Implants do not have an "expiration date" when they have to be routinely replaced. But little by little they do wear out, and every year they get weaker. The national average figures just released in June 2000 are as follows: For round smooth implants the three-year figure is about 0.3% having failed, for textured implants about 2.5% having failed. Here is more information:
Mentor: (both smooth and textured mixed together) in 1264 augmentation patients, 31 implants had failed by 3 years, which is 2.4% which is from averaging together both under-filled and optimally-filled implants. Underfilled implants don't last as long as optimally-filled implants.
So what were the figures if we consider smooth and textured separately? For Mentor, the national average for Style 1600 smooth round implants after 3 years was 0.3% failed, for Style 2400 textured was 2.44% failed, and for Style 2600 textured was 2.49% failed. (Style 1400 was not included in the study, but read on.)
McGhan: (both smooth and textured mixed together) in 2333 augmentation patients, 56 implants had failed by 3 years, which is 2.4% which is from averaging together both under-filled and optimally-filled implants. Underfilled implants don't last as long as optimally-filled implants.
So what were the figures if we consider smooth and textured separately? For McGhan, I have not yet been able to get that information, but it is likely to be similar to the figures for Mentor, that is a 3 year failure percentage of 0.3% for smooth, and a 2.5% for textured.
What is the significance of the fact that these are National Averages? Plastic Surgeons can be more-or-less divided into two groups: those who try to fill the implants to their "optimum" and those who fill them below their "optimum". Those who fill the implants less than the optimum do so because the implants are softer and less round, but they are more wrinkled and fail faster. Those of us who do fill the implants to the optimum do so because there is less wrinkling, and the implants last longer, but the implants are rounder and firmer. So a 0.3% average failure rate is made of an average of those implants filled to the optimal level (ie a lower failure rate), averaged with those filled below the optimal level (ie a higher failure rate).
Based upon the best currently available information, I tell my patients to assume that for the smooth round implants the five-year failure rate would be about 1%, by ten years 5%, by fifteen years 25%. My own figures have been better than these, probably because I, as do many plastic surgeons, consistently fill these implants to their optimum range, even if that requires Overfill. Again, as mentioned, the failure rates for the textured implants are higher.
It is not required to just routinely replace old but still intact saline implants, because there is no known danger to the person when the saline leaks. (One sometimes hears scare-stories about leaking implants being dangerous due to bacteria or fungus inside, but there have not been any actual documented cases of this happening.) The salt water has the same concentration as body fluid, and in fact is straight out of a sterile intravenous bottle in the operating room. So if it were to leak, the saline would be absorbed and passed out of the body. Deflation of the implant would be apparent to the woman, in that within about two days, the implant gets down to about half the size. A silicone gel implant does not change size when it leaks. The patient cannot tell a failure has occurred, which is why the FDA recommends frequent MRI testing for silicone gel implants. She would need a new implant inserted, because the old one cannot be patched or pumped back up.
Insertion of a new (same-size) saline implant is usually done through the original scar, regardless of whether it is in the underarm, nipple, crease, or navel. Saline implant replacement is less involved than putting in the implant in the first place, provided that the same size or smaller implant is being inserted. Putting in larger implants is a bigger operation than putting in the implants the first time. Replacing a failed silicone gel implant is usually a larger operation than insertion the first time.
The implant manufacturers have a lifetime replacement assistance program on the implants themselves.
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