Last year, the F.D.A. approved silicone implants made by Allergan and Mentor for cosmetic use in people 22 or older, and for reconstruction for all ages. Besides instructing doctors to advise their patients about the M.R.I.’s and the need for removal, the manufacturers are required to follow their pre-existing study groups of silicone patients for 10 years and to create a database to track 80,000 new patients.
“The guidelines are critically important because we really don’t yet know how best to follow-up these patients, what tests they should get and how often,” said Dr. Michael H. Rosenberg, a plastic surgeon in Mount Kisco, N.Y., who is enrolling women who get silicone implants in a study that will monitor them using M.R.I.’s and ultrasound. “I don’t think it is unreasonable to come up with a standard method to determine the rate of problems with implants.”