After a fourteen year moratorium, the FDA has once again made silicone gel breast implants available for cosmetic surgery. In late November the FDA gave approval, with conditions, to the two implant companies to go forward with a new program. This was a result of numerous investigational studies, scientific meetings and governmental reviews. The conditions imposed on the companies require them to continue to track the histories of individual implants through registries, for another ten years. Implants are available to anyone over the age of 22 years.
Most surgeons and patients feel that silicone gel implants are cosmetically superior to saline implants. Rippling is much less evident, particularly in thin patients, and they are more natural in appearance and feel. However, silicone implants are more expensive than saline implants. In addition, knowing when a silicone implant ruptures can be very difficult. A saline implant simply deflates, the body absorbs the saline and the fact of rupture is obvious. However, when a silicone gel implant ruptures, the capsule which formed around the implant contains the leak, and the shape and size remain the same. If it is a traumatic break, as in a car accident or other major injury, the silicone gel may be extruded through the capsule into the soft tissues around the implant, causing scar tissue to form around this material. The body does not absorb this material and it must be removed surgically. Although rarely is a significant extrusion seen, it can be a significant problem. Mammograms and physical exams are notoriously bad at diagnosing silicone implant ruptures, MRI scans are often suggested as a means of diagnosis. The problem is their expense; this is rarely covered by insurance. Both implant types have an average life span of about fifteen years, therefore our recommendations too asymptomatic implants is to replace silicone implants every 15 years as a routine; saline implants may remain in place until obviously deflating.
Other concerns about implants are the development of capsule contracture (scar hardening around the implant) and implant effect on mammograms. Both types of implants are identical as to these potential risks.
We believe that silicone implants are an improvement over saline implants, however you may have some significant concerns in your own mind about silicone gel. Keep in mind that over the last fourteen years, most implants used were saline, and that the large majority of women have been very satisfied with them. If cost or safety issues are a concern to you, saline implants do a fine job and should meet your expectations.
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