Monday, September 21, 2009

How long do breast implants last?

One of the most frequent questions we get about breast implants is how long they are supposed to last. Our good friends at the FDA have added to the confusion by requiring disclosure that implants will probably need to be replaced every 10 years, so patients naturally assume that is the case when they read it. That would indeed be quite a commitment, but on the other hand the manufacturers of breast implants also have a lifetime replacement policy so that if the implant ever does develop a hole on the outer shell they will provide a new one free. Obviously they are not planning to do this every 10 years.

One reason the actual number is so hard to pin down is that implant designs and manufacturing standards continue to improve, so data from implants made 25 years ago isn't really applicable to implants made today. Another reason is that patients tend to drop out of studies over time, valuing their privacy over the need to contribute personal information to long-term clinical data. And of course people move, names change with divorces and marriages, and just keeping track of a large population of women with a specific type of implant is impossible over the long run. Adding to the problem is that most implant "ruptures" (really the wrong word) are silent and harmless events. So it isn't for lack of effort that the long-term data is hard to come by.

There are some numbers to go on though. Prior to FDA approval of silicone gel implants a couple of years ago, statistics from what is called the core study were submitted. In that group, the rate of "ruptures" was 2.7% at 4 years (for Allergan implants), implying that for the vast majority the implants will last a very long time. In my own experience, having used the implants for some 15 years (initially as part of what is called the adjunct study), I can't recall a single silicone implant rupture from one that I put in. About 80% of our patients are now going with silicone, for a more natural feel than saline.

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