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Author Topic: FDA approved device and experienced hip resurfacing doctor  (Read 109757 times)

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stevel

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FDA approved device and experienced hip resurfacing doctor
« on: July 27, 2008, 09:23:50 PM »
I have been doing a lot of research and my health insurance plan mandates using a FDA approved device for marketing.  Only two qualify;  Birmingham Hip Resurfacing Device and Cormet 2000.  Dr. Gross, South Carolina is using the Biomet device, Dr. Amstutz, Los Angeles is using the Conserve Plus Device.  So I'm leaning toward Dr. Su, New York who uses the Birmingham Device and has over 700 installations.  I'm also considering Dr. Schmalzried, Los Angeles who uses the Cormet 2000 and Dr. Mont, Baltimore who uses several devices.
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

xocy

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #1 on: July 28, 2008, 01:41:41 AM »
The Biomet device is approved, but must be used as THR in an "off label" manner. Email or call Dr. Gross's office and they can explain. I know it sounds stupid.

Mike


Dr. Gross
Bilateral
Left 6/23/08  Right 6/25/08
Mike
Bilateral
Dr. Thomas Gross
Left 6/23/08  Right 6/25/08

Vicky

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #2 on: July 28, 2008, 04:59:52 AM »
You can't go wrong if you choose Dr. Su IMO.

Vicky

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #3 on: July 28, 2008, 02:59:28 PM »
I believe Zimmer with the "Durom" cup is one of those "off label" devices.  Zimmer has recently suspended sales of their device due to failures of the cup.  Check out the news at www.hipresurfacingnews.com.

Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Pat Walter

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #4 on: July 28, 2008, 03:18:16 PM »
Hi

Here is the explanation of how the Biomet, Wright C+ and ASR are covered by insurance and are approved components by the FDA and used off lable.  They are not approved as a system, but the components are FDA approved.

http://www.surfacehippy.info/fdaapproval.php

Yes, Zimmer has pulled it's acetabular cups and that stopped it's FDA approval according to the article I posted on Hip Resurfacing News.

Hope that helps.

Pat
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #5 on: July 28, 2008, 09:51:19 PM »
I have searched the FDA web site and I found that Wright Conserve, Biomet and ASR have been approved for use on a femoral head for a partial or hemi hip resurfacing.  These devices have been found substantially equivalent according to 510(K) Summary of Safety and Effectiveness.  A partial hip resurfacing does not use a new socket.  I did not find where the socket devices have been approved unless they are used with an approved total hip replacement system.  Wright Conserve-Plus total hip resurfacing system is under review by the FDA and has not yet received approval for marketing.  Biomet is currently doing clinical trials (at Dr. Gross's clinic) of their total hip resurfacing system.
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Vicky

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #6 on: July 28, 2008, 10:10:20 PM »
Yes the cup side is approved for use as a THR.  It is all legal for the doctors to use the devices off label, they just can not market it that way and it gives the insurance companies another way to deny you.

Vicky

xocy

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #7 on: July 29, 2008, 04:24:20 AM »
There is a pretty good article on this web site by Dr. Gross addressing this and other issues. After reading it you will have to admit the man does not mind stating his opinion when it conflicts with that of a peer.

Mike

Bilateral
Dr. Gross
Left 6/23 Right6/25

PS I walked two miles tonight without a cane or a limp. It was off label, of course. LOL
Mike
Bilateral
Dr. Thomas Gross
Left 6/23/08  Right 6/25/08

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #8 on: July 29, 2008, 02:30:14 PM »
I read Dr. Gross's statement.  I also read D. Brown's successfull insurance appeal of Blue Cross's initial denial of the Conserve Plus device in California.  Utltimately 2 of 3 Drs. on an independent review panel agreed with his claim.  See "insurance appeal" on the home page of this web site.  I do not particularily want to go through this review process to get my future health care reimbursed.  My health plan clearly states the device must be approved for marketing by the FDA.  An health insurance rep. from my insurance company has confirmed this.  Maybe I could have a non FDA approved device for marketing installed, submit the claim and it be processed without objection, but I do not want to chance this.
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Vicky

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #9 on: July 29, 2008, 02:33:03 PM »
Your best bet in the U.S would be Dr. Su in NYC or Dr. Ure in Mt. Shasta.

