Re: How critical is FDA approval?

[Guest guest]

Well, I think the proof is in the pudding - if you are seeing good results and

you are happy

with it, I wold continue. If you aren't seeing results or are having concerns

about he

helmet, seek an FDA approved band. Just because it is not FDA approved does not

mean it

is not a good product, it just has not gone through all the rigorous testing to

gain

approval, probably because it comes from a small company and not a larger one

such as

CT or Hanger.

I definitely think this is one of those " go with your gut " moments, go luck!

- Meg, mom to Luc, 8m, STARband grad 1/09

Milwaukee, WI

>

> 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!

>

[Guest guest]

Hello again,

Just wanted to send out a quick update...

You may remember I was struggling with the fact that my son was wearing a

locally-made helmet from Advanced Orthopro (AOI) that didn't seem to be

providing any correction after 5 weeks.

I ended up calling OrthoAmerica and found (much to my surprise!) that we had a

STARband provider that we didn't know about in our area, Midwest Orthotics. I

relayed our entire story to them over the phone and they invited us to come in

for a free consultation and second opinion on the helmet we already had. Long

story short - many prayers were answered that day as they offered to make us a

STARband at NO cost to us. I've stopped trying to figure out why they might

want to do this, and have just accepted that they are nice people trying to make

right a difficult situation, even though nothing about it being difficult has

been their fault.

So, Ian has now been in his STARband for 3 weeks, and we've already seen

correction from 9mm to 5mm! They plan to scan him again at his next visit in

about 3 weeks, and I'm anxious to see the difference in his head shape. The

orthotist we've seen there, Josh, has been so good to us and we feel like he

genuinely cares that this works for Ian.

Cinde

Indianapolis, IN

Ian - 9 1/2 months (STARband since 3/4/09)

Caleb - 3 years (no tort/plagio)

>

> 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!

>

[Guest guest]

Thanks for the great update!!!! I am so glad to hear Ian is seeing correction. Please let us know how his next scan goes.

Angie

Re: How critical is FDA approval?

Hello again,Just wanted to send out a quick update...You may remember I was struggling with the fact that my son was wearing a locally-made helmet from Advanced Orthopro (AOI) that didn't seem to be providing any correction after 5 weeks.I ended up calling OrthoAmerica and found (much to my surprise!) that we had a STARband provider that we didn't know about in our area, Midwest Orthotics. I relayed our entire story to them over the phone and they invited us to come in for a free consultation and second opinion on the helmet we already had. Long story short - many prayers were answered that day as they offered to make us a STARband at NO cost to us. I've stopped trying to figure out why they might want to do this, and have just accepted that they are nice people trying to make right a difficult situation, even though nothing about it being difficult has been their fault.So, Ian has now been in his STARband for 3 weeks, and we've already seen correction from 9mm to 5mm! They plan to scan him again at his next visit in about 3 weeks, and I'm anxious to see the difference in his head shape. The orthotist we've seen there, Josh, has been so good to us and we feel like he genuinely cares that this works for Ian.CindeIndianapolis, IN Ian - 9 1/2 months (STARband since 3/4/09)Caleb - 3 years (no tort/plagio)>> 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!>

[Guest guest]

What great news! Glad you went with your gut and pursued another option. Please

keep us posted!

Jake-2.5 (DOCBand Grad 9/08)

Jordan-5

> >

> > 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!

> >

>

[Guest guest]

WOW! That is Fantastic news!!!!!!

Jen

Mom to Luli - 3 yrs old

Torticollis, Plagio, Syringomyelia

Re: How critical is FDA approval?

Hello again,

Just wanted to send out a quick update...

You may remember I was struggling with the fact that my son was wearing a locally-made helmet from Advanced Orthopro (AOI) that didn't seem to be providing any correction after 5 weeks.

I ended up calling OrthoAmerica and found (much to my surprise!) that we had a STARband provider that we didn't know about in our area, Midwest Orthotics. I relayed our entire story to them over the phone and they invited us to come in for a free consultation and second opinion on the helmet we already had. Long story short - many prayers were answered that day as they offered to make us a STARband at NO cost to us. I've stopped trying to figure out why they might want to do this, and have just accepted that they are nice people trying to make right a difficult situation, even though nothing about it being difficult has been their fault.

So, Ian has now been in his STARband for 3 weeks, and we've already seen correction from 9mm to 5mm! They plan to scan him again at his next visit in about 3 weeks, and I'm anxious to see the difference in his head shape. The orthotist we've seen there, Josh, has been so good to us and we feel like he genuinely cares that this works for Ian.

Cinde

Indianapolis, IN

Ian - 9 1/2 months (STARband since 3/4/09)

Caleb - 3 years (no tort/plagio)

>

> 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!

>

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[Guest guest]

Wow, I have never heard of a free starband (or any band for that matter). You're

definitely very lucky. I'm glad you're getting correction.

-christine

sydney, 3 yrs, starband grad

> > >

> > > 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!

> > >

> >

>