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Author Topic: Smith & Nephew Voluntary Removal of Small Sized BHRs  (Read 6404 times)

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kimberly52

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Smith & Nephew Voluntary Removal of Small Sized BHRs
« on: August 10, 2015, 09:55:48 PM »
Hi everyone,

I received a letter from my surgeon indicating that Smith & Nephew has recalled all BHR that are sized 46mm and under.  They noted that the "Hip Registry studies conducted across the globe shows that these device sizes have recently been shown to have a higher failure rate than other hip devices available on the market."

Has anyone else received a notice like this?  I have been having problems with my hip for quite some time where my doc wanted to aspirate the fluid in there but was at the time leaning toward my pain being referred from the 2 bad discs in my back. It was my choice to proceed with the aspiration or go see a back doctor. Of course I choose the less invasive.

The back doctor basically told me to go back to my hip doctor because he felt the pain was from the hip. That was a few months ago and I was doing a wait-and-see whether it would get better. Now the letter arrived and I had to make an appointment and know surely that he will want to do the aspiration as the pain is still there and lately it has even been painful to do a lot of the activities I previously had no problem with.

Anyway, I am angry, frustrated, and sad about all of this and maybe I am premature in asking about any recourse I might have with Smith & Nephew.  I will not know whether doc will want to remove it or not but I do want as much information as possible in the event that this goes south on me.

I am very interested to hear if anyone else got a letter or has the S&N BHR size 46mm or smaller.

« Last Edit: August 11, 2015, 01:34:03 AM by Pat Walter »
LBHR 4/6/13
42/44
Dr. Michael Clarke

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #1 on: August 11, 2015, 01:33:38 AM »
Hi  I understand that you might have problems and certainly should pursue opinions about your hip resurfacing.

I wanted to make sure you and others understand that Smith & Nephew did not have a recall - they choose voluntarily to remove the smaller sizes. I changed the title of your post so it won't alarm people that have small sized BHRs.

Here is the actual news release from Smith & Nephew

http://www.surfacehippy.info/BHR-small-sizes-removed-stops-use-in-females.php

I have a number of surgeons responses to this here:

http://www.surfacehippy.info/hip-resurfacing-small-men-women-2015.php

Dr. Rogerson explained the situation clearly very clearly:

http://www.surfacehippy.info/dr-rogerson-hip-resurfacing-women-2015.php

Dr. Rogerson of WI  6-19-2015 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. "
There has been a lot of press and posts about this.  Everyone has their own opinions, but I just wanted to make sure you did not call their actions a Recall.
I hope you can find a solution to your problems.
Pat


« Last Edit: August 11, 2015, 01:34:52 AM by Pat Walter »
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kimberly52

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #2 on: August 11, 2015, 10:41:33 AM »
That is interesting that you say it is not a recall Pat. The letter that I received from my doctor clearly says that it is a recall.  Possibly his secretary needs to be informed that it is not.

Also, I am wondering if S&N is covering themselves by calling it a "voluntary recall".  It still is a bit muddy since Market Watch and my physician are using the word recall.

Thank you for the links. I will read them over and discuss with Dr. Clark.
« Last Edit: August 11, 2015, 03:46:44 PM by kimberly52 »
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Dr. Michael Clarke

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #3 on: August 11, 2015, 11:32:23 PM »
Hi

Who knows what people are saying, even doctors.  My inputs from the surgeons are that it is a "voluntary removal (NOT RECALL)"   a quote from Dr. Rogerson.

This is Smith & Nephews full statement
http://www.surfacehippy.info/BHR-small-sizes-removed-stops-use-in-females.php
Statement regarding BHR System by Smith & Nephew 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
No matter what the words are, it is still a shame because the experienced surgeons have very high retention rates for women.

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

DeSmet http://www.surfacehippy.info/dr-de-smet-hip-resurfacing-for-females-2015.php

Gross  http://www.surfacehippy.info/dr-gross-hip-resurfacing-women-2015.php

Pritchett  http://www.surfacehippy.info/dr-pritchett-hip-resurfacing-women-2015.php

and other comments  http://www.surfacehippy.info/hip-resurfacing-small-men-women-2015.php

No matter the language, if you are a women with a working BHR, that's great. There are a lot of them.  If you are a person with problems, then you are upset and don't care what it is called.  You feel it is their fault to supply BHRs.  Fortunately, the people with properly working BHRs, male and female, are in the greater majority.

No matter what surgery a person has, there is always a small percentage for failure.  My open heart surgrery for aortic valve replacement had a 1% change of death.  Very small, unless you are the statistic.

Good Luck.  I will be happy to hear what your surgeon has to say. Dr. Clarke is a very experienced hip resurfacing surgeon.

