Many medical devices implanted into American consumers – including all-metal hip replacements, surgical mesh and cardiac implants – were never properly tested for safety before they hit the market, a new Consumer Reports investigation claims.
In some cases, manufacturers merely filed paperwork and paid a user fee before bringing their products to market, the study found.
“In fact, because of our broken regulatory system, often the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients,” according to a statement issued by Consumer Reports with the magazine’s findings.
The report was released in the wake of growing concerns about the safety of all-metal hip replacement implants, which have caused hundreds of patient problems and thousands of consumer complaints to the U.S. Food and Drug Administration in the past year.
“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,” said Nancy Metcalf, senior program editor for Consumer Reports.
According to a recent survey by the Consumer Reports National Research Center, nearly one in five American adults has an implanted medical device. Last year, an Institute of Medicine expert panel recommended the FDA overhaul its system for regulating medical devices, citing patient safety concerns.
The new report detailed risks associated with four common devices: surgical mesh, Lap-Bands, metal hips, and cardiac devices. According to Consumer Reports:
• Tens of thousands of women were implanted with transvaginal surgical mesh for prolapse repair and bladder support, despite the absence of “advance safety testing.” Thousands of complaints and multiple lawsuits have been filed over the mesh.
• More than 650,000 Lap-Bands have been sold worldwide, according to the product’s manufacturer, Allergan, despite a high rate of problems noted in safety studies conducted to demonstrate safety and effectiveness.
• The all-metal artificial hip introduced in 2005 by DePuy, a division of Johnson & Johnson, was cleared by the FDA without clinical testing. DePuy recalled 93,000 of these hips worldwide in 2010. Studies have found metal-on-metal hips often fail and can cause metal poisoning and tissue destruction.
• Implantable cardioverter-defibrillators are one of three types of cardiac devices that have had significant problems. Since 2009, the FDA has received reports of nearly 29,000 deaths or injuries from these devices.
Metcalf urged patients who may be facing surgery to implant a medical device to research it first by using the FDA’s website at www.FDA.gov, consulting Internet patient forums and asking their doctors about alternatives and possible risks.
Consumers Union, the advocacy arm of Consumer Reports, recommends that the FDA:
• Require implants and other devices be tested as rigorously as drugs.
• End the practice of “grandfathering” high-risk new implants and devices.
• Create a “unique identifier system” for implants, so that patients can be quickly notified about recalls and safety problems.
• Create national registries so problems can be spotted quickly and patients notified.
• Increase user fees paid by manufacturers for regulatory reviews so that the FDA has enough money to do its job.