Silicone Breast Implant FAQ's
Many years ago when implants were first developed, a significant number of them
experienced failure of the shell. This allowed the liquid, or loose gel silicone to become
free within the pocket. A study which looked at implants found that almost all of a
particular type of implant failed after 10 years. This led to the false rumor
that all implants needed to be changed after 10 years.
If the shell of an implant does fail, the silicone does not "run all over the
place"! Remember, a fibrous capsule is formed around the implant by the body. This is
normal. That capsule should contain most of the silicone within the pocket in cases
of shell failure. Very small droplets may incorporate into the surrounding tissue.
Research continues, but the FDA and Federal Court Panel reviews do not
point to a likelihood that this problem has caused cancer or autoimmune
disease.
A suspected implant failure is usually best investigated with MRI. Changing a saline
implant when needed, is usually not a big surgical procedure. The pocket is already made
and this can often be done under local anesthesia. In cases of silicone failure, the
implant should usually be removed with the surrounding capsule and can be a more involved
procedure.
What are the rupture rates for MemoryGel™ Implants?
Mentor has very low rupture rates for our MemoryGel™ products. Our Core Study
had 1007 patients, 420 of which participated in a MRI cohort to help study
silent ruptures. At three years, our confirmed rupture rate (through explant) is
0.2% by patient and 0.3% by implant.
Some patients in the study have had MRI's that appear to have ruptures.
However, the patients have chosen not to have surgery to confirm the status of
their implants-- these are called suspected ruptures. The confirmed and
suspected rupture rate is 1.1% by patient and 1.6% by implant.
It is important to note that 3 suspected ruptures have undergone explant
surgery and all implants were intact.
The augmentation patient satisfaction rate was 98% for the respondents.
Once again, it is my belief that implant failure can happen and may lead to the need
for additional surgery, but the likelihood of this causing systemic disease is very small.
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