Even though there
is a list of potential complications,
breast augmentation remains one of
the safest and most conventional surgical procedures performed in
plastic surgery. There is an extreme low incidence of
complications, which has enticed many potential patients of undergoing
this surgical procedure. This surgery has a way to provide the
size and shape of an individual’s breast and keep it in proportion with
the person’s overall body stature and size. It is the one
procedure that the patient can see immediate results right after
surgery.
Anything that is foreign to the human body will cause a reaction in
which the body will naturally form a small amount of scar tissue around
that object. Breast implants are no exception to this rule and the
human body does this as a means of protecting itself from the foreign
object. This capsule that the body makes is made up tightly woven
collagen which forms a barrier between the implant the rest of the body.
If the body has an over-reaction to the implant, then the scar tissue
starts building up inside the capsule and starts contracting and
compressing the implant. The excess or constricting scar tissue
ends up resulting in capsular contracture. Depending on the
severity of the scar tissue build up, the implant tends to be harder to
move around in the pocket. Breast implants do not become hard
- it is the capsule that becomes hardened. For one reason or
another, the capsule becomes thickened and contracts, squeezing the
implant into a smaller space and causing the feeling of "firmness". Depending upon the severity
of the capsular contracture, the breast can feel firm, hard, distorted,
and begin to cause pain.
The prevailing theory on how capsular contracture starts has been linked
to a low grade infection - however; there are many other
contributing factors. Capsular contracture causes are
unclear. There are outside variables which will increase your
chances of this complication including hematoma,
seroma,
bacterial infection,
non-sterile equipment, radiation therapy (pre or post operatively) and
severe trauma to the breast.
Prevention of capsular contracture starts with the surgeon's technique
in the operating room including the type of of irrigation he performs,
the way the implant is handled and whether or not he endorses post
operative massage with
smooth shell implants.
The worse the capsular constriction
gets the more visible the deformity will become with the implant shape
being misshapen and pain is usually associated with the later stages.
There are four different levels of capsular contracture as determined by
the Baker Grading System, named after a plastic surgeon who divided
capsular constriction into four different sub-groups:
Grade 1–
the breast appears normally soft and looks natural. No
noticeable contracture. Every patient who has breast augmentation
has Grade 1 – due to the body’s natural immune response with sealing off
a foreign object from the rest of the body.
Grade II
- the breast appears slightly firm, but looks normal. At this
stage, surgery is not warranted, but it may be a sign that the capsule
is beginning to contract. This is the stage that prescription
medication such as
Accolate or Singular can be started.
Grade
III
– the breast is very firm and starts to look visibly distorted – slight
pain might be associated with this stage.
Grade IV
– this is the stage that the breast is hard, painful looks very abnormal
with visible distortion. To repair breast implants at a Baker
grade three or four, surgery is usually required with either a full open
capsulectomy or a
capsulotomy.
The important factor to remember is all capsule formation is normal, as
every patient who has breast implants has Stage 1 capsular contracture
according to the Baker Grading Scale. It is only when this capsule
becomes hardens or shrinks and compresses the implant that capsular
contracture occurs.
Early mild cases of capsular contracture can
usually be helped with
breast massage
or the taking of
prescription
medication such as
Accolate or Singulair. Both of
these medications have shown great promise with the lower level Capsular
constriction. With the lower level capsular constriction the
patient also has an option of the capsular scar tissue to be surgically
released or removed. Severe cases will likely require that the
capsular scar tissue be surgically released or removed (either a capsulectomy or a capsulotomy), and the breast
implant repositioned or replaced.
Capsular contracture usually occurs in about 5% of patients, and
unfortunately can occur at any time the patient has implants. This
is one complication that can be seen around three months post operative or
anytime thereafter.
Another factor
that has to be taken into account is the severity of the contracture –
which is increased by an acceleration of the inflammatory condition. The longer the breast stays inflamed, the better the chances that
capsular contracture will happen.
Pros:
Can help with the inflammatory response that is making the capsule contract
around the prosthesis.
Cons:
Steroid irrigation
can lead to mal-position of the implant in the pocket, as steroids tend to thin
the tissue - leading to a downward migration of the implant.
