Tags
Birmingham, Birmingham Hip Modular Head, Hip Replacement, hip resurfacing, Johnson, Nephew, NephewSmith, science, Smith, Technology
Source: Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips | MassDevice – Medical Device Industry News.
Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips
September 25, 2012 by Arezu Sarvestani
The metal-on-metal hip implant failure controversy finally claims Smith & Nephew, maker of the first MoM hip to hit the market.
Smith & Nephew (FTSE:SN, NYSE:SNN) issued an “Urgent Field Safety Notice” for its Birmingham Hip Modular Head implants, part of the suite of devices that pioneered the metal-on-metal hip field when they 1st hit the market in 1997.
The orthopedic giant warned the Hong Kong department of health that new data on the implants, gathered since 2010, suggests a 1.29% failure rate based on the National Joint Registry of England and Wales and a 1.12% failure rate based on the Australian Orthopaedic Association’s National Joint Replacement Registry.
On their own the rates exceed the 1% benchmark established by the U.K.’s National Institute for Health and Clinical Excellence. Prior to 2010 registry data showed a 1% revision rate for the devices, according to the company.
“Smith & Nephew’s highest priority is to deliver safe and effective medical technology to benefit patients,” Smith & Nephew spokesman Joe Metzger told MassDevice.com today. “As such, we have notified customers and regulatory bodies of a change to the indications for use for the Birmingham Hip Modular Head used during total hip replacement and revision.
Smith & Nephew did not issue a recall on the device, but updated its indications for use. The company noted that, when used strictly with the Smith & Nephew’s Synergy stems, the hip implants exhibited a 1.07% failure rate, which is within acceptable limits.
“The potential risks that may result from use of the device have not changed,” according to a letter the company sent to healthcare providers. “They may include pain and limited mobility, potentially leading to revision surgery. Females of child bearing age are at greater risk with metal-on-metal implants. Severely overweight individuals have been observed to be at greater risk of revision surgery.”
The new indications on the Birmingham Hip Modular Heads restricts use only to revision surgeries “in cases where a Birmingham Hip Resurfacing femoral component is being revised, the patient shows no signs of metal sensitivity, and it is being implanted in conjunction with an uncemented Synergy stem,” according to a Smith & Nephew web page.
The re-labeling does not change current practice for follow-up care for the Birmingham Hip Modular Head devices, Metzger told us.
“This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure,” he added. “This change does not apply to our BHR resurfacing device, which is performing very well, and is supported by data from several registries and independent, peer-reviewed articles.”
The alert is a new blow in the ongoing MoM implant controversy that has embroiled several orthopedic device makers, most notably Johnson & Johnson‘s (NYSE:JNJ) subsidiary DePuy Orthopaedics, in a flurry of lawsuits and public outcry.
As the 1st MoM hip implant to hit the global market, a knock against Smith & Nephew’s Birmingham devices may portend a fatal blow to the suite of products that followed, including those by Biomet Inc., Encore Medical, Wright Medical (NSDQ:WMGI) and Zimmer (NYSE:ZMH).
The Birmingham implants 1st hit the world in 1997, pioneered in Birmingham, England, by McMinn in a back-yard shed. McMinn believed that the risk of metal ions being introduced into patients’ bodies could be minimized with a design that kept the metal surfaces apart.
Rival orthopedic devices maker Wright Medical (NSDQ:WMGI) sought to block Smith & Nephew from getting its Birmingham metal-on-metal hip implant into the U.S. marketplace, according to filings with the FDA. Wright filed a citizen’s petition alleging that the study behind the PMA application was inadequate to prove safety and effectiveness.*
Correction, September 25, 2012, 5:00 p.m.: This article’s final paragraphs mistakenly used data about Smith & Nephew’s Birmingham Hip Resurfacing device in reference to the Birmingham Hip Modular Head implant.
