Silicone breast implants: Are they safe?

Are the complications different for saline and silicone gel implants? And if so why would women (or surgeons) prefer the silicone type?
The silicone gel implant feels more natural than that made with saline and is associated with less dimpling of the skin. Sometimes wave-like ripples occur on the surface of the augmented breast, especially with a shift of position. Many surgeons feel this occurs more frequently with saline implants. There may also be a lower rate of capsular contraction (scarring and hardening around the implant) with gel-filled implants as compared to those filled with saline. In general, no matter what the implant is filled with, a less than perfect appearance also depends on where the implant is placed:

Submuscular placement (under the chest wall muscles): This surgical placement takes more time, may be more difficult and may initially be more painful. However it feels more natural (it’s covered up by the breast tissue). “Under the muscle implants” are also less likely to undergo capsular contracture or hardening and their placement allows for easier imaging of the breast tissue during mammogram screening.

Subglandular placement (directly under the breast tissue and above the chest muscles): The surgery may be shorter, less painful and it’s easier to “redo” if future surgery is needed. The implants and their edge or rim are, however, more easily felt and seen when placed right under the breast tissue. There is also a greater likelihood of capsular contraction. Finally, it’s harder to image the breast tissue during mammogram.

The two types of implants also come in textured or smooth shells. Some studies in the past suggested that a rough shell surface was less likely to cause severe capsular contraction but recent studies by Mentor don’t show this. Surgeons may prefer a smooth capsule implant because it can be more easily “slid into” the pocket  and requires a smaller incision

All augmentation surgery can have complications which include bleeding, infection, pain and a change or lack of sensitivity of the nipples. There may be problems with future breast feeding especially if the initial incision was done around the areola (the pigmented area surrounding the nipple). The most frequent cause of re-operation or removal of implants is capsular contraction (the outer capsule scars  making the implant hard, contracted and painful). The cosmetic result of any breast implant may not always be stellar—the implants may not be symmetrical, and may shift with time. As the body ages, breast tissue changes, more fat can accumulate, gravity takes over and sagging may occur, especially if the implants are large; the implants may just not look right.

A major difference between a saline implant and that made of silicone gel is the “obviousness” of an implant rupture or leak and subsequent leakage problems. If a saline implant ruptures, the fluid (which is harmless) will be absorbed by the surrounding tissue, the implant collapses and the remaining capsule can be felt as a lump in the breast. So of course, the breast will lose its shape and volume. This is certainly noticeable! But if a gel implant leaks or ruptures it may not be detectable. (The implant will not deflate.) If silicone gel implants rupture or leak, the silicone can remain within the capsule (intracapsular rupture) or it may leak out to the surrounding tissue (extracapsular) or in rare instances it can move beyond the breast (migrated gel). There are some reports of the gel migrating to the armpits, lymph nodes and even further down the arm or even to the abdomen. This can lead to nerve damage, formation of lumps and breakdown of overlying tissue and skin. There is also concern that this could cause or increase the development of connective tissue diseases, arthritis or fibromyalgia. The overall studies that examined the cause and effect of silicone gel implants with the incidence of these diseases did not prove a direct correlation, however most of the studies did not differentiate between women with intact and ruptured implants. So in the case of a rupture, the consensus is “remove and if so desired, replace!”. In some cases this can be a long and complicated surgery.

How often does rupture occur?
There is an epidemiologic disagreement on rupture rates of past silicone gel implants. Some studies have shown a general wear and tear with a “bleed” of minute amounts of gel in nearly half of the “older implants” inserted during the '60’s, '70’s and early '80’s. The shells used at that time were less durable and the silicone gel was oilier and was polymerized differently at that time. As a result, short fragments of silicone could migrate through the shell. All this has changed and rupture rates are now felt to be negligible in “primary” (first time) augmentation. The most recent data that was presented to the FDA showed the following:

         Mentor rupture rates based on MRI after 3 years

                        0.5% for augmentation

                        7.7% for revision (re-do) augmentation

                        0.9% for primary reconstruction after mastectomy

        Allergan rupture rates based on MRI and non MRI findings after 4 years

                        2.7% for augmentation

                        4% for revision augmentation

                        0% for primary reconstruction

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