New Data Reinforces the Proven Safety and Effectiveness of the BIRMINGHAM HIP Resurfacing System

80-percent of US surgeons choose the BHR hip as it outperforms all other metal-on-metal resurfacing devices

MEMPHIS, Tenn., May 4 /PRNewswire-FirstCall/ — Recent new data(1) presented at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting reinforces the BIRMINGHAM HIP™ Resurfacing (BHR) System as a safe and effective hip resurfacing device. The multi-site study, performed by orthopedic surgeons practicing at nine Canadian academic centers, showed that three years after surgery, 99.91% of their 3,400 hip resurfacing patients experienced no implant failure due to metal wear debris. The BHR Hip was the most used resurfacing device in this study.

This week, the Hospital for Special Surgery (HSS) in New York City will be holding a medical education course titled “Total Hip: Replacement and Resurfacing” on May 7 and 8 for leading hip surgery specialists from across the U.S. Chairing the course will be Edwin Su, MD, of the Hospital for Special Surgery, and the teaching faculty will include pioneering British surgeon Derek McMinn, MD, inventor of the BHR hip.

During a press conference and Q&A webcast on Thursday, May 6, at 3 p.m. US EDT, 7 p.m. GMT, Joseph M. DeVivo, president of Smith & Nephew Orthopaedics (NYSE: SNN, LSE: SN), the maker of the BHR Hip, will be joined by Dr. Su and Mr. McMinn, as well as Scott Marwin, MD, an orthopedic surgeon with New York University’s Hospital for Joint Diseases. The panel will review current data confirming the safety and effectiveness of hip resurfacing and the BHR Hip. Smith & Nephew Orthopaedics will host the call, and additional details are at the bottom of this release.

The new study recently presented at the AAOS meeting aligns with previously released BHR Hip data from other prestigious sources and further addresses the metal wear debris concerns raised about metal-on-metal hip implants.  The BHR Hip’s track record for longevity remains unchallenged in the literature, as well. These sources include:

• The Journal of Bone and Joint Surgery published in January of this year a study tracking 155 consecutive BHR patients over three years. The data showed no revisions of BHR Hips due to metal wear, but patients who received a competing metal-on-metal resurfacing device were revised within three years of surgery at a rate of 3.4-percent due to adverse tissue reactions.(2)
• The Australian Orthopaedic Association’s 2008 National Joint Replacement Registry, a record of nearly every hip implanted in that country over the previous 10 years, tracked 6,773 BHR Hips and found that less than one-third of one-percent may have been revised due to the patient’s reaction to the metal component.(3)
• The Australian Registry hip resurfacing data for 2009, 70-percent of which comes from BHR Hip procedures, indicates that for men under age 65, hip resurfacing performs at the same or a better rate than total hip replacement. This registry also shows that the BHR Hip remains successful in 95-percent of cases eight years after surgery, whereas no other implant performs better than 94.7-percent just five years after surgery.(4)
• Great Britain’s Oswestry Outcomes Centre’s patient registry,  which tracked 5,000 BHR Hips implanted by 148 different surgeons in 37 countries over 10 years (1998-2008), reports that the BHR Hip remains successful in 95.4-percent of all patient segments 10 years after surgery. This registry also reported that 98.6-percent of patients were “pleased” or “extremely satisfied” with their BHR Hip implants 10 years after their resurfacing procedure.(5)
• Mr. McMinn’s clinical data, based on 3,095 hip resurfacing patients implanted between 1997 and 2009, shows that more than 12 years after surgery, the BHR hip remains successful in 99-percent of men aged 60 and over, and 97-percent for men under age 60.

“The BHR Hip’s outcomes are remarkable when compared to other resurfacing devices,” said Dr. Marwin. “The depth and consistency of the data collected globally shows the BHR Hip is truly different.”

“For the right patients in my practice, hip resurfacing has proven to be an excellent choice,” said Dr. Su. “They have extremely high levels of satisfaction after returning to their regular lifestyle.”

To explain the patient advantages seen consistently in the literature, surgeons indicate the key differences between the BHR Hip and other resurfacing devices are its metal composition, its design geometry and its surgical instrumentation.

The BHR Hip has a unique metallurgy heritage which goes back more than 30 years and includes a first-generation metal-on-metal resurfacing process which contributes to long-term survivorship of BHR Hip recipients.