I think you said Dr. Rogerson is not in your plan right?  There is also Dr. Raterman in Tampa, FL, Dr. Clsrke in Syracuse NY.

Vicky

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #10 on: July 29, 2008, 05:30:08 PM »
Thank you for the additional Dr. references.  Yes, I am focussing on Dr. Su.  I priority mailed my latest hip x rays to Dr. Su last Wednesday, but they haven't been delivered yet.  I emailed year old hip x rays to Dr. Mont a couple days after chatting with him on July 16 but haven't heard back yet.  I listened to Dr. Rogerson video interview and was impressed by his responses.  My insurance will pay for travel to the nearest facility that does hip resurfacing which is Seattle since I live in Douglas, Alaska.  Dr. James Pritchett does hip resurfacing in Seattle.  I've read information provided by his web site and information provided on your web site.  Right know, I am most confident with Dr. Su at the Hospital for Special Surgery in New York as this hospital was recently awarded the No. 1 ranking in Orthopedics by U.S. News and World Report for the second year in a row.  The current issue on the newstand rates Best Hospitals in U.S. for all disciplines.

I find it odd that it seems not much hip resurfacing is done at the Mayo Clinic in Minnesota as this hospital is ranked no. 2 in Orthopedics and no. 2 (Best all around behind John Hopkins in Baltimore).
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Vicky

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #11 on: July 29, 2008, 06:08:30 PM »
Dr. Su is outstanding.  If I had to have surgery here in the U.S. he is the doctor I would go to.  The hospital infection rate is the lowest in the U.S. too, which is a BIG issue here right now.  Hospital infection rates are becoming an epidemic and definitely a major concern for anyone having surgery IMO.

Vicky

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #12 on: July 30, 2008, 07:08:39 PM »
Well, the Hospital for Special Surgery received my x-rays yesterday, but Dr. Su is on vacation until August 18.  They will have somebody else do a preliminary screening and advise if I am a candidate for hip resurfacing, but Dr. Su will need to review and have the final say.  I got a copy of my local orthopedic surgeon's report from my visit on 7/21/08, when x-rays were taken.  After reading this, I'm wondering if my left hip is too far gone for hip resurfacing.  Maybe I should send x-rays to Dr. Schmalzaried in Los Angeles, as I have their patient package with all of the legal forms, medical release forms, medical history and assessment of hip condition form.  I need to pay $350 out of pocket for their review and telephone consultation.  I understand Dr. Schmalzaried installs full size metal hip replacements if hip resurfacing is not indicated.  My local orthopedic surgeon does not install full size metal hip replacement because of metal ion issues.  He recommends "Strong as an Ox" hip replacement which has a oxinum metal femoral head and the surface turns into a ceramic for better wear resistance.  The socket is still metal with a polyethlyene liner and the femoral head is undersized.
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Vicky

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #13 on: July 30, 2008, 08:02:18 PM »
If you have a complicated case, your best bet again would be Dr. Su here in the U.S.  He also does the large Metal on Metal THR's if you did not qualify for resurfacing.  I know one patient of his that was given a 50/50 chance of getting resurfaced by another top doctor and Dr. Su gave him a 90% chance.  The patient has a BHR and has been out skiing again at four weeks and again at 8 weeks.  He just sent me videos of him skiing after getting resurfaced.  I will have Pat post the videos on her site.  I would NOT go with any poly type device at all. But, please do not jump the gun, wait until you get a definitive diagnosis first from Dr. Su.  If you would like, you can also just email your x-rays to Dr. De Smet and Dr. Bose to find out if you are a candidate for resurfacing?

