Why Hasn't the FDA Approved Cohesive Gel Implants for Buttock Enhancement?

What are the risks of cohesive gel implants? They are approved in other countries (Argentina, Brazil, etc). Why hasn't the FDA approved them for use in buttocks enhancement in the US?

Doctor Answers 1

Cohesive gel implants for the buttock

{{ voteCount >= 0 ? '+' + (voteCount + 1) : (voteCount + 1) }}

I am not an expert in the FDA approval process, but unless a manufacturer spends a lot of money doing the research necessary to get approval, and then submits that research to the FDA, the approval process would not even get started.  

I am not aware of any manufacturer who has submitted an application to have cohesive gel implants approved for buttock enhancement, so I would not expect any FDA approval to be forthcoming anytime soon.

Scottsdale Plastic Surgeon

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.