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 Oie
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,
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