Breast implant

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The pre-operative (left) and post-operative (right) aspects of a bilateral breast augmentation with
high-profile, 500cc silicone-gel implants.
The post-operative aspect of a breast cancer mastectomy; the woman is a candidate for a primary
breast-reconstruction procedure of her right breast.
A breast implant is a prosthesis used to change the size, form, and texture of a woman's breast; in
plastic surgery, breast implants are applied for post-mastectomy breast reconstruction; for
correcting congenital defects and deformities of the chest wall; for aesthetic breast augmentation;
and for creating breasts in the male-to-female transsexual patient.
There are three general types of breast implant devices, defined by their filler material: saline
solution, silicone gel, and composite filler. The saline implant has an elastomer silicone shell filled
with sterile saline solution; the silicone implant has an elastomer silicone shell filled with viscous
silicone gel; and the alternative composition implants featured miscellaneous fillers, such as soy oil,
polypropylene string, et cetera.
In surgical practice, for the reconstruction of a breast, the tissue expander device is a temporary
breast prosthesis used to form and establish an implant pocket for emplacing the permanent breast
implant. For the correction of male breast defects and deformities, the pectoral implant is the breast
prosthesis used for the reconstruction and the aesthetic repair of a man's chest wall (see:
gynecomastia and mastopexy).
Contents
1 History
2 Types
2.1 Saline implants
2.2 Silicone gel implants
3 The patient
4 Surgical procedures
4.1 Indications
4.2 Incision types
4.3 Implant pocket placement
4.4 Post-surgical recovery
5 Complications
5.1 Implant rupture
5.2 Capsular contracture
5.3 Repair and revision surgeries
6 Alleged complications
6.1 Systemic disease and sickness
6.2 Platinum toxicity
7 Implants and breast-feeding
8 Implants and mammography
9 U.S. FDA approval
10 Criticism
11 See also
12 References
13 External links
History
Vincenz Czerny (1842-1916), a surgical pioneer in breast reconstruction.
The 19th century
Since the late nineteenth century, breast implants have been used to surgically augment the size
(volume), modify the shape (contour), and enhance the feel (tact) of a woman's breasts. In 1895,
surgeon Vincenz Czerny effected the earliest breast implant emplacement when he used the
patient's autologous adipose tissue, harvested from a benign lumbar lipoma, to repair the asymmetry
of the breast from which he had removed a tumor.[1] In 1889, surgeon Robert Gersuny
experimented with paraffin injections, with disastrous results. From the first half of the twentieth
century, physicians used other substances as breast implant fillers--ivory, glass balls, ground rubber,
ox cartilage, Terylene wool, gutta-percha, Dicora, polyethylene chips, Ivalon (polyvinyl alcohol-
-formaldehyde polymer sponge), a polyethylene sac with Ivalon, polyether foam sponge (Etheron),
polyethylene tape (Polystan) strips wound into a ball, polyester (polyurethane foam sponge) Silastic
rubber, and teflon-silicone prostheses.[2]
The 20th century
In the mid-twentieth century, Morton I. Berson, in 1945, and Jacques Maliniac, in 1950, each
performed flap-based breast augmentations by rotating the patient's chest wall tissue into the breast
to increase its volume. Furthermore, throughout the 1950s and the 1960s, plastic surgeons used
synthetic fillers--including silicone injections received by some 50,000 women, from which developed
silicone granulomas and breast hardening that required treatment by mastectomy.[3] In 1961, the
American plastic surgeons Thomas Cronin and Frank Gerow, and the Dow Corning Corporation,
developed the first silicone breast prosthesis, filled with silicone gel; in due course, the first
augmentation mammoplasty was performed in 1962 using the Cronin-Gerow Implant, prosthesis
model 1963. In 1964, the French company Laboratoires Arion developed and manufactured the
saline breast implant, filled with saline solution, and then introduced for use as a medical device in
1964.[4]
Types
Saline-solution-filled breast implant device models.
The original breast implant: the Cronin-Gerow Implant, prosthesis model 1963, was an anatomic
tear-shaped) design that featured a posterior fastener made of Dacron, to affix it in the implant
pocket.
Late-generation models of silicone gel-filled prostheses.
There are three types of breast implant used for mammoplasty, breast reconstruction, and breast
augmentation procedures
saline implant filled with sterile saline solution.
silicone implant filled with viscous silicone gel.
alternative-composition implant with miscellaneous fillers (e.g. soy oil, polypropylene string, etc.)
that are no longer manufactured.
Saline implants
The saline breast implant--filled with saline solution (biological-concentration salt water 0.90% w/v
of NaCl, ca. 300 mOsm/L.)--was first manufactured by the Laboratoires Arion company, in France,
and was introduced for use as a prosthetic medical device in 1964. The contemporary models of
saline breast implant are manufactured with thicker, room-temperature vulcanized (RTV) shells
made of a silicone elastomer. The study In vitro Deflation of Pre-filled Saline Breast Implants (2006)
reported that the rates of deflation (filler leakage) of the pre-filled saline breast implant made it a
second-choice prosthesis for corrective breast surgery.[4] Nonetheless, in the 1990s, the saline
breast implant was the prosthesis usual for breast augmentation surgery, because of the U.S. FDA's
restriction against the importation of silicone-filled breast implants.
The technical goal of saline-implant technology was a physically less invasive surgical technique for
emplacing an empty breast implant device through a smaller surgical incision.[5] In surgical praxis,
after having emplaced the empty breast implants to the implant pockets, the plastic surgeon then
filled each device with saline solution, and, because the required insertion-incisions are short and
small, the resultant incision-scars will be smaller and shorter than the surgical scars usual to the
long incisions required for inserting pre-filled, silicone-gel implants.
