FDAnews
www.fdanews.com/articles/138106-breast-implant-makers-may-need-larger-postapproval-studies-fda-says

Breast Implant Makers May Need Larger Postapproval Studies, FDA says

July 5, 2011
Manufacturers of breast implants may have to perform larger and longer post-approval studies in the future as a condition of FDA market approval. That assertion came from CDRH Director Jeffery Shuren during a press call Wednesday over concerns that silicone breast implants may lead to increased risk of some cancers and other health issues.
Devices & Diagnostics Letter