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US FDA Releases Silicone Gel Breast Implant Ban

Posted Nov 24 2006 12:00am


Although most of my colleagues are rejoicing, I receive the news of the lift of the silicone gel breast implant ban equivocally.

The real question is what defines “safe.”

Silicone gel implants do cause more problems than their saline-filled counterparts. They are certainly more prone to encapsulation (breast hardening) and many more patients with gel implants need additional surgery (at least in my experience) relative to patients with their saline-filled counterparts. Perhaps the FDA figures that the information is out and women can make their decision based upon that evidence. I will still use silicone gel implants only after a discussion of the risks involved and will use the specialty consents required by the FDA.

A follow-up question is reasonable here:

The gel implants still require registration and this consent whereas the saline-filled versions do not. If the FDA felt that silicone gel implants were so safe, why is there a difference?

This will remain confusing.

Best Regards,

John Di Saia MD

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