Review

Infection in breast implants

Lancet Infect Dis 2005;
5: 94–106
BP and DM are in the Plastic and
Reconstructive Surgery Unit,
Department of Surgery,
University of Geneva Hospitals,
Geneva, Switzerland; and DP is
the director of the Infection
Control Programme, University
of Geneva Hospitals, Geneva,
Switzerland.
Correspondence to:
Professor Didier Pittet, Infection
Control Programme, University
of Geneva Hospitals, 24 Rue
Micheli-du-Crest, 1211 Geneva
14, Switzerland.
Tel +41 22 372 9828;
fax +41 22 372 3987;
didier.pittet@hcuge.ch
Brigitte Pittet, Denys Montandon, and Didier Pittet
Infection is the leading cause of morbidity that occurs after breast implantation and complicates 2·0–2·5% of
interventions in most case series. Two-thirds of infections develop within the acute post-operative period, whereas
some infections may develop years or even decades after surgery. Infection rates are higher after breast
reconstruction and subsequent implantation than after breast augmentation. Risk factors for infection associated
with breast implantation have not been carefully assessed in prospective studies with long-term follow-up. Surgical
technique and the patient’s underlying condition are the most important determinants. In particular, breast
reconstruction after mastectomy and radiotherapy for cancer is associated with a higher risk for infection. The
origin of infection in women with implants remains difficult to determine, but potential sources include a
contaminated implant, contaminated saline, the surgery itself or the surgical environment, the patient’s skin or
mammary ducts, or, as suggested by many reports, seeding of the implant from remote infection sites. Late
infection usually results from secondary bacteraemia or an invasive procedure at a location other than breasts.
Diagnostic and management strategies are proposed and the value of peri-operative surgical prophylaxis is
revisited. The current hypothesis of the possible role of low-grade or subclinical infection in the origin of capsular
contracture is also reviewed.

Human beings are constantly striving to improve their
fate. Mammary implants are used in breast augmentation
and reconstruction after mastectomy. In 1989, as many as
8·08 per 1000 women in the USA reported having had
some type of breast implant.1 In 2000, it was estimated
that at least 2 million women in the USA had breast
implants, and that close to 200 000 would be implanted
every year.2,3 Breast augmentation is the third most
common type of plastic surgery done for cosmetic reasons
in the USA after nose reshaping and liposuction, with
268 808 procedures in 2002. In that year, at least 10 000
women had primary breast implantation surgery or
replacement procedures in the UK.4
In 1899, Gersuny introduced the use of subcutaneous
paraffin injections to augment the breast.13 Reported
complications included ulceration and fistulation of the
breast several years after injection,14 as well as retinal,
pulmonary, and cerebral embolism, and chronic
polyarthritis.15,16 By the 1950s, many other injectable
substances had been tried, including petroleum jelly,
beeswax, shellac, and epoxy resins.17

Historic overview of breast augmentation

For centuries women have attempted to create the look
of a full and voluptuous bosom through modification of
clothing. As early as 3000 BC, Minoan women used
primitive brassieres and corsets to emphasise their
breasts (figure 1).5 With the exception of relatively brief
periods in the 15th and 20th centuries when women
attempted to underemphasise breast size, large breast
size has been more or less in vogue since antiquity and
continues to represent a major ideal of beauty.5–8
The 19th century marked the onset of invasive
attempts to enlarge the breast by use of ivory, glass,
metal, and rubber as implant materials.9,10 Large breasts
were so coveted that women underwent painful and
disfiguring procedures, often associated with myriad
medical problems. In 1895, Czerny did the first reported
successful human mammary reconstruction by
transplanting a lipoma from the hip to reconstruct a
breast after removal of a fibroadenoma in an actress.11
Autogenous materials such as fat dermis and dermis
Robert Cazeau

grafts were also used for augmentation, but met without

success due to the unpredictable and undesirable results
that generally resulted in liquefaction, infection, Figure 1: Statue of a Minoan woman using a primitive corset to emphasise
shrinkage, or total expulsion.12 her breasts

94 http://infection.thelancet.com Vol 5 February 2005


In the early 1950s, the liquid injection silicone
technique was used for breast contour restoration.
Within a decade, the initial enthusiasm had to be
revised.18,19 The silicone proved to disperse and cause
satellites throughout the entire breast, leading to
inflammatory responses with mastitis, destruction of
breast parenchyma, percutaneous silicone drainage, and
abdominal migration,18–20 most often resulting in
subcutaneous mastectomy.
Developments in chemistry in the first part of the 20th
century marked the beginning of the era of alloplastic,
preformed exogenous implants. One of the earliest
sponge-like materials was the Ivalon sponge, which was
made of polyvinylalcohol formaldehyde polymer. These
sponges were supplied as a block that the surgeon curved
to the size and shape desired (figure 2). Because the rough
surface of these implants resulted in tissue ingrowth and
the breasts became hard and distorted as the sponge
shrank, surgeons began to encase the sponge prosthesis
in polyethylene sacs. These sacs, however, often
accumulated fluid and were associated with infection and
fistula.22 Polystan (made from polyethylene tape) and
Etheron (a derivative of di-isocyanate polyethers) sponges
were also used with somewhat similar complications.23–25
Other contemporaneous substances used to create
implants included polyurethane, nylon, polypropylene,
and Teflon.17 By 1960, a survey estimated that
approximately 16 600 polyvinyl or polyethylene implants
were in place, done by 184 of the 294 plastic surgeons
practising at that time in the USA.26
The silicone gel prosthesis was developed in 1963.27,28
The initial Cronin implant had seams and fixation
patches, the shell was thick, and the gel was viscous.
Around 1974, the shell was made much thinner and the
gel made more fluid with the aim of softening the
breasts and decreasing the risk of capsular contracture,
the primary complication reported. Importantly, during
the 1970s, surgeons observed the phenomenon of gel
bleed (diffusion of non-crosslinked silicones from the
gel through the shell) occurring with intact implants29
and thought to be associated with the development of
connective tissue diseases and other autoimmune
disorders.30–32 Subsequently, shells were made thicker.
Polyurethane foam was introduced in 1961 to combat
capsular contracture because it was thought that the
open cell nature of the polyurethane would allow tissue
ingrowth, thus producing a random vectoring of forces
in the capsule and thereby reduce contracture.29 Because
polyurethane may produce a toxic byproduct within the
body, toluene diamine, known to be oncogenic in
animals,33 these implants (or polyurethane-coated
prostheses) were withdrawn from the market by
manufacturers in 1991.34
Microbiology of the breast
The human breast is not a sterile anatomic structure; it
contains endogenous flora, derived from the nipple
http://infection.thelancet.com Vol 5 February 2005
Review
Whitehorn Publishing Company
Figure 2: Surgeon curving a sponge made of synthetic polymer to the desired size and shape of the future breasts
Reproduced from the story of Linda Lee, triumph of beauty surgery over misery, in Franklyn.21
ducts, that is essentially similar to that found in normal
skin. Multiple breast ducts provide a passage from the
skin surface to deep within the breast tissue.
Coagulase-negative staphylococci were isolated from
53% of specimens in women undergoing breast
augmentation or reduction;35 a third of the cultures
showed no growth. Other microorganisms identified
were diphtheroids and lactobacilli (9%), Bacillus spp
(5%), and beta-haemolytic streptococci (3%). Anaerobic
microorganisms were mostly Propionibacterium acnes.
Cultures of material milked from the nipples before
breast augmentation grew mainly Staphylococcus
epidermidis (16 of 24, 67%), but also Bacillus subtilis (two
of 24, 8%) and diphtheroids (two of 24, 8%).36
Endogenous flora could be responsible for
contamination of the prosthesis at time of implantation,
in particular when using periareolar or transareolar
surgical approaches (see below). This flora could also be
responsible for acute infections developing during one-
step procedures such as mastectomy followed by
immediate reconstruction.
Breast implants
Silicone breast implants have been available
commercially since 1963 in the USA.27 Middleton has
identified more than 240 types of breast implants and
expanders manufactured in the USA.37 Prostheses may
be placed above the muscle and under the gland
(subglandular) or under the muscle (submuscular;
figure 3). Surgical approaches are either inframammary,
transaxillary, periareolar, or transareolar (figure 4). For
the inframammary approach, the incision is made at the
fold beneath the breasts, which limits the risk of
95
 Review