Vicky

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #14 on: July 30, 2008, 10:30:24 PM »
Wow, everything is coming together.  I just received a email answer back from Dr. Mont, Baltimore regarding the one year old x-rays I sent on July 21.  I could be a candidate and I need to call him.  Coincidentally in an hour and a half at 8 PM EST, another live chat with Dr. Mont is scheduled on this web site.  I don't want to miss this.
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #15 on: July 31, 2008, 03:02:12 PM »
I just received an email from Dr Su's office and I am a good candidate for hip resurfacing, but this will need to be confirmed by Dr. Su when he returns from vacation on August 18.  If not he installs large metal femoral head total hip replacements and smaller oxinium femoral head hip replacements.

I don't particularily want to have a hip resurfacing if screws are needed to hold the socket or cap on femoral head.

I also contacted Dr. Mont's office in Baltimore by phone and left a voice mail.  I learned a lot from chatting with him twice of this web site.  He has nearly double the hip resurfacings (1400 vs 700) than Dr. Su and also does total hip replacements.

I still favor Dr. Su at the Hospital for Special Surgery and because of the Hospital's no. 1 rating in orthopedics by US News and World Report.  Since I will travel from Douglas, Alaska and New York is just as far as Baltimore, why not go to the best hospital unless Dr. Mont is the best surgeon? 
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Pat Walter

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #16 on: July 31, 2008, 04:09:03 PM »
Hi Steve

Just wanted to say Hi and that I am following your journey.  Vicky is giving you a lot of good information.  You can't beat trying to use the most experienced surgeon you can find within your insurance coverage.

HOpefully, you have plenty of good choices at this point. 

Good Luck,

Pat
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #17 on: August 01, 2008, 08:34:39 PM »
I talked to my health insurance administrator today.  They will pay for lodging and travel to the nearest facility that does hip resurfacing, which is Seattle, since Dr. James Pritchett works there.  They no longer provide credit (for travel to Seattle to be applied to travel to New York).  So I will need to pay for lodging and travel to New York.  They will pay for surgery in Belgian or India.  If the total surgery plus lodging and travel is cheaper than US surgery, they will pay for everything.  I need to pay up front and keep all receipts.

If there was an emergency after surgery in India or Belgium, they will pay travel to the nearest facility from that location.

They will also pay for surgery, lodging and travel for another location in the US if the total expenses are cheaper than Seattle.

I need to have the FDA approved device for marketing installed (Birmingham or Cormet) even for overseas surgery. 
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

Pat Walter

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #18 on: August 01, 2008, 08:49:30 PM »
Hi Steve

That sounds like pretty good news. 

You almost have your choice of surgeons.  Paying for travel would not be like paying for a whole surgery.  You have Dr. Pritchett close, Dr. Su in Ny and the overseas doctors.

I can't imagine surgery in Belgium or India could be anywhere as expensive as in the US.  I think most people going to Belgium have to pay up front, then get reimbursed later.

I guess you are going to have to do some homework to get all the expenses together for the doctors you are interested in.  That is not always easy, but I am sure you can work on it.

Sounds like you are going to be busy getting all the info together.

Pat
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

stevel

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Re: FDA approved device and experienced hip resurfacing doctor
« Reply #19 on: August 01, 2008, 10:21:40 PM »
I will need to compare the costs for surgery in Seattle vs Belgium or India.  They will reimburse necessary overnight lodging up to $80/day max.  I need to read more about Dr. Bose and Dr. DeSmet (and watch the videos).  I know either is highly recommended by Pat and Vicki.  I primarily have been researching the US doctors so far.  Do their hospitals compare to the Hospital for Special Surgery, New York which has received the no. 1 rating by US News and World Report, two years in a row (especially low infection rate)?  I will email x-rays to their web sites.  These x-rays are a year old.  I have only hard copies of more recent x-rays taken 7/21/08.  I can mail these express mail.

I imagine my post-op lodging reimbursement will be limited (e.g. a day or two after hospitalization vs 2 weeks recuperation?)

I'm looking forward to the upcoming chat with Dr. Bose.   
Steve
LBHR 60mm/54mm Dr Su 9/29/08
RBHR 60mm/54mm Dr Su 11/1/19

 

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