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Author Topic: I am a Female - Can I have a Hip Resurfacing Comments by HR Surgones  (Read 9456 times)

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Pat Walter

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In light of the current BHR changes, I have asked Experienced Hip Resurfacing Surgeons to explain whether they can give small men and women a hip resurfacing? I will be adding to these responses in the future. Also available here:  http://www.surfacehippy.info/hip-resurfacing-small-men-women-2015.php

Smith & Nephew Press Release 6/4/2015
Smith & Nephew ... is therefore removing small sizes and updating the IFU to contraindicate the BHR for women.
"However, the revision rates associated with men requiring femoral head sizes 46mm or smaller and with all women patients exceed the current benchmark established by the UK National Institute for Health and Care Excellence (NICE). Based on this information, Smith & Nephew considers that these patient groups may be at a greater risk of revision surgery than previously believed, and is therefore removing small sizes and updating the IFU to contraindicate the BHR for women." Oriignal press release available
"BHR continues to perform amongst the best hip replacements for the right patients according to Smith & Nephew."
« Last Edit: July 05, 2016, 02:35:10 PM by Pat Walter »
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Dr. Pritchett of WA
« Reply #1 on: June 11, 2015, 01:15:31 PM »
http://surfacehippy.info/10-year-results-highly-cross-linked-polyethlene-pritchett-2015.php

Pat: Thanks for asking.  In my view Smith & Nephew has acted responsibly. I have not been offering metal on metal resurfacing in the withdrawn  smaller sizes. We have been offering just polyethylene in these sizes.  I am attaching my abstract for an upcoming meeting.     Yes, we use the implants shown on the Synovo Preserve site.     We offer this to both men and women. We always use a cementless acetabular component and usually a cementless femoral component as well.     Let me know the best way to reach patients.  We are happy to talk with patients.   I am concerned that patients might misinterpret the recent decision by Smith & Nephew as not supportive of resurfacing. As you know resurfacing is alive and well and works better than ever.    We actually have more rather than less to offer patient.     James Pritchett MD
bonerecon@aol.com
« Last Edit: June 28, 2015, 04:31:41 PM by Pat Walter »
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Dr. Voelker of Germany -
« Reply #2 on: June 16, 2015, 01:43:41 PM »
Dr. Voelker of Germany - Dear Patricia,
 
 I would like to comment on Smith&Nephew's BHR decision to exclude females and smaller sizes than 48 mm.
 
 The decision has been based on the renewed NICE criteria. I wouldn't say that I don't want best outcomes for all of my patients. But if you compare those criteria to other surgical outcomes it looks extremely strict. I think it would be just consequent if the collected data would have been collected the same way. The data results could never be lets call it clean like they have been collected. They are naturally influenced by so many things. For example: Revision of resurfacing is so much easier (also the decision is easier) than revision of THRs especially of cemented stems, or let's face the understandable poor results by some surgeons especially in the past because of only few numbers of performed resurfacings. That's all in the statistics!
 
 I question also to base important decisions only on one registry. And on top: What's about the data collected by the international group of experts doing resurfacing?
 
 Advantages of resurfacing are well known. Even with possible higher risks we still would have very good outcomes. We also improved the follow up procedure and by doing so we do prevent really bad surprises. Female patients must not excluded of a well functioning method because of existing data. At the end maybe they won't be allowed anymore to even receive THR under certain circumstances like young age.
 
 If you compare the complication rate of hip surgery with other surgery like hernia repair, appendicitis or bigger surgeries for example you would be very happy with results we have in hip surgery of males and females as well.
 
 In conclusion we will continue resurfacing on women. We also continue to avoid smaller sizes than 46 like we did in the past. Instead of BHR we use ADEPT or ICON in the future, both are implants with excellent registry results.
 
 Best regards,
 Dr Raimund Voelker
 ATOS Munich / GERMANY
 
 PS: >1000 hip resurfacings to date performed by Dr Voelker   In my own data even 44 worked fine by the way.
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Pat Walter

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Dr. De Smet of Belgium
« Reply #3 on: June 25, 2015, 05:30:05 PM »
 SO YOU CAN PUBLISH THIS ON YOUR WEBSITE ALSO WITH MY REMARKS!!!
 