When compared to the results achieved with a silicone-gel breast implant, the saline implant can
yield acceptable results, of increased breast-size, smoother hemisphere-contour, and realistic
texture; yet, it is likelier to cause cosmetic problems, such as the rippling and the wrinkling of the
breast-envelope skin, accelerated lower breast pole stretch, and technical problems, such as the
presence of the implant being noticeable to the eye and to the touch. The occurrence of such
cosmetic problems is likelier in the case of the woman with very little breast tissue, and in the case
of the woman who requires post-mastectomy breast reconstruction; thus, the silicone-gel implant is
the technically superior prosthetic device for breast augmentation, and for breast reconstruction. In
the case of the woman with much breast tissue, for whom sub-muscular emplacement is the
recommended surgical approach, saline breast implants can produce an aesthetic result much like
that afforded by silicone breast implants, albeit with greater implant palpability .[6]
Silicone gel implants
As a medical device technology, there are five (5) generations of silicone breast implant, each
defined by common model-manufacturing techniques.
The modern prosthetic breast was invented in 1961, by the American plastic surgeons Thomas
Cronin and Frank Gerow, and manufactured by the Dow Corning Corporation; in due course, the
first augmentation mammoplasty was performed in 1962. There are five generations of medical
device technology for the breast implant models filled with silicone gel; each generation of breast
prosthesis is defined by common model-manufacturing techniques.
First generation
The Cronin-Gerow Implant, prosthesis model 1963, was a silicone rubber envelope-sac, shaped like a
teardrop, which was filled with viscous silicone-gel. To reduce the rotation of the emplaced breast
implant upon the chest wall, the model 1963 prosthesis was affixed to the implant pocket with a
fastener-patch, made of Dacron material (Polyethylene terephthalate), which was attached to the
rear of the breast implant shell.[7]
Second generation
In the 1970s, manufacturers presented the second generation of breast implant prostheses that
featured functional developments and aesthetic improvements to the technology:
the first technological developments were a thinner-gauge device-shell, and a filler gel of low-
cohesion silicone, which improved the functionality and the verisimilitude (size, appearance, and
texture) of the silicone-gel breast implant. Yet, in clinical practice, second-generation breast
implants proved fragile, and suffered greater incidences of shell rupture, and of filler leakage
("silicone-gel bleed") through the intact device shell. The consequent, increased incidence-rates of
medical complications (e.g. capsular contracture) precipitated faulty-product, class action-lawsuits,
by the U.S. government, against the Dow Corning Corporation, and other manufacturers of breast
prostheses.
the second technological development was a polyurethane foam coating for the shell of the breast
implant; the coating reduced the incidence of capsular contracture, by causing an inflammatory
reaction that impeded the formation of a capsule of fibrous collagen tissue around the breast
implant. Nevertheless, despite that prophylactic measure, the medical use of polyurethane-coated
breast implants was briefly discontinued, because of the potential health-risk posed by 2,4-
toluenediamine (TDA), a carcinogenic by-product of the chemical breakdown of the polyurethane
foam coating of the breast implant.[8]
After reviewing the medical data, the U.S. Food and Drug Administration concluded that TDA-
induced breast cancer was an infinitesimal health-risk to women with breast implants, and did not
justify legally requiring physicians to explain the matter to their patients. In the event, polyurethane-
coated breast implants remain in plastic surgery practice in Europe and in South America; and no
manufacturer has sought FDA approval for medical sales of such breast implants in the U.S.[9]
the third technological development was the double lumen breast implant device, a double-cavity
prosthesis composed of a silicone breast implant contained within a saline breast implant. The two-
fold, technical goal was: (i) the cosmetic benefits of silicone-gel (the inner lumen) enclosed in saline
solution (the outer lumen); (ii) a breast implant device the volume of which is post-operatively
adjustable. Nevertheless, the more complex design of the double-lumen breast implant suffered a
device-failure rate greater than that of single-lumen breast implants. The contemporary versions of
second-generation breast implant devices (presented in 1984) are the "Becker Expandable" models
of breast implant, which are primarily used for breast reconstruction.
Third and Fourth generations
In the 1980s, the models of the Third and of the Fourth generations of breast implant devices were
sequential advances in manufacturing technology, such as elastomer-coated shells that decreased
gel-bleed (filler leakage), and a thicker (increased-cohesion) filler gel. Sociologically, the
manufacturers of prosthetic breasts then designed and made anatomic models (natural breast) and
shaped models (round, tapered) that realistically corresponded with the breast- and body- types of
women. The tapered models of breast implant have a uniformly textured surface, which reduces the
rotation of the prosthesis within the implant pocket; the round models of breast implant are
available in smooth-surface- and textured-surface- types.
