Guest guest Posted May 9, 2008 Report Share Posted May 9, 2008 Hello All,I am new to this group. My daughter is diagnosed with a mild plagio. There is a little facial asymmetry too associated with the plagio which I am concerned about. I have researching about the helmet and I found the FDA approval for this device at:http://www.cranialtech.com/FDA_approval.htmlThere is paragraph in the approval on the risks and the third risk about impairment of brain growth really got me worried. I wanted to know what the mother's with experience think about this.With a mild plagio its so difficult to decide whether to opt for the helmet or not..----Snippet----FDA identified the following risks to health associated with this type of device: (1) Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin; (2) head and neck trauma due to alteration of the functional center of mass of the head and the additional weight of the device especially with an infant who is still developing the ability to control his/her head and neck movements; (3) impairment of brain growth and development from mechanical restriction of cranial growth; (4) asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant's ability to lift the head; (5) eye trauma due to mechanical failure, poor construction and/or inappropriate fit; and (6) contact dermatitis due to the materials used in the construction of the device.---Snippet----Looking forward to your inputs, Be a better friend, newshound, and know-it-all with Mobile. Try it now. Quote Link to comment Share on other sites More sharing options...
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