 THAT IS WHAT I WROTE IN MY BOOKLET ALREADY 6 YEARS AGO (you can find on my website) WITH THE DIFFERENCES BETWEEN BHR AND CONSERVE.  Also  Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement
 
 I published this problem in 2008!!!
  I DID TODAY 3 CONSERVES WITH LADIES OF US AND CANADA!  SIZES 42 AND 44!!!!!     KOEN  Koen De Smet, MD  AMC  Anca Medical Centre  Xavier De Cocklaan 68.1  9831 St Martens Latem Deurle   Belgium  +3292525903  www.heup.be  Valle Giulia Roma Italy www.ancaclinic.it
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Pat Walter

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Dr. Rogerson of WI
« Reply #4 on: June 25, 2015, 05:31:19 PM »
Recent BHR news flash for females & others Notice & Discussion of Recent BHR Data:


John Rogerson, M.D.  6/19/15

We recently (June 3, 2015) received notification from Smith & Nephew, Inc., the manufacturer and distributor of the Birmingham hip resurfacing prosthesis (BHR), of a voluntary removal (NOT RECALL) from the market of a number of the smaller prostheses sizes (see below Dr. letter about females).  Please note, no further action is needed if you are not having any symptoms of pain or decreased function following BHR hip resurfacing. If you are symptomatic, please contact us to set up a follow-up appointment for further evaluation.

Mid-term data analysis from the National Joint Registry of England & Wales indicates that prosthetic head sizes below 46 mm in diameter and prostheses implanted in females performed less well and exceeded current revision rate benchmarks for total hip arthroplasty.  Male patients, in contrast, with head sizes 50 mm and above performed better than the same benchmarks.

 The data analyzed included all BHR’s implanted in England and Wales by all orthopedic surgeons regardless of their volume or experience.  Dr. McMinn and Dr. Treacy’s data (the inventors of modern day BHR hip resurfacing) show much better mid-term results compared to the registry data at 16 years (see below Dr. McMinn data and results).

 The registry data analysis, unfortunately, did not take into consideration the component implant position, the surgeon’s volume of cases, the increased activity level of the resurfacing patients, hip dysplasia versus osteonecrosis versus osteoarthritis, and a number of other factors which might explain the result differences in these two patient population databases.
 Fortunately, our data correlates well with Dr. McMinn’s results.  Our females with osteoarthritis have a known revision rate of 0.4% since 2006, and 1.3% for females with hip dysplasia arthritis, with both groups enjoying a very high level of activity.

 Be that as it may, as of June 3, 2015 we will no longer be able to perform BHR hip resurfacing in the female population at large or in males with femoral head sizes templated below 50 mm.  I personally feel that this is most unfortunate for these younger patients, male or female, who want to remain extremely active.

For patients who are no longer BHR candidates, I believe the next best option in the younger hip arthritis population is a metal-on-polyethylene total hip prosthesis with a porous coated titanium stem and socket shell, with a ceramicized zirconium metal (Oxinium) femoral head and a highly cross-linked polyethylene socket insert.  Unfortunately, because the plastic insert is now mandated, high-impact activities would not be encouraged after total hip arthroplasty, even with this prosthesis.

 I will keep you apprised of more information as it becomes available to me.

Dr. Letter About Females 2015

Dr. McMinn BHR Data

Dr. McMinn 12-15 yr. BHR Results
« Last Edit: July 21, 2015, 06:27:47 PM by Pat Walter »
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Dr. Gross of SC
« Reply #5 on: June 25, 2015, 05:32:30 PM »
Dr. Gross of SC 6/10/2015 - Dr. Gross is on vacation, but Lee Webb gave a statement.  Dr. Gross will send additional information when he returns.

Dr. Gross still does resurfacing on women and men that require smaller sizes. The key is getting the acetabular inclination angle correct. He is happy to review X-rays for patients. We need the new patient forms from our website and recent X-rays.