contamination by endogenous breast flora, but may

result in a visible scar. The periareolar incision is
preferred by many surgeons38 since it generally results in
an almost undetectable scar. However, there may be
some complications, including prosthesis
contamination at time of insertion, impairment of
breastfeeding,39 and loss of nipple sensation.40 The
transaxillary approach seems to be used less often.
Implants consist of silicone gel contained within a
silicone rubber envelope. An alternative design consists
of an outer silicone shell filled with saline, glycerides, or
soya oil. The latter two have recently been withdrawn
from the market. Most saline implants are inflatable,
and are filled with saline by the surgeon after insertion,
with the advantage of a smaller incision and an
adjustable final volume. Their disadvantage, however, is
their susceptibility to leakage and sudden deflation. They
are also often prone to wrinkling, which may be palpable
if not observable.41
Silicone breast implants have become the gold
standard for breast implantation. In the early 1980s,
however, reports suggested an association between
silicone breast implants and various connective tissue
diseases,31,32,42–52 but only limited analytic epidemiological
data addressing this hypothesis were available at that
time.53 As a consequence, in 1992, the US Food and
Drug Administration (FDA) banned the use of silicone
breast implants, restricting them to breast cancer
reconstructive surgery in a strictly controlled clinical Figure 4: Skin incisions for breast prosthesis implantation
trial.53 Since then, many epidemiological studies have
addressed the potential association between silicone note, the lack of definitive data in many respects calls for
breast implants and connective tissue diseases.53–72 the requirement of continual long-term monitoring of
Interestingly, all but one66 failed to show an increased these diseases among implant recipients. Saline-filled
risk of systemic sclerosis or any other connective tissue breast implants remain the main option for women in
diseases. Another report suggested a possible link the USA.74
between breast implant rupture and fibromyalgia.73 Of
Complications of breast augmentation
During the past few decades, several studies have assessed
the potential health risks associated with implants,
particularly silicone breast implants. However, research
on the frequency, severity, risk factors, and clinical effect
of local complications is limited. Panel 1 shows the
adverse effects reported after breast augmentation.
Independent review bodies have assessed the available
data on silicone breast implants and have concluded that
there is no convincing evidence of an association
between implants and breast cancer, connective tissue
diseases, other rheumatic conditions, neurological
disorders, or effects among offspring.17,75–80 Recently, the
European Parliament has demanded the adoption and
implementation of specific measures to improve
information for patients, tracking and surveillance of the
implants, quality assurance, and key research on silicone
breast implants as they relate to patient health.81,82
Although breast implants have not been associated
Figure 3: Breast augmentation with an increased risk of breast cancer, they may
(A) Breast prosthesis in the subglandular position. (B) Breast prosthesis in the submuscular position interfere with routine mammography; therefore, women

96 http://infection.thelancet.com Vol 5 February 2005

 Review

with breast augmentation may be more likely to be represent the minimum number of reports of infection
diagnosed with advanced disease.83,84 Importantly, the because underreporting of adverse events is known to
radiologist must use implantation displacement views to occur for such procedures.
improve visualisation of breast tissue in women with
implants. In a large prospective cohort study,85 the raw Risk factors for infection
sensitivity of screening mammography was lower for Risk factors for infection associated with breast
women with augmentation (45%) than for those without implantation have not been carefully assessed in
(67%). Of note, the prognostic characteristics of tumours prospective studies with long-term follow-up. Almost all
was not influenced by augmentation. studies are retrospective, and case series do not allow a
definitive assessment and quantification of the relative
Incidence of infection importance of risk factors for infection. Surgical
Infection is the leading complication that occurs after technique and the patient’s underlying clinical condition
breast implantation surgery. Unfortunately, even recent are the most important determinants. Excellent surgical
epidemiological investigations of complications after technique to obviate haematoma and the occurrence of
breast implantation provide little information on tissue ischaemia is mandatory.
infectious complications.86–88 Infections were observed in The probability of infection is up to ten times higher in
2·5% of all operations in a worldwide survey in 10 941 women with reconstruction and depends on the degree
patients who underwent breast augmentation, with an of pre-existing tissue scarring and skin atrophy resulting
incidence of 1·7% for acute post-operative infections, from cancer surgery and radiation therapy, both of
and 0·8% for late infections.89 Published reports of post- which are associated with postoperative tissue ischaemia
operative infections span from 0% in some series90,91 to and delayed wound healing.36,96,98–104 24–53% of patients
53% in other series of women undergoing immediate developed implant infections in some series.28,36,92–95,105,106
reconstruction after mastectomy.28,36,92–95 More recently, Lymph-node dissection was an additional independent
large epidemiological retrospective cohort studies with risk factor for infection in the study by Nahabedian and
long-term follow-up found similar infection rates of colleagues.106
2·0–2·5%.86,96 De Cholnoky89 noted that infections were more common
In the absence of a surveillance network with
prospective recording of adverse events and a precise
count of the total number of breast implantation Panel 1: Complications after breast augmentation
procedures, reports of infections do not represent the true
Immediate adverse effects
incidence rates of infection, in particular because of the
Haematoma
lack of knowledge of individuals at risk. The FDA has a
Seroma
surveillance system for monitoring adverse events related
Wound dehiscence
to medical devices. Since 1984, manufacturers and
Surgical site infection
importers of medical devices have been required to report
Periprosthetic infection
to the FDA when they become aware of information
Perforation of the skin
suggesting that one of their marketed devices might have
Change in tactile sense
caused or contributed to death or serious injury.
Manufacturers are also required to report any malfunction Short-term adverse effects
of the device, defined as failure to meet performance Visible skin wrinkles
specifications or failure to perform as intended. Palpable implant folds
Infection reports submitted to the FDA between 1977 Asymmetry or displacement of the implant
and 1997 by breast implant manufacturers and related to Ptosis
silicone gel breast implants, saline breast implants, and Swelling of the breast
saline tissue expanders were analysed by Brown and Disconfiguration of the breast at time of muscular
colleagues.97 Overall, 1971 reports with infection contraction
recorded as the main adverse event were submitted Hypertrophic scar
during the study period. Importantly, only 21 reports Periprosthetic infection
were submitted between 1977 and 1988, with a dramatic Capsular contracture
increase in 1992, which peaked in 1994 with 600 reports Prolonged pain of the breast
submitted that year. Most of these reports were about Implant rupture
silicone breast implants (62%), with fewer reports on
Long-term adverse effects
saline breast implants (32%) and breast expanders
Late infection
(5·7%). This finding was mainly due to the publicity and
Capsular contracture
litigation associated with breast implantation. Although
Silicone granuloma
these data cannot be used to calculate the incidence of
infection associated with breast implantation, they

