May, 2006
Breast Implants
A Research and Regulatory Summary
By Diana Zuckerman, PhD, and Elizabeth Santoro,
RN, MPH
More women are getting breast implants than ever before. In 2005, more than 360,000 women and teenagers underwent breast implant surgery for augmentation1 and approximately 46,000 women underwent breast implant surgery for reconstruction after mastectomy.2 The number of breast augmentations of women and teenagers has more than tripled since 1997, when it was 101,176.3
However, the dramatic increase in breast implant surgery does not
necessarily reflect a similarly dramatic increase in the number
of women with breast implants. Many women who undergo surgery are
replacing old implants that have broken or caused problems; some
women report as many as ten or more surgeries as their implants
are replaced over the years. There are no available statistics on
how many women undergo their first breast implant surgery every
year.
Debate swirls over the risks of breast implants, and physicians
and patients are justifiably confused by the conflicting information
available. This summary provides information about what is known
and not known about the risks of breast implants.
The Role of the Food and Drug Administration (FDA) in Safety
Research
Breast implants were first sold in the 1960's, but the FDA did not
have the authority to regulate them until 1976. Sales were relatively
slow until the 1980's but by 1990, almost one million women had
breast implants, even though there were no published studies about
their safety, and the FDA had never approved them. Finally, in 1991,
the FDA required the manufacturers of silicone gel breast implants
to submit safety studies. Unfortunately, these studies were inadequate;
for example, in the McGhan prospective study, only 35% of the patients
had been followed for at least three months, and there were only
three reconstruction patients.4 Because
of the lack of clinical data, silicone implants were not approved.
Instead, the FDA approved a compassionate need exemption policy
on October 23, 1992, which allowed silicone implants to remain available,
primarily to reconstruction patients and women who already had breast
implants that they wanted replaced. Meanwhile, articles questioning
the health risks of breast implants were being published in medical
journals.
Under the FDA's compassionate need exemption policy, silicone gel
implants remain restricted in the U.S. to clinical trials, including
a large "adjunct study" for reconstruction patients and women with
broken implants. Smaller numbers of first-time augmentation, reconstruction,
and implant replacement patients are in each company's "core study."
It is important to note that the definition of reconstruction patients
includes many women who are not mastectomy patients; women can also
be "reconstructed" after "deformities" such as very droopy breasts
and "severe" asymmetry (both subjectively defined by the plastic
surgeons). In addition, women who are unhappy with their saline
breast implants are often able to find a physician who will enroll
them in the adjunct study of silicone gel implants. However, all
women who have had surgery with silicone gel implants since 1992
have been required to be informed that the implants are not approved
by the FDA, to provide informed consent, and to be regularly evaluated
by their plastic surgeons as part of the study. Implant manufacturers
could have collected and published extensive safety data from these
studies. However, they have not done so.
Major shortcomings have been reported regarding the adjunct studies
and core studies, in terms of entry criteria, data collection, and
patients' informed consent. Numerous patients have informed our
Center and testified before the FDA that plastic surgeons enrolled
them in these clinical trials for non-existing deformities, or did
not obtain informed consent. Many patients report that their physicians
encouraged them to enroll in the study as a way to qualify for silicone
implants, explaining that they could immediately drop out. That
anecdotal claim is supported by the enormous loss to follow-up;
Inamed data discussed at the FDA's October 2003 Advisory Panel meeting
indicates that only 27% of the reconstruction patients and 20% of
the revision patients were followed for three years. As a result
of this very low follow-up rate, these "studies" do not provide
meaningful safety data.
The October 2003 FDA Advisory Panel meeting was held to consider approval of silicone breast implants made by Inamed. After considering the Advisory Panel recommendations and the scientific data, the FDA decided not to approve Inamed silicone breast implants in January 2004. At the same time that the decision was announced, the FDA issued a new guidance specifying the type of research needed to obtain approval of any breast implants in the future. A major focus of the guidance document is for manufacturers to determine why implants break, how long they last, and the health consequences of broken and leaking breast implants On April 11-13, 2005, the FDA held an advisory panel meeting to consider the research on silicone breast implants that was subsequently submitted by two companies, Inamed and Mentor. In late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employees. As of July 2006, the FDA had not announced its decision about whether it would approve either Mentor or Inamed silicone gel breast implants.