Irrigation of the surgical area with antibiotics has also been shown to reduce
the risk of capsular contracture. A antibacterial irrigation containing
50,000 units of bacitracin, 1 gram of cefazolin, and 80 mg. of gentamicin in 500
mL of normal saline are currently recommended to minimize capsular contracture
formation.
The topic of
massaging after breast augmentation is a controversial one. There are some
surgeons who believe that patients who have smooth shell implants
should perform daily massage or compressions with their implants in order to
keep the pocket free of scar tissue. Women who have breast augmentation
should ask their plastic surgeon about the need for massage, as each surgeon has
their own post operative protocol. The
main idea behind massaging or breast compression exercises is to help prevent
the complication of excessive scar tissue formation that might squeeze the
implant and contribute to visible mal-positioning and pain.
The human body naturally closes off open
spaces made inside of it, so it is very important to try and keep the surgical
pockets open, so the implant can move around freely without restriction from
scarring or adhesions that come with capsular contracture.
If your surgeon
recommends massaging - it is normally done daily with massage or breast
compression exercises, forceful pushing the implant into the extremes of their
pockets. Most start from approximately the first week post operative. Your surgeon will go over in detail what he or she would like you to do post
operative with strict instructions, so if you are unsure about something, always
call their office and find out.
Performing pocket
quadrant exercises displace the implant, so the implants go toward the
collarbone or shoulder. It can also be beneficial to push the breast
implants laterally (to the sides) and towards the midline. Gravity for the
most part takes care of pushing the breasts down. Most surgeons have their
own methods for massaging or breast compression exercises, so it is always
best to first ask your physician what he recommends for you. Every
patient's treatment plan is unique and the recommendation for massage is equally
individual for every patient.
Vitamin E was
discovered in 1938, and has been used on surgical scars successfully with making
the scars softer. Because of this, many surgeons will suggest that
patients should take a regular dose of Vitamin E for the first year after
augmentation, as it helps to keep tissue soft and pliable. Vitamin E works
by reducing the strength of the cross-linking of the three strands that form
collagen - making them softer. Although there is no study available
showing improvement with Vitamin E and capsular contracture, there are many
surgeons that have seen a decrease of capsular contracture in their own practice
by prescribing high doses of Vitamin E for a period of time after implantation.
Another treatment
that has recently gained a lot of popularity is external ultrasound. This combined with prescription drug therapy seems to help patients with
capsular constriction see a reduction of the symptoms. External Ultrasound can be applied after surgery and before a capsular
hardening begins. This is especially important for those who have had
encapsulation in the past and have undergone a corrective surgery.
The
best treatment is prevention and waiting till contracture occurs,
lessens the effectiveness of this type of treatment. External
ultrasound is a painless digitally adjustable instrument that sends
sound waves to the affected breast. It is applied to the outside of the
affected breast and can be used after a contracture has started.
This procedure is the gold standard for most plastic surgeons when
surgery is mandated due to capsular contracture. The surgeon goes
in and fully removes the entire capsule including the implant. By
taking the entire capsule and all the scar tissue with it, gives the
patient the best odds of this not returning. Capsulectomy is a
more extensive operation than capsulotomy but has a higher rate of
success in correcting contracture.
With an open capsulectomy -
the plastic surgeon goes into the
breast and “scores” the capsular tissue to loosen up the capsule
pocket. Because the scar tissue is not completely taken out in its
entirety; the chances of the capsular contracture returning is much
greater with this procedure.
A closed capsulotomy
procedure is not endorsed by the implant manufacturers – and if
it is applied, it might void your warranty you have on the implants.
A closed capsulotomy is not done very often because of the unpredictable
outcome with this procedure.
With a closed capsulotomy, the firm implant is manually squeezed tightly
from the outside, in an attempt to disrupt or tear the scar envelope.
When successful the result is instantaneous and the implant immediately
feels soft. However, this is a short term fix, as usually the scar
tissue will reattach itself and the cycle will start all over again.
The
closed capsulotomy can contribute to bruising, bleeding, or even rupture
of the implant itself. If a rupture occurs, then the patient will
definitely need surgery to remove and replace the implant.
