- What Are Cohesive
Gel Breast Implants?
Which Surgeons Can Use Cohesive Gel
Implants in The United States?
Which Patients Can Receive Cohesive Gel
Implants in The United States?
What Are The Main Advantages of
Cohesive Gel Implants?
Why Are Cohesive Gel Implants Anatomically
Shaped?
- Is this the ideal breast implant?
- Why is the implant being studied?
- If I am part of the study is the surgical procedure
free?
- Are There Round Cohesive Gel Implants?
Do Cohesive Gel Implants Come with a
Smooth and a Textured Surface?
What Happens if a Cohesive Gel Implant
Ruptures?
How Would You Know if a Cohesive Gel Implant
has Leaked?
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. (refer to section on this in website.)
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. Back
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. Back
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. 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 geographic
vicinity of the implanting surgeon in order to facilitate this follow-up.
Back
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.
This unique filler produces
superior breast shaping compared to other existing
saline and silicone gel implants. 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. Back
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. Back
Is this the ideal breast implant?
There is no perfect implant, but this one is a big step in
that direction, with preliminary results better than any other implant data we
have seen. They offer an improved option for patients desiring either
reconstructive or cosmetic surgery. Back
Why is the implant being studied?
Cohesive gel implants have been used clinically in
Europe and Brazil for over 10 years and have become the most popular
implant internationally due to excellent results; however, new devices must
undergo well planned FDA clinical trials prior to approval in the US, and
the cohesive gel implants are currently under FDA clinical trials in the
US. Back
If I am part of the study is the surgical procedure
free?
No. All fees (surgeon, hospital, anesthesia and
implant) still apply in the clinical trial. The benefit to the patient is
access to a new technology otherwise not available in the US. Patients on
the clinical trial must be willing to return annually for a follow-up
visit in order to generate long term data for the study.Back
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, degree of
cohesion is not a black and white issue; there is an endless continuum in
cohesive gel from very liquidy to very solid. Back
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. Back
What Happens If A Cohesive Gel Implant Ruptures?
We do not really know,
because there is so little experience with this. In thousands
of cases in Sweden over the part 10 years there
has been only one reported implant rupture.
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. Back
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. Back