http://infection.thelancet.com Vol 5 February 2005 97

 Review
after subcutaneous mastectomy with immediate implant
placement than with delayed placement. Infection was
less likely to occur in a two-stage procedure in another
series.107 In the study by Vandeweyer and colleagues,108
adjuvant chemotherapy was associated with a significantly
higher rate of infection (10·7% vs 1·5%) after immediate
reconstruction. One hypothesis is that in immediate
reconstruction, the operation field is contaminated with
endogenous flora before the insertion of the prosthesis.
With delayed reconstruction, there has been time for
bacteria to have been removed from the tissue.
Furthermore, unlike augmentation surgery, recon-
structive surgery is associated with a higher incidence of
haematoma and delayed scarring due to the extension of
the dissection and secondary skin ischaemia.96 By
contrast with widespread supposition, the rough-
surfaced, textured, or polyurethane-coated implants do
not carry a greater susceptibility to infection than
smooth silicone implants.109
The origin of infection in women with implants
remains difficult to determine, but the potential sources
of infection are a contaminated implant, contaminated
saline, the surgery or surgical environment, the patient’s
skin or mammary ducts, or, as suggested by many
reports,89,109 seeding of the implant from remote
infection. Contamination of the implant during
manufacture or surgery could result in subclinical or
clinical infections. Microbial growth has also been
reported to occur inside saline-filled breast
implants.110–112 It has been reported that the implant
envelope is not permeable to bacteria,113 but this does not
rule out entry into the lumen via the implant’s valve.
Since most of the saline implants have to be filled by the
surgeon during the operation, they can be associated
with pre-operative contamination.
Other possible predisposing factors for breast
implant infection include skin-penetrating accidents,
general surgery, dental work, pyoderma, preceding
infectious processes, breast trauma, breast massage,
and breast skin irritation.109 The adhesive bandage of
the surgical site dressing could cause a severe contact
dermatitis at the surgical site, leading to infection of
the skin and the implant. In a study reporting this
condition, the causative microorganisms included
Enterobacteriaceae and Pseudomonas aeruginosa.109
Nipple piercing may be an additional risk factor for
breast implant infection.114
Clinical features
Acute infection
The incidence of breast implant infections after surgery
is generally low but correlates with the complexity of the
surgical procedure and the patient’s underlying
condition. Acute post-surgical infection has been found
in 0–4% of cases.28,89,92,98,99,109,115,116 Most acute infections
occur during the first month after implantation.109
However, because of the lack of a consensus on
98
definitions, it is difficult to obtain exact estimates of the
incidence of infection.
Acute infections around breast implants are usually
associated with fever, rapidly evolving pain, and marked
breast erythema95,109,117 (figure 5); onset of infection
occurs at between 6 days and 6 weeks after surgery
(median, 10–12 days).89 Ultrasonography can be used to
confirm the presence of fluid collection around the
breast implant in most cases.
Overall, neither the type of implant nor the surgical
procedure seems to have a significant influence on the
timing of infection.109 Information available from the
FDA’s device network database showed distinct trends
in the time from surgery to infection reported by
implant type: although most infections reported for
saline breast implants were recorded to occur within the
first 8 weeks after implantation, this trend was different
for silicone breast implants, in which over half of the
infections were reported to occur after 26 weeks. The
median time to infection reported for silicone gel breast
implants was 13 weeks versus 4 weeks for saline
implants; median time for breast expanders closely
resembled that for saline breast implants (5 weeks), thus
suggesting a possible role for handling and implant
manipulation in the origin of infection.
Toxic shock syndrome after the placement of
mammary prostheses is another form of acute infection.
In 1983, Barnett and colleagues118 reported a 32-year-old
woman who had periareolar subglandular placement of
double lumen implants and developed a sore throat with
fever of 39°C, watery diarrhoea, myalgias, lethargy, and a
rash later associated with hypotension and acute
respiratory distress syndrome. Although there were no
overt signs of infection, both prostheses were removed;
purulent material was found around the right prosthesis,
which grew Staphylococcus aureus. The patient received
broad-spectrum antibiotic coverage and was gradually
stabilised. Since then, there have been several reports of
toxic shock syndrome after breast implantation
surgery,118–127 including at least two reports of related
Figure 5: Marked skin and subcutaneous erythema in a case of acute breast
prosthesis infection after augmentation
http://infection.thelancet.com Vol 5 February 2005
 Review

death.121 In most cases, S aureus infection was acquired Reference Microorganism Significant clinical event or Delay between implant
during the operation. In the series reviewed by Holm and possible source of secondary surgery and late
Muhlbauer,120 the median period between surgery and spread to the implant implant infection
toxic shock syndrome was 4 days. The symptoms may De Cholnoky89 Gingival flora Infected molar tooth with subsequent 1·5 years
begin in the first 12–24 h after surgery, which is much bilateral implant infection
Brand109 Staphylococcus epidermidis Stye in one eye with inflammation in 8 months
earlier than the usual surgical site infection. The primary one breast 3 days later
surgical site is rarely impressive, and there is usually Pseudomonas aeruginosa Haemorrhagic cystitis 2·5 years
neither inflammation nor purulence. The paucity of local Staphylococcus aureus Severe bacterial stomatitis 7 months
signs of infection contrasts with the picture of fulminant Gibney133 Staphylococcus aureus Axillary hydradenitis 3 years
Bernardi and Klebsiella pneumoniae Breast augmentation combined 8 months
sepsis.120,121 Early recognition and implant removal can be Saccomanno137 with abdominoplasty
life saving.121 Streptococcal toxic shock syndrome was also Ablaza and Enterococcus avium Severe clinical infection of breast 16 years
reported as the cause of death on at least one occasion.97 LaTrenta138 implants requiring bilateral removal;
no definitive source identified
Implant-associated infections caused by atypical
Petit et al139 Bacteroides fragilis Peritonitis due to colon perforation 40 years
mycobacteria have been reported. The syndrome of late Johnson et al141 Pasteurella multocida Patient who owned and lived with several 3 weeks
developing, massive, odourless, severe effusion with cats and had to give daily oral medication
negative routine cultures may indicate that special to one of her cats in the recovery period
from breast implantation surgery
acid-fast cultures and stains should be requested. These
organisms have a wide distribution and are found in Table: Studies that illustrate late infection after breast implantation resulting from secondary
soil, water (eg, hospital and operating room water bloodstream infection
conduits), and dust. However, infections caused by these
atypical organisms are rare.92 Nevertheless, rapidly surgical procedures, especially when performed under
growing mycobacterial wound infection occurring after septic conditions, should be accompanied with antibiotic
cosmetic surgery, and breast implantation in particular, prophylaxis if possible.
are being reported regularly.128–131 In most cases, it is
difficult to ascertain the source of contamination; a skin- Diagnosis and management
marking solution was identified as a possible source of The clinical picture of breast implant infection is highly
infection in one investigation.132 variable. Fever is usually present and rapidly evolving
breast pain and erythema can be noted (figure 5). Severe
Late infection sepsis can develop, but in most circumstances signs and
Knowledge about late infections that occur months or symptoms remain non-specific.
years after implantation is mostly anecdotal. In the The management of breast implant infection includes
absence of a mammary implantation registry, the the following: (1) aspiration guided by ultrasonography
collection of comprehensive data has proved to be very may be done if fluid is present, taking great care to avoid
difficult. Moreover, because of the length of time damage to the prosthesis. (2) Exudate should be sent for
between implantation and infection, patients with late Gram stain, acid-fast stains, and aerobic, anaerobic, and
infection may not be seen by the surgeons who did the acid-fast cultures. Cultures should be kept for at least 14
implantation; as participants in a survey, surgeons would days. For faster recovery of atypical mycobacteria,
obviously not be in the position to report such patients.109 laboratories may use Lowenstein-Jensen media or the
In view of the many women who currently carry BACTEC MB900 automated instrumentation. (3) If
mammary implants, the question of late infection and tissue is removed, it should also be sent for
its prevention is of particular importance. In a survey of histopathological examination to search for granuloma
10 941 patients with breast augmentation, such and acid-fast organisms. (4) Surgical removal of the
infections rarely occurred (0·8%), with 27 observations implant is mandatory in most cases. In clinical
with smooth-surface implants reported a few months to situations with severe infectious condition in the
several years after the procedure.89 absence of an identified source of infection, removal of
Late infection usually results from secondary the implants should be strongly considered. Excision of
bacteraemia or an invasive procedure at a location other the capsule is not systematic, but can be considered in
than breasts.89,109,133–143 Illustrative cases are shown in the some cases. Post-surgical drainage is advocated. (5) A
table. Although the probability of late infection has been 10–14-day course of systemic antibiotics should be given
shown to be low, implant carriers should understand to remove the causative pathogens;144 successful results
that the site of implantation may act as a trap for have also been reported with appropriate oral treatment.
bacteria, particularly when bloodstream infection Immediate reimplantation is not advocated, and the
occurs. As a consequence, any potentially severe delay to proceed will depend on the causative organisms
bacterial infection anywhere in the body should be and the appropriateness and duration of antimicrobial
recognised as early as possible and treated with systemic therapy. Thus, management usually entails a two-stage
antibiotics promptly and aggressively to limit these rare replacement procedure;144 whether the contralateral
secondary infections. Likewise, invasive dental or implant should also be removed is a matter of debate. In

