Smith & Nephew Removes Certain Hip Implants From Market

Smith & Nephew plc is voluntarily removing certain hip implant sizes and related components from the market after data from the United Kingdom’s National Institute for Health and Care Excellence (NICE) found that smaller sizes of the Birmingham Hip Resurfacing System had revision rates that exceed its benchmarked expectations. It’s also advising against any use of the system in women.

But the company is not advising patients with the now-contraindicated implant to undergo proactive revisions. Patients experiencing unusual symptoms are advised to contact their surgeon.

“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 the Birmingham Hip Resurfacing is only used in those patient groups where it has demonstrated strong performance. These represent the vast majority of current patients,” Chief Medical Officer Andy Weymann M.D., said in a news release.

Specifically, the company is removing from the market femoral heads of 46 mm diameter and smaller and their corresponding components for the Birmingham Hip Resurfacing (BHR) System.

Smith & Nephew discovered the issue as part of its routine postmarket surveillance, which included a recent analysis of the National Joint Registry of England and Wales data. This found that the BHR System delivers the best performance, as compared to other total hip replacements, in male patients under 65 requiring femoral head components 50 mm in diameter and larger.

The data found that revision rates associated with men requiring femoral head sizes 46 mm or smaller and with all women patients exceed the current benchmark established by NICE. Smith & Nephew is updating the corresponding instructions for use to indicate the system is contraindicated for women.

The removed products accounted for 1 percent of global Smith & Nephew hip implant revenue in 2014 and only 0.1 percent of group revenues. The implants’ removal is not expected to impact the company’s 2015 guidance.