FDA breast implant labelling changes – What you need to know

Have you recently heard about breast implant package labeling changes recommended by the FDA? What does this mean and have there been new concerns?

You may remember the FDA hearings a few months ago due to concerns with a rare type of cancer called ALCL and also breast implant illness. ALCL is very rare and only related to textured implants, not smooth.

All of my patients only have smooth implants, so this is not a concern for you.

Regarding so-called breast implant illness, aches, pains, etc, although this is being studied, there is no scientific evidence for a link to any breast implant, no matter the dramatic things you may have read on social media. These are the same complaints that caused the FDA to remove silicone gel implants from the market back in 1992. The breast implant is the most studied medical device in the history of the world. With hundreds of thousands of patients studied, there was no link found, and these problems seemed to go away for decades until the advent of social media. As we age, muscle and joint aches and the other complaints, are related to just that- aging. Studies will continue, but there is no evidence of any link to breast implants.

Best advice? Be careful what you believe on social media.




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