Types of Breast Implants
The 40-year history of silicone breast implants is a history of
trying to reduce complications, especially common problems such
as breast hardness and pain caused by capsular contracture. Although
breast implants were not studied in clinical trials for the first
25 years, clinical experience indicated that design modifications
seemed to improve the outcome at first, but were later found to
be ineffective at fixing the problems and often caused new ones.
For example, since the mid-1960's implant modifications have included
adding a Dacron patch, removing the Dacron patch, changing the thick
gel to a thinner gel, changing the thinner gel to a thicker gel,
making the silicone shell textured, covering the shell with polyurethane
foam, removing the foam when it was found to break down to a carcinogen,
making the shell smooth, changing the shape of the implants, and
reducing "silicone bleed." All of these changes were "studied" informally
when patients underwent surgery, rather than in clinical trials.
A Congressional report summarizing these changes referred to the
patients as guinea pigs.4
The silicone gel breast implants being reviewed by the FDA in April
2005 are essentially identical to those made in the early 1990's.
Inamed's Senior Director of Regulatory and Clinical Affairs testified
to the FDA that "it is basically the same product it was 10 years
ago…it is essentially the same product.5
In addition to changes in silicone gel breast implants, implant
makers have tried to improve the product by using fewer materials
other than silicone gel. Saline breast implants have a silicone
envelope and are filled with salt water. Saline breast implants
have been available for decades, but it was not until May 2000 that
the FDA approved saline implants for the first time. Before approving
these devices, the FDA required 3-year studies of local complications,
such as pain, infection, hardening, and the need for additional
surgery. They did not require studies of other health problems.
In addition to saline, three other kinds of implants were available
in recent years, primarily outside the United States: Trilucent
implants (with soybean oil filler), and Novagold and PIP hydrogel
implants, which were filled with a plastic gel. Although never approved
as safe in the U.S., these implants were vigorously promoted by
plastic surgeons and the media as a "natural" and safer alternative
to silicone or saline implants. Clinical trials, however, were apparently
never conducted on humans with these implants, and all were removed
from the market in 2000 because of safety concerns.6,
7, 8, 9
Their removal from the market, after being enthusiastically praised
by doctors and patients, serves as a reminder that the long-term
risks of implants are not always obvious during the first few years
of use.
Frequency of Local Complications
Risks associated with surgery include infection, hematoma (blood
or tissue fluid collecting around an implant), and the risks associated
with anesthesia.
Pain and Capsular Contracture: All implants are
"foreign bodies," and a woman's body reacts by forming a capsule
of scar tissue around the implants that can become too tight for
the implant. This common problem is called capsular contracture.
When that occurs, the breasts can become very hard, misshapen, and
cause mild discomfort or severe, chronic pain. Research submitted
in support of Inamed's 2003 application showed severe capsular contracture
occurring in 16% of reconstruction patients and 8% of augmentation
patients within 3 years.
Comparing Inamed data on saline breast implants and silicone gel
breast implants shows many of the same types of complications; however,
complication rates from silicone implants tend to be higher.10,
11 For example, 46% of silicone gel
reconstruction patients and 21% of saline reconstruction patients
underwent at least one re-operation within three years, 25% of silicone
patients and 8% of saline patients had implants removed, and 6%
of silicone patients and 16% of saline patients had breast pain.
Complication rates were lower but still substantial for augmentation
patients.
A study of Danish women who had breast implants for an average of
19 years found that women with implants were almost three times
as likely to report breast pain compared to breast reduction patients;
the question was not asked of women in a control group since it
was assumed they did not experience breast pain.12
In addition, two-thirds of the women with implants reported moderate
or severe breast hardness.
There are other well-documented local complications that can result
from breast implants. For example, some women lose sensitivity in
their breasts, and others become overly sensitive; these problems
can interfere with sexual intimacy. The cosmetic outcome is sometimes
disappointing, with breasts looking or feeling unnatural or asymmetrical.
Rupture: All breast implants will eventually break.
