How will the FDA ensure that Allergan and Mentor complete their post-approval studies?
The FDA has been very careful in their decision to lift the ban on silicone breast implants and in order to further make sure that implant manufacturers follow through on the strict guidelines they have implemented a very detailed study post ban.
To assure that Mentor and Allergan (formerly Inamed) complete these studies, FDA will:
- Track the post-approval studies, using a new electronic tracking system
- Provide guidance on how and when companies should report the status of their post-approval studies
- Post the status of the studies on the FDA website to help keep the public informed
- Hold open public Panel meetings on the status of the conditions of approval five and 10 years after approval, as well as any other time the FDA decides is necessary (e.g., if significant new information from the post-approval studies becomes available)
Labels: FAQs, Silicone Breast Implants
