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Type of
Implant: (Also
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
intact. 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
gels. 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
formation. 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
easily. 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
made. 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
ET FDA Panel Deems 2 of 3 Breast Implant Brands
Safe
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
year. 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
concerns. 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. Scientific
American September 1999 SILICONE SAFE
A
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.
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The American Society of Cosmetic Breast Surgery 2018 Last modified: September 18, 2021 |