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Your May 11 editorial "Substantial Complications" calls into question the rigor of the Food and Drug Administration's premarket oversight of medical devices and may inadvertently cause patients to question the safety and reliability of medical devices reviewed by the agency.
In such a case, when closed-form solutions are still available, the results reported in Proposition 1 continue to hold in spite of substantial complications.
51 53 This is concerning as the procedure has been associated with substantial complications among survivors.
We hypothesized that topical ESWT would result in rapid pain relief and functional improvement without substantial complications.
It can also result in substantial complications and morbidity in the mother and her offspring (Duley 2009, Kuklina et al 2009).
Although we did not have any substantial complications associated with the gynecologic surgery in our series, there is a potential risk in adding the gynecologic procedure to prophylactic surgery, especially in the setting of autologous reconstructive surgery.
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A substantial complication is introduced by changes in the geographic classification of areas in the CPS.
Conclusions: Although the stomal/wound complication rate was significantly higher in group I, both groups had very substantial complication rates, emphasizing the vulnerability of this infant population.
PM, however, is a drastic and irreversible intervention, and in case of breast reconstruction (BR), is accompanied by a substantial complication rate.
Further, we found a substantial complication rate after breast reconstruction, which mainly concerned late cosmetic issues, almost always leading to additional surgery.
A recent document by the ECB said restoring a member state's old currency would "inevitably involve considerable risks and difficulties and entail substantial legal complications".
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