The FDA has approved British drugmaker BTG's Varithena, formerly called Varisolve, which is an injectable foam for varicose veins, the company announced. FDA approval had been delayed due to concerns about the product's effects if it enters the bloodstream.
Sapheon has filed with the FDA the first module of its premarket approval application for VenaSeal Sapheon, a device used for treating varicose veins. The system, which already has CE mark approval in Europe, is undergoing an investigational device exemption trial in the U.S.
Cranial reconstruction for a Pakistani girl attacked by the Taliban, facial reconstruction for a mutilated Afghan woman and a full face transplant for a 37-year-old man whose face was destroyed in an accidental shooting are among the plastic surgery wonders making recent headlines.
Operation Smile and Smile Train will partner on a project in Rwanda to repair cleft palates and facial deformities. Through the initiative, dubbed Rwanda Smiles, the charities aim to eliminate a backlog of cleft palate repairs by 2017. Volunteers will identify and treat people who need surgery and train local health care providers to give ongoing care.
Immediate post-mastectomy reconstruction with autologous tissue is an option even if the patient will undergo radiation treatment, according to a study in the Annals of Plastic Surgery. Similar percentages of women with free-flap breast reconstruction had to undergo revision whether or not they received post-reconstruction radiotherapy, but the University of Pennsylvania study was not large enough to achieve statistical significance for that comparison. Post-radiotherapy volume loss was more likely in bilateral surgery patients who received perforated flap reconstruction than in those who received muscle-sparing free transverse rectus abdominis myocutaneous flaps.