Ruptures, leakage, and overall safety have been the FDA’s primary concern ever since they first approved the use of breast implants in cosmetic surgery. Depending upon the type of implant, some ruptures reveal themselves quickly, while others are very difficult to detect.
Saline and silicone gel have been the standard implants for breast augmentation in the United States. This is truer of the saline implant since the silicone gel was banned from American use for fourteen years. It was once again approved for unrestricted use in 2006. Another breast implant is also trying to gain approval for the American market. Called the cohesive gel implant, it is commonly referred to as the Gummy Bear implant. At the time of this writing, it is still in clinical trials.
The saline and silicone gel implants have been scrutinized for years because of fear for their overall safety in regards to rupture and leakage. Implants can rupture for a number of different reasons, including damage during the implant surgery or another surgical procedure, the wrinkling or folding of the implant shell, or trauma against the breast.
It is very obvious when a saline implant ruptures. The breast deflates within a day or two, and the saline solution (saltwater) is absorbed by the body and passed out through the urine. The saline implant is arguably the safest breast implant available currently on the market.
It is not as easy to detect a rupture in a silicone gel implant. Not only is the patient unlikely to detect a leakage of the silicone gel, there is a strong chance that the surgeon will not be able to detect it either. A silicone gel leak is often called the “silent rupture” because it is difficult to tell if there has been a rupture or leakage without undergoing an MRI.
Since it is generally accepted that an MRI is the best method for detecting a ruptured implant, the FDA recommends all women with silicone gel implants have an MRI performed near the third anniversary of their implant surgery, and every two years after that.
When women pick silicone gel implants, they should realize they must also factor in the cost of an MRI every two years thereafter. The cost will not be covered by your medical insurance since it is a needed for a cosmetic procedure. Of course, if you had the breast augmentation for breast reconstruction purposes, your medical insurance may very well cover the MRI cost.
Presently, there is little data yet regarding ruptures or leaks in the cohesive gel implant. Theoretically, it should not leak if it ruptures because the implant is a solid mass of gel. Cut one in half and you have two halves of gel – there is no liquid to leak.
American women have options when choosing their breast implants, and that includes the new cohesive gel. If you decide you want Gummy Bear implants, however, you will have to join an FDA clinical trial study and agree to follow-up with your surgeon for the next ten years.
If you would like to learn more about the reduction of safety concerns in breast implants, make an appointment with a plastic surgeon that is a board-certified specialist in breast augmentation. If you are worried about the cost, ask if the surgeon offers a free initial consultation.
Please note: this article is not intended to be read as medical advice. Nor is it intended to provide medical recommendations. You should only heed medical advice and recommendations from a licensed physician.
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