When silicone gel breast implants break, there are often no symptoms,
so accurate estimates of rupture rates depend on magnetic resonance
imaging (MRIs). Patients who testified before the FDA and clinical
evidence indicates that some breast implants break during the first
few weeks or months, while others last more than 15 years. In a
study conducted by researchers at the FDA, most women had at least
one broken implant within 10 years, and the likelihood of rupture
increased over time.13 The women in
the FDA study had not had their implants removed, did not know that
their implants were broken, and were not seeking help because of
implant concerns. Despite the fact that these women were "satisfied
customers" rather than women seeking medical care, MRIs found that
silicone had migrated outside of the breast capsule for 21% of the
women in the study. Most of the women were unaware that this had
happened. Inamed's study of their silicone gel implants found that
between 1 - 6% break within three years.11 A Danish study of ruptured
silicone gel implants reported that most lasted for ten years; however,
by the time the women in that study had implants for 15 years or
more, a substantial percentage of the implants broke every year.14
Leakage: Numerous studies have shown silicone leakage
into the scar capsules surrounding breast implants, even for implants
that are not ruptured. More worrisome, researchers at Case Western
Reserve and the Armed Forces Institute of Pathology have reported
finding silicone in the lymph nodes of women with breast implants,
which can then migrate to other organs.15,16
Silicone in the lymph nodes can only be removed by removing the
lymph nodes; silicone in organs such as the lungs, liver, and brain
cannot be removed. The health risks associated with migrated silicone
are unknown; however, case reports have indicated fatalities and
serious health risks when liquid silicone injected in the breasts
migrated to the lungs or other organs. Although silicone implants
are filled with gel rather than the liquid form of silicone, the
implants sometimes leak a silicone liquid or thin gel.
A study published by the Royal Academy of Medicine in Scotland found
that a woman with a broken silicone gel implant in her calf was
coughing up silicone identical to the kind in her implant.17
This has potentially serious implications for women with leaking
breast implants, since silicone gel breast implants are considerably
larger and closer to the lungs than calf implants.
Mammography: Breast implants interfere with the
detection of breast cancer because implants can obscure the mammography
image of a tumor. Implants therefore have the potential to delay
the diagnosis of breast cancer. Although special techniques are designed to minimize the interference of the implants, the most recent research indicates that 55% of breast tumors will still be obscured. That is much higher than the 33% obscured in
women without implants in the same study. 18
Mammograms tend to be less accurate if the woman has capsular contracture.
In addition, women with implants may be reluctant to undergo mammograms
because of fear of rupture, and a study by FDA scientists indicates
that silicone or saline implants sometimes rupture when women undergo
mammograms.44 There is no research
evidence that implants cause breast cancer, and research findings
on whether there is a delay in diagnosis have been inconsistent.
A delay in diagnosis could have serious health implications, and
decrease women's options for breast-conserving surgery, and such delays have been reported by patients.44
Breastfeeding: According to the Institute of Medicine
(IOM), women with any kind of breast surgery, including breast implant
surgery, are up to three times more likely to have an inadequate
milk supply for breastfeeding.19 Concerns
about the chemicals from the implants passing to infants through
breastfeeding have also been raised, but there is insufficient research
information available. However, a study presented at the American
Chemical Society's 2004 August meeting found exceptionally high
concentrations of platinum, a known potential toxin, not only in
women with silicone breast implants, but also in the children they
bore and breastfed.20 The American
Academy of Pediatrics always encourages breastfeeding unless there
is clear evidence of risk, whether from implants or any other exposure.
However, they have not yet reviewed or formally commented on the
aforementioned study.
Autoimmune and Connective Tissue Diseases
The greatest controversy regarding the risks of breast implants
is whether they increase the risk of autoimmune disease and connective
tissue disease. Studies from the 1990's tend to show no increase
in risk, but more recent studies suggest an increased risk.
A study conducted by FDA scientists found a statistically significant
link between implants and fibromyalgia and several connective tissue
diseases.21 The study focused on women
who had silicone breast implants for at least six years, and found
that women with leaking silicone implants were significantly more
likely to report a diagnosis of painful and debilitating diseases
such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto's
thyroiditis, mixed connective tissue disease, pulmonary fibrosis,
eosinophilic fasciitis, and polymyalgia. The risk of fibromyalgia
remained even after controlling for patient's age, implant age,
and implant manufacturer. Extracapsular leakage was evaluated using
an MRI.
