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Connective Tissue Disease and Other Rheumatic Conditions Following Cosmetic Breast Implantation in Denmark
Kim Kjøller, MD;
Søren Friis, MD;
Lene Mellemkjær, PhD;
Joseph K. McLaughlin, PhD;
Jeanette F. Winther, MD;
Loren Lipworth, PhD;
William J. Blot, PhD;
Jon Fryzek, PhD;
Jørgen H. Olsen, DMSc
Arch Intern Med. 2001;161:973-979.
ABSTRACT
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Objective To examine the occurrence of connective tissue diseases (CTDs) as well
as ill-defined and other rheumatic conditions among Danish women with cosmetic
silicone breast implants.
Patients and Methods A total of 2761 women with breast implants and 8807 control subjects
were identified from plastic surgery private clinics and from public hospital
plastic surgery departments. Women operated on at plastic surgery private
clinics were identified through the files of each clinic, while women operated
on at public hospitals were identified using the nationwide Danish National
Registry of Patients. The control group consisted of women who underwent cosmetic
surgery other than breast implantation or who only had a consultation. All
women were followed up from January 1, 1977, through December 31, 1996, through
the Danish National Registry of Patients for the occurrence of CTD as well
as ill-defined and other rheumatic conditions. For the study period January
1, 1977, through December 31, 1994, the Danish National Registry of Patients
contains information on hospitalization only, whereas data on outpatient visits
are included from 1995 on, thus improving the sensitivity of the data. The
implant and control groups were compared with the Danish population rates
for CTD and ill-defined and other rheumatic conditions, and a direct comparison
between the implant and control groups was also performed.
Results When compared with rates from the general population, no excess of definite
CTD was observed in the implant cohorts. For ill-defined and other rheumatic
conditions, statistically significant excesses of unspecified rheumatism were
observed in both the implant and control cohorts when compared with national
rates. A direct comparison between the implant and control cohorts found no
material differences between the groups.
Conclusions The findings of this study support previous investigations and independent
review panel conclusions that an association between silicone breast implants
and definite CTDs is unlikely. The observation of an excess of unspecified
rheumatism among women with implants and among control women suggests that
women undergoing cosmetic plastic surgery have hospitalization rates for this
condition in excess of those from the general population.
INTRODUCTION
SILICONE BREAST implants were introduced in the early 1960s, following
decades of breast augmentation using paraffin and silicone oil injections,
autologous tissue, and polyvinyl sponge implants.1
The use of these techniques was greatly limited by adverse outcomes and numerous
local complications.1 Compared with these methods,
silicone implants had the advantage of significantly better outcomes, although
the risk of local complications, such as capsular contraction, was not eliminated.2-3
It was not until the 1970s that the adverse systemic effects of silicone
breast implants were considered. The placement of silicone implants adjacent
to the breast tissue raised concern about the carcinogenic potential of breast
implants. However, subsequent epidemiological studies have not identified
an association between silicone breast implants and breast cancer or cancer
at other sites.4-8
In the early 1980s case reports emerged suggesting an association between
silicone breast implants and various connective tissue diseases (CTDs), in
particular systemic sclerosis.9-21
Only limited analytic epidemiological data addressing this hypothesis were
available22 then. As a consequence, in 1992,
the Food and Drug Administration banned the use of silicone breast implants
in the United States other than for reconstructive purposes or as part of
prospective safety studies.22 Since then, many
epidemiological studies addressing the potential association between silicone
breast implants and CTD have been published.22-40
All22-33,35-40
but one34 have failed to demonstrate an increased
risk of systemic sclerosis or any other CTDs. The one study34
that found a small, but significant, excess of CTD was based on self-reporting
of diseases, the subsequent validation of reported CTDs found evidence for
overreporting, as only 22.7% of the self-reported cases could be confirmed.41 Three independent scientific review bodies have recently
evaluated the available data on silicone breast implants42-45;
all concluded that an association between silicone breast implants and CTDs
has not been demonstrated and is unlikely to exist.
