Thursday, September 01, 2011

Victory for Common Sense: FDA drops MRI suggestion for patients with silicone implants

BREAKING NEWS: A fairly significant announcement by the USFDA was in the paper today re. silicone gel breast implants (see NYT summary here). Based on testimony and evidence presented, the FDA has finally agreed that the suggestion that patients need routine MRI screening of their implants is no longer one they support. This is bringing the United States into line with the rest of the world on being more pragmatic on the issue and reserving workup for symptomatic patients only.  Recent papers in the surgery literature have been reporting that MRI has been associated with overestimation of rupture rates, particularly when applied to asymptomatic patients. The panel also concluded that no new evidence has been presented to change prior determinations that silicone implants are not causally linked to any known systemic illness.


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