| Breast, Implants,
The skin and Health./ Implantes Mamarios, la piel y la salud. ************************************
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****** DATA-MEDICOS **********
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IMPLANTES MAMARIOS, LA PIEL Y LA SALUD
BREAST IMPLANTS, THE SKIN AND HEALTH
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****** DERMAGIC-EXPRESS No.47 *******
****** 31 MARZO DE 1.999 *********
31 MARCH 1.999
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EDITORIAL ESPAŃOL
=================
Hola amigos del DERMA CYBER, DERMAGIC con ustedes de nuevo. El tema
bastante interesante, IMPLANTES MAMARIOS, LA PIEL Y LA SALUD. Los senos,
grandes o pequeńos siempre generan una opinion. La mujer de hoy dia por
cuestiones de estetica, recurre a los implantes para mejorar su figura,
estan muy de moda hoy dia les senos exuberantes. En otros casos se recurre
al implante luego de extirpacion de lesiones en ellos. Lo cierto del caso
es que todavia se discute su efecto nocivo para el cuerpo. Estas 38
referencias nos hablan de los pro y contra de estos implantes, espero que
las difruten.. los senos seguiran dando que hablar por mucho tiempo...!!!
En el attach 1 lamina ilustrativa de la referencia No. 0: Sézary syndrome
following rupture of silicone gel breast prosthesis
Nos veremos en la red en una nueva oportunidad !!!
Saludos a TODOS !!!
Dr. Jose Lapenta R.,,,
EDITORIAL ENGLISH
=================
Hello friends of the DERMA CYBER, DERMAGIC with you again. The quite
interesting topic, BREAST IMPLANTS, THE SKIN AND HEALTH. The breasts, big
or small they always generate an opinion. The woman of nowadays for
aesthetics questions, decides to implant them to improve their figure,
they are very in fashion nowadays the exuberant breasts. In other cases it
is used the implants after extirpation of lesions in them. The certain of
the case is that today many people still discusses their noxious effect for
the body. These 38 references speak us the pro and cons of these implant, I
hope you enjoy them.. The breasts will continue giving to speak for a lot
of time...!!!
In the attach 1 illustrative sheet of the reference No. 0: Sézary syndrome
following rupture of silicone gel breast prosthesis
We will see in the net in a new opportunity !!!
Greetings to ALL, !!
Dr. Jose Lapenta R.,,,
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DERMAGIC/EXPRESS(47)
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IMPLANTES MAMARIOS, LA PIEL Y LA SALUD
BREAST IMPLANTS, THE SKIN AND HEALTH
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0.) Sézary syndrome following rupture of silicone gel breast prosthesis
1.) Carcinogenic potential of silicone breast implants: a Connecticut
statewide study.
2.) Cutaneous T-cell lymphoma in association with silicone breast implants.
3.) Atypical chest pain syndrome in patients with breast implants.
4.) Serum antinuclear antibodies in women with silicone breast implants
[see comments]
5.) Silicone gel filled breast implants and connective tissue disease: an
overview [see comments]
6.) Silicone breast implant-associated scarring dystrophy of the arm.
7.) Sclerodermalike esophageal disease in children breast-fed by mothers
with silicone breast implants [see comments]
8.) Breast augmentation: a risk factor for breast cancer? [see comments]
9.) Clinical and laboratory features of patients with scleroderma and
silicone implants.
10.) A clinical and immunologic evaluation of women with silicone breast
implants and symptoms of rheumatic disease [see comments].
11.) Systemic sclerosis after augmentation mammoplasty with silicone
implants. [Review]
12.) Antinuclear autoantibodies in women with silicone breast implants.
13.) Antibodies to silicone elastomers and reactions to
ventriculoperitoneal shunts.
14.) Outcome study of the psychological changes after silicone breast
implant removal.
15.) [Hashimoto's thyroiditis and silicone breast implants: 2 cases]
16.) Cellular immune reactivities in women with silicone breast implants: a
preliminary
investigation [see comments]
17.) Unusual masses found within ruptured silicone gel breast prostheses.
18.) Silicone breast implants: pathology.
19.) Capsular contracture with textured versus smooth saline-filled
implants for breast
augmentation: a prospective clinical study.
20.) Lymphocyte response to silica among offspring of silicone breast implant
recipients.
21.) Ruptured or intact: what can linear echoes within silicone breast
implants tell us?
22.) Inflammatory reaction and capsular contracture around smooth silicone
implants.
23.) Breast implantation and the incidence of upper extremity somatic
complaints.
24.) A review of the possible health implications of silicone breast implants.
25.) [The value of sonography for the discovery of complications after the
implantation of silicone gel prostheses for breast augmentation or
reconstruction]
26.) Explantation of silicone breast implants.
27.) Neurosarcoidosis following augmentation mammoplasty with silicone.
28.) Are breast implants anticarcinogenic? A 14-year follow-up of the Los
Angeles Study.
29.) [Silicone breast implants and breast cancer]
30.) Lack of evidence of systemic inflammatory rheumatic disorders in
symptomatic women
with breast implants.
31.) Breast implants in patients with differentiated and undifferentiated
connective
tissue disease.
32.) Epidemiology of systemic sclerosis.
33.) Use of antipolymer antibody assay in recipients of silicone breast
implants.
34.) Complications leading to surgery after breast implantation [see comments]
35.) Silicone gel and octamethylcyclotetrasiloxane (D4) enhances antibody
production to
bovine serum albumin in mice.
36.) Visualization of silicone gel in human breast tissue using new
infrared imaging
spectroscopy.
37.) The epidemiology of scleroderma among women: assessment of risk from
exposure to
silicone and silica.
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0.) Sézary syndrome following rupture of silicone gel breast pro sthesis
========================================================================
Author: A. ledo, E. Sendagorta
Department of Dermatology Hospital »Ramón y Cajal«, Madrid, Spain
Case report.
A 48-year-old women underwent augmentation mammoplasty with silicone gel
prosthesis in February 1980. Three months later she developed scaling of
the palms and soles. This per-sisted until she progressively developed a
generalized pruritic, erythematous, scaly eruption in March 1983, when we
first studied this patient (Fig. 1). Physical ex-amination also showed
onychodystrophy and left axillary and bilateral inguinal nodes. There was
no evidence of hepato-splenomegaly. Breast implants were re-moved 3 months
later because of a sus-pected inflammatory reaction to the
silicone. The left implant was found to be ruptured; poorly encapsulated
gel was re-moved by sacrificing surrounding breast tissue. It was
impossible to determine if ah extravasated gel had been removed. A complete
work-up for erythroderma was done. The peripheral blood smear showed Sézary
celís from 1 to 4%; the total leuko-cyte count varying from 12,500 to
17,000/ mm3. Several skin biopsies showed only non-specific dermal
inflammation (Fig. 2). Bone marrow smear was normal. A biopsy
Fig. 1. Generalized erythroderma with edema and scaling of the skin.
Fig. 2. 5km biopsy showing nonspecific dermal inflammation. H & E x5()
(See the attach)
from a right inguinal node was diagnostic of dermatopathic lymphadenopathy.
De-layed hypersensitivity skin test were alí negative
Pre-Sézary erythroderma was diag-nosed, and treatment was started with
topical steroids with modest improvement. In September 1985 the
erythroderma be-come more severe but with no change in general status. The
absolute Sézary celí count was 3,552/mm3 at that time. A skin biopsy had
some features suggestive but not diagnostic of cutaneous T-cell lympho-ma.
A diagnosis of Sézary syndrome was made and therapy was started with 4 mg/
day chlorambucil and 20 mg/day of oral prednisone. Within the last 6 months
the Sézary celí counts have been substantially reduced with this combined
therapy.
Comment. Early forms of cosmetic breast augmentation surgery involved the
direct injection of liquid silicone into the breasts, often causing an
intense local inflammatory reaction (1). Although the advent of elastomeric
silicone envelope prosthesis reduced this severe reaction, it is well known
that silicone particles can still get from such implants into the
surrounding tissues and to regional lymph nodes (2) with resultant
inflammatory reactions. Silicone is a potentially antigenic material, and 2
cases of contact dermatitis to silicone have been described in the
literature (3, 4). Silicone may also provoke an autoimmune response by
conversion to silica, a substance known to exert pro-found effects on the
imifiune system. A variety of autoimmune diseases has been described in
association with cosmetic surgery, including progressive systemic
sclerosis, systemic lupus erythematosus, rheumatoid arthritis, thyroiditis,
Sjógren's syndrome and morphea (5). Digby and Wells (6) reported a case of
malignant lymphoma developing in a regional lymph node 9 years after
insertion of silicone finger prosthesis. They also cited a similar case
that had been brought to their notice but not reported. Benjamin et al. (7)
have
also described one patient with silicone lymphadenopathy with concomitant
malig-nant lymphoma following rupture of silas-tic joint implants.
That chronic stimulation of the immune system may lead to tumour formation
has been known for years. Tan et al. (8) suggested that mycosis fungoides
repre-sents a chronic granulomatous response to persistent unidentified
antigen. Epidemiologic observations have found that the incidence of prior
allergic condi-tions such as contact allergy, urticaria and drug allergy,
is notably increased in pa-tients with mycosis fungoides. Buechner and
Winkelmann (9) have recently de-scribed 7 patients with pre-Sézary
ery-throderma evolving to Sézary syndrome; interestingly, these patients
had a history of multiple allergic reactions.