He wrote an article about women and hip resurfacing which is on our website under current topics. You are welcome to post on your website.

http://www.surfacehippy.info/hip-resurfacing-for-women-dr-gross-2013.php

We are both on vacation this week and I can ask him to give me a statement when he returns. We did discuss before he left and he told me he has excellent results with hip resurfacing using smaller sizes and plans to continue.

Thanks for all your help as usual. 
   Best,
   Lee Webb MSN, APRN, FNP-C Nurse Practitioner
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Pat Walter

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Dr. Brooks of OH
« Reply #6 on: June 28, 2015, 04:30:03 PM »
Hi Pat

Yes, it is true.

Smith and Nephew was asked to respond to the long-known worse outcomes in females. This was precipitated by the UK's National Institute of Clinical Excellence (NICE) raising their 10 year outcomes requirement from 90% where it been for years, to 95%.

Raising the bar left females and small sizes below the bar (along with a great many total hips as well, so expect more fall-out), and males well above the bar.

If you remember, the UK registry, on which their regulators base decisions, had an average doctor's resurfacing volume of just 4 per year, of which 3 would be expected to be men. So this decision, made for the safety of women, was based on the combined data in the UK of docs doing 1 per year.

Honestly, if I did one heart transplant a year, it wouldn't do very well!
As a woman with a well-functioning BHR, I am sure this action is disturbing to you, as it is to my patients.

The actual product removal is sizes 46 mm heads and below, (which is virtually all my female patients) as well as females of any size.

Small men are also affected.

How about you start a write-in campaign, or online petition?

Best wishes,
Peter Brooks MD
[you may post this if you wish]
PS :They refer to this as a "voluntary product removal" in the US, rather than a "recall". I think in the UK it's something similar, like "voluntary market withdrawal".
Read Smith & Nephews News Release Here:
http://www.surfacehippy.info/BHR-small-sizes-removed-stops-use-in-females.php
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Pat Walter

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Mr. McMinn of UK
« Reply #7 on: June 28, 2015, 04:37:35 PM »
'Women do well with Hip Resurfacing in my hands' - Mr. Derek McMinn, June 25, 2015

The McMinn Centre - Web Lecture presented by Mr. Derek McMinn June 2015

Here is the very interesting and informative video

http://www.surfacehippy.info/mcminn-positive-results-hip-resurfacing-women-2015.php

I am sorry I can't post a Youtube video directly on the discussion group.

Pat
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Pat Walter

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Dr. Bose of India
« Reply #8 on: June 30, 2015, 02:23:10 PM »
From a very philosophical standpoint hip arthroplasty is very unfair towards women!!!

Most men will have a socket size of 52 or over and therefore a 36 mms head can be used in all types of hip replacements. The 36 mms head is technically a ‘large head’ and is a  good option having  serious resistance against dislocation. In addition men in general or not as lax / flexible as women and the risk of dislocation is significantly smaller. However the typical acetabular size in most women is  46 to 50. The small acetabular size in most women will dictate having a ridiculously small  28 mms or smaller  head  making it prone for dislocation.  Added to this is the flexibility / laxity in women which would accentuate the  problems imposing lot of restrictions in active patients.

 The decision by smith and nephew to withdraw 46 and below BHR head  size will impact women all over the world and more so in countries like the U.S and Canada where good alternative options for high performance  are not readily  available.

  In general it is universally  accepted that  smaller sizes of resurfacing are extremely  sensitive to  even very mild component malpositioning and therefore risky . The  cut off value is deemed to be 46mms head which will have a 52 socket couple.  This is the reason for smith and nephew to withdraw the small sizes. Most  women will be condemned to a 28 mms or smaller head size in a traditional THR which would be crippling to an active patient.  When I see a 28 or smaller head sized THR  patient in my clinic ( done elsewhere) I  cannot help but feel sorry for them.

