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FDA Update: Are Silicone-Filled Implants Really Safe?

FDA Update
FDA Update

There was quite a scare in the early 1990s about silicone-filled implants, and then another one in 2006.

Recently, however, the U.S. Food and Drug Administration has updated its information and recommendations about these devices and, thankfully, the FDA still considers silicone implants to be safe and effective if used as intended.

Good news: no new hazards

And, so far, the data reviewed don’t show any evidence that implants cause breast cancer, reproductive problems, or connective-tissue diseases. It’s comforting to know that the FDA’s results show the same levels of safety as before.

But be aware of the risks

However, those considering having silicone implants surgically inserted for breast augmentation or reconstruction need to keep in mind that there are some risks associated with these devices. All individuals who are considering silicone implants should factor these risks into their decision. (Note that I said “individuals” here, and not just “women,” because men also have mastectomy surgery for breast cancer, and afterward sometimes choose to have small implants placed under their pectoral muscle(s).)

No lifetime warranty

First, please know that breast implants do not come with a lifetime gurantee. This means that the longer you have an implant, the higher will be the probability that you will develop some type of problem with it. These problems might include:

  • Capsular contracture — An abnormal response by the immune system to the presence of a foreign object that’s been surgically installed in the body (for example, breast implants, artificial pacemakers, orthopedic prostheses, etc.). The immune system is actually trying to protect the body by surrounding the foreign object in a capsule of tightly-woven collagen fibers. Unfortunately, in a severe capsular contracture, the collagen capsule will start to tighten painfully around the implant, which results in abnormal firmness or hardening of the breast, or even in a distortion of its shape.
  • Reoperation — You may need to have one or more reoperations over the course of your life, due either to a single complication or to a combination of them.
  • Implant removal — Local complications and undesirable results can occur in at least 1 percent of breast-implant patients. The implant might need to be removed because of, among other things, breast pain, changes in nipple and breast sensation, or the rupture of saline- or silicone gel-filled implants.

For more information about this, visit the FDA’s website about breast implants.


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