Breast Implant Surgery: Boxed Warning, Patient Decision Checklist & Questions to Ask
The FDA's page on breast implant surgery — including the boxed warning and the patient decision checklist that must be reviewed and signed with your provider before surgery, plus questions to ask your surgeon.
What this source says
The FDA explains that approved implants now carry a boxed warning and a patient decision checklist that must be reviewed with, and initialed and signed by, both patient and provider before surgery. It also covers updated silicone-gel rupture-screening recommendations (MRI or ultrasound), the patient device card you should receive afterward, and a set of questions to ask your surgeon.
Why it matters
It is the U.S. regulator's own pre-surgery briefing — the basis for the informed-consent materials you should be given, and a ready checklist of what to ask before deciding.
Key findings
- Approved breast implants carry a boxed warning.
- A patient decision checklist must be reviewed with the provider and initialed and signed by both patient and physician before surgery.
- Updated silicone-gel rupture-screening recommendations use MRI or ultrasound; a patient device card is provided after surgery.
- The page lists questions to ask your surgeon about experience, expected outcomes, and recovery.
Limitations
General pre-surgery guidance, not personalized medical advice.
What this does not prove
It does not establish that implants cause systemic illness; it addresses risk communication and informed choice.
Source / citation
U.S. Food and Drug Administration (FDA) · Current as of March 8, 2023
https://www.fda.gov/medical-devices/breast-implants/breast-implant-surgery
Last reviewed against the original source: 2026-09-02. Summaries are written in plain language; the original source is authoritative.
Breast Implant Illness Tracker provides education and organizational tools only and does not provide medical diagnosis or treatment.