- 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 Øie
Smith & Nephew
+44 (0) 20 7401 7646
Media
Charles Reynolds
Smith & Nephew
+44 (0) 20 7401 7646
Joe Metzger
Smith & Nephew
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.