January 24, 2017
In the wake of a $1 billion settlement, Stryker continues to face heat from their hip implant recalls, and new reports suggest that such recalls are a common theme in the ever-growing surgical industry.
Recalls Widespread in Hip Implant Surgeries
As the geriatric generation grows and hip implant surgeries become more common in younger citizens, the hip implant surgery industry is expected to boom. In the next three years, the industry is expected to grow to an estimated US $41.2 billion dollars. That growth, however, will likely be hampered by what experts call “frequent product recalls.”
Reports from Persistence Market Research and Transparency Market Research both highlight the frequency of hip implant recalls as a hindrance to the growth of the hip implant industry.
Between 2002 and 2013 alone there were a staggering 578 hip implant products recalled, according to information from the US Food and Drug Administration (FDA), cited by Consumers Union. The majority of these recalls involved metal-on-metal hip implant components, and the FDA has linked hip implant complications to serious adverse health effects.
Voluntary hip implant recalls are common throughout the industry, according to these reports, but Stryker Corporation—one of the largest manufacturers of hip replacement devices and a company featured largely in the reports—is responsible for the most recalls. Stryker hip recalls made up 40 percent of the 578 hip implant recalls in the 11 years tracked. Of its recalls, 178 were categorized Class II and 53 were categorized Class III, meaning they were likely to cause serious and life-threatening harm.
Rushed Products Could Be Source of Hip Implant Recalls
One theory on the numerous hip implant recalls is the speed with which manufacturers, like Stryker, rush their products to market in an effort to keep up with changing technology and increased demand.
Two of Stryker’s most notorious recalled hip implant devices, the Rejuvenate Modular Hip System and the ABG II Modular Hip Stem, were able to get rush approval through the FDA by using the 510(K) pre-approval process, in which a company can avoid a more thorough FDA safety review by claiming the product is similar enough to an existing product to be safe.
Stryker hip recalls were issued for both devices just a few years later, and Stryker ultimately agreed to a global settlement for an estimated 3,000 patients who had hip implant complications from the Rejuvenate and ABG II devices and undergone revision surgery. Stryker is expected to pay over $1 billion as a result of the settlement.
Despite the lesson learned from rushing the Rejuvenate and ABG II products to market, Stryker continues to use the 510(K) pre-approval process to avoid more extensive FDA testing. The company did so with the Stryker LFIT V40 femoral heads and, in August of 2016, voluntarily recalled select lots due to “several complaints describing incidence of harm secondary to taper lock failure.” Another Stryker hip lawsuit is now underway concerning the LFIT V40.
FDA Strengthens Some Hip Implant Requirements
On February 18, 2016, the FDA issued a final order requiring manufacturers to submit a premarket approval application and undergo more safety testing for two types of metal-on-metal total hip replacement devices (the hip joint metal/metal semi-constrained with a cemented acetabular component and the hip joint metal/metal semi-constrained with an uncemented acetabular component).
The decision was reached after the FDA determined that “there are insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices.”
While the decision should help improve the safety of those types of metal-on-metal hip replacement devices, the responsibility to properly vet other hip implant devices remains with the manufacturers, many of whom continue to use the rush-approval process.
A Dangerous Gamble
As hip implant recalls remain common in the industry and manufacturers hurry their products through testing, patients pay the price. When Stryker’s Rejuvenate and ABG II devices began to fail, some patients found themselves with hip implant complications including metal poisoning (also known as metallosis), and many needed revision surgery to correct the problems introduced by the faulty devices.
Now, patients who received the Stryker LFIT V40 during surgery could be at risk for metallosis, as well as spontaneous dislocation and taper lock failure.
Find further information on the symptoms of hip implant complications here.