Object: The increase in the prevalence of nonsynostotic occipital deformational plagiocephaly in infants, which resulted from the American Academy of Pediatrics' 1992 recommendation to have healthy infants sleep supine, has been accompanied by significant controversy in diagnosis and management. The controversy was exacerbated by the 1998 FDA classification of cranial orthotic devices as Class II devices requiring premarket notification, and the subsequent increase in treatment-associated costs.
Methods: Two independent reviews of the literature were conducted to clarify the objective evidence available within the context of pediatric craniofacial knowledge.
Results: Although deformational plagiocephaly is not a life-threatening problem, it is a source of disfigurement for children that may be detrimental to their well-being. Current methods for quantifying the degree of disfigurement have limited interrater reliability, and no prospective randomized controlled trials comparing the efficacy of cranial orthoses to repositioning and physical therapy protocols have been published. Despite this lack of Class I evidence, cranial orthoses are routinely and effectively used to treat persistent severe deformational plagiocephaly. The need for the current FDA regulations has not been supported by clinical experience and reported complications.
Conclusions: This review resulted in the following recommendations: 1) more parental education is needed to minimize the development and progression of deformational plagiocephaly; 2) mild deformity can be treated with repositioning and physical therapy protocols; and 3) severe deformity is likely to be corrected more quickly and effectively with cranial orthosis (when used during the appropriate period of infancy) than with repositioning and physical therapy. The available data do not support the need for FDA classification for cranial orthoses as Class II devices requiring premarket notification. Removal of the regulations, which centralized production of the orthoses to larger companies and markedly increased charges, will probably eliminate much of the controversy and parental anxiety generated by marketing strategies.