We believe that the present case repre-sents a model of chronic lymphoid
stimula-tion that progressed from an inflammatory (pre-Sézary erythroderma)
to a prolifera-tive (Sézary syndrome) stage. Although an association
between the development of Sézary syndrome and the inflammatory reaction to
the silicone is not positively established, we would like to draw
atten-tion to the need for awareness of possible complications whenever
foreign materials are implanted into the body.
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1.) Carcinogenic potential of silicone breast implants: a Connecticut
statewide study.
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Kern KA; Flannery JT; Kuehn PG
Department of Surgery, Hartford Hospital, Connecticut, USA.
Plast Reconstr Surg (UNITED STATES) Sep 1997 100 (3) p737-47;
discussion 748-9
ISSN: 0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
To clarify the carcinogenic potential of silicone breast implants, 680
implant
procedures performed on women in Connecticut with no prior history of
cancer were
correlated with the subsequent development of primary breast and nonbreast
cancers.
Neoplastic events after the placement of silicone breast implants during
the 13-year
interval from October 1, 1980, through September 30, 1993, were quantified
using a
retrospective, linked-registry method. ICD-9-CM discharge codes contained
in the Uni
formed Hospital Discharge Data Sets (UHDDS) from 34 hospitals across
Connecticut were
linked to procedure codes for unilateral and bilateral implants, and to
medical
histories for new malignancies after the implant procedures. Data were
cross-linked
to the Connecticut Tumor Registry to confirm the clinical history of each
cancer.
The rates of breast and nonbreast cancers in patients with silicone breast
implants
were compared with those of a control population drawn from the UHDDS of
1022 women
undergoing sterilization by tubal ligation between 1981 to 1985. Ages
(mean +/- SD)
were similar in the implant group (34 +/- 10 years) and in the
sterilization group
(32 +/- 6 years). The mean follow-up in the implant group (4.6 years) was
also
similar to that of the control group (5.4 years). Compared with the
control group,
the implant group demonstrated lower rates of breast cancer (0.59 versus 0.88
percent, p = 0.35) and nonbreast cancer (0.59 versus 2.7 percent, p =
0.001).
Correspondingly, the implant group had a lower relative risk of breast cancer
(relative risk = 0.67, 95 percent, confidence interval = 0.20 to 2.17) and
nonbreast
cancer (relative risk = 0.21, 95 percent, confidence interval = 0.07 to
0.60). Based
on these data, it was concluded that silicone breast implants are not
carcinogenic,
because they are not associated with increased rates of either breast or
nonbreast
cancers. The validity and threats to the conclusions are discussed, and
the results
are placed into context with similar findings from other studies.
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2.) Cutaneous T-cell lymphoma in association with silicone breast implants.
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ARTICLE SOURCE: J Am Acad Dermatol (United States), Jun 1995, 32(6) p939-42
AUTHOR(S): Duvic M; Moore D; Menter A; Vonderheid EC
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND: Cutaneous T-cell lymphoma (CTCL) is a chronic
malignancy of helper T cells with the CD4 phenotype. It occurs less
frequently in young women but is increasing in incidence for unknown
reasons. Silicone breast implants have been associated with T-cell-mediated
autoimmune reactions. OBJECTIVE: Our purpose was to suggest the hypothesis
that CTCL may arise after breast implants and that different patients with
CTCL may be stimulated by different antigens. METHODS: Investigators with
many patients with CTCL were queried regarding the occurrence of CTCL in
women after breast implants. RESULTS: Three cases of confirmed CTCL after
breast implants were identified and are reported. In one patient with
Sezary syndrome and CTCL, the disease went into remission after removal of
implants, resolution of chronic staphylococcal infection, and initiation of
photopheresis and interferon alfa therapy. Another patient had progressive
disease. CONCLUSION: CTCL may occur in association with breast implants in
young female patients, but causality is unknown. If CTCL is antigen driven,
then it is likely to result from several different antigens in different
groups of patients.
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3.) Atypical chest pain syndrome in patients with breast implants.
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ARTICLE SOURCE: South Med J (United States), Oct 1994, 87(10) p978-84
AUTHOR(S): Lu LB; Shoaib BO; Patten BM
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: Eleven patients, aged 36 to 55 years, with silicone breast
implants had episodes of severe chest pain similar to heart attacks 6 weeks
to 7 years after breast implantation; one patient had a severe attack 1
month after explantation. The chest pain, which was not related to physical
exertion, lasted from 15 minutes to 4 days, and descriptions of it varied
from a "pressing" type of pain to "stabbing" pain with radiation to the
shoulders, left arm, and jaw. The associated symptoms were diaphoresis,
nausea, vomiting, dyspnea, and palpitations. All of the patients had a
normal electrocardiogram (ECG) with the exception of one, whose ECG showed
nonspecific ST changes. Ten had cardiac evaluations, all of which yielded
normal results. All had implant removal, and five were found to have at
least one ruptured implant. Nine had an implant capsule biopsy; all had
chronic inflammatory rinds, and five had free silicone in tissue whether or
not the implants were ruptured. All eight who had a pectoralis major muscle
biopsy had abnormal results: (neurogenic atrophy [six], fasciitis [three],
myositis [one], chronic inflammation [one], free silicone [one], and
neuroma [one]). We concluded that silicone breast implants may cause an
atypical chest pain syndrome, probably due to local inflammatory reactions
and neuroma formation.
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4.) Serum antinuclear antibodies in women with silicone breast implants
[see comments]
========================================================================
COMMENTS: Comment in: J Rheumatol 1995 Feb; 22(2):198-200
ARTICLE SOURCE: J Rheumatol (Canada), Feb 1995, 22(2) p236-40
AUTHOR(S): Cuellar ML; Scopelitis E; Tenenbaum SA; Garry RF; Silveira LH;
Cabrera G; Espinoza LR
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: OBJECTIVE. Recent evidence suggests that immunologic
abnormalities are not uncommon in individuals with silicone breast
implants. The purpose of our study was to evaluate in a consecutive manner,
the prevalence of autoimmunity as assessed by the presence of antinuclear
antibodies in a larger number of patients with silicone breast implants.
METHODS. Antinuclear antibody (ANA) testing using an indirect
immunofluorescence technique was performed on 813 individuals with silicone
breast implants. All subjects except for 3 transsexual males, were female.
The overwhelming majority, over 99%, were white. The average age of the
subjects was 46.2, with a range of 17 to 72 years. RESULTS. ANA positivity
was found in 244 of 813 individuals (30%) using a mouse kidney substrate;
and in 470 of 813 (57.8%) using a HEp-2 cell line. The most common
immunofluorescent pattern found using HEp-2 was speckled, present in 341
(72.5%) individuals, followed by homogeneous pattern in 113 (24%),
nucleolar in 63 (13.4%), and 5 (1.06%) were anticentromere. Anti-dsDNA
antibodies measured by an ELISA assay were found in 6 of 71 patients (8%).
Rheumatoid factor and C-reactive protein were found above healthy controls
in less than 10% of cases studied. The high prevalence of ANA found in
patients with silicone breast implants agrees with similar observations by
others. The finding of anticentromere and nucleolar patterns has great
interest and relevance. These fairly distinct ANA patterns are most
commonly seen in the idiopathic form of scleroderma and related conditions.
CONCLUSION. These findings suggest that ANA positivity is relatively common
in individuals with silicone breast implants, and may support the existence
of autoimmune mechanisms in the pathogenesis of the clinical manifestations
seen in this population.
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5.) Silicone gel filled breast implants and connective tissue disease: an
overview [see comments]
========================================================================
COMMENTS: Comment in: J Rheumatol 1994 Oct; 21(10):1979-80
ARTICLE SOURCE: J Rheumatol (Canada), Feb 1994, 21(2) p239-45
AUTHOR(S): Spiera RF; Gibofsky A; Spiera H
PUBLICATION TYPE: JOURNAL ARTICLE; REVIEW (79 references); REVIEW, TUTORIAL
ABSTRACT: OBJECTIVE. To review the literature examining the association of
silicone gel filled implants and connective tissue disease. METHODS.
Computerized literature searches and manual review of bibliographies.
RESULTS. Numerous concerns have arisen regarding the safety of silicone gel
filled breast implants. The structure of these prostheses is reviewed.
Silicones are not biologically inert. Injectable as well as implantable
silicones have proven capable of eliciting inflammatory and
fibroproliferative responses. Silicone leakage from silicone gel filled
implants is well documented as is distant migration of silicone in the
host. In the past decade, over 60 cases of connective tissue disease
following mammoplasty with silicone gel filled implants have been reported.
About half of these patients developed scleroderma or scleroderma-like
illnesses. This reported overrepresentation of scleroderma compared to
other rheumatic diseases mimics the Japanese experience with injectable
silicones. Possible biological rationale for the association is presented.
