Does the FDA publish any information on breast implants?

Breast Implant Questions and Answers (2006)

1. General Information About Breast Implants
2. What are breast implants?
3. What types are approved by FDA?
4. How are breast implants used?
5. Are there any age limits with respect to who can get breast implants?
6. Why is the age minimum different for augmentation for saline-filled and silicone gel-filled breast implants?
7. Are clinical studies of breast implants still being conducted?
8. How can I participate in a clinical study?
9. What are the risks of breast implants?
10. How long do breast implants last?
11. What causes breast implants to rupture?
12. How will I know if my breast implant has ruptured?
13. If my breast implant ruptures, should I have it removed?
14. Will the platinum in silicone breast implants harm me?
15. What are some of the important factors I should consider when deciding whether or not to get breast implants?
16. What are “gummy bear” gel breast implants? .
17. How can I report problems with my breast implants?
18. Where/how can I find the adverse event reports for silicone gel-filled breast implants?
19. Why do companies file summary reports of adverse events, instead of individual MDR reports for breast implants?
20. What guidance does FDA provide to the companies that make breast implants?
21. Details about the approved Silicone Gel-Filled Breast Implants
22. What was the basis for FDA’s decisions to approve silicone gel-filled breast implants made by Allergan and Mentor? .
23. Who can get Mentor and Allergan silicone gel-filled breast implants?
24. What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
25. What did the Core Studies show regarding the rate of rupture and the consequences of rupture?
26. What conditions of approval did FDA place on these implants?
27. If silicone gel-filled breast implants are safe, why is FDA requiring such large post-approval studies?
28. What if the post-approval studies uncover unexpected problems?
29. How will FDA ensure that Allergan and Mentor complete their post-approval studies?