Fifth generation
Since the mid-1990s, the Fifth generation of silicone-gel breast implant is made of a semi-solid gel
that mostly eliminates the occurrences of filler leakage ("silicone-gel bleed") and of the migration of
the silicone filler from the implant-pocket to elsewhere in the woman's body. The studies Experience
with Anatomical Soft Cohesive Silicone gel Prosthesis in Cosmetic and Reconstructive Breast
Implant Surgery (2004) and Cohesive Silicone gel Breast Implants in Aesthetic and Reconstructive
Breast Surgery (2005) reported low incidence-rates of capsular contracture and of device-shell
rupture; and greater rates of improved medical-safety and technical-efficacy than that of early
generation breast implant devices.[10][11][12]
The patient
Further information: Body dysmorphic disorder, Body image and Beauty
Psychology
The breast augmentation patient usually is a young woman whose personality profile indicates
psychological distress about her personal appearance and her bodily self image, and a history of
having endured criticism (teasing) about the aesthetics of her person.[13] The studies Body Image
Concerns of Breast Augmentation Patients (2003) and Body Dysmorphic Disorder and Cosmetic
Surgery (2006) reported that the woman who underwent breast augmentation surgery also had
undergone psychotherapy, suffered low self-esteem, presented frequent occurrences of
psychological depression, had attempted suicide, and suffered body dysmorphia, a type of mental
illness.
The pre-operative aspects (left), and the post-operative aspects (right) of a bilateral primary
augmentation with medium-volume (350cc) saline impants emplaced to a submuscular pocket
through an inframmary fold (IMF) incision.
Post-operative patient surveys about mental health and quality-of-life, reported improved physical
health, physical appearance, social life, self-confidence, self-esteem, and satisfactory sexual
functioning. Furthermore, the women reported long-term satisfaction with their breast implant
outcomes; some despite having suffered medical complications that required surgical revision, either
corrective or aesthetic. Likewise, in Denmark, 8.0 per cent of breast augmentation patients had a
pre-operative history of psychiatric hospitalization.[14][15][16][17][18][19][20][21][22]
Mental health
In 2008, the longitudinal study Excess Mortality from Suicide and other External Causes of Death
Among Women with Cosmetic Breast Implants (2007), reported that women who sought breast
implants are almost 3.0 times as likely to commit suicide as are women who have not sought breast
implants. Compared to the standard suicide-rate for women of the general populace, the suicide-rate
for women with augmented breasts remained constant until 10-years post-implantation, yet, it
increased to 4.5 times greater at the 11-year mark, and so remained until the 19-year mark, when it
increased to 6.0 times greater at 20-years post-implantation. Moreover, additional to the suicide-
risk, women with breast implants also faced a trebled death-risk from alcoholism and the abuse of
prescription and recreational drugs.[23][24] Although seven studies have statistically connected a
woman's breast augmentation to a greater suicide-rate, the research indicates that breast
augmenation surgery does not increase the death rate; and that, in the first instance, it is the
psychopathologically-inclined woman who is likelier to undergo a breast augmentation
procedure.[25][26][27][28][29][30]
The study Effect of Breast Augmentation Mammoplasty on Self-Esteem and Sexuality: A Quantitative
Analysis (2007), reported that the women attributed their improved self image, self-esteem, and
increased, satisfactory sexual functioning to having undergone breast augmentation; the cohort,
aged 21-57 years, averaged post-operative self-esteem increases that ranged from 20.7 to 24.9
points on the 30-point Rosenberg self-esteem scale, which data supported the 78.6 per cent increase
in the woman's libido, relative to her pre-operative level of libido.[31] Therefore, before agreeing to
any surgery, the plastic surgeon evaluates and considers the woman's mental health to determine if
breast implants can positively affect her self-esteem and sexual functioning.
Surgical procedures
Indications
A mammoplasty procedure for the emplacement of breast implant devices has three (3) purposes:
primary reconstruction: the replacement of breast tissues damaged by trauma (blunt, penetrating,
blast), disease (breast cancer), and failed anatomic development (tuberous breast deformity).
revision and reconstruction: to revise (correct) the outcome of a previous breast reconstruction
surgery.
primary augmentation: to aesthetically augment the size, form, and feel of the breasts.
The operating room (OR) time of post-mastectomy breast reconstruction, and of breast augmentation
surgery is determined by the procedure employed, the type of incisions, the breast implant (type and
materials), and the pectoral locale of the implant pocket.
Incision types
Breast implant emplacement is performed with five (5) types of surgical incisions:
Inframammary: an incision made to the infra-mammary fold (IMF), which affords maximal access for
precise dissection of the tissues and emplacement of the breast implants. It is the preferred surgical
technique for emplacing silicone-gel implants, because it better exposes the breast tissue-pectoralis
muscle interface; yet, IMF implantation can produce thicker, slightly more visible surgical scars.
Periareolar: a border-line incision along the periphery of the areola, which provides an optimal
approach when adjustments to the IMF position are required, or when a mastopexy (breast lift) is
included to the primary mammoplasty procedure. In periareolar emplacement, the incision is around
the medial-half (inferior half) of the areola's circumference. Silicone gel implants can be difficult to
emplace via periareolar incision, because of the short, five-centimetre length (~ 5.0 cm) of the
required access-incision. Aesthetically, because the scars are at the areola's border (periphery), they
usually are less visible than the IMF-incision scars of women with light-pigment areolae; when
compared to cutaneous-incision scars, the modified epithelia of the areolae are less prone to (raised)
hypertrophic scars.
Transaxillary: an incision made to the axilla (armpit), from which the dissection tunnels medially, to
emplace the implants, either bluntly or with an endoscope (illuminated video microcamera), without
producing visible scars on the breast proper; yet, it is likelier to produce inferior asymmetry of the
implant-device position. Therefore, surgical revision of transaxillary emplaced breast implants
usually requires either an IMF incision or a periareolar incision.
