The Food and Drug Administration (FDA) should have the ability to reject a prospective medical device if its manufacturer attempts to get it approved based on the notion it is the same as a previous device.
A number of the more recent medical devices to reach the U.S. market were approved through the FDA’s 510(k) “fast-track” approval system. This allows a manufacturer to get a new product to the public with minimal pre-market safety testing. Unfortunately for the public and the validity of the FDA’s program, the fast track has allowed some notorious devices to get through only to have to be recalled later, due to numerous complications and serious injuries to patients.
According to a Bloomberg report, Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, believes the agency should have the ability to reject a new device approval if it’s based on the design of a previously-approved device that’s since been recalled. Specifically, this new power could apply to several hip implants and transvaginal mesh devices which have been the source of numerous reports of complications and serious injuries suffered by recipients.
Several new models of DePuy Orthopaedics ASR and Pinnacle hip implants as well as some other metal-on-metal joint replacements were approved by the FDA based on the fact they were similar in design to devices already approved through traditional methods.
Today, thousands of people are suffering one or several of the numerous problems these devices can cause, including pain and inflammation at the site of the implant, infections, noise from the device, or an overall breaking of the implant. Further complicating the safety of these devices is their tendency to shred small metal fragments into the bloodstream and nearby muscles and tissues through normal wear-and-tear of the devices.
This has resulted in thousands of repeat and revision surgeries for recipients and just as many lawsuits filed against the makers of these devices.
Thousands of women are also now understanding the shortcomings of the fast-track system at the FDA due to the complications they’re suffering due to faulty transvaginal mesh products. This surgical mesh is based on the design of other surgical mesh devices but was never thoroughly tested for its use in treating problems like Stress Urinary Incontinence and Pelvic Organ Prolapse. Again, that shortfall of the FDA’s system allowed transvaginal mesh products to reach the public, ultimately resulting in a growing number of lawsuits and repeat surgeries, which often don’t fully solve the problems caused by the mesh. Women continue to suffer from intolerable pain and infections and the revision surgeries are only compounding medical costs.
The FDA currently does not have the power to reject a medical device rushed through the fast-track system, even if it’s been recalled by the agency or its manufacturer for any number of reasons. Bloomberg reports Democrats in the U.S. House have drafted a law which would give the FDA that power in the future, but it may be some time before it gets approved as this is a General Election year and Republicans have added “burdensome” regulations to their list of talking points as they rail against “big government.” This idea was backed by a lobby group representing the medical device industry recently. On Feb. 2, the Advanced Medical Technology Association issued a public criticism of the proposed new power for the FDA, believing it would cost manufacturers more money to get a product to the public.
With these devices, specifically, that argument is hard to maintain. It is believed as many as 30 percent of all metal-on-metal hip implants could be faulty and most, if not all, pose the risk of metal poisoning just through normal use.
Due to the backlash recently experienced, the makers of each metal-on-metal hip implants and transvaginal mesh devices have since been ordered by a Congressional committee to prepare post-market safety studies of these products.