Is this FDA Statement Regarding Breast Implants True?

Aug 5, 2011 by

The Furry Brazilian is not so sure, as the following statement is very vague: “Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications,” the FDA said.

What is vague about that statement you might ask? Well, silicone gel-filled breast implants are not all the same. There are smooth silicone gel-filled breast implants, textured silicone gel-filled breast implants and Polyurethane foam silicone gel breast implants. Each type of silicone gel implant has been shown to have different complication and re-operation rates. Polyurethane foam have the lowest rate of capsular contracture and re-operation, might they be considered lifetime devices.

Oh well, there the Furry Brazilian goes being vague. What is a lifetime? Why is a marketing term, like lifetime, being used by the FDA and regarding an implantable device?

Shouldn’t the FDA be determining the expectation for a “usage lifetime” based on medical studies?

The statement was pulled from this article:

The topic is breast implants- something that is implanted into your body. So why do we all accept words like “reasonably safe” when associated with an implantable device.

From the article: “Silicone breast implants appear to be relatively safe for most women, although recipients often have them removed because of leaks, infections and other problems, federal health officials said Wednesday.”

I think it is a reasonable expectation for implantable devices to either be declared safe, or unsafe.

Leave a Reply

Your email address will not be published. Required fields are marked *