CONCLUSION. The physical and biological properties of silicone gel filled
implants and their behavior in vivo is compatible with the hypothesis that
they may contribute to the development of connective tissue disease. The
association seems most likely with scleroderma; however, there is as yet
inadequate epidemiological data to definitively establish causality.
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6.) Silicone breast implant-associated scarring dystrophy of the arm.
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ARTICLE SOURCE: Arch Dermatol (United States), Jan 1995, 131(1) p54-6
AUTHOR(S): Teuber SS; Ito LK; Anderson M; Gershwin ME
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND: Breast implants have been known to rupture after
trauma or closed capsulotomy with spread of the gel down the arm or
abdominal wall. Nodular foreign-body granulomatous reactions have been
reported in these cases. We report the unique occurrence of significant
overlying scarring and ulceration following silicone gel migration down the
affected arm. OBSERVATIONS: A 47-year-old woman experienced rupture of her
right silicone gel implant with migration of the silicone down her arm 10
years before our examination. Skin changes with atrophic hidebound scarring
and ulceration slowly progressed over the last 7 years. Radiographs and
magnetic resonance imaging scans demonstrated material consistent with
silicone in the soft tissues. CONCLUSIONS: Silicone is not an inert
substance and can rarely result in devastating local tissue destruction
where migration has occurred. The possibility of significant silicone gel
migration should be considered during evaluation of patients with ruptured
implants.
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7.) Sclerodermalike esophageal disease in children breast-fed by mothers
with silicone breast implants [see comments] [published erratum appears
in JAMA 1994 Sep 14; 272(10):770]
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ARTICLE SOURCE: JAMA (United States), Jan 19 1994, 271(3) p213-6
AUTHOR(S): Levine JJ; Ilowite NT
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: OBJECTIVE--To determine whether breast-fed children of mothers
with silicone implants are at increased risk for the development of
sclerodermalike esophageal involvement compared with children not exposed
to silicone implants. DESIGN--Case-series [corrected].
SETTING--Referral-based pediatric gastroenterology clinic. PATIENTS--Eleven
children (mean age, 6.0 years; range, 1.5 to 13 years; six boys and five
girls) referred for abdominal pain who were born to mothers who had
silicone breast implants (eight breast-fed children and three bottle-fed)
were compared with 17 patients (mean age, 10.7 years; range, 2 to 18 years;
11 boys and six girls) with abdominal pain who were not exposed to silicone
implants. METHODS--All children underwent esophageal manometry and upper
intestinal endoscopy with esophageal biopsy and were tested for antinuclear
antibody and autoantibodies to Scl-70, centromere, ribonucleoprotein, Sm,
Ro, La, and phospholipid. RESULTS--Six of the eight breast-fed children
from mothers with silicone implants had significantly abnormal esophageal
motility with nearly absent peristalsis in the distal two thirds of the
esophagus and decreased lower sphincter pressure. Upper esophageal
pressures and motility were normal. Compared with controls, the breast-fed
children had significantly decreased lower sphincter pressure and abnormal
esophageal wave propagation. These manometric abnormalities were not seen
in the three bottle-fed children. There was no difference in the expression
of autoantibodies in the breast-fed children compared with the bottle-fed
children or controls. CONCLUSIONS--A relationship appears to exist between
breast-feeding by mothers with silicone implants and abnormal esophageal
motility. Studies evaluating larger numbers of children are needed to
determine the extent of the risk.
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8.) Breast augmentation: a risk factor for breast cancer? [see comments]
========================================================================
ARTICLE SOURCE: N Engl J Med (United States), Jun 18 1992, 326(25) p1649-53
AUTHOR(S): Berkel H; Birdsell DC; Jenkins H
PUBLICATION TYPE: JOURNAL ARTICLE
ABSTRACT: BACKGROUND. A relation between breast augmentation and the
subsequent risk of breast cancer has been postulated. Since an estimated 2
million women in the United States alone have received breast implants,
even a small increase in the risk of breast cancer could have considerable
public health consequences. METHODS. We performed a population-based
nonconcurrent cohort-linkage study. All women in Alberta, Canada, who
underwent cosmetic breast augmentation from 1973 through 1986 were included
in the implant cohort (n = 11,676). This cohort was compared with the
cohort of all women in Alberta in whom a first primary breast cancer was
diagnosed (n = 13,557). The expected number of breast-cancer cases in the
implant cohort was estimated by applying age-specific and calendar
year--specific incidence rates of breast cancer (obtained from the Alberta
Cancer Registry) to the implant cohort. Standardized incidence ratios were
calculated by dividing the observed by the expected number of breast-cancer
cases in the implant cohort. RESULTS. Forty-one patients with implants were
subsequently found to have breast cancer. The expected number was 86.2. The
standardized incidence ratio was thus 47.6 percent, significantly lower
than expected (P less than 0.01). The average length of follow-up in the
implant cohort was 10.2 years, and the average length of time from breast
augmentation to the diagnosis of breast cancer was 7.5 years. CONCLUSIONS.
Women who undergo breast augmentation with silicone implants have a lower
risk of breast cancer than the general population. This finding suggests
that these women are drawn from a population already at low risk and that
the implants do not substantially increase the risk.
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9.) Clinical and laboratory features of patients with scleroderma and
silicone implants.
========================================================================
AU: Field-T; Bridges-AJ
AD: Department of Medicine, University of Wisconsin Hospital, Madison
53792, USA.
SO: Curr-Top-Microbiol-Immunol. 1996; 210: 283-90
AB: We reviewed the available clinical and laboratory data from 56 patients
with scleroderma and silicone implants from the English medical literature
and 19 cases which have not been previously reported. The average age of
onset of scleroderma was 43.6 +/- 10 years (range 20-73). Patients had
silicone implants for an average of 9 +/- 4 years prior to the development
of scleroderma (range 1-32). Most patients had limited scleroderma (41%).
Twenty three percent had intermediate scleroderma and 36% had diffuse
scleroderma. Clinical findings included: Raynaud's phenomenon in 77%,
esophageal dysfunction in 53%, and pulmonary involvement in 47%. Cardiac
and renal involvement were uncommon. Antinuclear antibodies by
immunofluorescence were found in 83 percent of patients. The
immunofluorescence pattern was speckled in 53%, centromere in 31% and
nucleolar in 9%. Other antibodies (Scl-70, RNP, SSA/Ro, PM-Scl) were found
in only a small proportion of patients. A clinical, serologic and
immunogenetic comparison of patients with silicone implants and scleroderma
and patients with idiopathic scleroderma is needed to better understand the
pathogenesis of this disorder.
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10.) A clinical and immunologic evaluation of women with silicone breast
implants and symptoms of rheumatic disease [see comments].
========================================================================
AUTHOR(S): Bridges AJ; Conley C; Wang G; Burns DE; Vasey FB.
SOURCE: Annals of Internal Medicine 1993 Jun 15;118(12):929-36
OBJECTIVE: To describe the clinical and serologic features of women with
silicone breast implants who were referred for symptoms of rheumatic
disease. DESIGN: A case series. SETTING: University and private
rheumatology practices. PATIENTS: A total of 156 women with silicone breast
implants and rheumatic disease complaints. Controls for the serologic
studies included women with silicone implants and no rheumatic symptoms (n
= 12) and women with fibromyalgia without silicone implants (n = 174).
MEASUREMENTS: Complete physical examination and testing for
immunoglobulins; complement; C-reactive protein; rheumatoid factor; and
autoantibodies by indirect immunofluorescence, immunodiffusion, and Western
blot. RESULTS: Three subgroups of patients were defined based on clinical
and laboratory findings: joint and muscle pain (n = 95), joint swelling (n
= 32), and connective tissue disease (n = 29). Most women had normal
immunologic studies. The patients with joint swelling had mild, asymmetric,
rheumatoid-factor-negative synovitis that did not meet American College of
Rheumatology criteria for rheumatoid arthritis. Fourteen patients had a
scleroderma-like illness and anti-centromere or anti-PM-Sci antibodies by
Western blot. Ten patients had a positive Western blot for BB' polypeptide,
a small nuclear ribonucleoprotein (snRNP), but did not meet criteria for
systemic lupus erythematosus. No autoantibodies to known disease-related
polypeptides were detected on Western blot in the control groups.
CONCLUSION: Most women with silicone implants and rheumatic complaints had
normal results of serologic tests and nonspecific symptoms, suggesting no
serious connective tissue disease. However, a subset of women had clinical
signs and serologic tests that were unusual even for referred patients.
These observations suggest, but cannot establish, that some women with
silicone breast implants may develop atypical immunologic reactions.40
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11.) Systemic sclerosis after augmentation mammoplasty with silicone
implants. [Review]
========================================================================
AUTHOR(S): Varga J; Schumacher HR; Jimenez SA.