Some investigators46-51
have suggested an association between silicone breast implants and a new atypical
rheumatic condition or atypical CTD that does not fulfill established criteria
for any known CTD. To date no consensus has been reached as to the diagnostic
criteria for such a disease. It has been noted, though, that some of the central
symptoms such as myalgia, fatigue, and cognitive impairment bear some resemblance
to fibromyalgia and chronic fatigue syndrome.48-49,51
Herein we report the occurrence of CTDs as well as ill-defined and other
rheumatic conditions among Danish women who underwent cosmetic breast augmentation
with silicone breast implants in private clinics, and we extend our follow-up
of the public hospital cohort of women with implants reported on previously.36 Furthermore, since 1995 the Danish National Registry
of Patients (NRP), Copenhagen, Denmark, has included data on outpatient contact
as well, adding to the sensitivity of our investigation.
PATIENTS, MATERIALS, AND METHODS
Breast implantations have been performed at approximately 27 plastic
surgery private clinics in Denmark. Each identified clinic was approached
regarding participation in this study. Eight clinics, including 3 of the 4
largest, agreed to participate. From their files, we identified all women
who had received breast implants from January 1, 1973, through December 31,
1995. For each woman, the following information was extracted: personal number
of registration (PNR), date of implantation, type of implant (silicone gel
filled single or double lumen, saline or other type of filler material), indication
for implant surgery (cosmetic, reconstructive, asymmetry, revision, or other)
and prior implantations, if any. The PNR is a unique 10-digit number that
incorporates the date of birth and sex of all individuals in Denmark and secures
unambiguous linkage between registers.
A total of 1955 women with breast implants were identified at the private
clinics. Of these, 302 were excluded owing to the following reasons: invalid
PNR, 19 (1%); foreign residency, 170 (9%); missing information on date of
implantation, 2 (0.1%); reconstruction after breast cancer, 76 (4%); and older
than 55 years at implantation, 35 (2%), leaving 1653 women in the private
clinic implant cohort for follow-up (Table
1). Age restriction was applied to facilitate the age match with
women in the comparison cohort described below. The large majority (91%) of
women had had no prior implantation. Information on the validity of the PNR
and residency was obtained from the Central Population Register, Copenhagen.
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Table 1. Characteristics of the Study Cohorts
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For each woman undergoing breast implant surgery, another woman undergoing
other types of cosmetic treatment (including consultation only) was selected
from the clinic files and whenever possible matched by age (±3 years)
and calendar year (±18 months) at procedure or consultation, thus establishing
a comparison group. Matching by age was impossible at one of the clinics.
The variables extracted for women in the comparison group included PNR and
date and type of treatment. The comparison group thus identified consisted
of 2428 women. Exclusions from this group were made owing to invalid PNR,
52 (2%); foreign residency, 178 (7%); missing information on date or type
of treatment, 38 (2%); matched implantee had undergone reconstruction after
breast cancer, 59 (2%); older than 55 years at procedure or consultation,
282 (12%); and overlap with the implantation group, 83 (3%), leaving 1736
women in the private clinic comparison cohort for follow-up (Table 1). The most frequent treatments in the comparison cohort
were breast surgery other than implantation (breast reduction and mastopexia)
(24%), facial surgery (21%), skin excisions (21%), and abdominal surgery (15%).
Eighteen percent of the women in the comparison cohort had only an initial
consultation for cosmetic surgery at the clinic.
A second implant cohort was identified through the NRP. This cohort
comprises women who underwent cosmetic breast implant surgery at Danish public
hospitals during the period January 1, 1977, through December 31, 1992. The
identification of this cohort of 1135 women is described in detail elsewhere.36 Duplicate registries in both the private and public
implant cohorts were found for 27 of the 1135 women; in the individual cohort
analyses, these women were included in both cohorts, while they were included
only once in the combined cohort using the first date of implantation.
