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"Those mothers who are considering C-section in the absence of a medical indication should be counseled about this potential risk," said the lead author, Dr. Susanna Y. Huh, an assistant professor of pediatrics at Harvard.
But the F.D.A. clearance stipulates that Cynosure, the maker of Cellulaze, "can only make statements based on our decision on the three-month data," according to Erica Jefferson, an F.D.A. spokeswoman, who added, "The indication should be for 'short-term improvement.' " The F.D.A. does not police the claims of doctors who use the treatment.
Therefore, surgical indication should be carefully determined.
TEE was also useful, although its indication should be carefully considered.
However, esophagectomy is highly invasive surgery, and the indication should be carefully considered, particularly after major cardiovascular surgery.
In the case of bilateral pheochromocytomas, the surgical indication should be decided considering each patient's genetic background.
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These indications should be assessed in prospective clinical trials [12].
How many tumor indications should be investigated in the first wave for the development program to be cost-effective amid the uncertainties?
They may provide a first indication of the usage or of likely bottlenecks but such indications should be verified with more detailed and localized analyses by means of simulation or more comprehensive methods before significant actions might be taken.
Indications should be for repair of severe functional and/or aesthetic injuries, and must meet the criteria of healthy skin, the possibility of regular expansion, and psychologically stable patients.
Although it is difficult to provide firm recommendations, we would then propose a pragmatic approach in which surgical indications should be based on eventual clinical deterioration despite optimal medical treatment and advanced organ failure supports.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com