SOURCE: Annals of Internal Medicine 1989 Sep 1;111(5):377-83
We describe four women who presented with systemic sclerosis several years
after cosmetic augmentation mammoplasty with silicone-gel implants. The
interval between implantation mammoplasty and the onset of systemic
sclerosis ranged from 6 to 15 years. All patients fulfilled the criteria
established by the American Rheumatism Association for systemic sclerosis
and had Raynaud phenomenon, arthralgia, and evidence of pulmonary or
gastrointestinal involvement. Enlargement of lymph nodes draining the
prostheses was noted in two patients. Antinuclear antibodies were detected
in three patients and showed speckled or nucleolar patterns. Removal of the
prostheses in two cases did not result in improvement of systemic
sclerosis. Evidence of silicone leakage from the implants included the
following. The observation by light microscopy of refractile particles in
tissues distant from the prostheses, the observation by electron microscopy
of electron-dense structures consistent with silica, and the definitive
identification of the element silicon by energy-dispersive analysis in
these electron-dense structures. A marked, chronic inflammatory infiltrate
containing lymphocytes, "foamy" histiocytes, and larger numbers of
multi-nucleated giant cells with vacuoles and asteroid bodies was found at
the same sites. Our demonstration that silicone escapes from
elastomer-silicone-gel breast implants and appears to be closely associated
with a chronic inflammatory reaction suggests that silicone plays a role in
the development of certain cases of systemic sclerosis. [References: 32]130
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12.) Antinuclear autoantibodies in women with silicone breast implants.
========================================================================
AUTHOR(S): Press RI; Peebles CL; Kumagai Y; Ochs RL; Tan EM.
SOURCE: Lancet 1992 Nov 28;340(8831):1304-7
Clinical syndromes resembling autoimmune diseases have been reported in
women who have had breast augmentation procedures. To see whether there is
a humoral immune response in these diseases that is similar to the immune
response in their idiopathic counterparts, we assessed the immunological
specificity of antinuclear antibodies (ANAs) and certain epidemiological
features in 24 patients, all of whom (with 1 exception) had received
silicone gel breast implants. ANA specificities were identified by indirect
immunofluorescence, immunodiffusion, western blot analysis, and
immunoprecipitation of radiolabelled intracellular proteins. Of 11 patients
who had symptoms and signs that met criteria for defined autoimmune
diseases, 7 had scleroderma or subsets of this disorder and the others had
systemic lupus erythematosus, rheumatoid arthritis, or overlapping
autoimmune diseases. High ANA titres were present in 10 of these 11
patients and the ANA specificities were similar to those found in the
idiopathic forms of the corresponding autoimmune diseases. Trauma, with
resultant rupture of implants, accelerated onset of symptoms. 13 other
patients had autoimmune disorders of a less clearly defined nature and low
titres of ANAs whose specificities could not be identified. ANAs are
associated with the development of autoimmune complications in women with
silicone breast implants. Further studies are needed to see whether this
relation is one of cause and effect and whether ANAs might be early
serological markers preceding development of autoimmune symptoms.
========================================================================
13.) Antibodies to silicone elastomers and reactions to
ventriculoperitoneal shunts [published erratum appears in Lancet 1992 Sep
26;340(8822):800].
========================================================================
AUTHOR(S): Goldblum RM; Pelley RP; O'Donell AA; Pyron D; Heggers JP.
SOURCE: Lancet 1992 Aug 29;340(8818):510-3
Silicone elastomers used to make medical implants and prostheses are
generally believed to be biologically inert. However, we have seen two
patients who showed severe, apparently immunemediated, reactions to
ventriculoperitoneal (VP) shunts. We used an enzyme-linked immunosorbent
assay in which Silastic tubing served as the solid-phase antigen to test
serum from the two patients, five other VP shunt patients without
inflammatory reactions, and nine healthy adults. IgG binding to Silastic
tubing was consistently higher in the two patients than in the healthy or
patient controls. The IgG seemed to be binding specifically, since IgG Fab
fragments also bound to the tubing, and preincubation of serum with
Silastic or silylated proteins removed most of the activity. These findings
show that specific immune reactivity to elastomers of polydimethylsiloxane
can develop in human beings.
========================================================================
14.) Outcome study of the psychological changes after silicone breast
implant removal.
========================================================================
Roberts C; Wells KE; Daniels S
Department of Psychosocial Oncology, H.Lee Moffitt Cancer Center and
Research
Institute, Tampa, Fla, USA.
Plast Reconstr Surg (UNITED STATES) Sep 1997 100 (3) p595-9 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
INTRODUCTION: The purpose of this longitudinal study is to determine if
there are
changes in psychological well-being after breast implant removal. METHODS:
Thirty-
seven women underwent breast implant removal and completed a preoperative
baseline,
early postoperative (4 to 9 months), and late postoperative (> 10 months)
Brief
Symptom Inventory, a measure of psychological distress. RESULTS: After
breast
implant removal the mean Global Severity Scores on the Brief Symptom
Inventory of
women undergoing implant removal increased over the three time periods,
indicating
increasing psychological distress. When the group was divided into those
who had
breast reconstruction after implant removal (implant replacement with
saline-filled
implants or TRAM flaps) and those who did not have reconstruction, both
groups had
increasing psychological distress, but the women who had reconstruction had
slightly
higher scores. Women with a history of psychiatric treatment showed the
greatest
increase in psychological symptoms. CONCLUSION: Breast implant removal did
not have
psychological benefits in this group of women. Breast reconstruction after
removal
did not appear to be psychologically beneficial to this cohort.
========================================================================
15.) [Hashimoto's thyroiditis and silicone breast implants: 2 cases]
Thyroidite de hashimoto et protheses mammaires en silicone: 2 observations.
========================================================================
Vayssairat M; Mimoun M; Houot B; Abuaf N; Rouquette AM; Chaouat M
Hopital Tenon, Paris.
J Mal Vasc (FRANCE) Jul 1997 22 (3) p198-9 ISSN: 0398-0499
Language: FRENCH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE English Abstract
Journal Announcement: 9711
Subfile: INDEX MEDICUS
The silicone implant controversy wavers between reassuring
epidemiological studies
and about 300 case reports of patients developing a definite or
incomplete/atypical
connective tissue disease (CTD) after receiving a silicone gel-filled
breast implant
(SBI). Since Hashimoto's thyroiditis (HT) is rarely reported in this
context, we
report here two new cases of HT associated with a history of bilateral
cosmetic SBIs.
The first patient was a 45-year-old white woman who had SBIs in 1976. In
1991 she
developed HT, evolving to thyroid deficiency which was compensated with
levothyroxine
treatment. In addition, the patient complained of fatigue, arthralgia,
morning
stiffness and developed a sicca syndrome necessitating artificial tears.
The 1995
evaluation disclosed the presence of antinuclear antibodies at a titre of
1/640, and
high level anti-thyroid microsomal antibodies (1/256,000). Gamma globulins
rose to
22.6%. Thyroid ultrasonography showed an enlarged thyroid gland with a
diffusely
hypoechogenic pattern. The implants were painful, and in 1996 they were
removed.
Microscope examination of the fibrous capsule surrounding the prostheses
showed
extremely dense connective tissue with fibrosis. The second patient was a
55-year-
old white woman who had SBIs in 1984. In 1995, she developed HT with
clinical pain
and tenderness of the thyroid gland, with mild hyperthyroidism and positive
antithyroglobulin antibodies, and was given corticosteroid treatment for 5
months.
In 1996, the implants were again painful and the patient developed positive
antinuclear antibodies with a titre of 1/200. Ultrasonography showed a
heterogeneous
thyroid gland, and implant removal was advised. Hashimoto's thyroiditis is
recognized as a subset of chronic auto-immune thyroiditis, and its
association with
SBI is rare. In these 2 observations, an association without relation is
possible,
but a future survey of similar cases seems warranted.
========================================================================
16.) Cellular immune reactivities in women with silicone breast implants: a
preliminary
investigation [see comments]
========================================================================
Ellis TM; Hardt NS; Campbell L; Piacentini DA; Atkinson MA
Department of Pathology, University of Florida, Gainesville 32610-0275, USA.
Ann Allergy Asthma Immunol (UNITED STATES) Aug 1997 79 (2) p151-4
ISSN: 1081-
1206 Contract/Grant No.: R01AI/DK39250--AI--NIAID; R29DK45342--DK--NIDDK
Note: Comment in: Ann Allergy Asthma Immunol 1997 Aug;79(2):89-90
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: INDEX MEDICUS
BACKGROUND: Surgical implantation of silicone breast prostheses has been
conducted
and considered safe for over 30 years. Some implant recipients, however,
complain of
a group of symptoms similar to those observed in connective tissue disorders,
rheumatoid arthritis, systemic lupus erythematosus, or polymyositis. To
date,
immunologic sequelae have not been confirmed and remain controversial.
OBJECTIVE: To
examine an autoimmune-like basis for the "silicone associated disease"
reported by
some women with silicone breast prostheses. METHODS: Proliferative
responses of
peripheral blood mononuclear cells against a panel of control and
connective tissue
proteins and to compounds common to silicone prostheses were measured in 26
women who
received silicone breast implants (with implants in place an average of 166.4
[standard deviation (SD) 58.3] months), and 23 age-matched and sex-matched
healthy
controls. RESULTS: The frequency and intensity of cellular immune
responses against
collagen I, collagen III, fibrinogen, and fibronectin were significantly
increased in
silicone breast implant recipients versus controls. In implant subjects,
the highest
frequency of immune reactivity was directed against collagen I (11/26, 42%)
with
collagen III being the most immunostimulatory self-antigen with a mean
stimulation
index (SI) of 8.2 [95% confidence interval (95% CI) 3.2]. In addition,
10/26 (39%)
of the implant recipients responded to more than one of the connective tissue
antigens versus 0/23 (0%, P = .0007) healthy controls. Immunologic
reactivities to
other antigens, including silicone-based compounds, were remarkably similar.