A comparison group for the public hospital implant cohort was composed
of women who underwent breast reduction surgery at public hospitals. The identification
of this cohort, consisting of 7071 women, is described in detail elsewhere.36
All members of the 4 study cohorts were linked to the NRP for data on
the occurrence of CTD and other rheumatic conditions. The NRP contains information
for virtually every nonpsychiatric hospital admission in Denmark since 1977.52 Each record includes the PNR, dates of admission
and discharge, codes for surgical procedures performed during the admission,
and up to 20 discharge diagnoses. Starting in 1995, the NRP also recorded
information on outpatient contacts, which includes ambulatory and emergency
department visits. Discharge diagnoses were coded according to the Danish
modified version of the International Classification of
Diseases, Eighth Revision (ICD-8)53
from 1977 through 1993, and according to a Danish modified version of the International Classification of Diseases, 10th Revision (ICD-10) of the years that followed.54
Women in each cohort were followed up for the occurrence of CTDs and
ill-defined and other rheumatic conditions, from the date of the first hospital
discharge or outpatient visit for breast implantation, reduction, or other
treatments or from January 1, 1977, until the date of death, emigration, or
December 31, 1996, whichever came first. Follow-up included ambulatory or
emergency department visits from January 1, 1995, through December 31, 1996.
Definite CTD was defined as rheumatoid arthritis (ICD-8: 712.09-39, 712.59; ICD-10: M05, M06,
M08.0, M08.2-08.9), dermatopolymyositis (ICD-8: 716.09,
716.19; ICD-10: M33), systemic sclerosis (ICD-8: 734.00-734.09; ICD-10: M34), systemic
lupus erythematosus (ICD-8: 734.19; ICD-10: M32), or Sjögren syndrome (ICD-8:
734.90; ICD-10: M35.0).53-55
Ill-defined and other rheumatic conditions included the following: polyarteritis
nodosa (ICD-8: 446.09; ICD-10:
M30.0), Wegener granulomatosis (ICD-8: 446.29; ICD-10: M31.3), temporal arteritis and polymyalgia rheumatica
(ICD-8: 446.30-446.39; ICD-10:
M31.5, M31.6, M35.3), psoriatic arthritis (ICD-8:
696.09; ICD-10: L40.5, M07.0-07.3), ankylosing spondylitis
(ICD-8: 712.49; ICD-10:
M45.9, M08.1), arthritis not further specified (ICD-8:
715.99; ICD-10: M13.0, M13.1, M13.8, M13.9), unspecified
rheumatism (including fibromyalgia and myalgia) (ICD-8:
717.90, 717.99, 718.99; ICD-10: M25.5, M25.6, M25.8,
M25.9, M62.6, M62.8, M62.9, M79.0, M79.1, M79.8, M79.9), localized scleroderma
(ICD-8: 701.01-701.09; ICD-10:
L94.0-L94.3), localized (discoid) lupus erythematosus (ICD-8: 695.49; ICD-10: L93.0-L93.2), and/or
CTD not further specified (ICD-8: 734.91, 734.99; ICD-10: M35.1, M35.2, M35.4-M35.9, M79.3). Other conditions
considered included sarcoidosis (ICD-8: 135.99; ICD-10: D86), Hashimoto thyroiditis (ICD-8: 245.03; ICD-10: E06.3), and amyloidosis
(ICD-8: 276.00-276.09; ICD-10:
E85).