A study by Aziz et al examined 95 women who had silicone gel-filled
breast implants and rheumatologic symptoms. These researchers found
that the symptoms improved in 42 (97%) of the 43 women who had their
breast implants removed and not replaced.22
In contrast, rheumatologic symptoms worsened in 50 (96%) of the
52 women who did not have their implants removed.
Scientists at the National Cancer Institute (NCI) found a statistically
significant increase in reported connective tissue diseases among
breast augmentation patients, but also found that many of the women
made errors in their self-reported diagnoses.23
For example, many women who reported having rheumatoid arthritis
had osteoarthritis instead, according to their medical records.
The NCI study included women who had breast implants for at least
seven years. The findings suggest that there are
increased symptoms among women with breast implants, but it is not
clear if there is an increase in specific diagnoses. As a result,
the researchers concluded that the associations between breast implants
and arthritis, scleroderma, Sjogren's syndrome, and other connective
tissue diseases need further study.
A study of Danish women who had breast implants for an average of
19 years found that they were significantly more likely to report
fatigue, Raynaud-like symptoms (white fingers and toes when exposed
to cold), and memory loss and other cognitive symptoms, compared
to women of the same age in the general population.12
Ten percent of the women with implants had already had their implants
removed and not replaced, which might have reduced these symptoms.
Despite reporting that women with implants were between two and
three times as likely to report those symptoms, the researchers
concluded that long-term exposure to breast implants "does not appear
to be associated with" autoimmune "symptoms or diseases." The study was funded by Dow Corning.
Prior to these recent studies, most published research that has
focused on autoimmune or connective tissue diseases studied women
who had implants for a relatively short time, ranging from a few
months to a few years. The minimum exposure to breast implants was
usually one month. These studies are the basis for a report on implants
by the IOM, a report by Judge Pointer's scientific panel, and a
meta-analysis published in the New England Journal of Medicine regarding
the lack of evidence that implants cause systemic disease.19,
24, 25
All three of these reports are based on the same 17-20 epidemiological
studies that were published prior to 1999. Since many connective
tissue and autoimmune diseases are relatively rare among young women
and most take many years to develop and be diagnosed, these studies
are not designed to answer questions about long-term safety. Their
major flaws are as follows:
• The case-control studies relied
on women accurately telling a stranger whether they had breast
implants, and most included very few women who admitted having
breast implants. The accuracy of their responses was not verified.
• The studies include substantial numbers of women who had
implants for just a few months or years, and therefore do not
have the statistical power to deter mine whether or not breast
implants increase the long-term risks of getting these diseases.
• The number of women in the studies who had breast implants
for 10-15 years or more is too small to conclusively evaluate
an increased risk of disease.
• Disease diagnoses were based on medical records or self-reports,
not medical exams. Several studies had an even greater flaw: autoimmune
disease was based on hospital records rather than medical diagnoses.
Most women with autoimmune symptoms or diseases are not treated
in hospitals.
Among the studies reviewed by the IOM, only
one study, by Schusterman et al, includes a diagnosis based on a
medical exam, and all the women in that study had implants for less
than two years, which is too short a time to meaningfully evaluate
disease risk. In addition, several European studies that purported
to show no increased risk of autoimmune diseases actually indicated
an increased risk of neurological or autoimmune disease that was
similar for women who had breast augmentation or breast reduction.26,
27 Using breast reduction patients
as a comparison sample, the researchers reported that the augmentation
patients were not significantly more at risk. However, the articles
clearly stated that both groups had a higher proportion of women
with these diseases than expected. Therefore, the interpretation
of "no increased risk" was inappropriate; rather both types of breast
surgery patients were apparently at increased risk.
These findings raise concerns about autoimmune disease that need
to be answered with long-term studies. In addition, former FDA researchers
have reported that silicone stimulates an immune response, and their
cellular analyses indicate that these responses are associated with
atypical forms of connective tissue disease.28
In summary, research on connective tissue and autoimmune diseases
raises unanswered questions about long-term safety. Results are
not conclusive because of relatively short-term follow-up and limitations
of the outcome measures. Self-reports tend to show significant increases
in health risks, whereas studies that rely on medical records and
hospitalization are less likely to show significant increased risks.
