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Author Topic: Removing small sizes and updating the IFU to contraindicate the BHR for women  (Read 7175 times)

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Pat Walter

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News Release I just found:
Statement regarding BHR System   4 June 2015
 
 
  • Voluntary actions initiated to remove smaller size components and change Instructions for Use (IFU) following analysis of recent performance data
  • No action required from patients; no change to current practice for patient follow-up care
  • BHR continues to perform amongst the best hip replacements for the right patients
 
Smith & Nephew (LSE: SN; NYSE: SNN), the global medical technology business, announces the voluntary removal from the market of 46mm diameter and smaller femoral heads and corresponding acetabular cup components for the BIRMINGHAM HIP Resurfacing (BHR) System, and new Instructions for Use (IFU), reflecting recent performance data. Surgeons should maintain their routine follow-up protocol for patients, and patients are not required to take any new action.
Andy Weymann MD, Smith & Nephew’s Chief Medical Officer, said: “Patient welfare is Smith & Nephew’s top priority. Based on our analysis of our most recent data, we are taking the necessary steps to ensure that the BHR is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients.”
As part of its normal post-market surveillance, Smith & Nephew has conducted an analysis of recent National Joint Registry of England and Wales (NJREW) data. This indicated that the BHR continues to deliver performance in line with the best total hip replacements in male patients under 65 requiring femoral head components 50mm in diameter and larger. 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.
Smith & Nephew is not advising proactive revisions for existing patients unless required for clinical reasons. As with all medical devices, anyone experiencing unusual symptoms should contact their surgeon. BHR patients can also visit the website www.smith-nephew.com/BHR.   
The removed products accounted for around 1% of Smith & Nephew’s global hip implant revenue in 2014, and 0.1% of Group revenues. This action will have no impact on guidance for the Full Year.
 
 Notes to editors: Definition of Resurfacing In a traditional total hip replacement the femoral head and acetabular socket are both removed and replaced.  The femoral implant is a stemmed device that is placed down the shaft of the femur and accepts a head which articulates against the acetabular implant.  In hip resurfacing the femoral head is not removed but is instead trimmed and capped (resurfaced) with a smooth metal covering. The damaged bone and cartilage within the acetabular socket is removed and replaced with a monolithic metal shell which articulates against the resurfaced head.
On a procedure volume basis, the global resurfacing market represents <0.5% of the total hip arthroplasty market.
 
 Enquiries:  Investors
 Ingeborg Řie
 Smith & Nephew
+44 (0) 20 7401 7646
Media
 Charles Reynolds
 Smith & Nephew
+44 (0) 20 7401 7646
Joe Metzger
 Smith & Nephew
+1 (978) 749-1330
Ben Atwell / Debbie   Scott
 FTI Strategic Consulting
+44 (0) 20 3727 1000
 
 About Smith & Nephew Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 90 countries. Annual sales in 2014 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
For more information about Smith & Nephew, please visit our corporate website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com
 
 Forward-looking Statements This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.
Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.
 
Webmaster/Owner of Surface Hippy
3/15/06 LBHR De Smet

JHippy

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This is horrible news. I hope other companies don't do the same.
Left HR; Dec. 17, 2014; Dr. Gross and Lee Webb NP;
uncemented Biomet Recap/Magnum; 50mm/56mm.

Anniee

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This is sad.  My implant (Biomet) is 46 mm, and I'm big boned.  If other manufacturers follow suit, most women will no longer be able to have this surgery.
Annie/ Right Uncemented Biomet 4-20-11/Left Uncemented Biomet 10-12-11/Dr. Gross

hernanu

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Wow. This is not fair to women who need hip resurfacing / replacement. What is the option, then if even THR is out of bounds.

Hernan, LHR 8/24/2010, RHR 11/29/2010 - Cormet, Dr. Snyder

MattJersey

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I'm male and 48mm. Hope the bar doesn't get raised higher.


The rationale seems flawed as Dr Gross points out, and I would expect other surgeons who are very experienced to show, in time, how successful their results are when placed carefully, to show the research up as flawed. May be a temporary issue, but that's not much good for those who now will have to look for alternatives.



28 April 2015, RBHR Mr McMinn

karlos.bell

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Hi Anniee. see what Dr De Smet thinks about it. Email him he is very responsive and a massive experience.       dr.koendesmet@gmail.com       No harm in asking questions. Cheers K
2019-2020 THR Left & Right COC Revision Zim Continuum cup with Biolox Delta Cer Liner, Biolox Delta Cer Head 40mm 12/14 Taper, CPT Stem Cem.
2019-2020 removal of Hip Resurfacing due to Metal Toxicity Cobalt - Chromium.
2015 MOM Conserve plus
2011-2013 FAI hip surgery failure
2007-Injury wakeboarding

Anniee

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Karlos, Dr. Gross resurfaced my hips in 2011, but I appreciate your trying to help me!  I'm concerned about this issue for other women who may need the surgery.
Annie/ Right Uncemented Biomet 4-20-11/Left Uncemented Biomet 10-12-11/Dr. Gross

karlos.bell

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Thanks Anniee. Your experience far out ways mine. The fitting as I understand from Dr De Smet is paramount. There seem to be so many variables, makes and models  and Surgeon experience.
2019-2020 THR Left & Right COC Revision Zim Continuum cup with Biolox Delta Cer Liner, Biolox Delta Cer Head 40mm 12/14 Taper, CPT Stem Cem.
2019-2020 removal of Hip Resurfacing due to Metal Toxicity Cobalt - Chromium.
2015 MOM Conserve plus
2011-2013 FAI hip surgery failure
2007-Injury wakeboarding

