subject: Gel Breast Implants - Safety Considerations [print this page] Gel breast implants have many misconceptions about them, due largely to the fact that they were banned for several years pending FDA investigations about their safety. For women who want a larger chest but wish for the results to feel as real as possible, these devices are the best choice, yet many women feel they need reassurance about their safety.
In November of 2006, the FDA once again approved silicone gel breast implants. While the products are still under heavy monitoring by the FDA, the FDA performed sufficient testing to determine that the devices do not seem to pose a significant risk to the women who get them. This approval was offered based on the manufacturers' clinical and pre-clinical studies about the devices, as well as independent inspections of the manufacturing facilities by the FDA.
So what is the big issue? In the past, people have wondered whether or not these implants increase a woman's risk of developing connective tissue disease or cancer. The good news for women considering this surgery is that no convincing evidence has come to light indicating that the devices have any effect on these diseases.
These devices are typically filled with silicone, which is commonly used in the cosmetic surgery field. They are soft and flexible, creating a chest with a natural feel. The filling is added to the devices by the manufacturer, so the doctor does not have to fill them during the surgery. This does mean that the surgery requires a larger incision site, however, because the full implant must be placed in the body, rather than the empty shell. This does not add any increased risk to the patient.
In addition, silicone gel implants are quite durable. They can leak or deflate, but they are designed to withstand 25 times the force of a normal mammogram procedure, the most forceful event most women experience in that part of their bodies, without failing. For most women, these devices last 20 to 30 years, giving an advantage over saline options that need to be replaced much sooner.
If these devices do break or leak, the silicone usually leaks out very slowly. For many women it stays within the scar tissue capsule that the body forms around the implant. Sometimes it can leak into the body, which is somewhat dangerous. To protect patients from this scenario, some doctors will schedule routine MRIs to detect breakages or leaks. By keeping these appointments, you will ensure that you catch any problems with your implants before they cause a serious health risk.
by: Abigail Aaronson
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