http://infection.thelancet.com Vol 5 February 2005 99

 Review
rare, selected cases, immediate reimplantation of new
prostheses has been successful, implying aggressive
salvage measures.145,146
Capsular contracture and silicone granuloma
Formation of an acellular collagenous sheath around an
inert foreign material usually follows the placement of a
prosthesis. However, contracture of this scar around a
soft deformable implant will lead to a hard spherical
mass; this type of envelope is referred to as a capsule
(figure 6). Capsular contracture is the leading long-term
complication that occurs after breast implantation.147
Factors thought to be associated with capsular
contracture include infection, haematoma, silicone
bleed, and individual predisposition for hypertrophic
scarring. Implant filler material, placement, and surface
texture might also affect the risk of capsular
contracture.148 A recent investigation failed to show the
possible value of antipolymer antibodies for diagnostic
Figure 6: Bilateral capsular contracture after subglandular augmentation
(A) Front, (B) oblique, and (C) lateral views. (D) The prostheses were removed along with the calcified capsules.
(E,F) Opening of the calcified capsule showing the prosthesis
100
purposes in the clinical assessment of symptomatic
silicone-breast-implant recipients.149 In the absence of
large prospective cohort studies with long-term follow-
up, the exact incidence of capsular contracture after
breast implantation is unknown. Capsular contracture
(grades II–IV according to Baker;150 panel 2) was
observed among 4·1% with a 2-year follow-up period for
an incidence rate of 1·66 per 1000 implant-months and
2·83 per 1000 person-months.151 Figure 7 illustrates a
case of Baker grade IV capsular contracture.
The current hypothesis for the possible origin of
capsular contracture around breast implants is that it
may be caused by a low-grade or subclinical infection that
could be prevented by antibiotics.28,89,152–156 By contrast, in a
study involving 31 women with 49 removed implants,
electron microscopic examination of 25 hard and 24 soft
capsules from around silicone breast prostheses did not
show any bacteria, except for a single possible
intracellular bacterium.157 Other studies suggested that
immune mechanisms rather than bacterial flora may
play a key part in capsular contracture.158
Studies of patients with breast implants have shown
that many implant pockets (20–60%) are culture
positive, most often with S epidermidis,156 which often
correlates with capsular contracture.156,159–161 Cultures
done at time of surgical capsulotomy were often positive,
and predominantly grew S epidermidis and P acnes.117,155,161
In a study by Pajkos and colleagues,162 the presence of
coagulase-negative staphylococcal biofilm on removed
implants and capsules was significantly associated with
capsular contracture. It seems obvious, however, that
further substantiation of the proposed theory of an
infectious cause of capsular contracture is required.163–165
It has also been proposed that subchronic infection may
result in chronic pain, migration, and late extrusion of
the prosthesis,166 or be responsible for the systemic
symptoms such as arthralgias, myalgias, and malaise
that have been reported by women with breast
implants.167 On the basis of this finding, some clinicians
began to use antibiotics in the implant pocket155 or in the
implants themselves161 with a decreased incidence of
Panel 2: Baker classification of capsular contracture150
Grade I
Breast absolutely natural; no one could tell breast was
augmented
Grade II
Minimum contracture; I can tell surgery was done, but
patient has no complaint
Grade III
Moderate contracture; patient feels some firmness
Grade IV
Severe contracture; obvious just from observation
http://infection.thelancet.com Vol 5 February 2005
 Review

capsular contracture. The possible benefit of local

povidone-iodine (Betadine) irrigation at time of implant
placement, with or without intraprosthetic cefalotin or
antibiotic-steroid foam irrigation, has been suggested by
Burkhardt and colleagues161 in a prospective controlled
study of 124 patients undergoing breast augmentation;
an overall 50% reduction in capsule formation was
reported in the treatment groups. The practice of breast-
pocket irrigation with various antimicrobial solutions, in
particular povidone-iodine, is supported by some data
and extensive clinical practice among most plastic
surgeons.168 Although additional evidence has been
provided in mice,169 the issue is still a matter of much
debate.162–165 The recent and controversial decision in
2000 by the US FDA, which stated that contact of any
breast implant with povidone-iodine is contraindicated
because of the possible association with the deflation of
saline-filled prostheses in a small proportion of patients,
is troublesome and places surgeons who continue to use
it at medicolegal risk.
However, the source of bacteria could be the skin or
breast ducts.36,109,117,170 Experimental studies by Shah and
colleagues,156 in which implant capsules in rabbits were
deliberately seeded with S epidermidis, showed increased
hardness and thickness of the capsule. Intraluminal
antibiotics reduced capsule hardness in these rabbits.
Similarly, saline-filled silicone implants that were
impregnated with minocycline or rifampicin were less
likely to be colonised and cause S aureus infection than
non-impregnated implants when inserted subcu-
taneously into rabbits.171 The clinical effectiveness and the
potential for resistance development need further study
before such strategies can be used in human medicine.
Although possible adverse effects of microbial
organisms have been implicated in patients with breast
implants who are symptomatic, the clinical relevance of
microbial colonisation on implant surfaces removed from
symptomatic patients remains unclear, as well as its
possible effect on integrity.117,172 More research needs to be
done to understand the possible relation between bacterial
colonisation and capsular contracture of breast implants.
The past decade has seen interest in virtually all
aspects of breast implantation surgery, ranging from the
frequency of its performance to the long-term safety of
implanted devices. Litigation has demanded answers to
a wide variety of questions, challenging virtually each
aspect of surgeons’ preconceptions of breast
implantation surgery, in particular in the USA. One of
these areas of contention centres on the nature and
biological role of silicone granuloma associated with
implantation. Formation of granuloma is a common
tissue response to various foreign materials.173 A silicone
granuloma is by definition a type of tissue reaction
occasionally elicited by silicone. Although their occasional Figure 7: Illustration of a case of Baker grade IV capsular contracture150
(A) Bilateral capsular contracture after subglandular breast augmentation. (B)
occurrence has been established in the literature and in
Chest radiography showing the calcified capsules and breast implants. (C) Post-
the awareness of surgeons for over 30 years, litigation operative result 3 months after removal of the prostheses and capsules, and
suddenly raised the possibility that silicone granulomas submuscular replacement through inframammary incisions

http://infection.thelancet.com Vol 5 February 2005 101

 Review
have a significance beyond their role as a rare but real local
complication.174 Their true incidence in the total
population of women with breast implants is unknown.
The specific cause of silicone granuloma formation
cannot be determined from the scientific literature.
Chronic low-grade infection has been advanced as a theory
in litigation. Thus, the development of a silicone
granuloma could be associated, at least in part, with the
presence of chronic low-grade infection that
opportunistically and preferentially resides on the foreign
material. Clinically apparent silicone granulomas are a
relatively rare complication of breast implant placement,
and surgical resection is indicated when they are
symptomatic or of diagnostic concern. However,
additional studies are needed before a possible link
between silcone granuloma and chronic low-grade
infection or systemic disease related to implantation can
be firmly established.175
Prophylactic antibiotics
The need for prophylaxis in breast surgery is
controversial. Although most experts do not routinely
recommend prophylaxis for breast procedures, they do
in cases of implant placement. Brand109 reported the
results of a large survey (54 661 implants) of a group of
73 cosmetic surgeons with long-term experience in
mammary augmentation and reconstruction. Most
respondents adhered routinely to one or both of the
following prophylactic measures: systemic admin-
istration of antibiotics (most commonly a cephalo-
sporin), starting before surgery and continuing for up to
1 week after implantation; and irrigation of the surgical
pocket and rinsing of the implant before insertion in a
solution containing either an antiseptic or an antibiotic
(eg, cephalosporin, bacitracin, neosporin [neomycin,
polymyxin, and gramicidin]). In the absence of a control
group, the effectiveness of these measures cannot be
ascertained.
Systemic antibiotic prophylaxis at the time of surgery
was associated with a significant reduction of the infection
rate (0·42% vs 0·87%) in a large study of 39 455 patients
undergoing breast augmentation. The prophylactic reg-
imen should be directed against the most likely infecting
microorganisms, particularly staphylococci. A single dose,
given just before the procedure, provides adequate tissue
concentrations throughout the operation. In the case of a
lengthened procedure or substantial blood loss, we
recommend a second dose. First-generation or second-
generation cephalosporins are the most widely used
antibiotics for this indication. In this context, some
clinicians have proposed incorporation of an antibiotic in
the expander fluid.175 Cefalotin and gentamicin placed
within the lumen of inflatable breast implants in vitro
have been shown to diffuse outward through the silicone
shell. The use of intraluminal cefalotin and gentamicin in
vivo has significantly reduced the incidence of capsular
contracture after both primary breast augmentation and
102
Search strategy and selection criteria
Information for review was identified by searches in Medline
between 1978 and November 2004, references of relevant
articles, and of the extensive files of the authors. Search
terms were “breast implants”, “breast augmentation”,
“infection”, “silicone”, “biocompatibility”. English, German,
and French language publications were reviewed.
secondary open capsulotomy,154 but further clinical trials
are required before systematic recommendations can be
made, particularly in terms of the possible acquisition of
resistance.168
Some experts have recommended that antibiotic
prophylaxis should be given before a patient with breast
implants undergoes any dental procedure. It is still a
matter of debate and should be assessed on an individual
basis.176 However, there is no scientific evidence at the
present time to support such a recommendation.
Conclusions
Overall, three major strategies have been developed to
prevent infection associated with breast implantation: a
sterile environment, better operating procedures, and the
appropriate use of antibacterial agents. Thus far, sterile
environment and quality of surgical procedures cannot
be assessed in a randomised study for ethical reasons.
Antibiotic prophylaxis to prevent infections associated
with implantation has proven efficacy for prosthetic
heart-valve replacement, implantation of orthopaedic
prosthesis (hip and knee), and insertion of vascular
prostheses. In these conditions, systemic antibiotics will
decrease the risk of early infections. We propose an
extrapolation from this experience to breast implantation
surgery and consider that the local liberation of stable
antibiotic by novel devices needs to be investigated.
Incorporation of other antibacterial substances, such as
silver impregnation, bonding of copolymers with
antiseptic agents, and quaternary amines containing
organosilicons needs to be explored further. Clearly,
prevention of breast implant infection will continue to be
an area for high priority not only for the fields of surgery
and infectious diseases but also for biotechnology.
Conflicts of interest
We have no conflicts of interest to declare.
Acknowledgments
We thank Rosemary Sudan for expert editorial assistance in the
preparation of this work. We thank the UK Breast Implant Registry for
kindly providing preliminary information and a pre-publication copy of
their 2002 annual report.
Every reasonable effort has been made to trace the copyright holder of
figure 2. If you have any further details please contact the publisher.
References
1 Cook RR, Perkins LL. The prevalence of breast implants among
women in the United States. Curr Top Microbiol Immunol 1996;
210: 419–25.
2 Herdman RC, Fahey TJ Jr. Silicone breast implants and cancer.
Cancer Invest 2001; 19: 821–32.
http://infection.thelancet.com Vol 5 February 2005

