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Breast surgery can be accomplished using any
one of four incision sites:
1. Nipple (areolar)
2. Axillary (armpit)
3. Inframammary (under the breast)
4. Umbilical (belly button)
Four types or shapes of implants in both
saline and silicone are available:
3. Round in shape
4. High profile, teardrop, or
Three sites of placement are routinely used
1. Above the muscle
2. Below the muscle
3. Below the fascia
There are many options (4 x 4 x 3 = 48 total) and
many other less common variations, plus the range of implant volumes possible.
Silicone implants are still available in
special circumstances and in most all other countries around the world.
You and your surgeon should have the same
goal of achieving the most beautiful and natural result possible. And the
surgeon will explain why some of these alternatives may be better for you than
The following information may help you
understand the differences in the approaches described above.
Allowing the patient to choose the site of
the incision may sound like an upsetting idea to some surgeons, but more than
98% of the patients will accept the doctor's recommendation anyway, so why not
allow the patient to have as much say in the matter as possible?
For the patient whose breasts droop enough so
that the skin of the breast is touching the skin of the chest wall when standing
erect, the inframammary incision placed slightly up on the breast just 1/2 to 1
cm above the new inframammary fold should be almost completely hidden, and may
be the preferable and most recommended sight.
In the patient with very small areolae, the
areola incision may be nearly impossible. It is preferable to have this incision
at least 2 cm long, and if it is to be less than 1.5 cm and the patient really
insists on not having it under the arm, we may insist on permission to extend it
laterally as much as 1/2 to 1 cm in each direction because it may not be
possible to get an implant of over 200 cc volume through it.
Ordinarily we tell our patients the
following: 1.) The areola incision made in the wrinkles of the brown skin of the
areola heals with the least scar, 2.) The inframammary incision is most visible
of all except in pendulous breasts, and 3.) The axillary incision is the least
visible of all, unless the patient is a ballet dancer or for some other reason
has her arms in the air with the axillae exposed very frequently.
The techniques of the different approaches
and associated problems will be discussed in detail in further chapters. The
patient may wish to know that the areola approach is the only one of the three
that invades the breast tissue; yet in performing this in hundreds of women and
knowing others who have also done hundreds with this approach, I have yet to see
or hear of breast nodules or cysts developing in the lower portion of the breast
because of this approach. Many patients I have done with this approach have
subsequently become pregnant and were able to breast-feed.
Also, with the areola approach there has been
no greater incidence of hypaesthesia (numbness) of the nipple or lower breast
skin than with the other approaches in my experience of performing more than 500
surgeries using areola incisions.
There is an article in the literature that
states that patients who have the areolar approach have more difficulty
breast-feeding than those with the axillary or inframammary incisions. This is a
retrospective study and is unreliable, but the suggestion may still be correct.
see breast implants in the FDA web site at http://www.fda.gov)
Almost always the patient will accept the
doctor's recommendation for the type of implant. There were seven implant
manufacturers before 1992 and the FDA. Now there are only four - McGhan, Mentor, PIP
and Hutchinson. And their names, addresses and phone numbers are listed in their
web sites. The choice of implants for the surgeon is discussed in chapter twelve
of our handbook on breast implant surgery.
At times these companies will have videotapes
on how to do the surgery. Wells Johnson supplies endoscopic equipment for the
umbilical approach and has videotapes of that approach.
What the patient wants is the best possible
result, with no future problems. Many of the reasons for choosing a saline over
a gel, or a combination, or the meme is because of the rationale each one has
for reducing the chance of or preventing the capsule contracture problem. The
meme was the best. But since it was covered with polyurethane foam, it was
removed from the market and will probably never return. It was this interface of
texturing that led to the textured silicone implants.
Historically, in the beginning, after it was
discovered that silicone injections could lead to unacceptable complications and
silicone was first placed in a silicone bag, the first implants in the early
1960s were silicone gel. They were firm and teardrop shaped. The capsule
contracture rate was greater than 90%, with most being as hard as your elbow,
except for whatever breast tissue was overlying them. So, softer implants were
developed in the late 1960s.
These softer implants would assume a teardrop
position in the upright position, and so the teardrop shape was no longer
necessary. Dacron patches were popular at that time to hold the implants up, and
while they did this to a certain extent, the capsule contracture rate again
approached 100% because of tissue reactions to the Dacron. As well, the breast
tissue continued to sag over the implants, even when the implants stayed firmly
fixed to the chest wall; this resulted in distortion. Dacron patches are very
rarely used now.
