Most Medical Implants Are Not Tested Before Market: Report

A new report reveals that most medical devices implanted in patients in the United States are never required to undergo rigorous testing before they are approved by the FDA, causing the first generation of patients to serve as test subjects.

Consumer Reports released an investigative report on dangerous medical devices, focusing on the FDA’s 510(k) approval process, which allows medical device manufacturers to pay a $4,000 fee and begin selling untested medical implants like artificial hips and heart stents without pre-approval clinical trials.

The report also notes that even when medical devices are required to undergo a full approval process, a rarity, they face less thorough testing than those required by the makers of new drugs.

Consumer Reports points out that because of how the 510(k) approval process is set up, to fast-track medical devices to market, most devices never get tested until they are already being implanted into patients’ bodies, a fact that most Americans are unaware of.

The investigation also highlights how there is no system in place by which the public, or even the government, can quickly research a product for past problems, leaving patients fairly defenseless against defective or poorly designed medical implants.

Several examples are provided in the report where consumers were seriously injured by medical devices that were allowed onto the market without rigorous testing, such as transvaginal mesh, metal-on-metal hip implants, and the Lap-Band adjustable gastric band.

The 510(k) fast track approval program only requires that medical devices be “substantially equivalent” to a device that is already on the market for the FDA to allow the manufacturer to being marketing and selling the product.

Originally designed for non-critical medical devices, like band-aids and tongue suppressors, the definition has expanded over the years to include numerous medical implants, like surgical mesh, artificial implants, defibrillators, stents and other critical devices. The program has come under increasing fire over the last several years due to the number of recalls associated with 510(k) approved devices.

While many assume that the older devices, which are the basis of approval for the new devices, were at some point tested, that is often not the case

Many medical devices were “grandfathered” into the 510(k) program without having been tested before its existence. That means that there are multiple generations of some invasive medical implants, each one slightly different from the last, that have never, throughout their entire history, undergone clinical testing for safety or effectiveness.

Both the Government Accounting Office (GAO) and the Institute of Medicine have called for overhauls of the program, and lawmakers have introduced legislation to change how the FDA approves devices.

Consumer Reports made a list of recommendations on how to fix the FDA’s approval process. The recommendations suggest that:

• Life-sustaining medical devices go through testing at least as rigorous as those used for new drugs.
•  Eliminate the option of high-risk or life-sustaining devices being “grandfathered” into approval.
•  Create an identifier system, like serial numbers, for implants that allows patients to be quickly notified about recalls and problems.
•  Create national registries for medical devices that allow trending problems to be quickly identified.
•  Increase user fees for manufacturers so that the FDA can be better funded.