Should You Consider Non-FDA Approved Breast Implants?

For those of you researching your breast augmentation options, you may have come across overseas implants that are not yet cleared by the FDA for use in the US market. As you weigh the pros and cons of different manufacturers and their implants, remember that an FDA implant approval signifies a comprehensive safety testing history and a rigorous oversight of its manufacturing quality.  

The importance of FDA approval with breast implants

  • Seeking out non-FDA breast implants comes with some risks. The FDA approval process requires years of clinical trials and data analysis to confirm safety and effectiveness. Opting for an untested implant is a gamble as it may lack  long-term durability and safety testing.
  • Foreign brands that appear entirely “new” are often rebranded versions of existing US options. Therefore, a different name overseas doesn’t necessarily indicate something innovative or novel. 
  • Just because an implant is common in other countries doesn’t mean it’s superior. A lack of FDA approval generally indicates that the implant itself has not been studied enough or it doesn’t have the comprehensive clinical data needed for the US market.  It has no bearing on the performance or durability per se.
  • New styles of implants can face many delays coming to market even with established FDA-approved manufacturers like Mentor and Allergan. The process of getting any breast implant approved is cumbersome and time consuming.  

As you weigh implant choices, an FDA clearance does give the implant a meaningful stamp of approval.  It also indicates that extensive testing and checks have been completed. While the approval process is cumbersome and can slow implant innovation, it remains the gold standard for ensuring your safety. Most plastic surgeons only use FDA-cleared breast implants in the US.  Using devices without this approval introduces too many unnecessary risks for a very safe surgery.