Textured implants were designed to help reduce the incidence of capsular
contracture – because their design with the rough textured surface tends
to deter a hard capsule of scar tissue from forming around the breast
implant. This benefit however has only been shown to be successful
in only
sub-glandular (above the muscle) breast augmentations, and is
still a very debatable issue.
Because of the popularity of behind
the muscle placement or
partial sub-muscular placement, the benefits of
textured implants is somewhat limiting and they tend not to be used for
this purpose. Because textured implants are made with a thicker
shell than
smooth shell implants, the implant edges are thicker.
Seeing the edges of the implant is more commonly seen with this type of
surface implant versus smooth shell. Also another disadvantage of
textured implants is that they are more prone to rupture or leaks
because of their surface. Textured implants can also give a
patient what is called “traction rippling”. This happens when the
implant grabs onto the surface of where the tissue grabs the textured
surface and pulls on it – forming a much uniformed visible rippling
pattern.
Leukotriene
antagonists (Accolate) which is indicated for the use of asthma and lung
diseases - has been potentially useful in counteracting the inflammatory
pathway which leads to a dense collagen membrane around the breast implant or
prosthesis. This ends up preventing contracture of the capsule. Not
every patient will respond with this medication however.
Accolate
whose generic name is Zafirlukast -
is an oral
leukotriene receptor antagonist (LTRA) for the
maintenance treatment of asthma - often used in conjunction with an
inhaled steroid and/or long-acting bronchodilator. It is available as a
tablet and is usually dosed twice daily. Another leukotriene receptor
antagonist is generic name which is montelukast or Singular,
which is usually taken just once daily.
Both of these medications have shown great promise with the reduction of
Capsular Constriction occurrence – along with existing contracture
conditions if the contracture is not that far along. Using
prescription drug therapy with Accolate or Singular seems to work best
if the Capsular Constriction is at the Baker Grade II level, so early
detection of this is of utmost concern, so that you can get started on
this drug regimen.
Accolate
(Zafirlukast) is marketed and distributed by Astra-Zeneca with the brand names Accolate,
Accoleit, and Vanticon. This medication comes in pill form
to treat asthma. Zafirlukast mode of action in targeting capsular
contracture works by it’s leukotriene receptor inhibitor which prevents
the common inflammatory response caused by certain components of white
blood cells called leukocytes.
Zafirlukast when being prescribed for asthma blocks the action of the
cysteinyl leukotrienes on the CysLT1 receptors, thus reducing
constriction of the airways, build-up of mucus in the lungs and
inflammation of the breathing passages. With
capsular constriction one school of thought is that it comes from an
overactive immune response, just like an asthma attack would be
triggered. It is this drug Zafirlukast that literally fights the
body’s immune reaction by preventing contracture from forming, and
slowly softening and possibly releasing pre-existing low level
contracture conditions.
Benefits of using Accolate with patients who have capsular contracture:
Asthma
Medication may have Benefits in Treating most Common Problem of Breast
Implant Surgery
Journal Article
from Dr. Schlesinger, MD of Maui, Hawaii.
Preliminary Report
Slated for ASAPS Meeting, Las Vegas
NEW YORK, NY
(April 12, 2002) Accolateapproved by the U.S. Food
and Drug
Administration for
the treatment of asthma; may be the newest weapon against capsular
contracture, the undesirable breast firmness that sometimes follows
breast augmentation or reconstruction with implants. A preliminary
report based on several surgeons’ clinical experience will be presented
at a special session on research and innovative technology during the
Annual
Meeting of the American Society for Aesthetic Plastic
Surgery
(ASAPS), April 27-May 3, in Las Vegas.
Capsular
contracture, the most frequent problem following breast implant surgery,
occurs when the naturally-resulting scar tissue around the implant
contracts, squeezing the implant and making the breast feel firm. In
severe cases, capsular contracture may cause significant breast
distortion and discomfort. When severe contracture occurs, the only
remedy is surgery; even then, the problem may recur months or years
later.
Plastic Surgeon
Larry Schlesinger, MD, of Maui, HI, reports on a series of cases in
which the asthma medication Accolatewas
prescribed, as an off-label use, for capsular contracture following
breast augmentation or reconstruction with implants. "In many cases, the
patients and surgeon noted a very significant softening and improved
appearance of the breast following treatment with Accolatefor a period of one to three months," says Dr. Schlesinger. "For
some women who otherwise would have needed surgical correction of their
contracture, surgery was no longer needed.
