FDA Strengthens Breast Implant Safety Requirements
and Updates Study Results
On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions.
Second, the FDA approved new labeling for all legally marketed breast implants that includes:
Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
Updated silicone gel-filled breast implant rupture screening recommendations.
Device description with a list of specific materials in the device.
Patient device card.
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Worldwide Experience of Breast Implant-Associated Large Cell Lymphoma (BIA-ALCL): Expert Panel and Roundtable Discussion
This session was recorded live at The Aesthetic Meeting 2019 in New Orleans, featuring the most up-to-date, evidence-based knowledge on breast implant-associated large cell lymphoma (BIA-ALCL)
At the 14:00 minute point in the video, there's a good explanation of early diagnostic testing criteria for those presenting with fluid or swollen breast.
Approx. 80-85% of diagnosed women present with effusion / fluid around Implant
15-20% of diagnosed do not.
Reminder: addition symptoms include pain, itching, rash, lumps, thickening scar capsule.