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One condition was that the label would recommend patients get an MRI scan 5 years after receiving the implants and then every 2 years in an effort to detect silent ruptures.
A study of screening mammograms suggested that 5 percent of asymptomatic women had experienced "silent rupture" of their implants.
Panelist Amy New-burger, 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.