🇺🇸 Implant in United States

643 US adverse-event reports

Marketing authorisation

FDA

• Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 27 March 2025 – 27 March 2026
• Total reports: 643

Most-reported reactions

1. Complication Associated With Device — 120 reports (18.66%)
2. Pregnancy With Implant Contraceptive — 83 reports (12.91%)
3. Unintended Pregnancy — 80 reports (12.44%)
4. Device Difficult To Use — 72 reports (11.2%)
5. No Adverse Event — 55 reports (8.55%)
6. Device Deployment Issue — 54 reports (8.4%)
7. Incorrect Drug Administration Duration — 54 reports (8.4%)
8. Complication Of Device Removal — 44 reports (6.84%)
9. Device Dislocation — 41 reports (6.38%)
10. Complication Of Device Insertion — 40 reports (6.22%)

Source database →

Frequently asked questions

Is Implant approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Implant in United States?

University of Sao Paulo is the originator. The local marketing authorisation holder may differ — check the official source linked above.