Are Silicone Gel Implants Safe?

In 1992, silicone gel implants were taken off the market because of the fear that they could be linked to cancer and connective tissue disorders. In 2006, the FDA approved their use again. Subsequently, many women and surgeons have opted to use them rather than the implants filled with saline. Even though these gel implants have been approved by the FDA, are they safe for women to use?

There are two types of implants that have been approved by the FDA. Saline filled device consists of an outer silicone shell which is filled with saline fluid. Silicone-gel filled devices are made of a similar silicone based shell and filled with silicone gel.

In the 1980, there were allegations that silicone system could be linked to cancer and other disorders. Several law suits were filed and millions of dollars were paid to settle the resultant lawsuits.

The FDA then banned the general use of gel implants for augmentation, except for women who required breast reconstruction subsequent to breast cancer and mastectomy. In 1993, the FDA revised this ban and allowed silicon breast system to be used in clinical studies. During these studies, data was supplied and collected.

Finally in 2006, the implants were deemed safe and the FDA gave a qualified approval for these gel devices. They did state that women who decide to get implants should be warned by the doctor about the risks. For example, the doctor must state that the implants will not last forever. Furthermore, if the implants are removed the breasts will not return to their original shape and there is a chance that they will dimple, wrinkle or sag. If the implant is replaced there is a higher risk of complications compared to the first time.

So are silicone devices less safe than saline? Many doctors believe that saline systems have a greater risk because they are more likely to produce wave-like ripples. These ripples occur on the surface of the augmented breast, especially with a shift of position. There may also be a lower rate of capsular contraction with silicone filled devices 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. Sub muscular placement takes more time, may be more difficult to work with and may initially be more painful. However it feels more natural. Silicone systems are also less likely to undergo capsular contracture or hardening and their placement allows for easier imaging of the breast tissue during mammogram. Sub glandular placement is less painful and it is easier to do again if future surgery is needed.

The implants and their edges are more easily felt and seen when placed right under the breast tissue. There is also a higher likelihood of capsular contraction. It is also harder to image the breast tissue during the mammogram.

A major difference between saline and silicon implant is seen during a rupture or leak and subsequent leakage problems. If a saline implant ruptures, the fluid will be absorbed by the surrounding tissue. The implant collapses and the remaining capsule can be felt as a lump. The breast will lose its shape. If a gel implant ruptures it may not be detectable and the silicone can remain within the capsule. It may also leak out to the surrounding tissue or move beyond the bust.

The latest development in breast implant surgery is the memory gel silicone devices filled with a cohesive gel. This cohesive material formulation acts as a unit rather than a liquid. This implant has slowly started gaining popularity because there is no migration, or running of the gel during a rupture.

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