National hospital discharge rates, including separate rates for ambulatory
and emergency department visits, were calculated for definite CTDs as well
as ill-defined and other rheumatic conditions by dividing the number of women
discharged with these conditions (for first known discharge of the specific
diseases) by the mean female population for each 5-year age group and calendar
period. The expected numbers of CTDs and ill-defined and other rheumatic conditions
were calculated by multiplying the number of person-years of follow-up in
the 4 cohorts (Table 1) by the
sex-specific national hospital discharge rates for these conditions, for each
5-year age group and calendar period of observation. The ratio of observed
to expected cases (O/E ratio) of CTDs and ill-defined and other rheumatic
conditions and 95% confidence intervals (95% CIs) were calculated assuming
a Poisson distribution for the observed number of diseases or conditions.56 A direct comparison between the combined implant
and the combined control cohorts was also performed whereby the ratio of the
O/E ratios from the 2 cohorts, as well as 95% CIs were calculated.57
RESULTS
The age distribution at the time of surgery was similar for the 2 implant
cohorts and the reduction cohort, with a median age at first recorded procedure
of 31 years, whereas the private comparison cohort tended to be slightly older,
with a median age of 33 years at the time of treatment or consultation (Table 1). On average women in the public
hospital implant cohort received their implants earlier in the study period
than women in the private clinic implant cohort and, thus, the mean follow-up
of the hospital implant cohort (mean follow-up, 11.5 years; range, 0-19 years)
was longer than that of the private clinic implant cohort (mean follow-up,
6.8 years; range, 0-19 years).
Results for the outcomes under study were similar for both private and
public implant cohorts (Table 2)
and for both control cohorts; consequently, the implant cohorts were combined
as were the control cohorts for analyses (Table 3).
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Table 2. Observed-Expected (O/E) Ratios for Definite Connective Tissue
Diseases (CTDs) and Other and Ill-Defined Rheumatic Conditions Among Women
in the Study Cohorts*
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Table 3. Observed-Expected (O/E) Ratios for Definite Connective Tissue
Diseases (CTDs) and Other and Ill-Defined Rheumatic Conditions Among Women
in the Study Cohorts*
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In the combined breast implant cohort, we observed 10 cases of definite
CTDs compared with 8.8 expected (O/E ratio = 1.1; 95% CI = 0.5-2.1) (Table 3). Of the 10 observed cases, 8 were
rheumatoid arthritis (O/E ratio = 1.4; 95% CI = 0.6-2.7) and 2 were systemic
sclerosis (O/E ratio = 3.8; 95% CI = 0.5-13.8). No cases of dermatopolymyositis,
systemic lupus erythematosus, or Sjögren syndrome were observed in the
combined implant cohort, with 0.2, 1.4, and 0.9 cases expected, respectively.
Ill-defined and other rheumatic conditions had O/E ratios not significantly
different from unity, with the exception of unspecified rheumatism (including
fibromyalgia and myalgia) (O/E ratio = 1.9; 95% CI = 1.5-2.3) (Table 3). In total (all definite CTDs and ill-defined and other
rheumatic conditions), we observed 102 cases in the combined implant cohort
compared with 59.6 expected (O/E ratio = 1.7; 95% CI = 1.4-2.1); excluding
cases of unspecified rheumatism brings the observed number of cases to 17
compared with 14.9 expected (O/E ratio = 1.1; 95% CI = 0.7-1.8). Forty-five
(44%) of the 102 cases of all rheumatic conditions were identified through
outpatient contacts only (definite CTDs, 4 [40%] of 10 cases; unspecified
rheumatism, 39 [46%] of 85 cases; and both cases of psoriatic arthritis and
CTD not further specified).
In the combined comparison cohort we observed 42 cases of definite CTDs
compared with 35.9 expected (O/E ratio = 1.2; 95% CI = 0.8-1.6) (Table 3). In particular there were 26 cases
of rheumatoid arthritis (O/E ratio = 1.0; 95% CI = 0.7-1.5), 1 case of dermatopolymyositis
(O/E ratio = 1.1; 95% CI = 0.0-6.3), 2 cases of systemic sclerosis (O/E ratio
= 1.1; 95% CI = 0.1-4.0), 7 cases of systemic lupus erythematosus (O/E ratio
= 1.6; 95% CI = 0.6-3.2), and 6 cases of Sjögren syndrome (O/E ratio
= 1.8; 95% CI = 0.7-1.6) (Table 3).
