Alternative medicine, Anticoagulant, Apixaban, Australia, Australian Medical Association, Australian National Audit Office, Autotransplantation, Birmingham Hip Resurfacing, BMJ, hip resurfacing, Patient, Smith & Nephew, Therapeutic Goods Administration
Birmingham Hip Resurfacing system | Therapeutic Goods Administration (TGA).
Birmingham Hip Resurfacing system
Update – recall and new hazard alert
Consumers and health professionals are advised that Smith & Nephew, in consultation with the TGA, is recalling certain unused Birmingham Hip Resurfacing (BHR) system components and issuing a related hazard alert update.
Affected products include:
The TGA published information on 6 February 2015 based on a previous hazard alert issued for this device (see alert below).
Since then, based on further consideration of the data, Smith & Nephew has taken the following strengthened actions:
- The BHR system is no longer to be used for female patients.
- BHR femoral head components sized 46 mm in diameter and smaller, and their corresponding acetabular cup sizes, are being withdrawn from the market and unused stock should be returned to Smith & Nephew.
- Patients requiring a 48 mm femoral head size should not be considered as candidates for BHR implantation due to a moderately elevated risk of revision. The 48 mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50 mm to a measured 48 mm at the time of surgery.
The Instructions for Use for the BHR system will be updated to reflect these changes.
Information regarding this issue, including details of the recall process and recommendations for management of patients who have had these devices implanted, has been sent to orthopaedic surgeons who have implanted the BHR system.
Information for patients and health professionals published in the below safety alert remains relevant.
Consumers who have any questions or concerns should contact their health professional.
Meanwhile, health professionals should contact Smith & Nephew on 02 9857 3999 or email RegulatoryAffairs.ANZ@smith-nephew.com if they have any further questions or concerns.
Hazard alert – additional warnings for use in certain patient groups
6 February 2015
Consumers and health professionals are advised that Smith & Nephew, in consultation with the TGA, has issued a hazard alert regarding the Birmingham Hip Resurfacing (BHR) system, advising of additional warnings when used in certain patient groups.
The BHR system is made up of multiple components and is used in hip resurfacing procedures.
A BHR Resurfacing Head fitting into a
BHR Acetabular Cup
The warnings have been updated in the Instructions for Use (IFU) and advise that the following groups of patients are at greater risk of requiring early revision surgery if implanted with a BHR system:
- males aged 65 or greater
- patients requiring an implant head size ≤48mm.
The additional warnings followed a statistical analysis commissioned by Smith & Nephew of data from various joint registries around the world, including the Australian Orthopaedic Association National Joint Replacement Registry.
The statistical analysis also identified two additional conditions that could contribute to increased risk of early revision:
- patients who have a diagnosis of avascular necrosis
- patients who have congenital dysplasia.
The IFU have also been updated to note that the more risk factors a patient has, the greater the risk of requiring a revision.
Information for consumers
Smith & Nephew has written to health professionals who have implanted BHR components providing them with this information.
The BHR system belongs to the class of devices known as metal-on-metal implants. Patients who have undergone a hip resurfacing procedure, and/or their carers, are encouraged to review the TGA statement: Metal-on-metal hip implants: Information for patients.
If you are not sure what type of hip replacement you have or if you have concerns about your hip replacement, you should seek information from the surgeon who performed the operation or the hospital where the operation was performed.
If you have a hip replacement and have pain in your hip or thigh, you should consult your general practitioner (GP) and/or your orthopaedic surgeon. Your GP/surgeon will usually order X-rays and may in some instances order further tests such as ultrasound, MRI and blood tests.
Information for health professionals
Patients with any hip replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if the patient complains of pain and other symptoms associated with their hip implant and surgery.
Information for orthopaedic surgeons
Smith & Nephew has written to surgeons notifying them of the changes to the IFU.
Surgeons are advised to ensure that the additional warning statement and indications for use are considered when using the BHR system.
Surgeons are also advised to review the TGA’s guidelines for MoM hip replacement implants and the Arthroplasty Society of Australia guidelines.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Jenny D said:
Thanks for that, Earl.
How about this:
(You have to feel happy for them, poor S & N have a win in court while ignoring the plight of their victims):
Kind regards, Jenny
that is sickening.
Makes me sick thinking about it!
Hanna Viner said:
Thank you for your post.
Is this information for Australian patients and Their surgeons too?
Sent from my iPhone
This is from the Australian Therapeutic Goods Administration. So totally applicable here.
P. Taylor. said:
Wonder if this will apply to the UK eventually. Although much too little, too late for many of us. Even though my BHR was taken out 2yrs ago I am still suffering from the damage it caused.
Hi. I am facing early revision due to failing BHR (Smith & Nephew) I am a woman, head size was 44mm and all 4 components used in my surgery have been withdrawn.
I had bilateral surgery.
Has anybody bought a successful claim in the uk yet?
no successful claims that I am aware of – suggest you join our Facebook group & there are UK members there who are more up to date.
Wonder if this will apply to the UK as well eventually. Much too little, too late for many of us. My BHR was removed 2yrs ago, but I am still suffering daily from the damage it caused to me.
Yes it does. I think it will open the way for lawsuits everywhere.
Kris Hadley said:
How will this change judgement in court if the BHR was pre market approved by the FDA? I thought that was the reason attorneys here in the US couldnt litigate Smith & Newphew’s BHR prosthetic cases. I can only pray that a door has been pushed wide open for all of us still physically, emotionally & financially struggling because of this product not going through proper testing prior to it’s grand market saturation!
Pingback: Stuart Cain’s 4th Video on Metal on Metal Hip Damage & Suffering | Earl's View
Earl, I had my BHR implant done in June 2007. After years of pain & suffering I had my revision surgery March 2014. My Acetabulum Size 54 MM #74120154 & Femoral Head Size 46 MM #74121146 is now being recalled by the TGA in Australia. Do you know if this gives those of us here in the USA the right to take legal action?.
sorry to hear that. Many are attempting legal action in the USA but so far S&N has been teflon due to its PMA (pre market approval) and so not many attorneys will even consider it.
I suggest you join our Facebook group as you will find quite a few other S&N sufferers there – Howard Sadwin is in Florida and knows the legal landscape for S&N well.