Breast Implant Questions and Answers (2006)
- General Information About Breast Implants
- What are breast implants?
- What types are approved by FDA?
- How are breast implants used?
- Are there any age limits with respect to who can get breast implants?
- Why is the age minimum different for augmentation for saline-filled and silicone gel-filled breast implants?
- Are clinical studies of breast implants still being conducted?
- How can I participate in a clinical study?
- What are the risks of breast implants?
- How long do breast implants last?
- What causes breast implants to rupture?
- How will I know if my breast implant has ruptured?
- If my breast implant ruptures, should I have it removed?
- Will the platinum in silicone breast implants harm me?
- What are some of the important factors I should consider when deciding whether or not to get breast implants?
- What are “gummy bear” gel breast implants? .
- How can I report problems with my breast implants?
- Where/how can I find the adverse event reports for silicone gel-filled breast implants?
- Why do companies file summary reports of adverse events, instead of individual MDR reports for breast implants?
- What guidance does FDA provide to the companies that make breast implants?
- Details about the approved Silicone Gel-Filled Breast Implants
- What was the basis for FDA’s decisions to approve silicone gel-filled breast implants made by Allergan and Mentor? .
- Who can get Mentor and Allergan silicone gel-filled breast implants?
- What were the most frequent complications seen in the Core Studies for the Allergan and Mentor silicone gel-filled breast implants?
- What did the Core Studies show regarding the rate of rupture and the consequences of rupture?
- What conditions of approval did FDA place on these implants?
- If silicone gel-filled breast implants are safe, why is FDA requiring such large post-approval studies?
- What if the post-approval studies uncover unexpected problems?
- How will FDA ensure that Allergan and Mentor complete their post-approval studies?