In industry-funded studies, even when studies indicate an increase
in symptoms among women with implants, the authors sometimes conclude
that there is no evidence of increased health problems. Overall,
there is evidence of increased symptoms in several studies, and
more research is needed to draw conclusions about the safety of
implants in terms of systemic autoimmune disease.
Cancer, Lung Disease, and Suicide
Implant manufacturers claim that there are dozens of long-term studies
proving that implants are safe. Most of these "long-term" studies include large numbers of women who have had implants for a short period of time, ranging from one day to several years. Although
the women may have implants for an average of 5 or 8 or even 10
years, the number of women with implants for more than 10 years
is quite small. Epidemiologists estimate that 15-20 years of follow-up
would be necessary for a well-designed study of cancer after exposure,
whether to asbestos, tobacco, or breast implants. Most of these
studies were funded by Dow Corning, conducted by a core group of
researchers at a research institute that receives substantial funding
from Dow Corning, and have been used to defend the company from
liability.
There are very few published studies that have medically evaluated
sufficient numbers of women with implants for a long enough period
of time to evaluate whether or not implants cause cancer. A study
by scientists from the NCI found that women with breast implants
were more likely to die from brain cancer, lung cancer, other respiratory
diseases, and suicide compared with other plastic surgery patients.29
The NCI study compared augmentation patients to other plastic surgery
patients, who were very similar in socio-economic status, health
status, and health habits (including smoking). Another strength
of the study was that all the women had implants for at least 12 years, which although not a long enough follow-up for a conclusive
cancer study, is considerably longer than other implant studies.
A second NCI study found a 21% overall increased risk of cancer
for women with implants, compared with women of the same age in
the general population.30 The increase
was primarily due to an increase in brain cancer, respiratory tract
cancers, cervical cancer, and vulva cancer.
A Swedish study, Finnish study, and Danish study all found that
women who have breast implants for augmentation were three times
as likely to commit suicide as women in the general population of
those countries.31, 32,
33 The Swedish and Danish studies also
found a significant increased risk of lung cancer, but did not control
for smoking. A recent study of mastectomy reconstruction patients
in the U.S. also found a higher rate of suicide among implant patients
compared to women who underwent mastectomies without reconstruction.34
The statistically significant increase in suicide in five studies
has been subject of considerable debate. Review articles funded
by the American Society of Aesthetic Plastic Surgeons35
and by Dow Corning36 conclude that
the increased risk of suicide is likely to predate implant surgery,
and that women who choose breast implants are more likely to be
depressed or have low self-esteem, as well as demographic traits
that put them at higher risk of suicide. However, these assumptions
are not supported by research data. One study pointed out that 8%
of Danish augmentation patients had a psychiatric admission prior
to augmentation surgery, compared to 6% of women undergoing other
cosmetic procedures. However, Danish women needed a psychiatric
referral in order to qualify for free augmentation surgery, which
could easily explain this small, non-significant difference.37
Like other plastic surgery patients in an era where plastic surgery
is quite common and generally accepted, patients tend to be less
satisfied with the body part that they are having surgically altered,
but not less satisfied with their general appearance or themselves.38
Moreover, the most important demographic predictors of suicide,
which are age, race, and sex, were already controlled in the studies
finding an increased risk of suicide.
It is also important to note that a recent Danish study found an
increase in depression among women who had undergone breast augmentation.12
In that study, the women with breast implants were five to seven
times more likely to be taking antidepressants than comparison samples
of women who underwent breast reduction surgery or women of the
same age from the general population. Among the augmentation patients,
the women who had their implants removed and replaced at least once
were more likely to be taking antidepressants than those who still
had their original implants. Although it is impossible to determine
whether the women were also more depressed prior to breast augmentation,
the relationship between multiple surgeries and use of anti-depressants
suggests that complications from the implants may contribute to
depression.
General Health and Quality of Life.