Transumbilical: a trans-umbilical breast augmentation (TUBA) is a less common implant-device
emplacement technique wherein the incision is at the umbilicus (navel), and the dissection tunnels
superiorly, up towards the bust. The TUBA approach allows emplacing the breast implants without
producing visible scars upon the breast proper; but makes appropriate dissection and device-
emplacement more technically difficult. A TUBA procedure is performed bluntly--without the
endoscope's visual assistance--and is not appropriate for emplacing (pre-filled) silicone-gel implants,
because of the great potential for damaging the elastomer silicone shell of the breast implant during
its manual insertion through the short (~2.0 cm) incision at the navel, and because pre-filled
silicone gel implants are incompressible, and cannot be inserted through so small an incision.[32]
Transabdominal: as in the TUBA procedure, in the transabdominoplasty breast augmentation
(TABA), the breast implants are tunneled superiorly from the abdominal incision into bluntly
dissected implant pockets, whilst the patient simultaneously undergoes an abdominoplasty.[33]
Implant pocket placement
The four (4) surgical approaches to emplacing a breast implant to the implant pocket are described
in anatomical relation to the pectoralis major muscle.
Subglandular: the breast implant is emplaced to the retromammary space, between the breast tissue
(the mammary gland) and the pectoralis major muscle (major muscle of the chest), which most
approximates the plane of normal breast tissue, and affords the most aesthetic results. Yet, in
women with thin pectoral soft-tissue, the subglandular position is likelier to show the ripples and
wrinkles of the underlying implant. Moreover, the capsular contracture incidence rate is slightly
greater with subglandular implantation.
Subfascial: the breast implant is emplaced beneath the fascia of the pectoralis major muscle; the
subfascial position is a variant of the subglandular position for the breast implant.[34] The technical
advantages of the subfascial implant-pocket technique are debated; proponent surgeons report that
the layer of fascial tissue provides greater implant coverage and better sustains its position.[35]
Subpectoral (dual plane): the breast implant is emplaced beneath the pectoralis major muscle, after
the surgeon releases the inferior muscular attachments, with or without partial dissection of the
subglandular plane. Resultantly, the upper pole of the implant is partially beneath the pectoralis
major muscle, while the lower pole of the implant is in the subglandular plane. This implantation
technique achieves maximal coverage of the upper pole of the implant, whilst allowing the expansion
of the implant's lower pole; however, "animation deformity", the movement of the implants in the
subpectoral plane can be excessive for some patients.[36]
Submuscular: the breast implant is emplaced beneath the pectoralis major muscle, without releasing
the inferior origin of the muscle proper. Total muscular coverage of the implant can be achieved by
releasing the lateral muscles of the chest wall--either the serratus muscle or the pectoralis minor
muscle, or both--and suturing it, or them, to the pectoralis major muscle. In breast reconstruction
surgery, the submuscular implantation approach effects maximal coverage of the breast implants.
This technique is rarely used in cosmetic surgery due to high risk of animation deformities.
Post-surgical recovery
The surgical scars of a breast augmentation mammoplasty develop approximately at 6-weeks post-
operative, and fade within months. Depending upon the daily-life physical activities required of the
woman, the breast augmentation patient usually resumes her normal life at 1-week post-operative.
Moreover, women whose breast implants were emplaced beneath the chest muscles (submuscular
placement) usually have a longer, slightly more painful convalescence, because of the healing of the
incisions to the chest muscles. Usually, she does not exercise or engage in strenuous physical
activities for approximately 6 weeks. During the initial post-operative recovery, the woman is
encouraged to regularly exercise (flex and move) her arm to alleviate pain and discomfort; if
required, analgesic indwelling medication catheters can alleviate pain.[37][38] Moreover,
significantly improved patient recovery has resulted from refined breast-device implantation
techniques (submuscular, subglandular) that allow 95 per cent of women to resume their normal
lives at 24-hours post-procedure, without bandages, fluid drains, pain pumps, catheters, medical
support brassires, or narcotic pain plastic surgery Pittsburgh medication.[39][40][41][42]
Complications
The plastic surgical emplacement of breast implant devices, either for breast reconstruction or for
aesthetic purpose, presents the same health risks common to surgery, such as adverse reaction to
anesthesia, hematoma (post-operative bleeding), late hematoma (post-operative bleeding after 6
months or more),[43]seroma (fluid accumulation), incision-site breakdown (wound infection).
Complications specific to breast augmentation include breast pain, altered sensation, impeded
breast-feeding function, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia,
the "bread loafing" of the bust that interrupts the natural plane between the breasts. Specific
treatments for the complications of indwelling breast implants--capsular contracture and capsular
rupture--are periodic MRI monitoring and physical examinations. Furthermore, complications and
re-operations related to the implantation surgery, and to tissue expanders (implant place-holders
during surgery) can cause unfavorable scarring in approximately 6-7 per cent of the patients.
[44][45][46]Statistically, 20 per cent of women who underwent cosmetic implantation, and 50 per
cent of women who underwent breast reconstruction implantation, required their explantation at the
10-year mark.[47]
Implant rupture
Because a breast implant is a Class III medical device of limited product-life, the principal rupture-
rate factors are its age and design; Nonetheless, a breast implant device can retain its mechanical
integrity for decades in a woman's body.[48] When a saline breast implant ruptures, leaks, and
empties, it quickly deflates, and thus can be readily explanted (surgically removed). The follow-up
report, Natrelle Saline-filled Breast Implants: a Prospective 10-year Study (2009) indicated rupture-
deflation rates of 3-5 per cent at 3-years post-implantation, and 7-10 per cent rupture-deflation rates
at 10-years post-implantation.[49]
A breast implant failure: the parts of a surgically explanted breast implant are the red, fibrous
capsule (left), the ruptured silicone implant (center), and the transparent filler-gel that leaked with
the capsule (right).