ASTHMA MEDICATION
Dr. Schlesinger
says that he has been using Accolate for
approximately three years and has found it most effective in treating
early-phase contracture (less than six months) and as a preventative
treatment in patients considered "high risk" for contracture; this group
includes those with a history of previous capsular contracture and
patients with a tendency toward hypertrophic scarring. However, he says
there has also been some success in using the drug to treat established
contracture.
"Our preliminary
findings do not suggest that Accolate is the answer
for every patients with contracture," advises Dr. Schlesinger. "For
patients whose capsular contracture is severe and long-standing, meaning
a year or more, surgical intervention is still the best option. But for
patients who are not good candidates for surgery or elect not to undergo
surgery – such as breast reconstruction patients who may have
experienced capsular contracture following radiation therapy it may be
possible to achieve some degree of improvement using Accolate"
Dr. Schlesinger’s
results are based on a treatment of 20 milligrams of Accolate administered
orally twice daily – the same dosage indicated for the preventative and
chronic treatment of asthma in adults and children 12 years of age or
older. From November 1996 through 1998, Accolate
tablets were prescribed more than 4 million times for asthma treatment
and, reportedly, the drug is well tolerated. Side effects may include
headache (12.9%) and nausea (3.1%).”
Dr. Schlesinger’s
clinical experience with Accolate is very
preliminary, but is consistent with other research suggesting that
certain medications may be useful in helping to prevent or improve the
symptoms of capsular contracture in properly selected patients," says
James Baker, J r., MD, Breast Surgery Committee chair for the American
Society for Aesthetic Plastic Surgery.
The effect of zafirlukast (Accolate)
on early capsular contracture in the primary augmentation patient: A
pilot study.
The development of
capsular contracture following breast augmentation presents a challenge
to the plastic surgeon. Treatment of capsular contracture with the
leukotriene antagonist zafirlukast (Accolate, AstraZeneca, Wayne, PA)
has received much attention in the media; however, there is limited
proof of its effectiveness.
The purpose of
this study was to prospectively examine a single surgeon's experience
using zafirlukast in the treatment of capsular contracture in primary,
submuscular breast augmentation with saline-filled, smooth-walled
implants.
Thirty-seven
patients (74 breasts) who underwent primary sub-muscular breast
augmentation with saline-filled, smooth-walled implants were evaluated
at 1, 2, 4, 6, 12, 24, and 48 weeks postoperatively by 3 independent
observers and rated for capsular contracture using a modification of the
Baker classification. Patients who demonstrated any capsular contracture
(higher than modified Baker 1.0) were offered off-label use of
zafirlukast 20 mg PO BID for 3 or 6 months after full informed consent
was reviewed and accepted.
In addition, patients were offered liver
function chemistries at the start of treatment and at 1, 3, and 6 months
following zafirlukast treatment. The patients were assessed for implant
mobility and capsular contracture at the initiation of leukotriene
therapy and then again at 3- and 6-month time points.
Forty-one breasts
in this series (55.0%) were found to have early, mild capsular
contracture. Specifically, 25 breasts were graded 1.5 (33.8% of total),
14 breasts graded 2.0 (18.9%), 1 breast graded 2.5 (1.4%), and 1 breast
graded 3.0 (1.4%). Mean follow-up was 6.3 months. A positive response
(complete or partial) was seen in a statistically significant proportion
of treated breasts (75.7%, P < 0.05).
This response was
maintained on a long-term basis, with a mean follow-up of 16.5 months.
Zafirlukast
appears effective in treating early capsular contracture after primary
sub-muscular breast augmentation using saline-filled, smooth-walled
implants. Further prospective studies with control groups and long-term
follow-up will be needed to address many unanswered questions, including
whether leukotriene inhibitors have long-term effects on capsular
contracture following breast augmentation.
Enhancing patient outcomes in
aesthetic and reconstructive breast surgery using triple antibiotic
breast irrigation: six-year prospective clinical study.