DeviceGuy

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It's been just over a month since S&N announced a voluntary removal from the market of femoral sizes 46mm and less for HRA.  Their justification is a result of revision rates for the smaller sizes having exceeded the benchmark established by NICE.  That is founded in one registry with numbers that are felt to be unacceptable.  But what does that mean?  It is based on all cause for revisions.  Were there 200 people that skydived at 3 weeks and had femoral head fractures?  Was proper protocol not followed as 100 people returned to high impact sports at one month?  Were all the surgeons "best in class" for orthopedics?  Had all the surgeons performed at least 300, 500, 1000 or more implants?  The point is, you can deduce anything you want from raw data which can mire the acceptability, usefulness, safety, or exposure to a medical implant.  Yes, I said exposure.  Exposure from what you ask?  Exposure to lawsuits.  Ours is a litigious society.  I have no doubt that the actuarials at S&N looked at the exposure to lawsuits, class action or otherwise, and decided that it was not prudent to continue on with the smaller sizes because of the dollars it could cost the company.  Mr. McMinn was absolutely correct when he stated that S&N could just approve of well established surgeons with tons of experience under their belts to implant the smaller sizes.  But, S&N knows that would alienate a great number of their physician base as that would identify those that were in fact NOT qualified to implant small sizes for HRA.  So it was much easier to just eliminate the 25-35% or so of the resurfacing market in smaller sizes.  It all comes down to MONEY.  There is nothing altruistic in how they have gone about this.  If there was they would have broken down the numbers showing that the majority of doctors in the registry were doing 4 or 5 resurfacings a year, far too few to lend merit to the benefits of hip resurfacing.  Logic says that they are turning their backs of the incomplete science of the data collected with the resultant decision they have made.  I say, FOLLOW THE MONEY!!  It's not like they are leaving patients in the lurch without an option.  They can still get a THR or seek out the few remaining small size options available.  It just won't be on S&N's dime should things go wrong. 
Patients in need of 46mm and smaller head sizes have been thrown a curve ball and I feel for them.  However, I hope they remain diligent and jump a few hurdles in front of them now in order to get a resurfacing if that is in fact what they want.  In the hands of a qualified surgeon, small sizes are still a great option with a high degree of success to be expected.  Very few things in life are 100% guaranteed and detractors will point to individuals that have had less than stellar outcomes with smaller sizes.  But you have to sift through the "all cause" stats and come to reasons for failures and determine whether more stringent guidelines for implant, experience, patient fault, etc., could be used to improve those outcomes.  Sadly, in the end, we have to follow the money......
L-Hip Biomet U/C, Gross, MD & Webb, NP; 12/14
R-Hip Biomet U/C, Gross, MD & Webb, NP; 04/15

chuckm

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Nice post. Don't leave out that following the money is what led to the BHR in the first place.
I am thankful for that.

Chuckm
Left BHR 11/30/12
Hospital for Special Surgery
46 years old

brown1sc

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I have an appointment with Dr. Gross in a couple of weeks.  I am a 45 yr. old male with a somewhat small frame.  Curious if anyone has any idea what the average femoral head diameter size is for males?

jd

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Dr Gross told me the average was ~50mm for the femoral component for males. It doesn't matter though, he'll operate with very small femoral components, covering small women, so you'll be fine.

brown1sc

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Thanks, JD.  I certainly do not wish to come out of surgery with a THR.

karlos.bell

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 :) Hi yep device guy has pointed this is all  out about the money it all seems to revolve around that.
I do know that the conserve plus ( striker) has had similar experiences in the US and was with drawn voluntary due to litigation. That was Dr De  Smets comment. Law suits in the US!!!. Device guys points it out it only takes one person to upset the sysytem and the companies get scared. Ok beside all that Conserve plus HR or Striker are still making the smaller sizes. These are not banned from use just withdrawn. Or can someone correct me if I am wrong...
What if some one was needing one (small unit) and found the right experienced surgeon to do the job in the US. They cannot surely be too much different from each other ??

I am quite amazed at how each month mine change the ROM  so hopefully some time it will all piece together.
Maybe someone even like Pat could update us on this???
Cheers K
2019-2020 THR Left & Right COC Revision Zim Continuum cup with Biolox Delta Cer Liner, Biolox Delta Cer Head 40mm 12/14 Taper, CPT Stem Cem.
2019-2020 removal of Hip Resurfacing due to Metal Toxicity Cobalt - Chromium.
2015 MOM Conserve plus
2011-2013 FAI hip surgery failure
2007-Injury wakeboarding

Pat Walter

  • Patricia Walter
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Hi
I wish I had an update, but I don't.  I know other devices are available and used overseas that are no longer used here except for the ASR. 

Many of the experienced surgeons explain their views about what devices they use here:

http://surfacehippy.info/category/hip-resurfacing/hip-resurfacing-for-women-and-small-men/

A few in the US are still doing women and small men such as Dr. Pritchett, Dr. Gross and even Dr. Su.   Dr. Su explained:   "I continue to offer resurfacing for men and women of all sizes, based upon my own personal experience that resurfacing can work well even in the smaller sizes." in an email to me.

That is all the information I have now.

Pat

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

blinky

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I was worried about waking up with a THR, too. Not due to small size, but due to my poor, wasted femoral head. Lee and Dr Gross said that wouldn't happen, that Dr Gross could look at my X-rays and know whether or not he could do a HR.(Yes, I still worried I would be that one person he couldn't predict!) I assume the same would be true with sizing. He doesn't use BHR, so the small size withdrawal isn't an issue for him.


They do estimate the size you will need before surgery so they have thought of this issue.

brown1sc

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I was also concerned that I had put off this off too long and there would be too much damage to move forward with the resurfacing.  I honestly just learned of the resurfacing option, and I am fortunate to live very close to Dr. Gross's practice.  I can't express how excited I am to get this done.

 

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