When a silicone breast implant ruptures it usually does not deflate, yet the filler gel does leak from
it, which can migrate to the implant pocket; therefore, an intracapsular rupture (in-capsule leak) can
become an extracapsular rupture (out-of-capsule leak), and each occurrence is resolved by
explantation. Although the leaked silicone filler-gel can migrate from the chest tissues to elsewhere
in the woman's body, most clinical complications are limited to the breast and armpit areas, usually
manifested as granulomas (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph
glands in the armpit area).[50][51][52]
The suspected mechanisms of breast implant rupture are:
damage during implantation
damage during (other) surgical procedures
chemical degradation of the breast implant shell
trauma (blunt trauma, penetrating trauma, blast trauma)
mechanical pressure of traditional mammographic breast examination [53]
Silicone implant rupture can be evaluated using magnetic resonance imaging; from the long-term
MRI data for single-lumen breast implants, the European literature about second generation
silicone-gel breast implants (1970s design), reported silent device-rupture rates of 8-15 per cent at
10-years post-implantation (15-30% of the patients).[54][55][56][57]
The study Safety and Effectiveness of Mentor's MemoryGel Implants at 6 Years (2009), which was a
branch study of the U.S. FDA's core clinical trials for primary breast augmentation surgery patients,
reported low device-rupture rates of 1.1 per cent at 6-years post-implantation.[58] The first series of
MRI evaluations of the silicone breast implants with thick filler-gel reported a device-rupture rate of
1.0 per cent, or less, at the median 6-year device-age.[59] Statistically, the manual examination
(palpation) of the woman is inadequate for accurately evaluating if a breast implant has ruptured.
The study, The Diagnosis of Silicone Breast implant Rupture: Clinical Findings Compared with
Findings at Magnetic Resonance Imaging (2005), reported that, in asymptomatic patients, only 30
per cent of the of ruptured breast implants is accurately palpated and detected by an experienced
plastic surgeon, whereas MRI examinations accurately detected 86 per cent of breast implant
ruptures.[60] Therefore, the U.S. FDA recommended scheduled MRI examinations, as silent-rupture
screenings, beginning at the 3-year-mark post-implantation, and then every two years,
thereafter.[44] Nonetheless, beyond the U.S., the medical establishments of other nations have not
endorsed routine MRI screening, and, in its stead, proposed that such a radiologic examination be
reserved for two purposes: (i) for the woman with a suspected breast implant rupture; and (ii) for
the confirmation of mammographic and ultrasonic studies that indicate the presence of a ruptured
breast implant.[61]
Furthermore, The Effect of Study design Biases on the Diagnostic Accuracy of Magnetic Resonance
Imaging for Detecting Silicone Breast Implant Ruptures: a Meta-analysis (2011) reported that the
breast-screening MRIs of asymptomatic women might overestimate the incidence of breast implant
rupture.[62] In the event, the U.S. Food and Drug Administration emphasised that "breast implants
are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely
she is to experience complications."[63]
Capsular contracture
Main article: Capsular contracture
The human body's immune response to a surgically installed foreign object--breast implant, cardiac
pacemaker, orthopedic prosthesis--is to encapsulate it with scar tissue capsules of tightly woven
collagen fibers, in order to maintain the integrity of the body by isolating the foreign object, and so
tolerate its presence. Capsular contracture--which should be distinguished from normal capsular
tissue--occurs when the collagen-fiber capsule thickens and compresses the breast implant; it is a
painful complication that might distort either the breast implant, or the breast, or both.
A breast implant failure: capsular contracture is a medical complication, in this case, a Baker scale
Grade IV contraction, of a subglandular silicone implant in the right breast.
The cause of capsular contracture is unknown, but the common incidence factors include bacterial
contamination, device-shell rupture, filler leakage, and hematoma. The surgical implantation
procedures that have reduced the incidence of capsular contracture include submuscular
emplacement, the use of breast implants with a textured surface (polyurethane-coated);[64][65][66]
limited pre-operative handling of the implants, limited contact with the chest skin of the implant
pocket before the emplacement of the breast implant, and irrigation of the recipient site with triple-
antibiotic solutions.[67][68]
The correction of capsular contracture might require an open capsulotomy (surgical release) of the
collagen-fiber capsule, or the removal, and possible replacement, of the breast implant.
Furthermore, in treating capsular contracture, the closed capsulotomy (disruption via external
manipulation) once was a common maneuver for treating hard capsules, but now is a discouraged
technique, because it can rupture the breast implant. Non-surgical treatments for collagen-fiber
capsules include massage, external ultrasonic therapy, leukotriene pathway inhibitors such as
zafirlukast (Accolate) or montelukast (Singulair), and pulsed electromagnetic field therapy
(PEMFT).[69][70][71][72]
Repair and revision surgeries
When the woman is unsatisfied with the outcome of the augmentation mammoplasty; or when
technical or medical complications occur; or because of the breast implants' limited product life
(Class III medical device, in the U.S.), it is likely she might require replacing the breast implants.
The common revision surgery indications include major and minor medical complications, capsular
contracture, shell rupture, and device deflation.[53] Revision incidence rates were greater for breast
reconstruction patients, because of the post-mastectomy changes to the soft-tissues and to the skin
envelope of the breast, and to the anatomical borders of the breast, especially in women who
received adjuvant external radiation therapy.[53] Moreover, besides breast reconstruction, breast
cancer patients usually undergo revision surgery of the nipple-areola complex (NAC), and symmetry
procedures upon the opposite breast, to create a bust of natural appearance, size, form, and feel.