Related articles
- YAHOO – Smith & Nephew Birmingham Hip Lawsuit Filed Over Metal Poisoning – AboutLawsuits.com (earlsview.com)
- GOOD NEWS – Smith and Nephew sees a decline Birmingham hip implant business (earlsview.com)
- Wright Medical Filed Petition to Block Smith & Nephews Metal Implant (earlsview.com)
- Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney (earlsview.com)
- Smith & Nephew Birmingham hip resurfacing at a mean of ten years (earlsview.com)
- Smith and Nephew – time to come clean – more facts, less spin (earlsview.com)
- No early link between all-metal hip implants and cancer-study | Reuters (earlsview.com)
- Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno (earlsview.com)
- Metal-on-Metal hip Implants Can Corrode | FDA Reports (earlsview.com)
- Smith & Nephew Hip Replacement Lawsuit Filed Over Failed Liner – AboutLawsuits.com (earlsview.com)
Pingback: Smith & Nephew Ethics… « Earl's View
Pingback: Orthopedic startup in Indiana aims to sell cheaper, more durable total hip implant | MedCity News « Earl's View
Pingback: Warning Over Birmingham Hip Modular Head (BHMH)… | Stuff.co.nz « Earl's View
Pingback: NZ – Metal on Metal – Smith & Nephew – Medsafe hip device statement | Scoop News « Earl's View
Pingback: Q: Who is going to pay the Mortgage Mr Smith & Nephew while two BHR’s are revised? « Earl's View
brooks said:
I meant to comment on this article but have been recovering from surgery and cannot get in front of this machine as much as I’d like. But I find this paragraph to be especially noteworthy:
“This modification does not apply to the U.S. market where the Birmingham Hip Modular Head is not approved for use as part of a primary hip replacement procedure,” he added. “This change does not apply to our BHR resurfacing device, which is performing very well, and is supported by data from several registries and independent, peer-reviewed articles.”
Why then, for goodness sake, did I have a Birmingham Hip Modular Head removed from my body here in the US, after it’s failure in less than three years, necessitated by the well-known MOM side effects, i.e., metalosis/Pseudotumor/AVAL leading to the wonderful world of toxicity and dead flesh.
I am no longer surprised as to why I was unable to find the FDA 510k approval on the BHR Modular Head, as it appears S&N never actually obtained one!
So mysterious, this escapade has become. The device on my desk here in it’s ‘Bio Hazardous Bag’ taken from my body has no identifiable marks upon it, but that is now easily explained; it simply doesn’t exist! Oh, the relief i feel now!
How high must their horseshit pile climb, before the honorable S&N spokesman Mr. Metzger steps round it and speaks to us the truth? He might consider the pile will soon engulf him, the longer he waits, whereupon much more effort will be required for Smith and Nephew to extricate themselves from what will by then be a nearly insurmountable pile of excrement!
Bottom line here, if you are a US Smith and Nephew, so-called BHR THA recipient, (that ‘label’ now obviously represents a fictional amalgam of disparate parts), your world just got a little brighter. If in fact you do have a BHR THA, you don’t have a BHR THA!
(Note to Earl: Should we make this a current post, considering its ramifications and importance to all Smith and Nephew BHR THA victims?)
earlstevens58 said:
Hi Brooks
seems you have a “miracle” – something implanted and then removed from your body that does not exist and has added so much rich meaning to your life!
BHR THR horseshit will cost S&N a few pennies I suspect…
Earl
Pingback: The FDA is there to protect patients? Bullsh*t … « Earl's View
Pingback: Growing metal-on-metal hip controversy threatens to swallow more device makers | MassDevice – Medical Device Industry News « Earl's View
Pingback: Smith and Nephew Issues Failure Warning on Metal Hip Implant – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts « Earl's View
Pingback: Toxic risk to 10,000 hip op patients say Birmingham-based Irwin Mitchell – Birmingham Mail « Earl's View
Pingback: Howard’s View on the FDA’s lack of action on MoM hip studies… « Earl's View
Pingback: Birmingham Hip Modular Head (used in hip replacements) « Earl's View