FDA potential risks
Caution: Federal law restricts this device to sale by or on the order of a physician in accordance with 21 CFR 801.109
The FDA has identified the following potential risks to health associated with this type of device:
- Skin irritation, skin breakdown and subsequent infection due to excessive pressure on the skin.
- Contact dermatitis due to the materials used in the construction of the device.
- Eye trauma due to mechanical failure, poor construction and/or inappropriate fit.
- 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.
- Impairment of the brain growth and development from mechanical restriction of cranial growth.
- Asphyxiation due to mechanical failure, poor fit, and/or excessive weight that alters the infant’s ability to lift the head.
- Contraindications: This device is not for use on infants with craniosynostosis hydrocephalus.
- If the positional plagiocephaly is associated with torticollis the torticollis will need to be additionally treated.
These potential risks are the same for all devices of this type (cranial orthosis) regardless of the manufacture. Due to the potential risks it is important that when you choose a company to begin treatment;
- That you first find out if the device has been FDA cleared for manufacture.
- That the company has had success with their fitting and follow-up procedures.
- That the device is lightweight.
- That you have a physician who is in charge of or overseeing the overall treatment program.
Fit-Well has a proven reputation for a safe, effective and enjoyable treatment program.
Back to the P.A.P. Orthosis Cranial Remolding section