Reader Laura’s Comment:

The FDA has announced that the makers of silicone breast implants have not been following up with the women who have received them as requested when they re approved silicone implants. How long can a woman safely have their implants in before they should have them removed or replaced? Is 10 years the norm? Do you have specific time in mind for replacement when the implants are first but in? Do you recommend that your patients get MRIs?

Makers of silicone breast implants have not followed up on thousands of women who received them as required by the Food and Drug Administration as a condition of approval, agency advisers said Wednesday. Mentor Worldwide and Allergan Incorporated received FDA approval for their silicone gel-filled breast implants in 2006 after agreeing to do large, 10-year post-market studies. But in a two-day meeting to update two FDA panels on the status of those trials, the companies admitted they had lost track of large numbers of women after implantation.
Source: cnn.com/2011/HEALTH/08/31/silicone.breast.implants/index.html?hpt=hp_c2

Silicone gel breast implants leak small amounts of silicone gel into a patient’s body over the time in which they reside there. There has never been much of an argument there. The real question is whether or not this is well tolerated. The answer is sometimes more than others. It has always left me a bit unsatisfied when implant makers and their spokespeople have stated that silicone breast implants are “safe.” What does that really mean? I recommend silicone breast implants for a small minority of my breast implant patients when their risks seem warranted by benefits. I do not call them “safe” however.

If my wife were to have breast implants she would be having saline-filled models. My opinion is that they are much safer over time.

On the subject of breast implant studies, most patients simply don’t like them. For years we tried to follow our silicone breast implant patients for purposes of follow-up studies. This was back before the FDA made study administration the implant manufacturer’s problem again. The average patient has little interest in coming in for re-evaluation unless there is a problem. Blaming the implant companies for lack of follow-up in this light is not fair.

On the longevity of silicone gel implants, that is an unknown. The newer generation “gummy bear” implants have not been around that long. I think replacement over a ten year cycle is probably conservative, but patients do not always stay with the same surgeon for ten years and that cycle time is not standard.

Breast MRIs are recommended for silicone gel implant patients at intervals but few of these women get them. Breast MRI studies are expensive and health insurance does not cover them usually. In fact, a woman admitting that she has breast implants can get her insurer to refuse to extend policy coverage or rescind it in many cases.

Silicone gel breast implants are controversial and by the looks of things are going to stay that way for the foreseeable future.

Best Regards,

John Di Saia MD

Related:

Options for Old Silicone Breast Implants