It is difficult to assess the impact of breast implants on health
and mortality generally, because women who undergo breast augmentation
tend to be healthier and more affluent than women in the general
population. For example, NCI researchers found a lower mortality
rate among augmentation patients compared to the general population
of women their age, but a higher mortality rate among augmentation
patients compared to other plastic surgery patients. The authors
concluded that plastic surgery patients are a more appropriate comparison
sample, because they are similar in social class, health, health
habits, and other key variables.29
A Canadian study of women with implants compared to the general
population of women of the same age found that augmentation patients
were more than four times as likely to be hospitalized, experienced
more hospitalizations, and visited physicians and specialists more
often. In other words, augmentation patients cost the healthcare
system significantly more than other patients of the same age and
geographic location.39
A recent study of women who had breast implants after mastectomy
came to the surprising conclusion that women with implants had a
significantly better survival rate than other women of similar age,
race, and diagnosis.34 However, a critique
of that study by NCI researchers pointed out that the better survival
rates could have been the result of other advantages of the implant
sample: including less obesity, higher social class, better prognosis,
treatment at designated cancer centers, and use of adjuvant treatment.40
It is often assumed that breast implants improve the self-esteem
and quality of life of women who undergo augmentation, as well as
those having reconstruction after breast cancer. However, the research
does not support this assumption. Studies of augmentation patients
show no difference or improvement in self-esteem, compared to women
who do not undergo augmentation.38
Studies by NCI researchers and other national experts indicate that
women who have undergone reconstruction report the same quality
of life as women who did not have reconstruction after mastectomy;
in fact, implant patients are more likely to report that cancer
harmed their sex life than women who underwent mastectomy without
reconstruction.41 Self-selection makes
it difficult to interpret these data, but the Inamed data presented
at the October 2003 FDA meeting indicated a decrease in all quality
of life measures two years after implants compared to before surgery.
Overall, these findings indicate that implants have yet to prove
that they objectively improve women's quality of life.
The Hidden Costs
The initial surgery for breast implants is the first, but not the
greatest expense for implant patients. If silicone breast implants
last approximately 7-10 years before breaking, replacement surgery
will add greatly to the cost. The implant itself may have a warrantee
for free replacement, but the surgical and anesthesia costs are
not free, nor are the costs of the medical facility. These expenses
may not be affordable for all implant patients, especially since
the initial breast augmentation is often available on an installment
plan.
Cosmetic surgery is not covered by health insurance, and problems
resulting from cosmetic surgery are usually excluded from coverage.
In some states, major health insurance providers do not insure women
with breast implants. Some insurers will sell health insurance to
women with implants, but charge them more, and some insurers will
not cover certain kinds of illnesses for women with breast implants,
or not cover any problems in the breast area. For women who are
diagnosed with diseases that are excluded, it will not matter if
those diseases are unrelated to the implants.
What if a woman no longer wants breast implants? Implants can be
removed and not replaced, but the breast tissue stretches from the
implant, and the breast is unlikely to be as attractive as it was
before the implant surgery.42 Women
with leaking silicone implants often lose breast tissue as part
of the removal surgery. According to testimony presented at the
October 2003 FDA meeting, this may result in surgery that is similar
to a mastectomy.
Conclusions
In 1990, breast implants had been sold for more than 25 years but
there were no published epidemiological studies or clinical trials.
There are now dozens of studies of women with implants, most of
them funded by Dow Corning or medical associations with a financial
interest in the outcome. These studies are persuasive in showing
that breast augmentation does not dramatically increase the risk
of diseases in the short-term. A co-author of most of those studies,
who served as a consultant to Inamed, argues that studies "with
a mean follow-up of a decade and almost three decades of follow-up
for the longest-term implant recipients" is "long enough."43
However, the studies he cites and co-authored included many women
with implants for only a few months or a few years, and therefore
did not have the statistical power to draw meaningful conclusions
about long-term safety. The small number of women providing relevant
long-term data is especially a problem when studying diseases such
as cancer, scleroderma, and lupus which take years to develop and
diagnose. Careful scrutiny of the research indicates an increase
in symptoms in many studies, but it is primarily in the studies
where all the augmentation patients had implants for at least six
years that increases in disease risks are statistically significant.
