MIAMI BEACH, Fla--The French response to the FDA ban on silicone breast implants was to issue a strong recommendation to plastic surgeons to stop using silicone-gel-filled implants or polyurethane prostheses. Now that stricter manufacturing controls are in place, that recommendation has been canceled, and today silicone implants are available in most European countries, Jean-Yves Petit, MD, said at the 12th Annual International Breast Cancer Conference.
Dr. Petit, currently with the European Institute of Oncology, Italy, explored the stability of silicone implants over time in a study at the Institut Gustave Roussy. The study involved 14 breast reconstruction patients with 17 implants who were having their implants replaced.
These patients had had their implants for more than 10 years and were worried about silicone leakage, but none had clinical signs and only one had a radiologic sign of rupture.
The study found five cases of leakage and five cases of rupture, but does such deterioration increase a woman's risk of autoimmune disease or cancer?
Studies show less than 20 cases of scleroderma following implantation among more than 2 million US women, he said. And in a retrospective analysis of 146 French women with silicone implants, Dr. Petit found no increased risk of death from breast cancer (relative risk, .5) or other causes (relative risk, .7).