomly selected for a study.
Are the Local Complications of All Implants?
There are some known risks of implants that are true
for either saline-filled or silicone gel-filled implants:
All surgery for breast implants, whether silicone gel
or saline, has risks. These include the risk of infection,
hematoma (blood or tissue fluid collecting around an
implant), the risk that one or both of the implants
will have to be removed (requiring additional surgery),
and the potential costs of repeated surgeries if the
implants are replaced.
All breast surgery, including implants, can interfere
with a woman’s ability to breast-feed a baby.
Women with implants are less likely to be able to nurse
than women who have not had breast surgery.
All breast implants will eventually break, but it is
not known how many years the breast implants that are
currently on the market will last. As shown in the recent
FDA study, most implants last seven to 12 years, but
some break during the first few months or years, and
some last more than 15 years.
The most common complaint is capsular contracture, which
occurs when a woman's body reacts to the “foreign
body” by forming a capsule of scar tissue around
the implants that can become too tight. If that happens,
the breasts can become very hard, misshapen, and painful
as a result, often requiring surgery or removal. The
appearance is common among actresses and models, who
sometimes look like they have two balls attached to
their chests instead of natural breasts. The result
is especially unattractive if one breast has contracture
and the other doesn’t, or if the contracture causes
the breast to feel very hard or to change in shape.
Although the epidemiological studies have not proved
that systemic disease is caused by breast implants,
several European studies have indicated that breast
surgery (whether for breast implants or to reduce the
size of breasts) may be associated with an increased
risk of connective tissue disease or rheumatism. If
these disorders, which include diseases such as scleroderma
and fibromyalgia (a syndrome characterized by chronic
fatigue and body aches and pains), are related to breast
surgery, all women with implants would be at increased
risk, regardless of whether the implants are filled
with saline or silicone gel. Since women with implants
often have multiple surgeries, the risks of systemic
illness are potentially increased even further.
All breast implants interfere with mammography, because
implants can obscure the view of a tumor. Implants,
therefore, have the potential to delay the diagnosis
of breast cancer. Although specially trained technicians
can perform mammography in ways that minimize the interference
of the implants, not all women have access to a mammography
technician with this expertise. Unfortunately, even
with expert technicians, about 30 percent of the breast
will still be obscured. Experts estimate that 20,000
to 40,000 women who already have implants will have
a delayed diagnosis of breast cancer because of their
Although there are no long-term safety studies of
saline implants, it is assumed that they are safer than
silicone gel implants because if they break, they can
be more easily removed. In contrast, silicone gel can
be very difficult or even impossible to completely remove
from the body once an implant has ruptured. In addition,
it is not always obvious that a silicone gel implant
has broken, and the gel can migrate slowly over time
into various parts of the body. However, there is research
evidence that bacteria and mold can grow in a saline-filled
implant, and nobody has studied what happens when the
implant breaks in a woman’s body. In addition,
even saline implants can leak small amounts of silicone
or platinum into the body, which come from the outer
shell (the “bag” that holds the saline)
of the implant. The long-term health risks of those
leaks are unknown.
and Insurance Concerns
Breast augmentation usually costs $5,000 to $7,000
and many physicians will sell the procedure on the installment
plan. However, the initial cost is small compared to
the lifetime costs, even for women who like their implants.
Financing is available online at www.cosmeticsurgeryfinancing.com.
Since implants can break at any time, and are almost
assured of breaking within seven to 12 years, a woman
needs to consider the lifetime expense of additional
surgery and replacement. Although unusual, some implants
break within a few days, weeks, or months of surgery.
Some implant manufacturers promise to replace the implants
for free, but the expense of the implant may be a small
percentage of the total cost of augmentation. Some doctors
also promise to provide their replacement services for
free, but that does not include the cost of the medical
facility, anesthesiologist, and so on.
Augmentation is almost never paid for by health insurance,
so the costs of additional surgery can be very expensive.
Women with implant problems can have many surgeries
within a few years.
An even greater problem is that breast implants can
make a woman uninsurable. While many insurance policies
will merely exclude the implants, or the entire breast
area from coverage (a terrible problem if the woman
later gets breast cancer), some major insurance companies
have decided to totally exclude any woman with breast
augmentation from their policies.
The costs of removing a broken silicone gel implant
are substantial. If the implant breaks and the silicone
gel spills out, it can mix with the breast tissue and
other tissue and be almost impossible to remove. Surgical
efforts to remove broken gel implants can take hours
and cost tens of thousands of dollars. In addition,
a mastectomy may be necessary to remove the silicone
in an otherwise healthy breast.
Have I Got to Lose?
Many cosmetic changes are easy to undo. Breast implants
are not. Once the skin and natural breast tissue have
been stretched by breast implants, they will never look
the same as they did before the implant surgery. Most
plastic surgeons try to persuade their patients to replace
a problem implant, warning them that they will be depressed
by their appearance if they are taken out and not replaced.
This should be of particular concern to parents who
are considering implants for their daughters. If a 17-year-old
dyes her hair, she can dye it back or grow it out. If
she decides to get breast implants, it is a decision
that will permanently change her body. If she wasn’t
satisfied with the size of her breasts before implants,
imagine how she will feel to have breasts that are just
as small and also sagging.
Weren’t Implants Studied Before They Were Sold
With all the problems and unanswered questions about
breast implants, the obvious question is “Why
weren’t implants studied first and improved before
selling them to women across the country?”
The FDA did not have the authority to regulate any
kinds of implants or medical devices until 1976. Implants
had been sold since the 1960s, so they were allowed
to stay on the market until the FDA reviewed them. Meanwhile,
there was a substantial backlog of products that the
FDA needed to review, and cosmetic products like breast
implants were not a priority. Unfortunately, the manufacturers
did not conduct long-term studies until the FDA required
The more than one million women who have breast implants
are, without their realizing it, part of a natural “study”
to learn what the risks are. Women deserve to be told
what is known, and what is not known, before they make
this decision. And, if a woman with implants complains
of symptoms, she needs to find a plastic surgeon who
has a reputation for helping women with implant problems.
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