It is also notable that the independently funded studies tend to
focus on women with implants for longer periods of time, and often
show increased risks that are not apparent in the industry-funded
studies.
References:
1 ASAPS 2005 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc., 2005. Available: www.surgery.org.
2 2005 Reconstructive Breast Surgery, American Society of Plastic Surgery (ASPS), Inc., 2005. Available: http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=17845.
3 ASAPS 2003 Statistics
on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery
(ASAPS), Inc., 2003. Available: www.surgery.org.
ASAPS estimates approximately 26,000 more augmentation surgeries
in 2003 compared to ASPS.
4 The FDA's Regulation of
Silicone Breast Implants: A Staff Report Prepared by the Human Resources
and Intergovernmental Relations Subcommittee of the House Government
Operations Committee, December 1992. Available: www.info-implants.com/BC/0028.html.
5 General and Plastic Surgery
Devices Panel Transcript, 2003. 14 October 2003; 231. Available:
www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.htm.
6 Device Alert - Breast
Implants: NovaGold. UK: Medical Devices Agency. Available: www.medical-devices.gov.uk/.
7 Medical Devices Agency.
Available: www.medical-devices.gov.uk/.
8 Laurance J, "Agonizing
wait for 5,000 women told that their breast implants might leak
and cause cancer." The Independent, 7 June 2000. Available:
www.independent.co.uk/story.jsp?story=5864.
9 Statement on the Safety
of Trilucent Breast Implants. United Kingdom: Medical Devices Agency.
Available: www.medical-devices.gov.uk/.
10 Local Complications
of Saline Breast Implants. Available: www.center4policy.org/implant.html.
11 Zuckerman D, Santoro
E, Hudak N. Silicone Breast Implants: Illnesses and Complications,
The Latest Research from Inamed's Core Study. National Research
Center for Women & Families. Washington: DC; 2003. Available: www.breastimplantinfo.org/what_know/oct03_summary.html
12 Breiting VB, Holmich,
LR, Brandt B, Long-term health status of Danish women with silicone
breast implants. Plastic and Reconstructive Surgery. 2004;
114: 217-226.
13 Brown SL, Middleton
MS, Berg WA, et al. Prevalence of rupture of silicone gel breast
implants revealed on MR imaging in a population of women in Birmingham,
Alabama. American Journal of Roentgenology. 2000; 175:
1057-1064.
14 Holmich L, Friis S,
Fryzek J, et al. Incidence of silicone breast implant rupture. Archives
of Surgery. 2003; 138: 801-6.
15 Beekman WH, Feitz R,
van Diest PJ, and Hage JJ. Migration of silicone through the fibrous
capsules of mammary prostheses. Annals Plastic Surgery.
1997; 38: 441-445.
16 Katzin WE, Centeno
JA, Feng LJ. Pathology of lymph nodes from patients with breast
implants: A histologic and spectroscopic evaluation. Modern
Pathology. 2002; 15: 246A. (abstract).
17 James SE, Tarr G, Butterworth
MS, et al. Silicone in the sputum after rupture of a calf implant.
Journal of the Royal Society of Medicine. 2001; 94:133-134.
18 Miglioretti DL, Rutter
CM, Geller BM, et al. Effects of breast augmentation on the accuracy
of mammography and cancer characteristics. Journal of the American
Medical Association. 2004; 291: 442-50.
19 Bondurant S, Ernster
V, Herdman, R, eds. Safety of silicone breast implants. Washington,
DC: Institute of Medicine; 1999.
20 "Platinum found in
women with implants." The Associated Press, 26 August 2004;
and Maharaj, SVM. Platinum and platinum species in explanted silicone
gel breast prosthetic devices using IC-ICP-MS. Presented at the
American Chemical Society, 22-26 August 2004.
21 Brown SL, Pennello
G, Berg WA, et al. Silicone gel breast implant rupture, extracapsular
silicone, and health status in a population of women. Journal
of Rheumatology. 2001; 28:996-1003.
22 Aziz NM, Vasey FB,
Leaverton PE, et al. Comparison of clinical status among women retaining
or removing gel breast implants. Presented at the American College
of Epidemiology, 1998.
