Silicone gel implants were first used for cosmetic breast surgery about forty years ago. Over time all silicone gel implants tend to leak certainly by the twenty year mark. The concept of silicone gel "bleed" and its consequences have been the source of consternation and debate since these gel implants were withdrawn by the FDA in 1992. Now they have relatively recently been re-released. The fact that many women desire silicone gel as opposed to saline breast implants in view of the uncertainty over their safety is remarkable. The recent "approval" by the FDA does not proclaim their safety interestingly enough; it merely makes disclosure of risk to the patient a larger issue than it has been in the past.
What is Known?
Silicone gel implant bleed with traditional gel implants leads to the increased potential for capsular contracture or breast hardening. This hardening usually requires surgical treatment and frequently recurs. It can lead to significant breast distortion or pain in severe cases. Concerns over breast cancer incidence and diseases such as Lupus relating to silicone gel implants were pretty much dismissed after a few large Canadian studies.
What about the FDA?
In late 2006, the FDA approved gel implants with the provision that informed consent be a little more involved. An online course for surgeons was also required. The implant studies of the last several years revealed a pretty high re-operative rate of 25-35% over four years.
The newer Cohesive Gel or gummy bear implants (Mentor) will soon be joined by a similar product by Allergan (formerly Inamed). These newer generation gel implants are designed with gel that "sticks together" better to hopefully decrease gel bleed and migration into tissues. What this means to implanted patients has yet to be determined.
The real relevance of the FDA approval is availability. They are available to women over 22 for augmentation.
"OK. What Should I Choose?"
Silicone gel implants are now more available than they have been in the recent past. These implants feel more like "real breast tissue" initially, but as far as we know have a higher chance of long term hardening requiring more surgery. They retard problems with rippling due to thin soft tissue cover. The "Cohesive Gel" product is so new that long term data on the breast "hardening" rate are not available. The traditional gel implants will eventually leak and come with that increased risk of hardening.
Saline-filled implants do not have the same history of hardening. They do not look very "breast-like" as we get larger relative to the soft tissue available to cover them. Really large saline-filled breast implants look progressively less natural.
The author's preference is to use saline-filled implants unless problems warranting consideration for silicone gel come into view - rippling in particular. Patients considering silicone gel implants are informed that there is some uncertainty with silicone gel. Long term risks for re-operation and distortion from scarring (some of which may not be repairable) are higher when silicone gel implants are used. BTW - Silicone gel implants are 2-4X more expensive. Medical insurance doesn't pay for them as your doctor needs to order them.
"What About These New Gummy Bears?"
The Cohesive gel implants are interesting in that the gel has the consistency of "jello." It is not a thin liquid gel. This combined with a new shell container is thought to reduce silicone gel bleed which should decrease the rate of scarring in the breast (contracture). The long term contracture rate is not yet known, but if you are considering silicone gel you should probably consider this implant. The FDA recommends that women desirous of silicone gel implants carefully consider their decision and have frequent breast MRIs to follow the status of the implants should they have them placed.
"What About Profile?"
Breast implant profile has become more variable in the last ten years. The most common shape implanted in years gone by was round and moderate profile. Profile indicates how far the implant stands forward relative to it width. Higher profile implants tend to provide more cleavage but stretch the tissues further and may lead to more rippling. Current options vary by filler material but include high profile, moderate plus profile, moderate profile and low profile. What is best for a given patient is really a matter of opinion. It is something to be discussed in consultation and certainly at pre-op.
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© John Di Saia, MD... an Orange County
California Plastic Surgeon
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