Pat


« Last Edit: August 13, 2015, 11:09:51 PM by Pat Walter »
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DeviceGuy

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #4 on: August 18, 2015, 10:40:25 PM »
Hi Pat,
Just a clarification on "voluntary" and "recall" actions.
If a company has a product problem and is aware of it, they will contact the FDA to discuss actions.  If the problem is not a function of device failure through poor design but rather an issue of wrong application for a certain patient set, the company will voluntarily withdraw the product from the field/shelves.  ALL product that is placed in the field but then removed for whatever reason and sent back to the company is classified by the FDA.  That is to include items that are in the representatives trunk.  There is a #1, #2, #3 classification of recall.  #1 can result in serious injury or death.  #2 can result in injury or adverse reaction of a serious nature.  #3 has little likelihood of injury or adverse consequences. 
The action by S&N will more than likely be classified as Class 3 recall.
If product is not returned but rather clinical advice is given such as further defining implant technique, this would simply be a "notification".
Companies cannot change a thing procedurally from manufacturing, to instructions for use by physicians, to removal of product from the field.  If there is to be any change from what was originally submitted to the FDA for approval for general use, the FDA has to be notified and render their approval or denial.


If S&N would have advised physicians to only set the acetabular cup to say an angle of >30 degrees but less than 50, and a minimum of 100, 200, 300, or some # of implants, it would have been a notification and qualified doctors would still be implanting the smaller sizes today.


I believe that with the small number of HRA's being done today, S&N did not want to alienate the less qualified surgeons by officially ruling them out.  That's bad politically.  Had they done so and an inexperienced doctor took it upon himself to implant and not heed the advice, if there was a bad outcome it would fall on the doctor if it ever went to court.  After all, he was warned. Companies don't want to play doctor but they do want to minimize their risk and exposure to litigation.  S&N took the easy way out politically and financially.
The name of the game is CYA.
« Last Edit: August 18, 2015, 10:44:59 PM by DeviceGuy »
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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #5 on: August 19, 2015, 12:51:36 PM »
DeviceGuy - Thanks for your insight.  Interesting.  And yes, corporate America seems to fear the legal system.  Don't blame them.  In our country it is sue, sue and sue.  Only people making money are the lawyers. 

The interesting fact is that it takes forever to be part of these class action lawsuits.  People think they will get lots of money.  My Mom was part of one medical lawsuit from 30 years ago.  It took almost 30 years before they paid out the settlements and she got a few hundred dollars, not the promised thousands!

It is always best to try and find out which doctors have excellent outcomes and stick with them in any field of medicine.  That is not always easy, but worth the effort. Unfortunately, even the best surgeons sometimes have problems.  It is not easy trying to replacement original human parts with manufactured parts.
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kimberly52

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #6 on: October 29, 2015, 03:31:35 PM »
Well I had my needle aspiration this morning and unfortunately it doesn't look good. He was able to extract 2cc's of cloudy brown fluid.  Next steps are to get a second opinion with a new back doctor about my bulging dics and while I am doing that Dr. Clarke is sending the fluid to pathology for further testing.  He wants to determine if those dics are playing into my pain as referred pain.



What it boils down to is that Clarke said that it looks like I am in the beginning stages of a failure.  When I go back for followup in December he will tell me what our next steps are.


Stay tuned.
LBHR 4/6/13
42/44
Dr. Michael Clarke

blinky

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #7 on: October 29, 2015, 03:49:56 PM »
I am really sorry to hear that.


Please come back and update us as your story develops.

karlos.bell

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #8 on: October 29, 2015, 06:29:13 PM »
 :) Hi Kimberly52.
 Not sure how you are placed. Backs can very much so be caused by your hips locking up or issues within the hip. If you have a couple of older disc's bulging that means really they are just older and had some wear and tear. As long as they are not torn and leaking and unstable...
The crook hip gives the back a hard time as then the back does a lot more work.
Every one has some crook disc's. I had 2 replaced in Germany but the main issue was the hips.

The disc's I opted for are spinal kinetics M6 Lumbar disc's due they replicate the natural disc. Hell I run on these no issues......... yet.... 2103.
They were designed for this use in mind. Anyway mine happened due to a Motorcycle accident when I was real young (bullet proof back then yeah right....)
Maybe really concentrate on the hip then go back to your back later on it may sort it self out when the hip is sorted. 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.
2011-2013 FAI hip surgery failure
2007-Injury wakeboarding with FAI Hyperflexion

kimberly52

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #9 on: October 30, 2015, 06:10:38 PM »
Hey Karlos,

Dr. Clarke does not want me to wait on the disc issue.  He said that I really need to have that looked at and should do now while I am waiting for the pathology on the hip aspiration to come back.  It was kind of baffling to me why he wanted the back looked at right away and after thinking about it last night I think I figured it out.

He told me that the hip is in the beginning stages of failure so I am assuming that in his mind once the pathology comes back that he will determine whether it needs to come out right away or if I can wait a bit.  And if the conclusion is that is needs to come out right away he probably wants to make sure that another surgery with him putting me in all sorts of positions won't do more damage to what is going on with my back.  :-\

I asked Dr. Clarke who he would see if it was his back and was able today to make an appointment with the recommended doctor. So I am sure that I will be in good hands with his assessment.  :)
LBHR 4/6/13
42/44
Dr. Michael Clarke

kimberly52

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Re: Smith & Nephew Voluntary Removal of Small Sized BHRs
« Reply #10 on: November 05, 2015, 10:58:01 PM »
Dr. Clarke's office called today with my pathology report from the aspiration. They said I am having an allergic reaction to the metals in the hip. They moved my appointment up 3 weeks and that is all I know.  :-\
LBHR 4/6/13
42/44
Dr. Michael Clarke

 

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