What Are Cohesive Gel Breast Implants?
The standard implant in the United States has been saline
filled, ever since the FDA moratorium on silicone gel filled breast
implants in 1992. The type of implants that were available before the
ban are available today as part of an "adjunct study," which is open to
patients with congenital deformities or having a revision for particular
reasons.
What distinguishes cohesive implants is that the silicone gel is firmer,
essentially a soft solid. If a cohesive implant is cut in half, there is
no gross movement of gel, and the implant maintains its shape.
The way these are made is that the company uses more "crosslinker" in
the making of the implant. The ingredients are the same, but with more
crosslinker added, it makes the gel firmer.
The term "cohesive" has been bastardized in recent years. Cohesive
breast implants implies form stability, or form retention. That means
that in any position, the implant maintains its shape. That is an
important distinction, because it means that the shell should not fold,
and that it will maintain a particular shape.
Unfortunately, given the recent media attention to cohesive implants,
many are using the term to describe "regular" silicone gel implants.
Technically, they are correct; all silicone gel is cohesive to some
degree. But the term cohesive has always meant form stability, and when
patients ask for cohesive gel, it is because they are looking for an
implant with those particular characteristics of durability and shape
retention. Hopefully, the terminology will be clarified in the coming
years.
Which Surgeons Can Use Cohesive Gel Implants In
The United States?
Each of the three studies has a group of only several dozen surgeons
that are allowed to order the implants and implant them. Surgical
expertise and a commitment to careful patient follow-up were the
criteria the manufacturers used to select the surgeons that they would
have implant their implants. Dr. Teitelbaum is the only surgeon in
California (and if not the only, one of the very few in the entire
nation) to have been asked by all three manufacturers to participate in
their clinical trials.
Which Patients Can Receive Cohesive Gel Implants
In The United States?
The trials are open to patients seeking a first time augmentation, a
revision of a breast augmentation, or breast reconstruction following
mastectomy. Patients with certain medical problems cannot participate.
Please see the enrollment specifications for each of the implants listed
below. In addition to the objective medical issues, patients must be
committed and willing to participate for a full ten years of follow-up
to be considered for the study. Patients must be in the immediate
geographic vicinity of the implanting surgeon in order to facilitate
this follow-up.
What Are The Main Advantages Of Cohesive Gel
Implants?
The main advantages of cohesive gel implants are longevity and shape.
Longevity, because they do not develop folds, and it is along folds that
implants ultimately fail. And if, somehow, the shell does fail, since
the gel is so thick, it hopefully will not migrate anywhere in any
significant quantity. Shape is enhanced because, from the point of view
of a surgeon, there is only control of breast shape if there is control
of distribution of fill in an augmentation. If the fill cannot be
controlled, then the shape cannot be controlled. And to control
distribution of fill in the breast, fill distribution must be controlled
in the breast implant. All fillers other than cohesive silicone gel -
saline or regular silicone gel -can migrate around within the shell of
an implant, which means that there is not control over breast shape.
Looking at results from breast augmentation objectively, these implants
appear to have the most aesthetically natural and beautiful results.
Why Are Cohesive Gel Implants Anatomically
Shaped?
A breast projects more at the bottom than at the top. Therefore, it
makes sense for an implant to be shaped that way. And the thinner an
implant is at the top, the more gradually and naturally it will feather
into the upper chest, making itself less conspicuous. Without a
cohesive, form stable filler, there is little point in making shape into
an implant, as the implant will ultimately lose the shape. But with a
form stable filler, the shape will be maintained.
Are There Round Cohesive Gel Implants?
Form stable round cohesive gel implants are available in Europe, but not
in the United States. There is actually very little use for them. If you
look at an implant lying on its side on a table, it looks much like an
M&M. But when it is held upright, the upper pole gradually collapses. It
is that upper collapse that allows those implants to look natural
(though it is doing so at the risk of folds on the implant shell.) A
true cohesive round does not do that. By maintaining that M&M shape when
vertical, it creates a dome-like, relatively top-protruding shape.
However, cohesivity is not a black and white issue; there is an endless
continuum in cohesive gel from very liquidy to very solid. On Silimed's
cohesive clinical trial, there are 4 different round gel options. These
are more cohesive than implants made in the past, and can be considered
cohesive, but they are not as cohesive as their anatomically shaped
cohesive gel implants or the anatomic cohesive implants by Mentor or
Inamed. They fold less than gel implants of the past, but they are not
quite form stable, in terms of their ability to resist folds or
predictably maintain a shape.
Do Cohesive Gel Implants Come With A Smooth And
A Textured Surface?
All anatomic (a.k.a. teardrop) shaped implants are textured, as the
texturing increases friction and helps keep them from rotating. Since a
teardrop implant is different at the bottom than the top, it is
important that it maintains its position.
The Silimed round implants come in both smooth and textured surface, but
remember that while relatively more cohesive than most other silicone
gel implants, they are not form stable like their anatomically shaped
cousins.
What Happens If A Cohesive Gel Implant Ruptures?
We do not really know, because there is so little experience with this.
At the time of writing this, there is report of a single rupture in a
series of several thousand in Sweden.
If it did happen, however, one would imagine that the gel, being
relatively stiff and solid, would not migrate in any significant amount.
Since it has the consistency of a gummy bear, the gel would presumably
stay in place. Microscopic migration of gel would presumably occur, and
this can even happen to some extent through an intact shell. This is a
subject of ongoing investigation, and more research will be needed to
answer this question.
How Would You Know If A Cohesive Gel Implant Has
Leaked?
Given the gummy bear nature of the filler of these implants, it is
likely that it would be difficult to tell if they ruptured. Perhaps it
might be detected by mammogram or MRI.
When any implant is placed in the body, the body forms a capsule around
the implant. If a cohesive implant were to leak, it would probably just
stay within the capsule. The capsule might thicken, and a patient may
notice a difference in the feel of the breast. But it is also possible
that there might be no change at all.
The important point, however, is that silicone gel has not been linked
with any health problem, so even if there were a shell disruption, it
should not prove to be of any medical problem.
Related Pages:
History of Cohesive Silicone Gel Breast Implants
Advantages and Disadvantages of Cohesive Gels
Cohesive Gel Breast Implants - General Info
Mentor Core Gel Study for Silicone Gel Breast Implants
McGhan Cohesil Study Information for Cohesive Silicone Gel Breast Implants