In the early 1970s, saline filled implants
were introduced and were softer than a gel implant in the same patient when
independent observers compared one side to the other. The problem with the
saline implants is the leakage and deflation rate (which seems to be about 50%
over a period of 10 years in my experience with about 100 pure saline and around
500 combination gel and saline implant surgeries). Yet many of the pure saline
and many of the combination implants that I used 20 to 25 years ago are still
Implant deflation necessitates an additional
operation, and since there is no doubt that some capsule contraction occurs with
saline implants, why do we have the additional problem of deflation? For
example, I removed some saline implants that had been put in previously and had
already required one revision because of deflation; one side was completely
collapsed and the other had a capsule. The implants were small, and the patient
could have tolerated the firm side but was chagrined to have the asymmetry of a
complete collapse of the other, so we replaced them both with silicone gel
implants. The gels formed more and harder capsules, but were more popular than
saline implants because of the reduced deflation problem, not because the result
was more natural or softer. The saline implants were, in fact, softer than the
When considering gel bleed as a cause of
capsule contraction, please note that many patients have a capsule develop only
on one side, and usually the capsule firmness and thickness is unequal on the
two sides. Not only are a few capsules unilateral, but most patients have
unequal firmness, and often it is markedly unequal with a soft breast on one
side and spherical contracture and deformity on the other. These well-known
findings must be considered for any theory of capsule contracture. Gel bleed
would occur almost equally and could not cause such asymmetry in capsule
The choices as of the year 2000 are all
saline - textured or smooth, and to be filled with a valve or pre-filled.
We see and have seen rippling from textured
silicone as well as saline implants. But the saline implants ripple to a greater
extent and are more palpable, i.e. they can be felt and detected by feel more
Textured implants have thicker walls and can
ripple more. The McGhan textured is deeper and the implant will not move or flow
in the pocket. This appears sometimes slightly less natural. But this deeply
textured implant is less likely to have distortion and capsule contracture, we
believe, but one study from Sweden shows this not to be true.
The McGhan 468, or anatomical implant,
is textured but still can ripple. It feels more firm and is more palpable below
the nipple, where the tissues are thin. The 468 is a shaped, overfilled, fairly
firm implant, but it does not allow much of a “stuck-on” appearance. Because
it is overfilled and less mobile, it does not seem quite as natural as the
softer, smooth salines. But in selected patients, it can be the best implant
The smooth implants have less rippling than
many of the textured, and are less palpable and less firm than the McGhan 468.
But they could be subject to more capsule contracture.
As noted by the FDA, August 1991 BG pp. 2,
"Since the saline filled implants do not have the silicone gel, they are
probably even less likely to increase the risk of autoimmune diseases or cancer.
But since both types of implants have the silicone rubber envelope, such effects
cannot be totally ruled out, even for the saline filled implants." For an
FDA update and a lot of information on implants, see breast implants at the FDA
web site: http://www.fda.gov.
So the FDA presumption or suspicion was that
the silicone gel is more likely to cause autoimmune disease or cancer than solid
silicone. Yet these reactions on the immune level are microscopic, and the
difference in the gel and the solid silicone chemically on the level of the
molecular structure is analogous to the difference in ice and water. And if the
chemistry is the same, the molecular reaction is approximately the same.
Saline implants are the only type approved by
FDA as of the year 2001, and at the FDA web site (http://www.fda.gov)
there is a thorough discussion of the reasons for this. There is a history of
implants and a presentation of McGhan and Mentor, the only manufacturers now
approved for implants.
Other factors for the choice of implants will
be discussed further elsewhere. Even if gel were to return, many probably
would continue to use saline because they are good implants, they may cause less
capsule contracture, they require smaller incisions, and they have an overall
reputation of greater safety from all the unproven but suspected problems
associated with gel.
Thursday March 2 6:54 PM
FDA Panel Deems 2 of 3 Breast Implant Brands
By Lisa Richwine
GAITHERSBURG (Reuters) - The two most popular
brands of saline-filled breast implants are safe and effective and should stay
on the U.S. market, a federal advisory panel said Thursday after reviewing new
data on possible complications.
The committee said, however, that the company
that makes a third brand of saline implants did not present enough information
to prove the benefits of its product outweighed its risks.
Saline implants first hit the market more
than 25 years ago when the FDA had no authority to determine whether they were
safe. The agency is scrutinizing them now because of concerns about
complications such as infections and rupturing.
