Wright Medical Sought to Kill FDA Approval of Smith & Nephew Metal-on-Metal Hip ImplantJul 25, 2012 | Parker Waichman LLP
Wright Medical wanted the Food and Drug Administration to block approval of a metal-on-metal hip implant manufactured by rivals Smith & Nephew, asserting the safety data used to get it on the U.S. market was flawed.
According to a report from MassDevice.com, Wright’s issues concerned the Smith & Nephew Birmingham model metal-on-metal hip implant. The company opposed to it being released on the U.S. market claimed the pre-market approval testing submitted by Smith & Nephew only contained data collected by one surgeon, who just happens to be the inventor of the device.
Skewed safety data and a rush to approve new devices has been an impediment to the hip replacement industry as new metal-on-metal hip implant technology has been the source of great controversy for at least the last two years, and longer in this case. Thousands of recipients of these devices have had the dubious distinction of being people who’ve been forced to learn first-hand of their deficiencies and defective designs.
As a class of medical devices, all-metal hips are more prone to early failures than older, more traditional models that use combinations of metal, plastic, and ceramic components. A variety of metal-on-metal hip implants is available on the U.S. market and safety concerns swirl around practically every model. Not only have they proven to cause serious pain and injuries at the site of the implant more than older models, but all-metal hip implants share a distinction in that they’ve been linked to a dangerous and potentially life-altering side effect, toxic metal poisoning.
Through everyday use, metal-on-metal hip implants can shed tiny visible metal particles throughout the body, depositing toxic cobalt and chromium into a recipient’s bloodstream, surrounding tissues, muscles, and organs. If unchecked for too long, this can cause these metals to collect in the body, potentially leading to organ damage and failure and the possible growth of small tumors throughout the body.
Wright Medical had taken issue with the FDA’s decision to approve the Birmingham model implant because Smith & Nephew had only submitted one safety trial report to the agency as part of its 2006 pre-market approval application. Wright filed a citizen’s petition with the FDA to seek the reversal of that approval on Smith & Nephew’s Birmingham hip implant. In its petition, Wright said the study used to gain approval “rests on a retrospective, uncontrolled case series at a single center by a single physician without any protocol and with incomplete follow-up.” Further, the company alleged the study was “not scientifically valid and does not satisfy the agency’s standards for safety and effectiveness.”
The Birmingham model of hip implant was the first metal-on-metal hip implant to hit the market back in 1997 and it led to an array of similar devices to be released in the following years. Today, dozens of manufacturers have an entry into this class of medical devices and at the same time, they’re all under federal scrutiny because they’ve been linked to thousands of injuries, countless revision surgeries, and some costly and dangerous early replacement surgeries.
Most metal-on-metal hip implants fail early at a rate of about 13 percent, with some as high as 30 percent. Traditional hip implant devices have an early failure rate well below 10 percent. Many of these devices were approved because they were similar in design to a previous model and that requires less pre-market testing than a traditional new medical device seeking FDA approval.
Wright Medical believed Smith & Nephew’s study on the Birmingham hip implant was misleading and was only conducted at one surgical center in England.