  I have no doubt in my mind that the best implant for female patients with small bone size is the   deltamotion which has incremental head size like the BHR ( ie,proportional to the native head size) and thus allows the same functional level postop as the BHR.  This begs the question as  to  why this delta on delta bearing  should not be used as a hip resurfacing and thereby  avoiding the stem. Alternatives to metal on metal  bearing in  resurfacing is not new. Ceramic on ceramic seems to be a logical choice and there are design teams around the world that are trying to develop the same. Now that we have the deltamotion socket with an excellent track record , it would be very easy to develop a ceramic femoral resurfacing component. The other option is ceramic / metal on highly cross linked poly resurfacing. Both these type of resurfacings have been developed many years ago.

  However there is one technical issue in my opinion that  will be impossible to surmount in a non-metal on metal  resurfacing even in the long term.

 This is the size differential between the femoral and acetabular component. The size differential in the BHR and all metal on metal resurfacings is 6 mms. This is the thickness of the normal cartilage that the resurfacing replaces. This is ideal. E.g.  46 BHR head will have a 52 mms BHR cup etc.

 Any other bearing material in a resurfacing will increase this differential ( usually 10 mms) . This is unacceptable. The only way of installing this would be to remove more bone from the acetabulum which would be a disaster in young patients . The other option of removing  more bone from the femoral head would decrease offset causing  impingement and  a compromised result.

 It is easy to install these alternative bearing resurfacings in patients but has some serious pitfalls. This would cause more bone loss from a revision standpoint than a THR. If any resurfacing component removes more bone from the socket than a THR , it  defeats the whole purpose of bone conservative surgery . Thus the only way of  fixing a delta on delta or any alternate bearing  would be on a stem. There is no doubt that a hip resurfacing conserves bone on the femoral side which would make revision easy if required. Combining the deltamotion with a bone conservative stem like the Corail would also  make revision easy if required. Thus  I am very happy to offer this option for very young patients.

 The Stryker MDM dual mobility is another option which will address one issue i.e. dislocation . However as there is poly in the dual mobility it may not be appropriate for younger and very active  patients due to wear issues. I have some info on the deltamotion & Stryker MDM dual mobility hip in my new website on complex hip reconstruction3

  http://www.hipreplacementsurgeryindia.com/high-performance/deltamotion.html
 I allow running and all unrestricted activities with the deltamotion but not with the stryker dual mobility . I use the stryker dual mobility only in older patients ( instead of standard THR) where return to activity is not critical but resistance to dislocation is the only issue. The gender of the patient has nothing to do with survival rates of  MoM hip resurfacing and I would always be very happy to do a BHR for a female patient if the size is available.

 I hope the above info is useful
 With warm personal  regards
 Dr. Vijay C. Bose M.S(orth); FRCS(orth) MCh (orth)
 Joint  Director & Consultant Orthopaedic surgeon
 AJRI
Asian Joint Reconstruction Institute
SIMS - SRM Institutes for Medical Science   
No 1, Jawaharlal Nehru Road (100 ft road.) Vadapalani
Chennai 600 026
 Ph:  secretary  +91 99400 73000
« Last Edit: June 30, 2015, 02:24:15 PM by Pat Walter »
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Hip Resurfacing in Women by Dr. Gross 2015
« Reply #9 on: July 08, 2015, 04:46:35 PM »
The continuing controversy - Thomas P. Gross MD. 7/4/2015
Young women who desire a more functional hip replacement were recently dealt a large blow  when the smaller sizes of the Birmingham Hip Resurfacing  (BHR) device were withdrawn from the market by Smith Nephew Richards because the 10-year revision rate for women was higher than for men in most large registry analyses. (The major national registries are Australia, Combined Scandinavia, and Great Britain).

Joint implant registries estimate an overall failure rate for different implants when used by the average surgeon in a country. Specialist surgeons can typically perform better than these data suggest.

Hip resurfacing is a treatment for severe hip arthritis that results in a nearly normally functioning hip. Scientific studies  demonstrate that patients walk more normally in gait studies, and are more likely to be able to resume full impact sports if they have a hip resurfacing rather than a traditional stemmed total hip replacement.