Ill-defined and other rheumatic conditions had moderately elevated O/E ratios
for all conditions with at least 1 observed case, although the only condition
that reached statistical significance was unspecified rheumatism, for which
238 cases were observed compared with 152 expected (O/E ratio = 1.6; 95% CI
= 1.4-1.8) (Table 3). Among private
clinic controls a similar excess of unspecified rheumatism was observed in
the subgroup who underwent cosmetic surgery other than breast reduction (O/E
ratio = 1.4; 95% CI = 0.9-1.9).
In total, we observed 322 cases of definite CTDs and ill-defined and
other rheumatic conditions in the combined comparison cohort compared with
217 expected (O/E ratio = 1.5; 1.3-1.7). Excluding cases of unspecified rheumatism
brings the observed number of cases to 84 compared with 65 expected (O/E ratio
= 1.3; 95% CI = 1.0-1.6). Eighty-six (26.7%) of the 322 cases of all rheumatic
conditions were identified through outpatient contacts only (definite CTDs,
9 [21.4%] of 42 cases; unspecified rheumatism, 71 [29.8%] of 238 cases; polymyalgia
rheumatica, 1 [8.3%] of 12 cases; psoriatic arthritis, 2 [50.0%] of 4 cases;
arthritis not further specified, 1 [10.0%] of 10 cases; discoid lupus, 1 [50.0%]
of 2 cases; and CTD not further specified, 1 [11.1%] of 9 cases).
Among the other conditions there were no observed cases of polyarteritis
nodosa, Wegener granulomatosis, localized scleroderma, localized (discoid)
lupus, sarcoidosis, Hashimoto thyroiditis, or amyloidosus in the combined
implant cohort. In the combined comparison cohort there were 13 cases of sarcoidosis
(O/E ratio = 2.1; 95% CI = 1.1-3.5) and 1 case of Hashimoto thyroiditis (O/E
ratio = 0.5; 95% CI = 0.0-2.8) (data not shown), and no cases of localized
(discoid) lupus, sarcoidosis, Wegener granulomatosis, localized scleroderma,
or amyloidosis. In the direct comparison between the implant and control cohorts
no differences were observed for definite CTDs (odds ratio = 1.0; 95% CI =
0.4-1.7), or for ill-defined and other rheumatic conditions (Table 3).
To assess whether media coverage affected diagnoses, we examined discharge
rates for the outcomes under study for the periods January 1977 through December
1991 and January 1992 through December 1996, and found no pattern to suggest
an increase in hospitalization for CTD or ill-defined and other rheumatic
conditions in the latter period (data not shown).
COMMENT
Overall, we found no excess of definite CTDs among 2761 women with breast
implants, which is consistent with our previous results,36
and with those of other epidemiological studies.22-33,35-40
The total observed number of definite CTDs was close to expectation, as were
those for the specific CTDs with the exception of systemic sclerosis, for
which the O/E ratio was not significantly elevated. A similar pattern was
observed in the combined control cohort, with observed cases of all definite
CTDs close to expectation; however, not significantly elevated O/E ratios
were observed for systemic lupus erythematosus and Sjögrens syndrome,
although based on small numbers. Previous epidemiological studies of women
with cosmetic breast implants reported risk ratios for definite CTDs combined
between 0.44 and 1.24.24, 26-27,31-32,34, 36-39
For individual definite CTDs, in particular systemic sclerosis, previous studies
have reported relative risks between 0 and 1.84.34, 39
Our finding of a not significantly elevated O/E ratio of 3.8 is not in accord
with previous studies, but the finding is based on only 2 cases and likely
reflects chance.
Considering all rheumatic conditions (definite CTDs and other rheumatic
conditions) a significant excess was observed in both the implant and control
cohorts, mainly owing to the excess of unspecified rheumatism in both cohorts.
