How critical is FDA approval?

[Guest guest]

My son, Ian is 8 1/2 months old and has been wearing a locally made

helmet for 4.5 weeks for 9mm plagio. We were referred to a local

orthotics company, Advanced Orthopro Inc. (AOI), in Indianapolis from a

neurosurgeon at Riley Children's Hospital. Because we didn't

anticipate prior to the appt that we would be getting a helmet (pedi

didn't think he needed one, she only sent us to the neurosurgeon for

second opinion); I had not done any prior research on banding options,

etc.

I now know (many thanks to this group!) that the helmet he is wearing

is not FDA approved and is fabricated in their office, although looks

exactly like a STARband (but with a chin strap). So, my question is

this: should I be concerned about this? Obviously the FDA has approval

mechanisms in place for a reason, however Riley Children's Hospital's

neurosurgeons assure me that they have used this company for many, many

years with excellent results. We even know several individuals that

have used them with good results.

Any advice would be appreciated!