Generally women have smaller hip joints than men and require the smaller sized implants. There is no way to make the larger ones fit. The only alternative, if no smaller sized hip resurfacing implants are available, is to amputate the whole femoral head and then perform a standard total hip replacement (THR). I would estimate 70% of women and 20% of men will now not be able to choose a hip resurfacing arthroplasty (HRA).

It is difficult to know from the preoperative x-ray for certain what implant size will be needed. If patients are now scheduled for a BHR, they may end up with a standard stemmed THR instead of a resurfacing once the surgeon has opened the hip and found that the hip requires a smaller size than they thought.

There is no doubt in young men. Resurfacing is more functional and more durable. All men under 60 should have resurfacing if there were enough qualified surgeons available.
In women there is a dilemma: Do you choose a more functional hip that has a higher chance of failure by 10 years? Unfortunately women are loosing the opportunity to decide for themselves. The decision is being made for them by implant companies and the policies promulgated by the FDA. On the other hand, the failure gap between men and women is much lower in the hands of experienced resurfacing surgeons (than in registry data) My data now shows a 98% 8-year implant survivorship in women. Very few THR studies can match this in young patients.
Men requiring smaller bearing sizes and women desiring HRA have several options:
1.    Leave the country for surgery. The Conserve Plus was withdrawn from the US market because of our overly litigious environment after Wright Medical was bought by Microport, a Chinese company. This implant has an excellent track record. Just before being sold they released an improved acetabular component that increased the coverage arc of all acetabular sizes to 170 degrees, which addressed the problems with smaller implant sizes. It is still available worldwide, but the company will no longer sell it in the US.

2.    See Dr. James Pritchett (Seattle) who performs a HRA with a ceramic on polyethylene device. The socket component is thicker than metal bearing implants. Therefore, implanting these requires more bone removal. Also previous results with standard polyethylene in the 1970s was poor. Cross linked polyethylene has not yet been adequately tested, but shows promise in preliminary testing. Currently cross linked polyethylene is not available for resurfacing.

3.    I still perform HRA using Biomet metal bearing implants for all patients. I have similar results in men and women and also perform resurfacing in patients with difficult deformities. I have performed over 3700 HRA with Biomet implants since 2005 with an excellent track record. Results are published on my website.

What is the problem with HRA in women?
10-year implant survivorship in young men is superior for HRA as compared to THR.
Implant survivorship in women and men with smaller bearings is lower than THR in large registry studies.

Implant survivorship is not the only criterion that should be used to decide whether THR or HRA is best. Furthermore only the patient and their surgeon should make the decision as to which operation is best for the patient. The government, insurance companies, hospitals are not qualified to make this decision. Orthopedic societies also should not make blanket policies, because they are not the treating physician and they are typically controlled by a group of surgeons who have strong biases of their own. Surgeons who politically control these societies are well-respected, but do not necessarily have greater knowledge or skills than any other surgeon.

If, based on registry data, HRA should be made unavailable to women, then by the same reasoning THR should be made unavailable to young men under 60. Neither of these make sense, the decision in each case should be made by the informed patient with the guidance of their chosen surgeon. Surgeons need to keep accurate data and inform patients of their track record with different procedures. My 8-year implant survivorship with the Biomet uncemented resurfacing is 99% for men and 98% for women in over 3000 cases.

Why  do women have a higher failure rate with HRA as compared to men?
The answer is multifactorial.

1.   Dysplasia is much more common in young women with end stage hip arthritis. Both THR and HRA have worse outcomes for dysplasia. A direct comparison of THR vs HRA has never been done for dysplasia patients. Before 2008 I had a 82% 8-year implant survivorship rate for dysplasia now I have a 99% 8-year rate. Problem solved. I have not seen any comparable results for THR.

2.    Adverse Wear Related Failures (AWRF) are more common with smaller implant sizes. Women require the smaller sizes. We have shown that AWRF can be avoided by proper acetabular component positioning. Prior to 2009 we had a 1% 10-year rate of AWRF; I have not had a single case of AWRF since 2009 in over 2000 consecutive cases. Problem solved.