Carefully matching the type and size of the breast implants to the patient's pectoral soft-tissue
characteristics reduces the incidence of revision surgery. Appropriate tissue matching, implant
selection, and proper implantation technique, the re-operation rate was 3.0 per cent at the 7-yea-
-mark, compared with the re-operation rate of 20 per cent at the 3-year-mark, as reported by the
U.S. Food and Drug Administration.[73][74]
Alleged complications
Systemic disease and sickness
Some women with breast implants have reported connective tissue diseases such as systemic
sclerosis, systemic lupus erythematosus, rheumatoid arthritis, and fibromyalgia, though any claims
of association with implants have been refuted by medical research.[75][76][77]
Chest X-ray showing breast implants
Platinum toxicity
Platinum is used in the production of silicone gel for breast implants and small amounts may leach
into surrounding tissues. However, there is no reliable medical evidence that this poses a significant
health risk.[78]
Implants and breast-feeding
The functional breast: a mammary gland in medias res, feeding an infant.
Cross-section scheme of the mammary gland.
1. Chest wall
2. Pectoralis muscles
3. Lobules
4. Nipple
5. Areola
6. Milk duct
7. Fatty tissue
8. Skin envelope
The functional breast
The breasts are apocrine glands that produce milk for the feeding of infant children; each breast has
a nipple within an areola (nipple-areola complex, NAC), the skin color of which varies from pink to
dark brown, and has sebaceous glands. Within the mammary gland, the lactiferous ducts produce
breast milk, and are distributed throughout the breast, with two-thirds of the tissue within 30-mm of
the base of the nipple. In each breast, 4-18 lactiferous ducts drain to the nipple; the glands-to-fat
ratio is 2:1 in lactating women, and to 1:1 in non-lactating women; besides milk glands, the breast is
composed of connective tissue (collagen, elastin), adipose tissue (white fat), and the suspensory
Cooper's ligaments. The peripheral nervous system innervation of the breast is by the anterior and
lateral cutaneous branches of the fourth-, fifth-, and sixth intercostal nerves, while the Thoracic
spinal nerve 4 (T4) innervating the dermatomic area supplies sensation to the nipple-areola
complex.[79][80]
Digestive contamination and systemic toxicity are the principal infant-health concerns; the leakage
of breast implant filler to the breast milk, and if the filler is dangerous to the nursing infant. Breast
implant device fillers are biologically inert--saline filler is salt water, and silicone filler is
indigestible--because each substance is chemically inert, and environmentally common. Moreover,
proponent physicians have said there "should be no absolute contraindication to breast-feeding by
women with silicone breast implants."[81] In the early 1990s, at the beginning of the silicone breast
implant sickness occurrences, small-scale, non-random studies (i.e. "patients came with complaints,
which might have many sources", not "doctors performed random tests") indicated possible breast-
feeding complications from silicone implants; yet no study reported device-disease causality.[82]
The augmented breast
Women with breast implants may have functional breast-feeding difficulties; mammoplasty
procedures that feature periareolar incisions are especially likely to cause breast-feeding difficulties.
Surgery may also damage the lactiferous ducts and the nerves in the nipple-areola area.[83][84][85]
Functional breast-feeding difficulties arise if the surgeon cut the milk ducts or the major nerves
innervating the breast, or if the milk glands were otherwise damaged. Milk duct and nerve damage
are more common if the incisions cut tissue near the nipple. The milk glands are most likely to be
affected by subglandular implants (under the gland), and by large-sized breast implants, which pinch
the lactiferous ducts and impede milk flow. Small-sized breast implants, and submuscular
implantation, cause fewer breast-function problems; however, it is impossible to predict whether a
woman who undergoes breast augmentation will be able to successfully breast feed since some
women are able to breast-fed after periareolarincisions and subglandular placement and some are
not able to after augmentation using submuscular and other types of surgical incisions.[85]
Implants and mammography
The presence of radiologically opaque breast implants (either saline or silicone) might interfere with
the radiographic sensitivity of the mammograph, that is, the image might not show any tumor(s)
present. In which case, anEklund view mammogram is required to ascertain either the presence or
the absence of a cancerous tumor, wherein the breast implant is manually displaced against the
chest wall and the breast is pulled forward, so that the mammograph can visualize a greater volume
of the internal tissues; Nonetheless, approximately one-third of the breast tissue remains
inadequately visualized, resulting in an increased incidence of mammograms with false-negative
results.[86]
A mammograph of a normal breast (left);a mammograph of a cancerous breast (right).