The FDA usually follows its panels' advice
and is expected to decide whether to officially approve the implants later this
Breast implants are more popular than ever.
About 150,000 women received them last year. Most are filled with saline, or
salt water. Silicone-gel implants were banned for most women in 1992 over safety
The panel recommended the FDA approve
implants made by Inamed Inc.'s (NasdaqNM:IMDC
- news) McGhan Medical unit and
Mentor Corp. (NasdaqNM:MNTR
- news), two California
companies that lead the breast implant market.
“The data shows these implants are
reasonably safe and effective,” said panel member Dr. Phyllis Chang of The
University of Iowa College of Medicine after studying McGhan's results.
But panelists said they were not reassured by
data from Poly Implant Prostheses (PIP). They said the U.S. study the company
presented did not include enough patients that were followed for an adequate
time to truly evaluate the device risks.
Panel member Boyd Burkhardt, a plastic
surgeon from Arizona, said he wanted to support PIP's implants because he
thought their design would “dramatically'' reduce the rate of infections. But
he found the company's data incomplete and found it difficult to understand that
the company was “as ill prepared as you appear to be.''
PIP President Rick Hawk responded by saying
the study results showed there was, “reasonable assurance of PIP's implant
safety and effectiveness.”
Earlier, McGhan said a one-year study of more
than 2,500 women showed the most common problem was contraction of scar tissue
around the implants, which can cause changes in breast appearance and deflation.
That occurred in 7.2 percent of women who had breast augmentation and in 12.5
percent of women who had breast reconstruction.
Leakage or deflation happened to 3.6 percent
of women who had augmentation and 2.6 percent of reconstruction patients.
An FDA official who analyzed the company's
studies said the risk of complications increased over time. Dr. Sahar Dawisha
said 95 percent of reconstruction patients had reported some type of
complication after five years.
Studies on serious ailments such as
connective tissue or autoimmune diseases were not designed well enough to draw
any conclusions about whether they were related to the implants, Dawisha said.
American September 1999
major report finds that silicone breast
Women who have silicone
breast implants are no more likely than the rest of the population to
develop cancer, immunological diseases or neurological disorders, a committee of
the Institute of Medicine (IOM) reported
on June 21. Moreover, mothers with implants may safely breast-feed their
infants, as there is no evidence of toxicity in the milk. The IOM committee drew
its conclusions after holding public hearings (during which women with implants
told of their experiences) and reviewing scientific literature on silicone
breast implants (first made in 1962) and silicone.
The analysis--funded by the U.S.
Department of Health and Human Services and the National
Institute of Arthritis and Musculoskeletal and Skin Diseases--is the latest
in a series to have found such results. Similar announcements were made last
year by scientists who were appointed by judges overseeing implant liability
litigation in the U.S. and by researchers in Britain reviewing implant safety
for the British Department of Health.
Still, the IOM committee points out, breast
implants are not without risks. The tissue around the implants may contract,
causing pain and disfigurement and leading to infection by skin bacteria that
normally reside in the lactiferous ducts of a healthy breast. Also, implants
have a finite life span, and rupture rates of gel implants and the deflation
frequencies of current saline models have not been determined. Problems lead to
additional surgery to replace or remove them.
Not everyone is convinced by the IOM report.
Some believe that a study based on other studies--called a meta-analysis--is
inherently flawed because of assumptions made about the quality of previous
research. In any case, implant manufacturers have already agreed to a total
settlement estimated at $4 billion with plaintiffs who claimed physical harm;
now-bankrupt Dow Corning will be paying
the most, some $3.2 billion.
SUBGLANDULAR, SUBPECTORAL or SUBFASCIAL
Originally when augmentations were first
performed in the early 1960s with silicone breast implants, they were placed in
the subglandular position over the pectoral muscle.
They were hard or became hard. They were hard to begin with.
If you look at the old Dow-Corning product descriptions of the implants, there
were no soft implants in the early sixties. They were teardrop shaped, often
with Dacron patches on the back, and they all became hard, and were quite firm
before they were implanted.
Since the early type implants were firm to
begin with, they were expected to be firm, and capsule contracture was not felt
to be a major problem.
This may be one of the secrets of the
polyurethane coated Meme
implant. That is that they are firm to begin with, and therefore do not contract
into a ball so easily like the softer implants do. In those early days, firmness
was thought to be desirable to a certain extent anyway.
Then in a few years, in the late sixties, the
patients were asking if something couldn't be done about the hardness, and
softer implants were soon on the market. Then in 1967, C.O. Griffiths first
reported the submuscular implants in augmentation.
