10 months ago
This really depends.
From an official standpoint, we have one definitve resource. That is the studies submitted to the FDA for approval of the current implants which sites a 0.5% (1/200) chance at 3 years.
It is for that reason, that the FDA recommends that 199 patients undergo an unnecessary MRI to detect one rupture at 3 years after surgery.
The FDA has also advised that subsequent MRIs be obtained every 2 years thereafter.
These studies were performed on round smooth surfaced silicone elastomer outer shell and silicone gel filled 3rd generation implants.
Other rates may apply to different generations (4th and 5th) implants
Otto Placik MD
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