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In 2008, the Food and Drug Administration warned that use of the implants was associated with complications but that the problems were rare.
He adds that experiments on the use of the implants in mice with breast cancers have been positive, although those with lung cancer were not.
In Brazil, the National Agency of Sanitary Vigilance prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France.
Those waivers, known as a "humanitarian device exemption," authorized limited use of the implants to close P.F.O.'s in patients deemed to be at special risk — those who had already had a second stroke.
The adhesion of bacteria and subsequent formation of biofilm on the surface of implants greatly affect the long-term use of the implants.
One consulting firm, the Millennium Research Group, estimates that the worldwide market for such closure devices worldwide will reach $100 million annually if the F.D.A. specifically approves the use of the implants for the prevention of stroke and transient strokelike attacks.
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Our findings form a first basis for clinical use of the implant, but its clinical effectiveness remains to be investigated.
Assuming the adherence performance of tissue on a mesh as possible marker for its biocompatibility seems logic independent from the respective clinical use of the implant.
In all our patients, the use of the implant resulted in a concentrically reduced elbow with no evidence of clinical instability.
The use of these implants can impair the quality of MRI investigations, and also necessitate further surgery in order to remove the implant.
The use of the same implants does not allow variation due to construct design.
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