CONCLUSIONS: The identification of self-reactivity towards these connective
tissue
antigens may provide important information for attempts at associating
silicone
breast implants with disease.
========================================================================
17.) Unusual masses found within ruptured silicone gel breast prostheses.
========================================================================
Hughes KC; Calabretta AM; Hirai T; Manders EK
Division of Plastic and Reconstructive Surgery, Milton S. Hershey Medical
Center,
Hershey, Pa., USA.
Plast Reconstr Surg (UNITED STATES) Aug 1997 100 (2) p525-8 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9711
Subfile: AIM; INDEX MEDICUS
Imaging of breast implants has assumed more importance in medicine than
ever before.
Radiologists and surgeons alike have struggled to accurately identify folds
in
prostheses, rupture of prostheses, and migration of gel. Here we present two
patients with an unusual presentation of masses within the gel of ruptured
silicone
gel-containing prostheses. In one instance, the mass was an organized
hematoma. In
the other, two round, calcified masses were found that we presume are
hematomas that
have become calcified over time. Radiologists and surgeons identifying
spherical or
ovoid masses seemingly within gel breast prostheses should entertain the
possibility
that the mass represents an organized hematoma and that the implant is
ruptured.
========================================================================
18.) Silicone breast implants: pathology.
========================================================================
Raso DS; Greene WB
Department of Pathology, Medical University of South Carolina,
Charleston, USA.
Ultrastruct Pathol (UNITED STATES) May-Jun 1997 21 (3) p263-71 ISSN:
0191-3123
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9709
Subfile: INDEX MEDICUS
Questions as to the bioreactivity of silicone breast implants (SBIs) have
recently
been intensely scrutinized, most notably by the media and legal system.
Pathologists
must be aware of the controversy and treat each SBI and associated tissue
as a
potential lawsuit. Grossly, silicone is a clear, viscous substance that
may be
observed either within or extruding from a silastic bag. By light
microscopy,
silicone is a nonstainable, nonpolarizable, refractile substance. Thicker
sections,
especially when viewed by non-Kohler illumination, phase-contrast, and
darkfield
microscopy will enhance visualization. Ultrastructurally, silicone is an
electron-
dense, amorphous substance often located within phagocytic vacuoles or
extracellularly within the stroma. Correlating electron probe
microanalysis allows
for reliable identification. In most cases, a fibrous capsule surrounds
the SBI,
with the interface lining varying from a virtually acellular to a
synovial-like
lining composed of phagocytic and secretory cells. Silicone can often be
identified
within the fibrous capsule and also in distant tissues biopsied for suspected
autoimmune disorders, such as synovium, skin, and lymph nodes, often without
ultrastructural evidence of cytologic effects. This study has demonstrated
that
silicone accumulates at distant tissue sites due to preexisting
inflammation acting
as a stimulus. Thus, silicone is not a primary inducer of inflammatory
disease
processes. These findings are supported by various large epidemiologic
studies. (46
References)
========================================================================
19.) Capsular contracture with textured versus smooth saline-filled
implants for breast
augmentation: a prospective clinical study.
========================================================================
Tarpila E; Ghassemifar R; Fagrell D; Berggren A
Department of Plastic Surgery, University Hospital, Linkoping, Sweden.
Plast Reconstr Surg (UNITED STATES) Jun 1997 99 (7) p1934-9 ISSN:
0032-1052
Language: ENGLISH
Document Type: CLINICAL TRIAL; JOURNAL ARTICLE; RANDOMIZED CONTROLLED
TRIAL
Journal Announcement: 9709
Subfile: AIM; INDEX MEDICUS
Texturization of silicone-filled breast implants has been shown to reduce
the
incidence of capsular contracture. A double-blind clinical study was
undertaken to
compare this incidence in saline-filled implants with textured or with smooth
surfaces. Twenty-one women underwent mammary augmentation with a textured
implant in
one breast and a smooth implant in the other. The implants were placed
subglandularly. All operations were performed by the same surgeon and all
follow-up
examinations by another. Breast hardness was evaluated 6 months
postoperatively with
applanation tonometry, using Baker's grading, and after 12 months, now also
with a
questionnaire concerning the patient's evaluation. Capsular contracture
(Baker 3)
had occurred in 33 percent of the breasts at the end of the study, and was
bilateral
in five cases. The incidence of contracture and the patients' views on the
results
did not differ between textured and smooth prostheses or between right and
left
breasts. Five patients requested reoperation, two of them because of
breast hardness.
Texturization of saline-filled implants thus did not reduce the incidence
of capsular
contracture.
========================================================================
20.) Lymphocyte response to silica among offspring of silicone breast implant
recipients.
========================================================================
Smalley DL; Levine JJ; Shanklin DR; Hall MF; Stevens MV
Baptist Memorial Health Care System, University of Tenessee, Memphis, USA.
Immunobiology (GERMANY) 97 1996 196 (5) p567-74 ISSN: 0171-2985
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9709
Subfile: INDEX MEDICUS
The current study evaluated immune response to silicon dioxide in
children born to
women with silicone breast implants. In part one of the study, the T
lymphocytes of
21 of 24 such children were significantly stimulated by silicon dioxide
(silica).
Part two consisted of eleven children, four born preimplantation and seven
born
postimplantation. None of the preimplant offspring showed T cell responses
to
silica; five of the seven postimplant children were positive for T cell
memory for
silica. Part three was a blinded study based on statistically significant
differences in T cell stimulation with silicon dioxide between postimplant
children
and controls. These findings indicate a common immune reaction, that of T
cell
memory, occurs in mothers and their children born after exposure to
silicone mammary
implants placed prior to pregnancy. Since not all such children were
breast fed the
result favors transplacental passage of immunogens such as silicone
oligomers or
through maternofetal cellular traffic.
========================================================================
21.) Ruptured or intact: what can linear echoes within silicone breast
implants tell us?
========================================================================
Palmon LU; Foshager MC; Parantainen H; Everson LI; Cunningham B
Department of Radiology, University of Minnesota Hospital and Clinic,
Minneapolis,
MN 55455, USA.
AJR Am J Roentgenol (UNITED STATES) Jun 1997 168 (6) p1595-8 ISSN:
0361-803X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: AIM; INDEX MEDICUS
OBJECTIVE: During sonographic evaluation of silicone breast implants for
possible
rupture, we have frequently encountered several patterns of linear echoes
within the
implants. To our knowledge, the significance of this finding has not been
established in the literature. The purpose of this study was to determine
whether
internal echoes are significant in predicting implant rupture. SUBJECTS
AND METHODS:
Thirty-three patients with 64 silicone implants were prospectively entered
into a
study that included gray-scale sonography of the implants and subsequent
surgical
removal. Echo patterns within the implants were retrospectively evaluated
on hard-
copy films and compared with the integrity of the implant at surgery.
RESULTS: Three
categories of internal echo patterns were identified: "thick linear
echoes." "thin
linear echoes," and "commas." One or more of these echo patterns were seen
in 57
(89%) of the 64 implants. Thick linear echoes were seen in 23 (36%) of the
64
implants, thin linear echoes were seen in 33 (52%) of the 64 implants, and
commas
were seen in 47 (73%) of the 64 implants. All echo patterns were seen in
intact and
ruptured implants with nearly equal frequency. We found no statistical
significance
for any echo pattern in predicting whether an implant was ruptured or
intact. Of the
64 implants, four were entirely free of internal echoes. All four implants
were
intact. CONCLUSION: A variety of linear echoes can be seen in most
silicone breast
implants on gray-scale sonography. The presence or absence of linear
echoes is not
useful in predicting implant rupture. Complete absence of internal echoes,
while
highly predictive of an intact implant, is infrequently seen.
========================================================================
22.) Inflammatory reaction and capsular contracture around smooth silicone
implants.
========================================================================
Carpaneda CA
Aesthetic Plast Surg (UNITED STATES) Mar-Apr 1997 21 (2) p110-4 ISSN:
0364-216X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: INDEX MEDICUS
Histologic studies were performed on capsular tissue resected from 21
patients who
were implanted with smooth silicone prostheses filled with gel. The results
disclosed a nonuniform response to the implants. The granulomatous
reaction to the
silicone showed important variations along the same surface of the
implants, between
the plane and the concave surfaces, between equivalent points at the right
and left
sides, and among the patients. Also, a significant difference was observed
between
reactions and capsules in early and late stages. The author believes these
variations of the capsular inflammatory reaction promote different sites of
contraction between cell-to-cell, or cell-to-collagen-to-cell. These
adding forces
result in vectors of different intensities and directions around the
implants which
explains the various clinical grades of capsular contracture.
========================================================================
23.) Breast implantation and the incidence of upper extremity somatic
complaints.
