Moreover, silicone gel recipients have to bear a continuing lifelong expense for FDA-mandated MRI evaluation in order to detect
silent rupture. The initial MRI is required at 3 years, then every 2 years thereafter.
Panelist Amy Newburger, M.D., a dermatologist from Scarsdale, N.Y., said that information on Mentor's rupture rates was not adequate, since data on MRIs used to determine
silent rupture rates had been collected only twice, which made it difficult to estimate long-term rupture rates.