A new consumer protection investigation into medical devices found that the majority of medical implants like hip replacements, lap bands, surgical mesh and defibrillators are not tested to confirm their safety and effectiveness before they are inserted into patients.
Consumer Reports said that the U.S. Food and Drug Administration only require medical implant or high-risk device manufacturers to file some paperwork and pay the watchdog agency a fee of about $4,000 with minimal testing for companies to start selling their products to tens of millions of American consumers.
“What they’re doing is conducting clinical trials on the American public,” Dan Walter, a political consultant from Maryland told investigators. His wife suffered heart and cognitive damage from an untested but approved specialty catheter that malfunctioned during a procedure to treat an abnormal heartbeat.
According to the latest Consumer Reports survey, 17 percent of American adults have an implanted medical device, and just last month researchers found that millions of people with metal on metal hip replacements may have been exposed to dangerously high levels of toxins that could have seeped into their bloodstreams.
"While most of us have heard about the safety problems with metal-on-metal hips in the news, these devices are just one illustration of a much larger failure in our regulatory system," Nancy Metcalf, senior program editor of Consumer Reports said in a statement released on Wednesday.
According to investigators government rules allow high-risk products that require advance safety studies to be sold the public based on evidence from studies that are smaller and less rigorous than those required for prescription drugs.
“Standards for devices exist, they just don’t make sense,” Diana Zuckerman, president of the National Research Center for Women & Families, a nonprofit advocacy organization told Consumer Reports.
Investigators found that despite thousands of reports of harmful side effects, transvaginal mesh for prolapse repair and bladder support implanted in tens of thousands of women still require no testing because manufactures took advantage of a loophole in the law that allowed them to grandfather their products onto the market without safety testing.
More than 650,000 Lap-Bands have been sold worldwide, according to Allergan, its manufacturer, but its safety and efficacy was based only a one study of less than 300 people, investigators revealed. What’s more, 51 percent of the participants in the small study reported nausea, vomiting or both, and a quarter of participants had their bands removed before the three-year study ended due to complication or failure to lose enough weight.
"Imagine if a car had a recall rate that high," Dr. John Santa of the Consumer Reports Health Ratings Center said in a statement. "Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden."
All 93,000 of Johnson and Johnson’s artificial hips from its DePuy division had been recalled in 2010 when research found that metal-on-metal hips fail significantly more often than average and can cause metal poisoning and tissue destruction was introduced in 2005 and cleared by the FDA without clinical testing because of "substantial equivalence" to earlier devices.
Since 2009, the FDA received reports of nearly 29,000 deaths or injuries related to cardiac devices like implantable cardioverter-defibrillators because of faulty wires that connect the device to the heart.
A panel from the Institute of Medicine in 2011 said that the FDA should revise its device regulatory system because it did not ensure adequate patient safety before and after the products go on the market, but Congress appears to have ignored those safety recommendations and is instead debating a new law that would maintain the current system and establish an agreement between FDA and manufacturers to get devices on the market even faster.
Investigators said that they agree with Institute of Medicine that the current regulatory system is faulty and does not protect patients from harm. They recommend that FDA require implants and other medical devices to be tested as rigorously as drugs, end the “grandfathering” practice, require unique identification codes for each device, establish national registries so that problems can be quickly identified and increase manufacturer user fees to pay for implementing new device safety regulations.
"Medical device industry lobbyists are working overtime to pressure Congress to preserve weak federal oversight that puts patient lives at risk," Lisa McGiffert, director of Consumers Union's Safe Patient Project said in a statement. "We need common sense reforms to assure consumers that these devices are safe and work like they are supposed to."