3 Bondurant S, Ernster V, Herdman RC, eds. Safety of silicone
breast implants. Washington, DC: National Academy Press, 1999.
4 Medicines and Healthcare Products Regulatory Agency. UK Breast
Implant Registry: annual report 2002. London: Department of
Health, 2004: 1–36 (in press).
5 Demargne P. Naissance de l’Art Grec. In: Malraux A, Parrot A, eds.
L’Univers des Formes (no. 6), 2nd edn. Paris: Gallimard, 1974: 102.
6 Grazer F, Klingbeil J. Body image: a surgical perspective. St Louis:
Mosby, 1980.
7 Sarwer DB, Nordmann JE, Herbert JD. Cosmetic breast
augmentation surgery: a critical overview. J Womens Health Gend
Based Med 2000; 9: 843–56.
8 Yalom M. A history of the breast. New York: AA Knopf, 1997.
9 Fallon A. Culture in the mirror: sociocultural determinants of body
image. In: Cash T, Pruzinsky T, eds. Body images: development,
deviance and change. New York: Guilford Press, 1990: 80.
10 Haiken E. Venus envy: a history of cosmetic surgery. Baltimore:
Johns Hopkins University Press, 1997.
11 Czerny V. Plastischer Erzats de Brustdruse durch ein Lipom
[abstract]. Zentralbl Chir 1895; 27: 72.
12 Broadbent TR, Woolf RM. Augmentation mammaplasty. Plast
Reconstr Surg 1967; 40: 517–23.
13 Gersuny R. Harte und wieche praffinprothesen. Zentralbl Chir
1903; 30: 1–5.
14 Morestin H. Inconvénients et abus des injections de paraffine. Bull
Soc Chir (Paris) 1908; 34: 124–28.
15 Kach F. Uber gelegentliche Gefärhe kostmetischen Paraffin
Injektion. Munch Med Wochenschr 1919; 34: 965–67.
16 Bettmann H. Uber Folgeerscheinugen subcutaner
Paraffininjektionen. Berl Klin Wochenschr 1922; 22: 1040–41.
17 Bondurant S, Ernster V, Herdman RC, eds. Safety of silicone
breast implants. Washington, DC: National Academy Press, 2000.
18 Boo-Chai K. The complications of augmentation mammaplasty by
silicone injection. Br J Plast Surg 1969; 22: 281–85.
19 Ortiz-Monasterio F, Trigos I. Management of patients with
complications from injections of foreign materials into the breasts.
Plast Reconstr Surg 1972; 50: 42–47.
20 Vinnick C. Silicone mastopathy. In: Owsley JQ, Peterson RA, eds.
Symposium on aesthetic surgery of the breast. St Louis: Mosby,
1978: 151–55.
21 Franklyn RA. Beauty surgeon. Long Beach: Whitehorn, 1960: 239.
22 Pangman WJ, Wallace RM. The use of plastic prosthesis in breast
plastic and other soft tissue surgery. West J Surg Obstet Gynecol
1955; 63: 503–12.
23 Neuman Z. The use of the non-absorbable polyethylene sponge,
“Polystan sponge”, as a subcutaneous prosthesis (an experimental
study in rats). Br J Plast Surg 1957; 9: 195–99.
24 Arons M, Sabesin S, Sith R. Experimental studies with Etheron
sponge. Plast Reconstr Surg 1961; 28: 72–80.
25 Edgerton MT, Meyer E, Jacobson WE. Augmentation
mammaplasty. II. Further surgical and psychiatric evaluation. Plast
Reconstr Surg 1961; 27: 279–302.
26 Harris HI. Survey of breast implants from the point of view of
carcinogenesis. Plast Reconstr Surg 1961; 28: 81–83.
27 Cronin T, Gerow F. Augmentation mammaplasty: a new “natural
feel” prosthesis. In: Broadbent TR, ed. Transactions of the Third
International Congress of Plastic and Reconstructive Surgery;
1963; Amsterdam: Excerpta Medica Foundation: 41–49
28 Cronin TD, Greenberg RL. Our experiences with the silastic gel
breast prosthesis. Plast Reconstr Surg 1970; 46: 1–7.
29 Young VL, Watson ME. Breast implant research: where we have
been, where we are, where we need to go. Clin Plast Surg 2001; 28:
451–83, vi.
30 Byron MA, Venning VA, Mowat AG. Post-mammoplasty human
adjuvant disease. Br J Rheumatol 1984; 23: 227–29.
31 Van Nunen S, Gatenby P, Basten A. Post-mammoplasty connective
tissue disease. Arthritis Rheum 1982; 25: 694.
32 Baldwin CM Jr, Kaplan EN. Silicone-induced human adjuvant
disease? Ann Plast Surg 1983; 10: 270–73.
33 Loeser E. Long-term toxicity and carcinogenicity studies with
2,4/2,6-toluene-diisocyanate (80/20) in rats and mice. Toxicol Lett
1983; 15: 71–81.
http://infection.thelancet.com Vol 5 February 2005
Review
34 Reynolds HE. Evaluation of the augmented breast. Radiol Clin
North Am 1995; 33: 1131–45.
35 Thornton JW, Argenta LC, McClatchey KD, Marks MW. Studies on
the endogenous flora of the human breast. Ann Plast Surg 1988; 20:
39–42.
36 Courtiss EH, Goldwyn RM, Anastasi GW. The fate of breast implants
with infections around them. Plast Reconstr Surg 1979; 63: 812–16.
37 Middleton MS. Magnetic resonance evaluation of breast implants
and soft-tissue silicone. Top Magn Reson Imaging 1998; 9: 92–137.
38 Wilkinson T. Breast augmentation by periareolar incisions. In:
Georgiade N, ed. Aesthetic breast surgery. Baltimore: Williams &
Wilkins, 1983: 71–86.
39 Neifert M, DeMarzo S, Seacat J, Young D, Leff M, Orleans M. The
influence of breast surgery, breast appearance, and pregnancy-
induced breast changes on lactation sufficiency as measured by
infant weight gain. Birth 1990; 17: 31–38.
40 Barton F, Tebbetts J. Augmentation mammaplasty. Selected
Readings in Plastic Surgery 1989; 5: 1–26.
41 Gylbert L, Asplund OA, Jurell G. Capsular contracture after breast
reconstruction with silicone-gel and saline filled implants: a 6-year
follow-up. Plast Reconstr Surg 1990; 85: 373–77.
42 Fock KM, Feng PH. Connective tissue disease after augmentation
mammoplasty. Arthritis Rheum 1984; 27: 1440.
43 Fock KM, Feng PH, Tey BH. Autoimmune disease developing after
augmentation mammoplasty: report of 3 cases. J Rheumatol 1984;
11: 98–100.
44 Okano Y, Nishikai M, Sato A. Scleroderma, primary
biliary cirrhosis, and Sjogren’s syndrome after cosmetic
breast augmentation with silicone injection: a case report
of possible human adjuvant disease. Ann Rheum Dis 1984;
43: 520–22.
45 Weiner SR, Paulus HE. Chronic arthropathy occurring after
augmentation mammaplasty. Plast Reconstr Surg 1986; 77: 185–92.
46 Sergott TJ, Limoli JP, Baldwin CM Jr, Laub DR. Human adjuvant
disease, possible autoimmune disease after silicone implantation: a
review of the literature, case studies, and speculation for the future.
Plast Reconstr Surg 1986; 78: 104–14.
47 Spiera H. Scleroderma after silicone augmentation mammoplasty.
JAMA 1988; 260: 236–38.
48 Varga J, Schumacher HR, Jimenez SA. Systemic sclerosis after
augmentation mammoplasty with silicone implants. Ann Intern
Med 1989; 111: 377–83.
49 Marik PE, Kark AL, Zambakides A. Scleroderma after silicone
augmentation mammoplasty. A report of 2 cases. S Afr Med J 1990;
77: 212–13.
50 Sahn EE, Garen PD, Silver RM, Maize JC. Scleroderma following
augmentation mammoplasty. Report of a case and review of the
literature. Arch Dermatol 1990; 126: 1198–202.
51 Spiera H, Kerr LD. Scleroderma following silicone implantation: a
cumulative experience of 11 cases. J Rheumatol 1993; 20: 958–61.
52 Copeland M, Kressel A, Spiera H, Hermann G, Bleiweiss IJ.
Systemic inflammatory disorder related to fibrous breast capsules
after silicone implant removal. Plast Reconstr Surg 1993; 92: 1179–81.
53 Kessler DA. Special report: the basis of the FDA’s decision on
breast implants. N Engl J Med 1992; 326: 1713–15.
54 Kjoller K, Friis S, Mellemkjaer L, et al. Connective tissue
disease and other rheumatic conditions following cosmetic
breast implantation in Denmark. Arch Intern Med 2001;
161: 973–79.
55 Weisman MH, Vecchione TR, Albert D, Moore LT, Mueller MR.
Connective-tissue disease following breast augmentation: a
preliminary test of the human adjuvant disease hypothesis. Plast
Reconstr Surg 1988; 82: 626–30.
56 Schusterman MA, Kroll SS, Reece GP, et al. Incidence of
autoimmune disease in patients after breast reconstruction with
silicone gel implants versus autogenous tissue: a preliminary
report. Ann Plast Surg 1993; 31: 1–6.
57 Englert HJ, Brooks P. Scleroderma and augmentation
mammoplasty – a causal relationship? Aust N Z J Med 1994; 24:
74–80.
58 Gabriel SE, O’Fallon WM, Kurland LT, Beard CM, Woods JE, Melton
LJ 3rd. Risk of connective-tissue diseases and other disorders after
breast implantation. N Engl J Med 1994; 330: 1697–702.
103
 Review
59 Giltay EJ, Bernelot Moens HJ, Riley AH, Tan RG. Silicone breast