3.   Failure of Bone Ingrowth of acetabular component is more common for severely deformed sockets (such as some dysplasia cases). This was my most common failure mode in dysplasia cases previously. In 2007 the Biomet Trispike Magnum was released. This implant has spikes for supplemental fixation. I use it in the worst 5% of Dysplasia cases. I have had no failures of fixation in any dysplasia cases since 2007. problem solved.

4. Femoral neck fracture occurs more commonly in patients with weaker bone. fracture only occurs in the first 6 months after surgery. Women have weaker bone. Since 2007 we have been measuring bone density on all patients and use this to adjust postoperative management. We have had no femoral neck fractures in 2000 consecutive cases since 2009. problem solved.
5.  Uncemented femoral components have eliminated late loosening as a failure mode up to 8 years so far. this has improved results in men and women.

Advantages of hip resurfacing:
1.    Better implant survivorship in young patients. women now have very similar results as men. Hip resurfacing done by an expert is more durable than THR for men and women.
2.  Better functional outcome. Impact sports are much more commonly possible after resurfacing. Also, formal gait lab studies always show more normal function for resurfacing. If you want to play sports,  you are much more likely to do so with a resurfacing.
3. Better stability. Dislocation rates are much lower for resurfacing because biomechanically a resurfaced hip is closer to a normal hip.  In THR the bearing size is artificially smaller, leading to a higher risk of dislocation. With HRA there are no worries with extreme range of motion activities such as yoga, gymnastics or kayaking.
4.  Better patient survivorship. Two large studies based on the British implant registry have shown that resurfacing patients are much more likely to be alive at 5 and 10 years after surgery than age, gender and health status matched groups of patients who receive THR. Resurfacing patients can tolerate more vigorous exercise which may keep them healthier and alive longer.
5. No thigh pain. 3-5% of THR patients have thigh pain due to irritation from the stem. This does not occur in HRA. This may be the reason that function is generally poorer with THR.
6. Bone preservation. Much less bone is removed from the femoral side with resurfacing. Socket side bone removal is the same for both procedures. Removing a well-fixed femoral THR stem can require splitting the top of the femur, a resurfacing is removed by cutting the neck off, just as one does in a primary THR operation. Bone preservation in young patients leaves them better future options.
7. Philosophical. If you have lost your cartilage layer, why not just replace it with metal and leave the hip as close to a natural hip as possible? Amputating the head and neck, driving a spike into your femoral shaft, and leaving you with a biomechanically unsound smaller hip bearing just doesn't  seem right.
Disadvantages of hip resurfacing:
1.   Technically difficult. it takes a few hundred cases to master. some surgeons just don't have the ability to take this on. Most surgeons learn THR in residency, few learn resurfacing. Now surgeons are scared to learn because of all of the misinformation about adverse wear problems.

2.  Adverse wear related failure. This is the main argument against it by THR advocates. This is totally preventable by proper implant positioning. I have had no cases of AWRF in over 2000 consecutive cases since 2009.

Total Hip replacement has been called "the operation of the century" because of its dramatic impact on society. But that was the 20th century. Hip resurfacing is the operation for the 21st century!

Write to your congressman and let him/her know that the FDAs needs to lighten up. just because some surgeons have difficulty with resurfacing, does not mean that these implants should be removed from the market.  Resurfacing has been shown to result in a more normal functioning hip reconstruction than THR.  Failure rates have been higher in women in the past. But we have discovered the causes for these higher failure rates and have addressed them. There is no reason to abandon resurfacing in women. In the hands of experienced resurfacing surgeons the failure rate in women now approaches that of men.

Write to Smith Nephew Richards and let them know that you are disappointed that they removed BHR implants for women from the market. Women want a high functioning hip option as well.
If implant companies modified the smaller implant sizes to increase the coverage arc to 165 degrees, AWRF would rarely occur, even in the hands of less skilled surgeons. If the FDA did not make the approval process so onerous and costly, implant companies might consider taking this approach. this would be a better approach than just withdrawing implants from the market.

Visit me at www.grossortho.com  for more information
« Last Edit: July 08, 2015, 04:50:31 PM by Pat Walter »
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