The breast cancer studies Cancer in the Augmented Breast: Diagnosis and Prognosis (1993) and
Breast Cancer after Augmentation Mammoplasty (2001) of women with breast implant prostheses
reported no significant differences in disease-stage at the time of the diagnosis of cancer; prognoses
are similar in both groups of women, with augmented patients at a lower risk for subsequent cancer
recurrence or death.[87][88] Conversely, the use of implants for breast reconstruction after breast
cancer mastectomy appears to have no negative effect upon the incidence of cancer-related
death.[89] That patients with breast implants are more often diagnosed with palpable--but not
larger--tumors indicates that equal-sized tumors might be more readily palpated in augmented
patients, which might compensate for the impaired mammogram images.[66] The ready palpability
of the breast-cancer tumor(s) is consequent to breast tissue thinning by compression, innately in
smaller breasts a priori (because they have lesser tissue volumes), and that the implant serves as a
radio-opaque base against which a cancerous tumor can be differentiated.[90]
The breast implant has no clinical bearing upon lumpectomy breast-conservation surgery for women
who developed breast cancer after the implantation procedure, nor does the breast implant interfere
with external beam radiation treatments (XRT); moreover, the post-treatment incidence of breast-
tissue fibrosis is common, and thus a consequent increased rate of capsular contracture.[91] The
study Breast Cancer Detection and Survival among Women with Cosmetic Breast Implants:
Systematic Review and Meta-analysis of Observational Studies, reported a significant delay in the
diagnoses of women who developed breast cancer after undergoing breast augmentation, when
compared to breast cancer patients who had not undergone breast augmentation.[92] The metadata
study Breast Implants following Mastectomy in Women with Early-stage Breast Cancer: Prevalence
and Impact on Survival (2005) reported that breast augmentation patients were statistically likelier
to die from breast cancer. Although the use of implants for breast reconstruction after breast cancer
mastectomy appears to have no negative effect upon the incidence of cancer-related death, women
who underwent a mastectomy procedure tend to die earlier than women who underwent a
lumpectomy procedure, with like diagnoses.[89][93]
U.S. FDA approval
In 1988, twenty-six years after the 1962 introduction of breast implants filled with silicone gel, the
U.S. Food and Drug Administration (FDA) investigated breast implant failures and the subsequent
complications, and re-classified breast implant devices as Class III medical devices, and required
from manufacturers the documentary data substantiating the safety and efficacy of their breast
implant devices.[94] In 1992, the FDA placed silicone-gel breast implants in moratorium in the U.S.,
because there was "inadequate information to demonstrate that breast implants were safe and
effective". Nonetheless, medical access to silicone-gel breast implant devices continued for clinical
studies of post-mastectomy breast reconstruction, the correction of congenital deformities, and the
replacement of ruptured silicone-gel implants. The FDA required from the manufacturers the clinical
trial data, and permitted their providing breast implants to the breast augmentation patients for the
statistical studies required by the U.S. Food and Drug Administration.[94] In mid-1992, the FDA
approved an adjunct study protocol for silicone-gel filled implants for breast reconstruction patients,
and for revision-surgery patients. Also in 1992, the Dow Corning Corporation, a silicone products
and breast implant manufacturer, announced the discontinuation of five implant-grade silicones, but
would continue producing 45 other, medical-grade, silicone materials--three years later, in 1995, the
Dow Corning Corporation went bankrupt when it faced 19,000 breast implant sickness lawsuits.[94]
In 1997, the U.S. Department of Health and Human Services (HHS) appointed the Institute of
Medicine (IOM) of the U.S. National Academy of Sciences (NAS) to investigate the potential risks of
operative and post-operative complications from the emplacement of silicone breast implants. The
IOM's review of the safety and efficacy of silicone gel-filled breast implants, reported that the
"evidence suggests diseases or conditions, such as connective tissue diseases, cancer, neurological
diseases, or other systemic complaints or conditions are no more common in women with breast
implants, than in women without implants"; subsequent studies and systemic review found no causal
link between silicone breast implants and disease.[94]
The U.S. Department of Health and Human Services verifies the scientific, medical, and clinical data
of medical devices.
In 1998, the U.S. FDA approved adjunct study protocols for silicone-gel filled implants only for
breast reconstruction patients and for revision-surgery patients; and also approved the Dow Corning
Corporation's Investigational Device Exemption (IDE) study for silicone-gel breast implants for a
limited number of breast augmentation-, reconstruction-, and revision-surgery patients.[94]
In 1999, the Institute of Medicine published the Safety of Silicone Breast Implants (1999) study that
reported no evidence that saline-filled and silicone-gel filled breast implant devices caused systemic
health problems; that their use posed no new health or safety risks; and that local complications are
"the primary safety issue with silicone breast implants", in distinguishing among routine and local
medical complications and systemic health concerns."[94][95][96]
In 2000, the FDA approved saline breast implant Premarket Approval Applications (PMA) containing
the type and rate data of the local medical complications experienced by the breast surgery
patients.[97] "Despite complications experienced by some women, the majority of those women still
in the Inamed Corporation and Mentor Corporation studies, after three years, reported being
satisfied with their implants."[94] The premarket approvals were granted for breast augmentation,
for women at least 18 years old, and for women requiring breast reconstruction.[98][99]
In 2006, for the Inamed Corporation and for the Mentor Corporation, the U.S. Food and Drug
Administration lifted its restrictions against using silicone-gel breast implants for breast
reconstruction and for augmentation mammoplasty. Yet, the approval was conditional upon
accepting FDA monitoring, the completion of 10-year-mark studies of the women who already had
the breast implants, and the completion of a second, 10-year-mark study of the safety of the breast
implants in 40,000 other women.[100] The FDA warned the public that breast implants do carry
medical risks, and recommended that women who undergo breast augmentation should periodically
undergo MRI examinations to screen for signs of either shell rupture or of filler leakage, or both
conditions; and ordered that breast surgery patients be provided with detailed, informational
brochures explaining the medical risks of using silicone-gel breast implants.[94]
The U.S. Food and Drug Administration established the age ranges for women seeking breast
implants; for breast reconstruction, silicone-gel filled implants and saline-filled implants were
approved for women of all ages; for breast augmentation, saline implants were approved for women
18 years of age and older; silicone implants were approved for women 22 years of age and
older.[101] Because each breast implant device entails different medical risks, the minimum age of
the patient for saline breast implants is different from the minimum age of the patient for silicone
breast implants--because of the filler leakage and silent shell-rupture risks; thus, periodic MRI
screening examinations are the recommended post-operative, follow-up therapy for the patient.[102]
In other countries, in Europe and Oceania, the national health ministries' breast implant policies do
not endorse periodic MRI screening of asymptomatic patients, but example suggest palpation
proper--with or without an ultrasonic screening--to be sufficient post-operative therapy for
Pittsburgh most patients.