Department of
Plastic Surgery, Parkland Health and Hospital System, Dallas, Texas,
USA. dr@dr-adams.com
BACKGROUND:
Capsular contracture remains one of the most commonly reported
complications in aesthetic and reconstructive breast patients. Previous
in vitro studies from the authors' laboratory have recommended an new
triple antibiotic povidone-iodine irrigation (2000) and subsequently a
triple antibiotic non-povidone-iodine-containing irrigant (2001) to
optimize broad-spectrum coverage of various bacteria implicated in
capsular contracture; however, the clinical efficacy of these in vitro
studies remains unproven. The purpose of this study was to determine the
clinical efficacy for the previously reported triple antibiotic breast
irrigation. The cost-effectiveness of universal application of
irrigation solutions in breast prosthesis surgery was analyzed as well.
METHODS:
Patients undergoing aesthetic and reconstructive breast implant
procedures were treated with a standardized operative technique,
including the use of triple antibiotic breast irrigation by a single
surgeon. Capsular contracture was assessed using a simplified Baker
scale and graded by two independent caregivers to maximize objectivity
and consistency. Additional complications were also recorded, including
re-operation. Patient charges for antibiotic irrigation and re-operation
for contracture were determined and compared.
RESULTS:
A total of 335 patients operated on since 1997 were evaluated
prospectively. They ranged in age from 18 to 86 years, and the mean
follow-up was 14 months (range, 6 to 75 months)The rate of grade
III/IV capsular contracture in the study groups was 1.8 percent for
patients undergoing primary breast augmentation. Patients undergoing
augmentation-mastopexy had a grade III/IV contracture rate of 0 percent.
Breast reconstruction patients had a 9.5 percent rate of grade III/IV
contracture.
CONCLUSIONS:
Triple antibiotic breast irrigation is clinically associated with a low
incidence of capsular contracture compared with other published reports,
and its clinical efficacy supports previously published in vitro
studies. Application of triple antibiotic irrigation is recommended for
all aesthetic and reconstructive breast procedures and is cost
effective.
Division of
Plastic Surgery, Georgetown University Medical Center, Washington, DC
2007, USA. spears@gunet.georgetown.edu
Little has been
published regarding the treatment of patients with long-established
capsular contracture after previous sub-muscular or sub-glandular breast
augmentation. This study reviews 7 years of experience in treating
established capsular contracture after augmentation mammaplasty by
relocating implants to the "dual-plane" or partly sub-pectoral position.
A retrospective chart review was performed on all patients who were
treated for capsular contracture using this technique between 1993 and
1999.
Data collected included the date of the original augmentation, the
original implant location, date of revision and type of implant used,
length of follow-up, outcome, and any ensuing complications. Different
surgical techniques were used, depending on whether the prior implant
was located in a sub-glandular or sub-muscular plane.
All patients had
revisions such that their implants were relocated to a dual plane, with
the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located
sub-glandularly. Of 85 patients reviewed, 54 had their original implants
in a sub-muscular position and 31 had their initial augmentation in a
sub-glandular position. Of the 54 patients whose implants were initially
sub-muscular, 23 patients (43 percent) had silicone gel implants, 15
patients (28 percent) had double-lumen implants, and the remaining 16
patients (30 percent) had saline implants.
Of the 31 patients whose
implants were initially sub-glandular, 20 patients (65 percent) had
silicone gel implants, three patients (10 percent) had double-lumen
implants, and the remaining eight patients (26 percent) had saline
implants. Fifty-one patients (60 percent) had replacement with saline
implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent)
had silicone gel implants (seven smooth gel, 27 textured gel). The
average time from previous augmentation to revision was 9 years 9
months.
The average follow-up time after conversion to the dual-plane
position was 11.5 months. Only three of 85 patients required
re-operation for complications, all of which involved some degree of
implant mal-position. Of patients converted to the dual plane, 98
percent were free of capsular contracture and were Baker class I at
follow-up, whereas 2 percent were judged as Baker class II. There were
no Baker level III or IV contractures at follow-up.
The
dual-plane method of breast augmentation has proved to be an effective
technique for correcting established capsular contracture after previous
augmentation mammaplasty. This technique appears to be effective when
performed with either silicone or saline-filled implants.