========================================================================
Kulick M; Daneshmand H
Department of Plastic and Reconstructive Surgery, Saint Francis Memorial
Hospital,
San Francisco, California 94108, USA.
Aesthetic Plast Surg (UNITED STATES) Mar-Apr 1997 21 (2) p105-9 ISSN:
0364-216X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9708
Subfile: INDEX MEDICUS
Attention has been drawn to elevated laboratory tests of inflammation as
indicators
of a possible reaction to silicone breast implants. These patients have
complaints
of joint pain, pain, and myalgia that were possibly caused by a reaction to
silicone.
This study is a retrospective review of 100 consecutive patients (79
female, 21 male)
who were evaluated because of a purported industrial injury to the upper
extremity.
Patients were examined by a single examiner and all had laboratory
screening for
indicators of inflammation (sedimentation rate, anti-nuclear antibody
levels, C-
reactive protein, anti-streptolysin, rheumatic factor), endocrine
abnormalities
(thyroid panel), and serum glucose. None of the patients had any history
of breast
augmentation with any implant. Of the 79 female patients, 50 had an
identifiable
clinical diagnosis and 18 of them had elevation of at least one of the
indicators of
inflammation. The remaining 29 did not have an identifiable diagnosis and
21 of them
had elevation of at least one indicator of inflammation (P < 0.01). There
were 74
out of 79 females with subjective complaints of upper extremity pain, joint
pain, and
aching. Forty-five of these patients had an identifiable diagnosis and 17
of them
had elevation of at least one inflammatory indicator. Of the 74 female
patients, 29
had no identifiable diagnosis and 21 of them had elevation of at least one
inflammatory indicator (P < 0.01). In summary, there were a high number of
female
patients with complaints of upper extremity symptoms with no prior exposure
to
silicone from breast implantation. There was a statistically significant
correlation
in these patients who had no identifiable diagnosis and elevated indicators
in
inflammation. This study suggests these markers of inflammation should not
be used
as indicators of a reaction to silicone from breast implantation in
patients with
upper extremity subjective complaints.
========================================================================
24.) A review of the possible health implications of silicone breast implants.
========================================================================
Noone RB
Department of Surgery, University of Pennsylvania School of Medicine,
Philadelphia,
USA.
Cancer (UNITED STATES) May 1 1997 79 (9) p1747-56 ISSN: 0008-543X
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9707
Subfile: AIM; INDEX MEDICUS
BACKGROUND: The silicone gel breast implant has long been an important
method of
reconstruction for the mastectomy patient. Because of concerns about
possible health
implications of the implant, the Food and Drug Administration banned its
use for
augmentation mammaplasty and limited its use in the mastectomy patient to a
research
protocol study. This article reviews the recent literature about the
possible health
hazards of the silicone implant. METHODS: In this review of the
literature, specific
attention was directed toward structural failure of the device as well as the
diagnosis of rupture, tissue response to silicone, systemic immunologic
response to
silicone, the relationship of silicone to connective tissue diseases, and the
association of the silicone implant with breast carcinoma in both the
augmentation
mammaplasty patient and the patient undergoing postmastectomy
reconstruction. A
total of 88 works were reviewed. RESULTS: The literature fails to support an
association between silicone gel breast implants and systemic diseases.
Although
implants may cause local symptoms, rupture over time, or be associated with
an
immunologic reaction, comprehensive epidemiologic studies have concluded
that there
is no connection between breast implants and the known connective tissue
diseases or
between the implants and breast carcinoma. There is no increase in the
risk of
recurrence in mastectomy patients reconstructed with implants and no delay
in the
detection of recurrences. Recent laboratory studies in animals suggest
that silicone
may have anticarcinogenic effects. CONCLUSIONS: Silicone gel breast
implants may
rupture and cause local symptoms, but they have not been demonstrated to be a
systemic health hazard for patients who have undergone augmentation
mammaplasty or
postmastectomy reconstruction. (88 References)
========================================================================
25.) [The value of sonography for the discovery of complications after the
implantation of silicone gel prostheses for breast augmentation or
reconstruction]
Stellenwert der Sonographie fur die Aufdeckung von Komplikationen nach
Implantation
von Silikongelkissen zur Mammaaugmentation bzw. -rekonstruktion.
========================================================================
Lorenz R; Stark GB; Hedde JP
Abteilung fur Diagnostische Radiologie, Stadt. Krankenhaus Solingen.
Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr (GERMANY) Mar 1997
166 (3)
p233-7 ISSN: 0936-6652
Language: GERMAN Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE English Abstract
Journal Announcement: 9707
Subfile: INDEX MEDICUS
PURPOSE: To determine sensitivity and specificity of real-time
ultrasonography in
detecting breast implant complications. MATERIAL AND METHODS: The results of
preoperative ultrasonography of 121 silicone implants in 65 patients were
compared
with the results after operative implant removal. RESULTS: With a
sensitivity of
89.25% and a specificity of 92.1%, complications such as gel bleeding (n =
43),
rupture with leakage (n = 63), and implant dissolution (n = 4) become
manifest.
Capsule formation, fibrosis, siliconoma and calcifications were often
underestimated
in their extent. Negative ultrasonography findings were found in 10.7% (n
= 13) with
positive clinical findings. CONCLUSIONS: The combination of clinical and
ultrasonography findings leads to the detection of implant complications.
========================================================================
26.) Explantation of silicone breast implants.
========================================================================
Thomas WO 3rd; Harper LL; Wong SW; Michalski JP; Harris CN; Moore JT;
Rodning CB
Department of Surgery, College of Medicine/Medical Center, University of
South
Alabama, Mobile, USA.
Am Surg (UNITED STATES) May 1997 63 (5) p421-9 ISSN: 0003-1348
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: INDEX MEDICUS
Silicone gel-filled breast implants have been employed clinically for
decades for
aesthetic augmentation or postmastectomy reconstruction. Most patients and
surgeons
attest to the efficacy and safety of these devices. However, more recently
in the
medical literature and popular media, silicone gel-filled breast implants
have been
claimed to incite an array of clinical sequelae such as capsular formation,
granulomatous disease, arthritis, arthralgia, fibromyalgia, autoimmune
collagen
vascular disease, human adjuvant disease, siliconosis, silicone-related
disease, and
silicone implant-associated syndrome. During a recent 24-month period, 25
referred
patients underwent explantation of bilateral silicone gel-filled prostheses
at the
University of South Alabama. Patient-reported symptoms and signs included
mastodynia, arthralgia, fibromyalgia, xerophthalmia, xerostomia,
hypesthesia, and
amblyopia. Clinical examination and mammography were reliable in
diagnosing implant
rupture, but only re-exploration reliably detected implant leakage. Most
patients
underwent concurrent replacement with saline-filled devices. Histopathologic
analyses of all tissue samples revealed chronic inflammation. Subjective
improvement
of patient-reported symptoms and signs occurred over the course of months
postoperatively. There was no mortality associated with explantation, with
or
without replacement, but an overall morbidity incidence of 20 per cent (5
of 25) was
observed. Predicated upon review of the available scientific literature
and analysis
of this modest number of patients, the following perspectives are germane.
1) A
small cohort of patients of status postimplantation of silicone gel-filled
devices
will manifest chronic morbidity. Identifying such patients prospectively
remains
problematic. 2) Whether or not silicone gel incites adverse systemic
phenomena is
unproven, although it has been implicated. 3) Symptomatic patients with
silicone gel-
filled implants in place should be considered for removal, with full
knowledge of the
morbidity associated with revisional procedures. 4) Patients currently
undergoing
breast augmentation or reconstruction employing prosthetics are perhaps
best served
by insertion of saline-filled devices. 5) Patient-physician dialogue
regarding the
risk-benefit analysis of prosthetic implantation is imperative. Patients
consenting
to such procedures must be willing to assume risks.
========================================================================
27.) Neurosarcoidosis following augmentation mammoplasty with silicone.
========================================================================
Yoshida T; Tanaka M; Okamoto K; Hirai S
Department of Neurology, Gunma University School of Medicine, Japan.
Neurol Res (ENGLAND) Aug 1996 18 (4) p319-20 ISSN: 0161-6412
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: INDEX MEDICUS
We report a patient with neurosarcoidosis, which developed 22 years after
augmentation mammoplasty by the injection of silicone gel. She presented
with
bilateral hilar lymphadenopathy, left-sided lower cranial nerve palsies
(8th, 9th,
and 10th), and vestibular ataxia, which improved following the
administration of
prednisolone. Biopsy of the breast nodules showed granulomatous changes
identical
with those of sarcoidosis, while infrared spectrophotometry disclosed that
the
nodules contained polydimethylsiloxane, a major component of the silicone gel
injection. This is the first report of neurosarcoidosis following silicone
mammoplasty.
========================================================================
28.) Are breast implants anticarcinogenic? A 14-year follow-up of the Los
Angeles Study.
========================================================================
Deapen DM; Bernstein L; Brody GS
Department of Preventive Medicine, School of Medicine, University of
Southern
California, Los Angeles, USA.