prostheses and rheumatic symptoms: a retrospective follow up
study. Ann Rheum Dis 1994; 53: 194–96.
60 McLaughlin JK, Fraumeni JF Jr, Olsen J, Mellemkjaer L. Re: Breast
implants, cancer, and systemic sclerosis. J Natl Cancer Inst 1994;
86: 1424.
61 Strom BL, Reidenberg MM, Freundlich B, Schinnar R. Breast
silicone implants and risk of systemic lupus erythematosus. J Clin
Epidemiol 1994; 47: 1211–14.
62 Wells KE, Cruse CW, Baker JL Jr, et al. The health status of women
following cosmetic surgery. Plast Reconstr Surg 1994; 93: 907–12.
63 Goldman JA, Greenblatt J, Joines R, White L, Aylward B, Lamm SH.
Breast implants, rheumatoid arthritis, and connective tissue
diseases in a clinical practice. J Clin Epidemiol 1995; 48: 571–82.
64 Sanchez-Guerrero J, Colditz GA, Karlson EW, Hunter DJ,
Speizer FE, Liang MH. Silicone breast implants and the risk
of connective-tissue diseases and symptoms. N Engl J Med 1995;
332: 1666–70.
65 Burns CJ, Laing TJ, Gillespie BW, et al. The epidemiology of
scleroderma among women: assessment of risk from exposure to
silicone and silica. J Rheumatol 1996; 23: 1904–11.
66 Hennekens CH, Lee IM, Cook NR, et al. Self-reported breast
implants and connective-tissue diseases in female health
professionals. A retrospective cohort study. JAMA 1996; 275: 616–21.
67 Hochberg MC, Perlmutter DL, Medsger TA Jr, et al. Lack of
association between augmentation mammoplasty and systemic
sclerosis (scleroderma). Arthritis Rheum 1996; 39: 1125–31.
68 Friis S, Mellemkjaer L, McLaughlin JK, et al. Connective tissue
disease and other rheumatic conditions following breast implants
in Denmark. Ann Plast Surg 1997; 39: 1–8.
69 Williams HJ, Weisman MH, Berry CC. Breast implants in patients
with differentiated and undifferentiated connective tissue disease.
Arthritis Rheum 1997; 40: 437–40.
70 Edworthy SM, Martin L, Barr SG, Birdsell DC, Brant RF, Fritzler MJ.
A clinical study of the relationship between silicone breast implants
and connective tissue disease. J Rheumatol 1998; 25: 254–60.
71 Nyren O, Yin L, Josefsson S, et al. Risk of connective tissue disease
and related disorders among women with breast implants: a
nation-wide retrospective cohort study in Sweden. BMJ 1998; 316:
417–22.
72 Park AJ, Black RJ, Sarhadi NS, Chetty U, Watson AC. Silicone gel-
filled breast implants and connective tissue diseases. Plast Reconstr
Surg 1998; 101: 261–68.
73 Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone
gel breast implant rupture, extracapsular silicone, and health status
in a population of women. J Rheumatol 2001; 28: 996–1003.
74 US FDA, Center for Devices and Radiological Health. Draft
guidance for industry and FDA staff: saline, silicone gel, and
alternative breast implants (issued Jan 13, 2004).
http://www.fda.gov/cdrh/ode/guidance/1239.html (accessed Dec
19, 2004).
75 The Independent Review Group. Silicone gel breast implants: the
report of the independent review group. London: Crown Copyright,
1998. http://www.silicone-review.gov.uk (accessed Jan 3, 2005).
76 Hulka D. Epidemiological analysis of silicone breast implants and
connective tissue disease: National Science Panel, 1998: Report of
the National Science Panel. London: Little Brown & Company,
1998.
77 Tugwell P, Wells G, Peterson J, et al. Do silicone breast implants
cause rheumatologic disorders? A systematic review for a court-
appointed national science panel. Arthritis Rheum 2001; 44:
2477–84.
78 European Parliament Directorate General for Research, Scientific
and Technical Options Assessment. Health risks posed by sililcone
implants in general, with special attention to breast implants.
Luxembourg: European Parliament, 2000.
79 European Committee on Quality Assurance and Medical Devices
in Plastic Surgery. Consensus declaration on breast implants.
Fourth consensus declaration. Herzliya: European Committee on
Quality Assurance, 2000.
80 European Committee on Quality Assurance and Medical Devices
in Plastic Surgery. Consensus declaration of EQUAM. Fifth
consensus declaration. Groningen: European Committee on
Quality Assurance, 2002.
104
81 European Committee for Standardization. Body contouring
implants: specific requirements for mammary implants. Delft,
Nederlands: Normalisatie-instituut, 2003. CEN/TC 285 WG 6 TF1.
http://europa.eu.int/comm/enterprise/medical_devices/index.htm
(accessed Jan 3, 2005).
82 The Commission of the European Communities. Commission
directive 2003/12/EC of 3 February 2003 on the reclassification of
breast implants in the framework of directive 93/42/EEC
concerning medical devices. Brussels: Official Journal of the
European Union, 2003.
83 Brinton L, Lubin J, Burich M, Colton T, Brown S, Hoover R. Breast
cancer following augmentation mammoplasty (United States).
Cancer Causes Control 2000; 11: 819–27.
84 Skinner A, Silberman H, Dougherty W, et al. Breast cancer after
augmentation mammaplasty. Ann Surg Oncol 2001; 8: 138–44.
85 Miglioretti D, Rutter C, Geller B, et al. Effect of breast
augmentation on the accuracy of mammography and cancer
characteristics. JAMA 2004; 291: 442–50.
86 Kjoller K, Holmich LR, Jacobsen PH, et al. Epidemiological
investigation of local complications after cosmetic breast implant
surgery in Denmark. Ann Plast Surg 2002; 48: 229–37.
87 Stein Z. Silicone breast implants: epidemiological evidence of
sequelae. Am J Public Health 1999; 89: 484–87.
88 Brown SL. Epidemiology of silicone-gel breast implants.
Epidemiology 2002; 13 (suppl): S34–39.
89 De Cholnoky T. Augmentation mammaplasty. Survey of
complications in 10,941 patients by 265 surgeons. Plast Reconstr
Surg 1970; 45: 573–77.
90 Mladick RA. “No-touch” submuscular saline breast augmentation
technique. Aesthetic Plast Surg 1993; 17: 183–92.
91 Cocke WM Jr. A critical review of augmentation mammoplasty
with saline-filled prostheses. Ann Plast Surg 1994; 32: 266–69.
92 Clegg HW, Bertagnoll P, Hightower AW, Baine WB.
Mammaplasty-associated mycobacterial infection:
a survey of plastic surgeons. Plast Reconstr Surg 1983; 72:
165–69.
93 Rheingold LM, Yoo RP, Courtiss EH. Experience with
326 inflatable breast implants. Plast Reconstr Surg 1994; 93:
118–22.
94 Capozzi A. Clinical experience with Heyer-Schulte inflatable
implants in breast augmentation. Plast Reconstr Surg 1986; 77:
772–78.
95 Armstrong RW, Berkowitz RL, Bolding F. Infection following
breast reconstruction. Ann Plast Surg 1989; 23: 284–88.
96 Gabriel SE, Woods JE, O’Fallon WM, Beard CM, Kurland LT,
Melton LJ 3rd. Complications leading to surgery after breast
implantation. N Engl J Med 1997; 336: 677–82.
97 Brown SL, Hefflin B, Woo EK, Parmentier CM. Infections related
to breast implants reported to the Food and Drug Administration,
1977–1997. J Long Term Eff Med Implants 2001; 11: 1–12.
98 Schatten WE. Reconstruction of breasts following mastectomy with
polyurethane-covered, gel-filled prostheses. Ann Plast Surg 1984;
12: 147–56.
99 Hester TR Jr, Nahai F, Bostwick J, Cukic J. A 5-year experience
with polyurethane-covered mammary prostheses for treatment of
capsular contracture, primary augmentation mammoplasty, and
breast reconstruction. Clin Plast Surg 1988; 15: 569–85.
100 Schlenker JD, Bueno RA, Ricketson G, Lynch JB. Loss of silicone
implants after subcutaneous mastectomy and reconstruction. Plast
Reconstr Surg 1978; 62: 853–61.
101 Capozzi A, Pennisi VR. Clinical experience with polyurethane-
covered gel-filled mammary prostheses. Plast Reconstr Surg 1981;
68: 512–20.
102 Eyssen JE, von Werssowetz AJ, Middleton GD. Reconstruction of
the breast using polyurethane-coated prostheses. Plast Reconstr
Surg 1984; 73: 415–21.
103 Slade CL. Subcutaneous mastectomy: acute complications and
long-term follow-up. Plast Reconstr Surg 1984; 73: 84–90.
104 Jabaley ME, Das SK. Late breast pain following reconstruction with
polyurethane-covered implants. Plast Reconstr Surg 1986; 78: 390–95.
105 Herman D, Wilk A, Meyer C, Rodier-Bruant C, Kolbe A. Our
experience of infectious risk in prosthetic breast surgery.
Agressologie 1992; 33: 188–90 (in French).
http://infection.thelancet.com Vol 5 February 2005