Additionally, the BHR Hip’s design geometry replicates the natural hip’s ability to pull the body’s own joint fluids into the ball and socket interface, which is believed to be another source of its best-in-class performance.

Of particular importance during hip resurfacing surgery is the correct positioning of the acetabular cup, or hip socket. When this component is not properly aligned, studies show that metal wear can accelerate and resurfacing devices can fail before their time.  Surgeons believe that the instrument used to implant the BHR Hip is simpler and more accurate than other devices’ instruments, and may contribute to its success.

“Just like the lubricating barrier in a healthy hip, there is a natural fluid layer between the femoral head and the cup that the two metal surfaces glide across during physical activity,” said Mr. McMinn. “If the surgeon malpositions the acetabular cup causing edge loading, the lubrication is lost. It’s equivalent to running a car engine without lubrication oil. High wear will occur, resulting in premature failure. Overall, it is a combination of the metal composition, the design and the quality of the surgical technique that makes the BHR Hip the safest resurfacing implant on the market.”

“The bottom line is that the BHR Hip is not like other metal-on-metal hip implants,” said DeVivo. “Not only does it have the longest track record of any resurfacing device, but the most esteemed medical literature shows it outlasts other implants. It’s in a class all its own – it’s safe and effective, and is the best choice for active patients.”

To participate in the press conference webcast being held on May 6, please use the dial-in numbers below. Afterwards, a recording of the press conference and links to multiple sources of scientific data related to hip resurfacing and the BHR Hip will be available at HipResurfacing.com and at BirminghamHipResurfacing.com.

To access the conference call on the web, please go to http://w.on24.com/r.htm?e=210388&s=1&k=91947E6E4B424595708107005F241330.  An archived replay will be available at this same link for six months.

To access the call by phone in the United States, please dial 877-941-6011. In the United Kingdom, dial 0800 358 0857 and in Australia, 1800 032 175.  Ask for the “Smith & Nephew Orthopedics” call.

The replay will also be available by phone at 800-406-7325 in the U.S. and 0800 358 3474 in the U.K.; both numbers require the passcode 4293934.

Footnotes

(1) Beaule PE, Smith FC, Powell JN et al. A Survey on the Incidence of Pseudotumours with MOM Hip Resurfacings in Canadian Academic Centres. Podium presentation # 665. Proceedings of the American Academy of Orthopaedic Surgeons Annual Meeting, New Orleans LA. 2010

(2) Langton DJ, Jameson SS, Joyce TJ, Hallab NJ, Natu S, Nargol AVF.  Early failure of metal-on-metal bearings in hip resurfacing and large-diameter total hip replacement, A CONSEQUENCE OF EXCESS WEAR.J Bone Joint Surg Br. 2010; 92-B: 38-46

(3) Table HT 46. Australian Orthopaedic Association National Joint Replacement Registry Annual Report.Adelaide: AOA; 2008.

(4) Table HT 46. Australian Orthopaedic Association National Joint Replacement Registry Annual Report.Adelaide: AOA; 2009.

(5) Robinson E, Richardson JB, Khan M. MINIMUM 10 YEAR OUTCOME OF BIRMINGHAM HIP RESURFACING (BHR), A REVIEW OF 518 CASES FROM AN INTERNATIONAL REGISTER. Oswestry outcome centre, Oswestry, UK.

About Us

Smith & Nephew is a global medical technology business, specialising in Orthopaedics, including Reconstruction, Trauma and Clinical Therapies; Endoscopy and Advanced Wound Management.  Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.

Smith & Nephew is dedicated to helping improve people’s lives.  The Company prides itself on the strength of its relationships with its surgeons and professional healthcare customers, with whom its name is synonymous with high standards of performance, innovation and trust.  The Company operates in 32 countries around the world.  Annual sales in 2009 were nearly $3.8 billion.

Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the US Private Securities Litigation Reform Act of 1995.  In particular, statements regarding expected revenue growth and trading margins discussed under “Outlook” are forward-looking statements as are discussions of our product pipeline.  These statements, as well as the phrases “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions, are generally intended to identify forward-looking statements.  Such forward-looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation, claims and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.  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 20F, for a discussion of certain of these factors.

All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof.  All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing.  Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew’s expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office.