Plast Reconstr Surg (UNITED STATES) Apr 1997 99 (5) p1346-53 ISSN:
0032-1052
Contract/Grant No.: CA-14089--CA--NCI; CA-17054--CA--NCI
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9707
Subfile: AIM; INDEX MEDICUS
Despite decades of use, the long-term safety of breast implants in women
remains a
concern. While the incidence of breast cancer among women has increased
dramatically
in the past decade, the implant-related risk of carcinoma of the breast
only recently
has received widespread attention. An additional concern is that the
presence of the
implant may delay tumor detection. This study allows examination of breast
cancer
risk and detection issues among patients with long-term exposure. We
conducted a
record linkage cohort study of cosmetic breast implant patients. We
abstracted the
records of the private practices of 35 broad-certified plastic surgeons in
Los
Angeles County, California. We included 3182 white women who received
cosmetic
breast implants between 1953 and 1980. Spanish-surnamed women,
nonresidents of Los
Angeles County, and patients with prior subcutaneous mastectomy or breast
cancer were
excluded. Cancer outcomes through 1991 have been ascertained through
record linkage
with the Los Angeles County Cancer Surveillance Program. With a median
follow-up of
14.4 years, 31 breast cancer cases were observed, compared with 49.2
expected, based
on Los Angeles County population-based incidence rates (standardized
incidence ratio
= 63.0 percent; 95 percent confidence limits: 42.8 and 89.5 percent). The
distribution of stage of disease at diagnosis among women with implants did
not
differ from that of all similar breast cancer patients in Los Angeles
County. In Los
Angeles County, augmentation mammaplasty patients experience a
significantly lower
than expected risk of breast cancer and no delay in breast cancer detection
after an
average of 14.4 years of exposure. While the linkage methodology allows the
possibility of failing to detect diagnosed cancer cases and does not permit
collection of some pertinent risk factors, the six other published
epidemiologic
studies on the topic also report breast cancer risk to be at or below the
expected
rate.
========================================================================
29.) [Silicone breast implants and breast cancer]
Silikonebrystproteser og brystkraeft.
========================================================================
Kjoller KH; Krag C; Friis S
Plastikkirurgisk afdeling V, Amtssygehuset i Herlev.
Ugeskr Laeger (DENMARK) Mar 17 1997 159 (12) p1744-8 ISSN: 0041-5782
Language: DANISH Summary Language: ENGLISH
Document Type:
JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL English Abstract
Journal Announcement: 9706
Subfile: INDEX MEDICUS
Sarcomas have been shown to develop next to foreign body implants, silicone
included, in animal experiments. However, this carcinogenesis is not
believed to
have any human relevance. A review of the existing epidemiological studies
suggests
that women with silicone breast implants have a reduced risk for developing
breast
cancer. However, the presence of breast implants does obscure mammographic
visualization as well as palpation of mammary tissue. This has led to the
assumption
that breast cancer detection could be compromised in women with breast
implants. In
the few studies that have dealt with this issue, women with breast implants
were
diagnosed with the same stage of disease as women without implants.
However, the
percentage of false negative mammographies was increased in one study. In
conclusion, there is currently no evidence of an association between breast
implants
and cancer or postponed breast cancer detection. (37 References)
========================================================================
30.) Lack of evidence of systemic inflammatory rheumatic disorders in
symptomatic women
with breast implants.
========================================================================
Blackburn WD Jr; Grotting JC; Everson MP
Research Service, Birmingham VA Medical Center, Ala, USA.
Plast Reconstr Surg (UNITED STATES) Apr 1997 99 (4) p1054-60 ISSN:
0032-1052
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9706
Subfile: AIM; INDEX MEDICUS
Breast implants containing silicone have been used for approximately 30
years for
breast augmentation or reconstruction. In general, the implants have been
well
tolerated and reports have indicated a high degree of patient satisfaction.
Nonetheless, there have been anecdotal reports of patients with
musculoskeletal
complaints that have been attributed to silicone breast implants. To
investigate
this further, we prospectively examined 70 women with silicone breast
implants who
had complaints that they or their referring physicians thought were related
to their
implants. On clinical examination, the majority of the patients had
fibromyalgia,
osteoarthritis, or soft-tissue rheumatism. One patient had rheumatoid
arthritis,
which predated her implants, and one had Sjogren's syndrome. Because many
of our
patients had myalgic symptoms, we further evaluated these patients by
measuring
circulating levels of soluble factors including interleukin-6,
interleukin-8, tumor
necrosis factor-alpha, soluble intercellular adhesion molecule-1, and soluble
interleukin-2 receptor, which have been previously found to be elevated in
patients
with inflammatory diseases. We found that the levels of these molecules in
women
with silicone breast implants were not different from those seen in normal
subjects
and were significantly less than those seen when examining chronic
inflammatory
disorders such as rheumatoid arthritis or systemic lupus erythematosus. In
summary,
our clinical and laboratory evaluation of symptomatic breast implant
patients argues
against an association of silicone breast implants with a distinctive
rheumatic
disease or a systemic inflammatory disorder. Given these findings and the
clinical
picture, it is our impression that most symptomatic women with silicone
breast
implants have well-delineated noninflammatory musculoskeletal syndromes.
Moreover,
these data fail to support the concept that their symptoms are due to a
systemic
inflammatory response related to their implants.
========================================================================
31.) Breast implants in patients with differentiated and undifferentiated
connective
tissue disease.
========================================================================
Williams HJ; Weisman MH; Berry CC
University of Utah School of Medicine, Salt Lake City 84132, USA.
Arthritis Rheum (UNITED STATES) Mar 1997 40 (3) p437-40 ISSN: 0004-3591
Contract/Grant No.: 1-AM-6-2228--AM--NIADDK
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9706
Subfile: AIM; INDEX MEDICUS
OBJECTIVE: To assess the frequency of breast implantation and the
relationship of
the implants to the onset of symptoms in patients with differentiated and
undifferentiated connective tissue disease (CTD). METHODS: We evaluated an
inception
cohort of patients with differentiated and undifferentiated CTD and
symptoms of < 12
months duration when enrolled in 1983-1987. The risk of having breast
implants in
those patients with early symptoms of CTD was determined in comparison with
that in a
non-concurrent control group. RESULTS: Only 3 of 323 women in the cohort had
historical, physical, or chest radiographic evidence of breast
implantation. In 1 of
the 3 patients, the symptoms of CTD began before the breast implantation.
The odds
ratio was calculated at 1.15, with a 95% confidence interval ranging from
0.23 to
3.41. CONCLUSION: This study showed an absence of significant risk for
prior breast
implantation surgery in patients with well-defined or undifferentiated CTD.
========================================================================
32.) Epidemiology of systemic sclerosis.
========================================================================
Silman AJ; Newman J
University of Manchester, ARC Epidemiology Research Unit, School of
Epidemiology
and Health Sciences, UK.
Curr Opin Rheumatol (UNITED STATES) Nov 1996 8 (6) p585-9 ISSN:
1040-8711
Language: ENGLISH
Document Type: JOURNAL ARTICLE; REVIEW; REVIEW, TUTORIAL
Journal Announcement: 9705
Subfile: INDEX MEDICUS
There have been few recent studies of the descriptive epidemiology of
systemic
sclerosis, but in recent work the limited form of the disease seems more
prominent
than reported in previous studies. Molecular genetic investigation of
systemic
sclerosis remains disappointing in identifying susceptibility alleles.
There are
some associations in relation to HLA class II alleles, specifically DP, DQ,
and DR.
These associations, however, seem to be more important in predicting the
nature of
the autoimmune response rather than describing disease susceptibility
itself. The
study of occupational and environmental influences has been dominated by
studies on
the role of silicone gel breast implants. These studies, driven by
medicolegal
constraints, have overwhelmingly failed to prove any association. Other
studies
confirm the continuing likelihood that organic solvents are implicated, at
least in a
proportion of cases. (38 References)
========================================================================
33.) Use of antipolymer antibody assay in recipients of silicone breast
implants.
========================================================================
Tenenbaum SA; Rice JC; Espinoza LR; Cuellar ML; Plymale DR; Sander DM;
Williamson
LL; Haislip AM; Gluck OS; Tesser JR; Nogy L; Stribrny KM; Bevan JA; Garry RF
Department of Microbiology and Immunology, Tulane University School of
Medicine,
New Orleans, LA 70112, USA.
Lancet (ENGLAND) Feb 15 1997 349 (9050) p449-54 ISSN: 0140-6736
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: AIM; INDEX MEDICUS
BACKGROUND: Local complications (encapsulation, rashes, rupture, and
leakage) can
occur after placement of silicone gel-containing breast implants (SBI).