106 Nahabedian MY, Tsangaris T, Momen B, Manson PN. Infectious
complications following breast reconstruction with expanders and
implants. Plast Reconstr Surg 2003; 112: 467–76.
107 Worton E, Siefert L. Augmentation mammaplasty: a review of fifty
consecutive patients. In: Owsley JQ, Peterson RA, eds. Symposium
on aesthetic surgery of the breast. St Louis: Mosby, 1978: 341–43.
108 Vandeweyer E, Deraemaecker R, Nogaret JM, Hertens D.
Immediate breast reconstruction with implants and adjuvant
chemotherapy: a good option? Acta Chir Belg 2003; 103: 98–101.
109 Brand KG. Infection of mammary prostheses: a survey and the
question of prevention. Ann Plast Surg 1993; 30: 289–95.
110 Young VL, Hertl MC, Murray PR, Jensen J, Witt H, Schorr MW.
Microbial growth inside saline-filled breast implants. Plast Reconstr
Surg 1997; 100: 182–96.
111 Young VL, Hertl MC, Murray PR, Lambros VS. Paecilomyces variotii
contamination in the lumen of a saline-filled breast implant. Plast
Reconstr Surg 1995; 96: 1430–34.
112 Chen NT, Butler PE, Hooper DC, May JW Jr. Bacterial growth in
saline implants: in vitro and in vivo studies. Ann Plast Surg 1996;
36: 337–41.
113 Liang MD, Narayanan K, Ravilochan K, Roche K. The permeability
of tissue expanders to bacteria: an experimental study. Plast
Reconstr Surg 1993; 92: 1294–97.
114 Javaid M, Shibu M. Breast implant infection following nipple
piercing. Br J Plast Surg 1999; 52: 676–77.
115 McGrath MH, Burkhardt BR. The safety and efficacy of breast
implants for augmentation mammaplasty. Plast Reconstr Surg 1984;
74: 550–60.
116 Dolsky RL. Polyurethane-coated implants. Plast Reconstr Surg 1985;
76: 974–75.
117 Ahn CY, Ko CY, Wagar EA, Wong RS, Shaw WW. Microbial
evaluation: 139 implants removed from symptomatic patients. Plast
Reconstr Surg 1996; 98: 1225–29.
118 Barnett A, Lavey E, Pearl RM, Vistnes LM. Toxic shock syndrome
from an infected breast prosthesis. Ann Plast Surg 1983; 10: 408–10.
119 Freedman AM, Jackson IT. Infections in breast implants. Infect Dis
Clin North Am 1989; 3: 275–87.
120 Holm C, Muhlbauer W. Toxic shock syndrome in plastic surgery
patients: case report and review of the literature. Aesthetic Plast Surg
1998; 22: 180–84.
121 Walker LE, Breiner MJ, Goodman CM. Toxic shock syndrome after
explantation of breast implants: a case report and review of the
literature. Plast Reconstr Surg 1997; 99: 875–79.
122 Bartlett P, Reingold AL, Graham DR, et al. Toxic shock syndrome
associated with surgical wound infections. JAMA 1982; 247: 1448–50.
123 Knudsen F, Olesen AS, Hojbjerg T, Jorgensen JP, Nielsen KK.
Toxic shock syndrome. Br Med J (Clin Res Ed) 1981; 282: 399.
124 Giesecke J, Arnander C. Toxic shock syndrome after augmentation
mammaplasty. Ann Plast Surg 1986; 17: 532–33.
125 Tobin G, Shaw RC, Goodpasture HC. Toxic shock syndrome
following breast and nasal surgery. Plast Reconstr Surg 1987; 80:
111–14.
126 Olesen LL, Ejlertsen T, Nielsen J. Toxic shock syndrome following
insertion of breast prostheses. Br J Surg 1991; 78: 585–86.
127 Poblete JV, Rodgers JA, Wolfort FG. Toxic shock syndrome as a
complication of breast prostheses. Plast Reconstr Surg 1995; 96:
1702–08.
128 Wallace RJ Jr, Steele LC, Labidi A, Silcox VA. Heterogeneity among
isolates of rapidly growing mycobacteria responsible for infections
following augmentation mammaplasty despite case clustering in
Texas and other southern coastal states. J Infect Dis 1989; 160:
281–88.
129 Clegg HW, Foster MT, Sanders WE Jr, Baine WB. Infection due to
organisms of the Mycobacterium fortuitum complex after
augmentation mammaplasty: clinical and epidemiologic features.
J Infect Dis 1983; 147: 427–33.
130 Heistein JB, Mangino JE, Ruberg RL, Bergese JJ. A prosthetic
breast implant infected with Mycobacterium fortuitum. Ann Plast
Surg 2000; 44: 330–33.
131 Haiavy J, Tobin H. Mycobacterium fortuitum infection in prosthetic
breast implants. Plast Reconstr Surg 2002; 109: 2124–28.
132 Safranek TJ, Jarvis WR, Carson LA, et al. Mycobacterium chelonae
wound infections after plastic surgery employing contaminated
http://infection.thelancet.com Vol 5 February 2005
Review
gentian violet skin-marking solution. N Engl J Med 1987; 317:
197–201.
133 Gibney J. The long-term results of tissue expansion for breast
reconstruction. Clin Plast Surg 1987; 14: 509–18.
134 Gnanadesigan N, Pechter EA, Mascola L. Listeria infection of
silicone breast implant. Plast Reconstr Surg 1994; 94: 531–33,
discussion 534–35.
135 Hunger J, Padilla M, Cooper-Vastola S. Late Clostridium perfringens
breast implant infections after dental treatment. Ann Plast Surg
1996; 36: 309–312.
136 Niazi ZB, Salzberg CA, Montecalvo M. Candida albicans infection
of bilateral polyurethane-coated silicone gel breast implants. Ann
Plast Surg 1996; 37: 91–93.
137 Bernardi C, Saccomanno F. Late Klebsiella pneumoniae infection
following breast augmentation: case report. Aesthetic Plast Surg
1998; 22: 222–24.
138 Ablaza VJ, LaTrenta GS. Late infection of a breast prosthesis with
Enterococcus avium. Plast Reconstr Surg 1998; 102: 227–30.
139 Petit F, Maladry D, Werther JR, Mitz V. Late infection of breast
implant, complication of colonic perforation. Review of the
literature. Role of preventive treatment. Ann Chir Plast Esthet 1998;
43: 559–62 (in French).
140 Eliopoulos DA, Lyle G. Mycobacterium avium infection in a patient
with the acquired immunodeficiency syndrome and silicone breast
implants. South Med J 1999; 92: 80–83.
141 Johnson LB, Busuito MJ, Khatib R. Breast implant infection in a
cat owner due to Pasteurella multocida. J Infect 2000; 41: 110–11.
142 Memish ZA, Alazzawi M, Bannatyne R. Unusual complication of