23 Brinton LA, Buckley
LM, Dvorkina O et al. Risks of connective tissue disorders among
breast implant patients. American Journal of Epidemiology.
2004; 180: 619-27.
24 Silicone Breast Implants
in Relation to Connective Tissue Diseases and Immunologic Dysfunction.
Summary of Report of National Science Panel. Available:
www.fjc.gov/BREIMLIT/SCIENCE/summary.htm.
25 Janowsky EC, Kupper
LL, Hulka BS. Meta-analyses of the relation between silicone breast
implants and the risk of connective tissue diseases. New England
Journal of Medicine. 2000; 342:781-790.
26 Friis S, Mellemkjaer
L, McLaughlin JK, et al. Connective tissue disease and other rheumatic
conditions following breast implants in Denmark. Annals of Plastic
Surgery. 1997; 39: 1-8.
27 Nyren O, Yin L, Josefsson
S, et al. Risk of connective tissue disease and related disorders
among women with breast implants: A nation-wide retrospective cohort
study in Sweden. British Medical Journal. 1998; 316: 417-422.
28 O'Hanlon TP. Restricted
and shared patterns of TCR b-chain gene expression in silicone breast
implant capsules and remote sites of tissue inflammation. Journal
of Autoimmunity. 2000; 14: 283-293.
29Brinton LA, Lubin, JH,
Murray MC, et al. Mortality among augmentation mammoplasty patients:
An update. Epidemiology. 2006; 17: 162-9.
30 Brinton, LA, Lubin
JH, Burich MC, et al. Cancer risk at sites other than the breast
following augmentation mammoplasty. Annals of Epidemiology.
2001; 11: 248-256f.
31 Koot VCM, Peeters PHM,
Granath F, et al. Total and cause specific mortality among Swedish
women with cosmetic breast implants: prospective study. British
Medical Journal. 2003; 326: 527-528.
32 Pukkala E, Kulmala
I, Sirpa-Liis H, et al. Causes of death among Finnish women with
cosmetic breast implants. Annals of Plastic Surgery. 2003;
51: 339-42.
33 Jacobsen PH, Holmich
LR, McLaughlin JK Mortality and suicide among Danish women with
cosmetic breast implants. Archives of Internal Medicine.
2004; 164: 2450.
34 Le GM, O'Malley CD,
Glaser SL et al. Breast implants following mastectomy in women with
early-stage breast cancer: prevalence and impact on survival.
Breast Cancer Research. 2005.
35 Joiner TE. Does breast
augmentation confer risk of or protection from suicide. Aesthetic
Surgery Journal. 2003; 370-375.
36 McLaughlin JK. Do Cosmetic
breast implants cause suicide? Plastic and Reconstructive Surgery.
2003; 112: 1721-23.
37 Jacobsen PH, Hölmich
LR, and McLaughlin JK. Mortality and suicide among Danish women
with cosmetic implants. Archives of Internal Medicine.
2004; 164(22): 2450-55.
38 Sawrer DB, LaRosa D,
Bartlett SP. Body image concerns of breast augmentation patients.
Plastic and Reconstructive Surgery. 2003; 112: 83-90.
39 Tweed A. Health care
utilization among women who have undergone breast implant surgery.
British Columbia Centre of Excellence for Women's Health.
Available: www.bccewh.bc.ca/PDFs/hcubreastimplants.pdf.
40 Brinton LA. Do breast
implants after a mastectomy affect subsequent prognosis and survival?
Breast Cancer Research. 2005; 7: 61-63.
41 Rowland JH, Desmond
KA, Meyerowitz BE. Role of breast reconstructive surgery in physical
and emotional outcomes among breast cancer survivors. Journal
of the National Cancer Institute. 2000; 92: 1422-29.
42 See photo #3 at www.fda.gov/cdrh/breastimplants/breast_implants_photos.html.
43 McLaughlin JK. Long-term follow-up
of women with cosmetic breast implants: How long is long enough?
Plastic and Reconstructive Surgery. 2004; 114: 801-03.
44 Brown SL, Todd JF,
and Luu HD, Breast Implant Adverse Events during mammography: Reports
to he Food and Drug Administration, Journal of Women's Health
2004, 13: 371-378.
