BREAKING NEWS: THE FDA CALLS FOR NEW WARNINGS FOR BREAST IMPLANTS
On Wednesday, October 27th, 2021, the Food and Drug Administration announced certain labeling recommendations to strengthen safety requirements for breast implants, improve patient communication, and mandating that manufacturers and plastic surgeons warn patients of the possible complications — I believe these updated safety measures are a really good thing!!
This will help us have a clear understanding of the risks and benefits of breast implants BEFORE we decide to undergo reconstruction and decide whether or not we want to have implants…
I have gotten countless DM’s about this and I am deep diving in and starting my INBREASTIGATION for us now into these new guidelines so please drop any and all questions you have below and I’ll get us answers, but in the meantime…
From what I have gathered so far, the information about the risks associated with breast implants has been around for awhile, and this update from the FDA is about enforcing the manufacturers and more importantly, our plastic surgeons, to take the time to actually tell us about these risks in a way that we understand before making the decision!
FROM THE FDA:
“The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of breast implants. These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of breast implants that uniquely pertain to individual patients.”
To help ensure that patients have this information the FDA is mandating:
- a boxed warning
- a patient decision checklist
- a patient information booklet/brochure specific to the breast implant should be provided by manufacturers and given to patients prior to implantation.
- For those patients who decide to have breast implants, a patient device card should also be provided to patients after surgery.
WHEN DECIDING WHETHER OR NOT TO HAVE BREAST IMPLANTS, WHAT CONVERSATIONS DID YOUR PLASTIC SURGEONS HAVE WITH YOU ABOUT THE RISKS VS BENEFITS?
To learn the differences between the three brands of implants distributed in the United States, watch this!