Amid the din and clamor of reports bemoaning the long and laborious FDA process for approving medical devices, one would think that the medical device industry is so inundated by burdensome testing that it is being prevented from bringing ever-newer and ever-better products to market. But, exactly the opposite is the case, according to a Consumer Reports article that is destined to rock many an OEM's boat. Hardly a day old, the story has already been picked up by the mass media far and wide, from the Los Angeles Times to CBS news and ABC.
"For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue," writes Consumer Reports. "Often, the only safety 'testing' that occurs is in the bodies of unsuspecting patients." While a smaller number of high-risk products require advance safety studies, government rules, according to Consumer Reports, allow them to be sold based on studies that are smaller and less rigorous than those required for prescription drugs. Instead of instituting more-rigorous testing to ensure medical device safety, Congress is debating a new law that would maintain the present system virtually unchanged while making it easier for companies to get an FDA green light to market their products even faster.
The Consumer Reports article homes in on three types of devices: transvaginal mesh used for prolapse repair and bladder support, lap-bands used to treat obesity, and metal hip replacements. In all three cases, testing was either nonexistent or minimal.
In the case of cervical mesh, manufacturers took advantage of a loophole that allowed them to grandfather their products onto the market without safety testing. In 1976, a new law established a three-tier system for medical devices, requiring that only Class III devices had to be test. Seizing on that loophole, manufacturers of transvaginal mesh cleared their products based on their "substantial equivalence" to an earlier mesh that had been used to repair abdominal hernias. The two types of devices, were different, both in terms of the parts of the body they were designed for and in terms of how they were implanted. Only in 2010 was cervical mesh pulled from the market, pending an FDA order that its manufacturers subject their products to postmarket safety studies.