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It also called for mandatory reporting of complications and a national register of high-risk medical devices.
Since 2012 uniformed reporting of complications after urological procedures has been advocated by the European Association of Urology (EAU) guidelines.
One prospective randomized study showed no significant difference in post-operative outcomes between LHM and ED but this was limited by lack of standardization in the endoscopic dilatation procedure, limited reporting of complications and poor long-term follow up.
The reporting of complications was limited in the included studies.
The reporting of complications was of mixed quality, especially in terms of patients requiring further surgical procedures.
But Makary says that the new requirement covers only a small number of procedures, and wider reporting of complications will initially be voluntary.
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Based on self-report of complications, women were categorized as having obstetric complications, near misses, or non-complicated pregnancies using definitions modified from the World Health Organization.
The researchers identified 20 reports of complications requiring surgery, including instances in which three mothers and five neonates died.
The column also misstated the year Tysabri was withdrawn from the market after reports of complications in three patients.
By 2006, Carragee said reports of complications with the bioengineered protein began to turn up in the medical literature.
However, reports of complications related to implant removal after solid fusion are rare.
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