Silicone Breast Implants Are Still Available in Europe

August 1, 1995

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.

MIAMI BEACH, Fla--The French response to the FDA ban on siliconebreast implants was to issue a strong recommendation to plasticsurgeons to stop using silicone-gel-filled implants or polyurethaneprostheses. Now that stricter manufacturing controls are in place,that recommendation has been canceled, and today silicone implantsare 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 ina study at the Institut Gustave Roussy. The study involved 14breast reconstruction patients with 17 implants who were havingtheir implants replaced.

These patients had had their implants for more than 10 years andwere worried about silicone leakage, but none had clinical signsand 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 autoimmunedisease or cancer?

Studies show less than 20 cases of scleroderma following implantationamong more than 2 million US women, he said. And in a retrospectiveanalysis of 146 French women with silicone implants, Dr. Petitfound no increased risk of death from breast cancer (relativerisk, .5) or other causes (relative risk, .7).