What medical conditions have not had safety and effectiveness established in accordance with FDA standards with respect to saline breast implantation?

Safety has not been established in hematologic disorders that interfere with blood clotting, blood thinning, wound healing, immune system derangements, such as immunosuppressive regiments for cancer, HIV, autoimmune conditions like scleroderma, or lupus, and compromised blood supply, as would be found after radiation for cancer.