Criticism
In the early 1990s, the national health ministries of the listed countries reviewed the pertinent
studies for causal links among silicone-gel breast implants and systemic and auto-immune diseases.
The collective conclusion is that there is no evidence establishing a causal connection between the
implantation of silicone breast implants and either type of disease. The affected women complained
of systemic disease manifested as fungal, neurologic, and rheumatologic ailments. The Danish study
Long-term Health Status of Danish Women with Silicone Breast Implants (2004) reported that
women who had breast implants for an average of 19 years were no more likely to report an
excessive number of rheumatic disease symptoms than would the women of the control group.[103]
The follow-up study Mortality Rates Among Augmentation Mammoplasty Patients: An Update (2006)
reported a decreased standardized mortality ratio and an increased risk of lung cancer death among
breast implant patients, than among patients for other types of plastic surgery; the mortality rate
differences were attributed to tobacco smoking.[104] The study Mortality Among Canadian Women
with Cosmetic Breast Implants (2006), about some 25,000 women with breast implants, reported a
43 per cent lower rate of breast cancer among them than among the general populace, and a lower-
than-average risk of cancer.[105]
Year
Country
Systemic Review Group
Conclusions
1991-93
United Kingdom
Independent Expert Advisory Group (IEAG)
There was no evidence of an increased risk of connective-tissue disease in patients who had
undergone silicone-gel breast implant emplacement, and no cause for changing either breast
implant practice or policy in the U.K.
1996
United States
U.S. Institute of Medicine (IOM)[106]
There was "insufficient evidence for an association of silicone gel- or saline-filled breast implants
with defined connective tissue disease."
1996
France
Agence Nationale pour le Developpement de l'Evaluation Medicale (ANDEM) [National Agency for
Medical Development and Evaluation] [107]
French original: "Nous n'avons pas observ de connectivit ni d'autre pathologie auto-immune
susceptible d'tre directement ou indirectement induite par la prsence d'un implant mammaire
en particulier en gel de silicone...."
English translation: "We did not observe connective tissue diseases to be directly or indirectly
associated by the presence of a breast implant, in particular one of silicone gel...."
1997
Australia
Therapeutic Devices Evaluation Committee (TDEC)
The "current, high-quality literature suggest that there is no association between breast implants
and connective tissue disease-like syndromes (atypical connective tissue diseases)."[108]
1998
Germany
Federal Institute for Medicine and Medical Products
Reported that "silicone breast implants neither cause auto-immune diseases nor rheumatic diseases
and have no disadvantageous effects on pregnancy, breast-feeding capability, or the health of
children who are breast-fed. There is no scientific evidence for the existence of silicone allergy,
silicone poisoning, atypical silicone diseases or a new silicone disease."[109]
2000
United States
Federal court-ordered review[110]
"No evidence of an association between... silicone-gel-filled breast implants specifically, and any of
the individual CTDs, all definite CTDs combined, or other auto-immune or rheumatic conditions."
2000
European Union
European Committee on Quality Assurance & Medical Devices in Plastic Surgery (EQUAM)
"Additional medical studies have not demonstrated any association between silicone-gel filled breast
implants and traditional auto-immune or connective tissue diseases, cancer, nor any other malignant
disease. . . . EQUAM continues to believe that there is no scientific evidence that silicone allergy,
silicone intoxication, atypical disease or a 'new silicone disease' exists."[111]
2001
United Kingdom
UK Independent Review Group (UK-IRG)
"There is no evidence of an association with an abnormal immune response or typical or atypical
connective tissue diseases or syndromes."[112]
2001
United States
Court-appointed National Science Panel review[113]
The panel evaluated established and undifferentiated connective tissue diseases (CTD), and
concluded there was no causal evidence between breast implants and these CTDs.
2003
Spain
Science and Technology Options Assessment (STOA)
The STOA report to the European Parliament Petitions Committee reported that the current
scientific evidence demonstrates no solid, causal evidence linking SBI [silicone breast implants] to
severe diseases, e.g. breast cancer, connective tissue diseases.[114]
2009
European Union
International Committee for Quality Assurance, Medical Technologies & Devices in Plastic Surgery
panel (IQUAM)
The consensus statement of the Transatlantic Innovations conference (April 2009) indicated that
additional medical studies demonstrated no association between silicone gel-filled breast implants
and carcinoma, or any metabolic, immune, or allergic disorder.[115]
See also
Breast
Breast augmentation (Augmentation mammoplasty)
Breast enlargement supplements
Breast reconstruction
Breast reduction plasty
Mammoplasty
Mastopexy (breast lift)
Poly Implant Prothse
Polypropylene breast implants
Trans-umbilical breast augmentation (TUBA)
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External links
Wikimedia Commons has media related to Breast implants.
Basics of implant based breast reconstruction (E-medicine)
Institute of Medicine (IOM) Report on Silicone Implants
National Science Panel report "Silicone Breast Implants in Relation to Connective Tissue Diseases
and Immunologic Dysfunction"
U.S. Food and Drug Administration (FDA)--breast implant page
U.K. Medicines & Health Care Products Regulatory Agency (MHRA)--breast implant page
Australia's Department of Health & Aging Therapeutic Goods Administration breast implant page
Breast implant at DMOZ
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