Whether SBI
exposure results in systemic manifestations in some recipients is
controversial. We
have carried out a blinded study to assess whether there is any difference
between
SBI recipients and non-exposed controls in the proportions positive for serum
antibodies directed against polymeric substances. METHODS: We recruited
female SBI
recipients (including those without symptoms) who presented to a single
rheumatology
clinic. A physician global assessment was used to classify SBI recipients
who did
not meet criteria for specific autoimmune diseases according to the
severity of local
and systemic signs and symptoms. Controls were recruited from among clinic
staff and
their acquaintances. Results of the antipolymer antibody (APA) assay were
compared
with those of an assay for antinuclear antibodies (ANA) and with the
severity of the
signs and symptoms. FINDINGS: Positive APA results were found in one (3%)
of 34 SBI
recipients with limited symptoms, two (8%) of 26 with mild symptoms, seven
(44%) of
16 with moderate symptoms, and 13 (68%) of 19 with advanced symptoms. Four
(17%) of
23 healthy non-SBI-exposed controls and two (10%) of 20 non-exposed women
with
classic autoimmune diseases were positive for APA. Thus, women with
moderate or
advanced symptoms were significantly more likely than those with limited or
mild
symptoms, or non-exposed controls to have APA (p < 0.001). The proportion
with
positive ANA results was higher for women with classic autoimmune diseases
14 (70%)
of 20 than for any SBI-exposed subgroup (0-33%). INTERPRETATION: The APA
assay can
objectively contribute to distinguishing between SBI recipients with
limited or mild
signs and symptoms. SBI recipients with more severe manifestations, and
patients
with specific autoimmune diseases. Further studies will be needed to
define the
signs and symptoms associated with exposure to SBI.
========================================================================
34.) Complications leading to surgery after breast implantation [see comments]
========================================================================
Gabriel SE; Woods JE; O'Fallon WM; Beard CM; Kurland LT; Melton LJ 3rd
Division of Rheumatology and Internal Medicine, Mayo Clinic and Mayo
Foundation,
Rochester, MN 55905, USA.
N Engl J Med (UNITED STATES) Mar 6 1997 336 (10) p677-82 ISSN: 0028-4793
Contract/Grant No.: AR30582--AR--NIAMS
Note: Comment in: N Engl J Med 1997 Mar 6;336(10 ):718-9
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: AIM; INDEX MEDICUS
BACKGROUND: Local complications that require additional surgical
procedures are an
important problem for women with breast implants. METHODS: We studied 749
women who
lived in Olmsted County, Minnesota, and received a first breast implant at
the Mayo
Clinic between 1964 and 1991. We identified complications that occurred
after the
initial procedure and after any subsequent implantation. A complication
was defined
as a surgical procedure performed for any of the following reasons: capsular
contracture; rupture of the implant; hematoma or bleeding; infection or
seroma of the
wound; chronic pain; extrusion, leakage, or sweating of the implant;
necrosis of the
nipple, areola, or flap; malfunction of the filler port of a tissue
expander; and
wound dehiscence. RESULTS: During follow-up (mean, 7.8 years; range, 0 to
25.8), 208
(27.8 percent) of the women underwent 450 additional implant-related surgical
procedures. Ninety-one (20.2 percent) were anticipated, staged procedures
or were
done because the patient requested a size change or aesthetic improvement,
and 359
procedures (79.8 percent) had at least one clinical indication (thus
constituting a
complication). Complications occurred in 178 (23.8 percent) of the 749
women and
involved 274 (18.8 percent) of the 1454 breasts with implants and 321 (18.8
percent)
of the 1703 implants. The most frequent problem was capsular contraction
(272
cases), followed by rupture of the implant (60), hematoma (55), and wound
infection
(23). The rate of complications was significantly lower (P<0.001) among
women with
cosmetic implants (6.5 percent at one year, 12 percent at five years) than
among
women who underwent implantation after mastectomy for breast cancer (21.8
percent at
one year, 34 percent at five years) or prophylactic mastectomy (17.3
percent at one
year, 30.4 percent at five years). CONCLUSIONS: Women who have had breast
implantation frequently experience local complications during the
subsequent five
years. Complications were significantly less frequent among patients who
received
implants for cosmetic reasons than among those who received implants after
mastectomy
for cancer or for cancer prophylaxis.
========================================================================
35.) Silicone gel and octamethylcyclotetrasiloxane (D4) enhances antibody
production to
bovine serum albumin in mice.
========================================================================
Nicholson JJ 3rd; Hill SL; Frondoza CG; Rose NR
Department of Molecular Microbiology and Immunology, Johns Hopkins
University,
Baltimore, Maryland 21239, USA.
J Biomed Mater Res (UNITED STATES) Jul 1996 31 (3) p345-53 ISSN:
0021-9304
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
The purpose of the present study was to determine whether components of
silicone
breast implants [silicon (polydimethylsiloxane) oil, silicone gel, and
octamethylcyclotetrasiloxane (D4)] potentiate the antibody response to
bovine serum
albumin (BSA) in mice. Seventy A/J mice were divided into seven groups which
received the following: group I--phosphate buffer solution (PBS); group
II--20
centistoke (cs) silicone oil; group III--50% silicone gel homogenized in
silicone
oil; group IV--incomplete Freunds' adjuvant (IFA); group V--IFA mixed with
an equal
volume of silicone oil; group VI--D4; and group VII--IFA mixed with an
equal volume
of DA. Each 0.1 mL of treatment material(s) was mixed or emulsified with
an equal
0.1-mL volume of 250 micrograms/mL BSA in PBS solution. Antibodies to BSA
were
measured using an enzyme-linked immunosorbent assay. Our study
demonstrates for the
first time that both D4 and the silicone gel potentiate antibody production
to BSA in
mice. Histopathologic evaluation of the injection sites reveals granulomas
for mice
injected with IFA and D4 preparations. Whether D4 or silicone gel acts as an
adjuvant against self-antigens has yet to be determined.
========================================================================
36.) Visualization of silicone gel in human breast tissue using new
infrared imaging
spectroscopy.
========================================================================
Kidder LH; Kalasinsky VF; Luke JL; Levin IW; Lewis EN
Laboratory of Chemical Physics, National Institute of Diabetes and
Digestive and
Kidney Diseases, National Institutes of Health, Bethesda, Maryland
20892-0510, USA.
Nat Med (UNITED STATES) Feb 1997 3 (2) p235-7 ISSN: 1078-8956
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
Between 1 and 2 million women in the United States have silicone breast
implants.
Complications include capsular contracture and calcification and possibly
connective
tissue diseases such as scleroderma and rheumatoid arthritis, a subject of
some
controversy. In order to accurately assess the role of silicone in any
histopathologic change, it is necessary to confirm its presence and to
identify other
foreign materials in the capsular tissue. Although light microscopy is
used to
visualize regions of tissue containing foreign inclusions, their chemical
identity
can only be determined using analytical techniques such as infrared or Raman
microscopy. However, these conventional microprobe techniques record
spectra only at
single points and require an a priori knowledge of the locations of the
inclusion to
be probed. To significantly extend the capabilities of both infrared
spectroscopy
and optical microscopy, we have developed a new infrared imaging system that
completely integrates these two methods. In this manuscript we highlight
the ability
of the technique to screen rapidly and to determine accurately the
presence, size and
chemical composition of silicone gel inclusions in human breast tissue.
========================================================================
37.) The epidemiology of scleroderma among women: assessment of risk from
exposure to
silicone and silica.
========================================================================
Burns CJ; Laing TJ; Gillespie BW; Heeringa SG; Alcser KH; Mayes MD; Wasko
MC;
Cooper BC; Garabrant DH; Schottenfeld D
Department of Epidemiology, University of Michigan, Ann Arbor, USA.
J Rheumatol (CANADA) Nov 1996 23 (11) p1904-11 ISSN: 0315-162X
Language: ENGLISH
Document Type: JOURNAL ARTICLE
Journal Announcement: 9705
Subfile: INDEX MEDICUS
OBJECTIVE: To investigate the relationship between exposure to silicone
(including
breast implants) and silica and the development of scleroderma (systemic
sclerosis,
SSc) among women. METHODS: A population based case-control study was
conducted among
women in Michigan. 274 confirmed cases of SSc diagnosed between 1985 and
1991 were
identified by contacting rheumatologists, hospitals, and a scleroderma
support group.
These cases and 1184 controls were interviewed by telephone to ascertain past
exposures to silicone or silica. RESULTS: Silicone in the form of breast
implants
was not associated with significantly increased risk of SSc (adjusted odds
ratio,
1.30; 95% confidence interval, 0.27 to 6.23). Among 20 other potential
silicone
exposure surveyed, self-reported exposure to silicone based glues,
sealants, and
caulks, manufacture or repair of windows or windshields, repairing or
frequently
using photocopy machines, consumption of simethicone-containing antacids, and
implanted medication delivery pumps were significantly associated with SSc.
However,
blinded assessment of all job and hobby descriptions in terms of their
potential for
silicone exposure failed to support the first 3 associations, antacid
consumption may
have been confounded by esophageal dysmotility before the diagnosis of SSc,
and other
silicone containing device categories (pacemakers, central nervous system
shunts,
other shunts and catheters) were not significantly associated with SSc.
Surgically
implanted metallic fixation devices were associated with significantly
reduced risk
for SSc. No association was detected between SSc and silica dust exposure.
CONCLUSION: Consistent with other studies, we found no increased risk of
SSc among
women with silicone breast implants, equivocal evidence of risk from other
silicone
exposures, and no evidence of risk from silica exposure.
======================================================================
DATA-MEDICOS/DERMAGIC-EXPRESS No (47) 31/03/99 DR. JOSE LAPENTA R.
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