Subtracting cases of unspecified rheumatism yielded an O/E ratio of 1.4 in
the combined breast implant cohort, and an O/E ratio of 1.3, of borderline
significance in the combined control cohort. Among ill-defined and other rheumatic
conditions, we previously reported among women with implants an excess of
muscular rheumatism, which in the present study is classified as unspecified
rheumatism.36 The present study also found
an elevated O/E ratio for unspecified rheumatism among women with breast implants
as well as among women in the control cohort. We previously concluded that
the excess of muscular rheumatism was related to breast surgery per se, rather
than to any systemic effect of silicone breast implants, owing to the fact
that similar excesses were observed among women with breast implants and breast
reduction. In the expanded study reported herein, an excess was also observed
in the private clinic control group, which included women who underwent breast
reduction as well as women with other types of cosmetic surgery and women
who sought only a consultation. The direct comparison revealed no material
difference in hospitalization for unspecified rheumatism between the combined
implant and combined control cohorts.
Although outpatient data were available only for the last 2 years of
follow-up, these records contributed significantly to the number of observed
cases of definite CTDs as well as to cases of ill-defined and other rheumatic
conditions, including unspecified rheumatism. Thus outpatient data seem to
add considerably to the sensitivity of data from the NRP, and may reduce bias
from underreporting of less severe conditions of definite CTD, as well as
ill-defined and other rheumatic conditions.
Our study population was well defined and the follow-up virtually complete
owing to the use of nationwide hospital and population registers. Information
on exposure in the public hospital cohorts had been validated earlier and
found to be accurate,58 and for the private
clinic cohorts, exposure was established for all patients through medical
record abstraction by 2 of us (K.K. and S.F.). Outcome data for specific CTDs
in the original public hospital cohort were validated previously and found
to be valid.36 The systematic national approach
with use of register data ensures that disease ascertainment was unbiased.
Based on our 95% CIs, we can exclude relative risks for definite CTDs of about
2-fold or higher. However, with the exception of rheumatoid arthritis, we
had only limited power to detect an increased risk of any individual CTD.
The outpatient data in the NRP from 1995 on enhances the potential to detect
milder and/or localized diseases. Although these data were only available
for a limited part of the study period, there was no indication of higher
risks for women in the implant than control cohorts. No changes in hospitalization
pattern after 1992 were observed, indicating that the publicity concerning
a potential link between silicone breast implants and CTD beginning in 1992
had little, if any, influence on hospitalization for rheumatic conditions
among Danish women with silicone breast implants.
CONCLUSIONS
This study lends further support to the conclusions of earlier investigations
and of independent review panels that an association between silicone breast
implants and definite CTD has not been demonstrated.The observation of an
excess of unspecified rheumatism among women with implants and among control
women indicates that women undergoing or seeking cosmetic plastic surgery
have rates of unspecified rheumatism in excess of those of the general population.
Future studies of atypical CTD among women with breast implants should consider
this finding when identifying appropriate control groups.
AUTHOR INFORMATION
Accepted for publication November 28, 2000.
This study was funded by the Dow Corning Corporation, Midland, Mich,
the International Epidemiology Institute, Bethesda, Md, and the Danish Cancer
Society, Copenhagen.
Reprints: Helle Madsen, Danish Cancer Society, Institute of Cancer
Epidemiology, Strandboulevarden 49, 2100 Copenhagen Ø, Denmark (e-mail: helle{at}cancer.dk).
From the Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen,
Denmark (Drs Kjøller, Friis, Olsen, Mellemkær, and Winther);
the International Epidemiology Institute, Rockville, Md (Drs McLaughlin, Lipworth,
Blot, and Fryzek); and Vanderbilt University Medical Center, Vanderbilt-Ingram
Cancer Center, Nashville, Tenn (Drs McLaughlin, Lipworth, Blot, and Fryzek).
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