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Author Topic: Durolane FDA approval  (Read 8362 times)

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Offline Alyce

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  • Pain is inevitable. Misery is optional.
Durolane FDA approval
« on: September 25, 2005, 05:55:41 PM »
I'm confused.  Is Durolane FDA approved in the United States for OA and knee injections?  It seems as though a version of it is approved for dermatological uses.

Also, does anyone know of any studies that compare Durolane to Synvisc?

Three OS have said that I need a uni patella replacement.  I live in Georgia, but my surgeon, and one of a handful of OS that perform this procedure, lives in MN.  I am Grade IV, bone on bone under the patella.  The rest of my knee is pristine.

I'm only 46, but will have it done when the pain and lack of activity become a huge issue.  Everyone says that I will know when that time comes.  I'm ready physically, but not mentally.  I'm still in PT after 3 1/2 years.

Any information would be helpful.

Many Thanks,
Alyce
Patella shaving & Lateral Release 6/2002
Reattachment of Lateral Retinaculum & Microfracture 6/2003.
Both procedures failed.  Reattachment was successful.
Lesion remains 15mm x 9mm x 6mm
Tibial rotational osteotomy May 2009
LPFL rebuild May 2009
Surgery for Baja Patella February 2010

Offline clueless

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Re: Durolane FDA approval
« Reply #1 on: September 25, 2005, 06:38:50 PM »
Hi Alyce:

I'm not sure if Durolane has approval in the US. It only just got recently approved here in Canada. According to my OS, the benefits from Durolane are the same as from Synvisc. The major difference is that Durolane has a higher concentration of hyaluronic acid and therefore you only need one injection instead of three. My OS used to recommend Synvisc injections, but since its approval has switched to giving his patients Durolane.

Clueless

shadehawk

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Re: Durolane FDA approval
« Reply #2 on: October 04, 2005, 10:24:50 PM »
Hi,

DUROLANE is different from other products containing hyaluronic acid that are used to treat osteoarthritis, as it is contains Non-Animal Stabilized Hyaluronic Acid (NASHA). This is a substance with greatly improved features compared with older hyaluronic acid products. These features mean that DUROLANE is able to stay within joints for a long time (at least 3 months) whilst still being treated by your body as a natural product.

DUROLANE is injected directly into your joint by a qualified doctor and, due to its unique properties, treatment of either hip or knee osteoarthritis involves only one injection.

Sounds like an interesting product and I have read that less swelling occurs from the use of this product compared to the other injections.

It seems like the product 'durolane' is called 'Restylane' in the U.S. & it looks like it has FDA approval for osteoarthritis of the knees and hip......

Shade
« Last Edit: October 04, 2005, 10:32:59 PM by Shade »

Offline Alyce

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Re: Durolane FDA approval
« Reply #3 on: October 05, 2005, 12:04:43 AM »


Shade,

Thanks for the information.  As best I can research, Durolane has not been approved by the FDA.  Restylane, which is essentially the same thing, has been approved for dermatological uses.  It helps reduce wrinkles.  They are both made from the streptococcus bacteria.  Sort of like Botox, I guess.

I wish I could get the Durolane.  I am starting with Synvisc next week, because I need to try something else to help with pain.

Thanks again for all the replies.  It gives me such hope.

Warmly,
Alyce
Patella shaving & Lateral Release 6/2002
Reattachment of Lateral Retinaculum & Microfracture 6/2003.
Both procedures failed.  Reattachment was successful.
Lesion remains 15mm x 9mm x 6mm
Tibial rotational osteotomy May 2009
LPFL rebuild May 2009
Surgery for Baja Patella February 2010

Offline mrtwenty

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Re: Durolane FDA approval
« Reply #4 on: January 18, 2007, 11:28:41 PM »
Durolane isn't FDA approved, i have done many studies regarding Ortho products and have a list of most products used as knee injections for OA and the date they were approved or if they are not approved, i also have some pages of each injection, what they are made of, what manufacturer and such, if anyone would like some of my info please just ask!

Mr.Twenty ;D

Offline Bernstein

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Re: Durolane FDA approval
« Reply #5 on: January 19, 2007, 02:30:05 PM »
Mr Twenty, could you send me that list of drugs used for OA.  I would really appreciate it.  My email is [email protected]















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