The FDA recently mandated that patients in the silicone gel study be told that the likelihood of needing an implant changed sometime in their life is greater than 50 percent.  I do not believe that this will turn out to be true either.  Here is why...

The FDA data looked at patients before 1988.  From about 1978 until 1986 implant manufacturers used second generation implant shells which were made with a process called room temperature vulcanization.  These suffered from a very high rate of failure.  After 1986 most manufacturers changed to high-temperature vulcanization.  I have found the failure rate of third generation implants to be very low in my practice.  No one, however, knows what the forty-year failure rate of these third generation implants is going to be!  1986 was only 14 years ago.

Given my present experience with third generation implants I believe the failure rate will not prove to be high, but only time will tell.  The good news is that changing a saline implant that has deflated can usually be done under local anesthesia and the major implant companies pay for both the new implant and the procedure.