As the capsular contracture problem became
more common with the softer implants, more surgeons shifted to the submuscular
technique, until now (since the 1980s) there are and have been many articles and
opinions in the literature that the implants tend to remain softer in the
submuscular position. The advantages of the subpectoral position are:
1. Dissection is just as easy as pre-pectoral
2. Bleeding is no greater.
3. Hemostasis is as easily obtained.
4. It is substantiated in the literature.
5. It is about as popular as pre-pectoral, if
6. The muscle over the implant reduces the
feel of hardness if contractures occur.
7. The muscle movement presses on the
implants and may thus keep them a little softer.
8. The muscle over the implants provides a
smoother, straighter contour from clavicle to nipple, without a demarcation line
(especially as seen with capsule contracture) - no “stuck-on” look.
9. The muscle force pushes the implants down,
counteracting the tendency of the capsule contracture to push the implants
10. The implants are further removed from
breast tissue, with less chance of being involved in breast diseases, lactation,
or breast biopsy.
11. There may be less numbness of the nipples
due to less damage to the third, fourth, and fifth intercostal nerves.
12. It is said to be better for mammography
to have implants placed below the muscle.
The main disadvantages of submuscular
1. Anesthesia, especially local, is more
difficult to achieve.
2. Post-operative pain maybe greater.
3. The muscle may be weakened.
4. The muscle force may push the implant down
5. There appears to be less cleavage, but
this is debatable.
6. Patients may have a flatter appearance,
with less projection of the breasts forward.
7. The muscles may be visible over the
implants when contracted, and press the implants laterally. This can usually be
prevented. It occurs more frequently with an areolar incision.
8. The breasts may not feel as soft or move
9. If capsule contracture occurs, closed
capsulotomy is more difficult.
With all these different debatable
considerations, one can see that there is no definite best way for all patients.
Each patient's special circumstances may determine which implant position is
best for her.
For example, if the patient is very slender
with very little subcutaneous or breast tissue covering the upper chest, the
patient is a good candidate for submuscular implants. If capsule contracture
occurs and the amount of tissue covering the breasts is exceedingly thin, the
condition will be more noticeable; a sharp demarcation line may occur at the
superior margin of a spherical contracture, causing a stuck on, coffee-cup like
appearance. The submuscular position can partly prevent this from happening.
If, however, the patient has considerable
subcutaneous and breast tissue to cover the implant and is particularly desirous
of cleavage, the submammary position might be better. For the patient who is a
professional or serious amateur athlete who uses her arms often, such as with
bowling, golf, tennis, swimming, etc., thorough counseling is needed to choose
the best approach.
A newer approach has now emerged in since 1996, and that is the subfascial approach.
The subfascial placement of breast
implants has many of the advantages of submuscular position without lifting the
muscle attachments from the ribs. The subfascial placement has become the
preferred position for the placement of breast implants in our practice. The
advantages and disadvantages of this position compared to above and below the
pectoral major muscle are discussed. The clinical experiences with more than
1000 breast augmentations in the subfascial position are reported. The
indications for this technique are proposed. The incidence of complications are
described from clinical experience and compared to other methods. The longest
term of after surgery observation has been more than three years. The average
time of observation of these cases has been about eighteen months. We have used
the subfascial position through axillary, areola and inframammary incisions. As
implants are placed routinely below the muscle through the umbilical approach,
it can be done through that incision as well.
The subfascial position prevents the stuck on appearance
caused by the interruption of the clavicle to nipple line just as the
submuscular does. It is a little less potent in this because it is not as thick
as the muscle.
The subfascial position prevents rippling above the areola
just as the submuscular position does and probably as well.
The SF (subfascial) position does not push the implant down
as the muscle does in the submuscular position (SM). This pressure of the muscle
provides some hemostasis right after surgery. This force of the muscle also
massages the breast implant and may help keep it soft. It also prevents the
rising up and too early healing of the inferior breast pocket at the
inframammary fold by the muscle pressure pushing down the implant against the
area of the fold. It may help prevent capsule contracture by pressing the
implant down. All these factors are logical and reasonable and clinically seem
to be correct but are unproven and may or may not be important.
The subfascial is definitely less injury to the patient than the submuscular. It has less morbidity. The patient is less uncomfortable. Also it prevents the muscle movement that is sometimes visible after submuscular placement of implants.
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1984-2013 American Society of Cosmetic Breast Surgery Last modified: September 9th, 2013