Posted May 7, 2014
Dear Parents, Physicians and Providers,
A new study published by researchers in the Netherlands was highlighted in the media recently. The study attempted to determine whether treatment with helmets for head shape deformities is better than doing nothing to treat these conditions. Unfortunately, many physicians and other medical professionals have detected flaws in this study.
The Dutch researchers noted a high number of fitting problems and poor outcomes with helmet treatment. An ill-fitting helmet may not provide optimal correction and in some cases, does more harm than good. At Orthomerica, every STARband is made from a cast or a scan of the baby’s head resulting in a precisely made, exact fitting orthosis based on the baby’s unique head shape and specific need for correction. Follow up measurements or scans are taken throughout treatment to ensure a proper fit to reach optimal correction. Printed documentation is available following each and every scan.
The Dutch study data and conclusions in no way reflect the excellent outcomes achieved by STARband Cranial Remolding Orthoses. Parents, referring physicians and insurance companies are provided with documentation of the head shape. This information includes pre/post treatment photographs, ongoing measurements, and in many cases, 3-D scans of the head shape. The outcomes data is precise and documents the effectiveness of treatment. In the United States, the FDA strictly regulates the manufacturers of these devices and is responsible for protecting public health by assuring the safety and efficacy of the finished device (helmet).
Professional organizations, practitioners and researchers are responding to the British Medical Journal and the media with their concerns. These include but are not limited to the very small number of subjects, differences between the treatment and non-treatment groups, lack of specific information about the helmet design and the exclusion of babies with severe deformities and those with torticollis.
Orthomerica is committed to providing babies and families with safe and effective STARband treatment. We continue to provide the care, education and expertise that you have come to expect from Orthomerica, the leading cranial manufacturer in the world.