breast implants: brucella infection. Infection 2001; 29: 291–92.
143 Reddy BT, Torres HA, Kontoyiannis DP. Breast implant infection
caused by Trichosporon beigelii. Scand J Infect Dis 2002; 34: 143–44.
144 Darouiche RO. Treatment of infections associated with surgical
implants. N Engl J Med 2004; 350: 1422–29.
145 Yii NW, Khoo CT. Salvage of infected expander prostheses in
breast reconstruction. Plast Reconstr Surg 2003; 111: 1087–92.
146 Spear SL, Howard MA, Boehmler JH, Ducic I, Low M,
Abbruzzesse MR. The infected or exposed breast implant:
management and treatment strategies. Plast Reconstr Surg 2004;
113: 1634–44.
147 Siggelkow W, Klosterhalfen B, Klinge U, Rath W, Faridi A.
Analysis of local complications following explantation of silicone
breast implants. Breast 2004; 13: 122–28.
148 Embrey M, Adams EE, Cunningham B, Peters W, Young VL,
Carlo GL. A review of the literature on the etiology of capsular
contracture and a pilot study to determine the outcome of capsular
contracture interventions. Aesthetic Plast Surg 1999; 23: 197–206.
149 De Jong WH, Kallewaard M, Goldhoorn CA, et al. Long-term
exposure to silicone breast implants does not induce antipolymer
antibodies. Biomaterials 2004; 25: 1095–103.
150 Little G, Baker J Jr. Results of closed compression capsulotomy for
treatment of contracted breast implant capsules. Plast Reconstruct
Surg 1985; 65: 30–3.
151 Henriksen T, Holmich L, Fryzek J, et al. Incidence and severity of
short-term complications after breast augmentation: results from a
nationwide breast implant registry. Ann Plast Surg 2003; 51:
531–39.
152 Cronin T, Persoff M, Upton J. Augmentional mammoplasty:
complications and etiology. In: Owsley JQ, Peterson RA, eds.
Symposium on aesthetic surgery of the breast. St Louis: Mosby,
1978.
153 Scully SJ. Augmentation mammaplasty without contracture. Ann
Plast Surg 1981; 6: 262–70.
154 Burkhardt BR, Fried M, Schnur PL, Tofield JJ. Capsules, infection,
and intraluminal antibiotics. Plast Reconstr Surg 1981; 68: 43–49.
155 Dubin D. The etiology, pathophysiology, predictability, and early
detection of spherical scar contracture of the breast: a detailed
explanation and protocol for prevention of spherical scar
contracture of the breast. Annual Meeting of the American Society
of Aesthetic Plastic Surgery; April 1990; Orlando, FL.
156 Shah Z, Lehman JA Jr, Tan J. Does infection play a role in breast
capsular contracture? Plast Reconstr Surg 1981; 68: 34–42.
157 Rudolph R, Woodward M. Absence of visible bacteria in capsules
around silicone breast implants. Plast Reconstr Surg 1983; 72: 32–35.
105
 Review
158 Kossovsky N, Heggers J, Parsons R, Robson M. Acceleration of
capsule formation around silicone implants by infection in a
guinea pig model. Plast Reconstr Surg 1984; 73: 91–96.
159 Netscher D, Weizer G, Wigoda P, Walker L, Thornby J, Bowen D.
Clinical relevance of positive breast periprosthetic cultures without
overt infection. Plast Reconstr Surg 1995; 96: 1125–29.
160 Virden C, Dobke M, Stein P, Parsons C, Frank D. Subclinical
infection of the silicone breast implant surface as a possible cause
of capsular contracture. Aesth Plast Surg 1992; 16: 173–79.
161 Burkhardt BR, Dempsey PD, Schnur PL, Tofield JJ. Capsular
contracture: a prospective study of the effect of local antibacterial
agents. Plast Reconstr Surg 1986; 77: 919–32.
162 Pajkos A, Deva AK, Vickery K, Cope C, Chang L, Cossart YE.
Detection of subclinical infection in significant breast implant
capsules. Plast Reconstr Surg 2003; 111: 1605–11.
163 Burkhardt BR. Detection of subclinical infections in significant
breast implant capsules. Plast Reconstr Surg 2004; 113: 448.
164 Netscher DT. Subclinical infection as a possible cause of significant
breast capsules. Plast Reconstr Surg 2004; 113: 2229–30.
165 Deva AK. Subclinical infection as a possible cause of significant
breast capsules: author’s reply. Plast Reconstr Surg 2004; 113: 2230.
166 Parsons C, Stein P, Dobke M, Virden C, Frank D. Diagnosis and
therapy of subclinically infected prostheses. Surg Gynecol Obstet
1993; 177: 504–06.
167 Sanger J, Sheth N, Franson T. Adherence of microroganisms to
breast prostheses: an in vitro study. Ann Plast Surg 1989; 22:
337–42.
106
168 Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing
breast-pocket irrigation: the post-betadine era. Plast Reconstr Surg
2001; 107: 1596–601.
169 Birnbaum L, Hopp D, Mertens B. The role of iodine-releasing
silicone implants in the prevention of spherical contractures in
mice. Plast Reconstr Surg 1982; 69: 956–59.
170 Ransjo U, Asplund OA, Gylbert L, Jurell G. Bacteria in the female
breast. Scand J Plast Reconstr Surg 1985; 19: 87–89.
171 Darouiche RO, Meade R, Mansouri MD, Netscher DT. In vivo
efficacy of antimicrobe-impregnated saline-filled silicone implants.
Plast Reconstr Surg 2002; 109: 1352–57.
172 Peters W, Smith D, Fornasier V, Lugowski S, Ibanez D. An
outcome analysis of 100 women after explantation of silicone gel
breast implants. Ann Plast Surg 1997; 39: 9–19.
173 Austad ED, Rohrich RJ. Silicone implants, granulomas, and
chronic infection: a causal relationship? Plast Reconstr Surg 2003;
111: 1363.
174 Austad E. Breast implant-related silicone granulomas: the literature
and the litigation. Plast Reconstr Surg 2002; 109: 1724–30.
175 Nordstrom RE. Antibiotics in the tissue expander to decrease the
rate of infection. Plast Reconstr Surg 1988; 81: 137–38.
176 Cutando-Soriano A, Galindo-Moreno P. Antibiotic prophylaxis in
dental patients with body prostheses. Med Oral 2002; 7: 348–59.
http://infection.thelancet.com Vol 5 February 2005